CN103736070B - Xiangsha (Chinese character) oral emulsion for nourishing stomach and preparation method thereof - Google Patents

Xiangsha (Chinese character) oral emulsion for nourishing stomach and preparation method thereof Download PDF

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CN103736070B
CN103736070B CN201410030205.4A CN201410030205A CN103736070B CN 103736070 B CN103736070 B CN 103736070B CN 201410030205 A CN201410030205 A CN 201410030205A CN 103736070 B CN103736070 B CN 103736070B
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oil
cyperus
water
stomach
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CN103736070A (en
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毛欣
李翔
黄燕
刘薇
叶楚清
罗晓健
傅宝庚
陈平
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Jiangxi Guangenhe Pharmaceutical Co ltd
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JIANGXI MEIYUANCHUN PHARMACEUTICAL INDUSTRY Co Ltd
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Abstract

The invention discloses a xiangsha (Chinese character) oral emulsion for nourishing the stomach, comprising the following components: (i) 60-85% of xiangsha stomach-nourishing soup and 0.5-1.2% of volatile oil, (ii) 1.0-15% of medicinal oil, (iii) 3.0-25% of emulsifier, (iv) 0-10% of auxiliary emulsifying agent, (v) 0.005-1.0% of antioxidant, (vi) 0-1.5% of preservative and the balance of water. The xiangsha oral emulsion for nourishing the stomach is simple in preparation technology, low in production cost, good in stability and high in bioavailability.

Description

一种香砂养胃口服乳剂及其制备方法Oral emulsion for nourishing the stomach with fragrant sand and its preparation method

技术领域 technical field

 本发明涉及中药制剂领域,特别涉及用于一种香砂养胃口服乳剂及其制备方法。 The invention relates to the field of traditional Chinese medicine preparations, in particular to an oral emulsion for nourishing the stomach with fragrant sand and a preparation method thereof.

背景技术 Background technique

 香砂养胃丸是2000版中国药典一部收载的品种,临床上应用较广,主要功能为温中和胃,用于不思饮食、呕吐酸水、胃脘满闷、四肢倦怠,全方由木香,砂仁,白术,陈皮,茯苓,半夏,香附,枳实,豆蔻,厚朴,广藿香,甘草,生姜,大枣共14味中药组成。其中,木香、砂仁、白术、陈皮、香附、枳实、豆蔻、厚朴、广藿香、生姜十味中药材中挥发油含量较高,具有解除胃肠平滑肌痉挛,理气宽中,暖胃消食,促进胃液分泌,增强消化能力的功效,是制剂的主要有效成份。 Xiangsha Yangwei Pill is a variety recorded in the first part of the Chinese Pharmacopoeia in 2000. It is widely used in clinical practice. Its main function is to warm the middle and stomach. The prescription is composed of 14 traditional Chinese medicines: woody, Amomum, Atractylodes macrocephala, tangerine peel, poria, pinellia, Cyperus cyperi, Citrus aurantium, cardamom, Magnolia officinalis, patchouli, licorice, ginger, and jujube. Among them, woody, Amomum, Atractylodes macrocephala, tangerine peel, Cyperus cyperi, Citrus aurantium, cardamom, Magnolia officinalis, Patchouli, and ginger have high volatile oil content, which can relieve gastrointestinal smooth muscle spasm, regulate qi, and warm Stomach digestion, promote the secretion of gastric juice, enhance the efficacy of digestion, is the main active ingredient of the preparation.

中华人民共和国卫生部出版的《药品标准 中药成方制剂》第二十册(中华人民共和国卫生部药典委员会,1998年)对香砂养胃口服液和香砂养胃软胶囊进行了记载。在传统中药制剂香砂养胃丸和上述记载的基础上,本领域又改进得到了香砂养胃颗粒、香砂养胃胶囊、香砂养胃片、香砂养胃口服液等一系列香砂养胃制剂。但是,在这些香砂养胃产品中,中药活性成分的释放不充分、吸收有限,生物利用度低,并且其中的中药成分具有很大的不良气味,消费者的接受程度差。 Xiangsha Yangwei Oral Liquid and Xiangsha Yangwei Soft Capsules are recorded in the twentieth volume of "Drug Standards Traditional Chinese Medicine Prescriptions" published by the Ministry of Health of the People's Republic of China (Pharmacopoeia Committee of the Ministry of Health of the People's Republic of China, 1998). On the basis of the traditional Chinese medicine preparation Xiangsha Yangwei Pills and the above records, this field has improved and obtained a series of Xiangsha Yangwei Granules, Xiangsha Yangwei Capsules, Xiangsha Yangwei Tablets, Xiangsha Yangwei Oral Liquid, etc. Stomach preparations. However, in these fragrant sand nourishing stomach products, the release of active components of traditional Chinese medicine is insufficient, the absorption is limited, the bioavailability is low, and the traditional Chinese medicine components therein have a great bad smell, and the acceptance degree of consumers is poor.

因此,仍然需要进一步开发香砂养胃的其它制剂形式,以克服上述香砂养胃产品的缺点。 Therefore, there is still a need to further develop other preparation forms of fragrant sand nourishing the stomach, to overcome the shortcomings of the above-mentioned fragrant sand nourishing the stomach product.

乳剂是制剂学中常见的剂型,一般多为水包油型(O/W),也有油包水型(W/O),极少数见复合型即水包油包水型(W/O/W)。口服乳剂作为胃肠给药的良好载体,具有很多优点,包括: Emulsion is a common dosage form in pharmacy. Generally, it is oil-in-water type (O/W), and there is also water-in-oil type (W/O). W). Oral emulsions are good carriers for gastrointestinal administration and have many advantages, including:

1、乳剂分散作用好,有效表面积大,有利于药物的释放、溶解和吸收; 1. The emulsion has good dispersion effect and large effective surface area, which is beneficial to the release, dissolution and absorption of drugs;

2、乳剂中含有乳化剂,有表面活性作用,可改善胃肠粘膜性能,促进药物吸收; 2. The emulsion contains an emulsifier, which has a surface active effect, can improve the performance of the gastrointestinal mucosa, and promote drug absorption;

3、乳剂中的油脂吸收后可促进胆汁分泌,增加血液和淋巴液的流速,有助于药物溶解和吸收,乳剂中的油脂性物质还可能通过淋巴系统转运吸收; 3. After the oil in the emulsion is absorbed, it can promote the secretion of bile, increase the flow rate of blood and lymph, and help the dissolution and absorption of drugs. The oily substances in the emulsion may also be transported and absorbed through the lymphatic system;

4、乳剂中的油脂经消化后生成亚油酸和油酸,可以抑制胃肠道的蠕动,延长药物在小肠的停留时间; 4. The fat in the emulsion is digested to generate linoleic acid and oleic acid, which can inhibit the peristalsis of the gastrointestinal tract and prolong the residence time of the drug in the small intestine;

5、口服乳剂能保证剂量准确,而且服用方便,水包油型乳剂可掩盖脂溶性药物的不良臭味,也可加入矫味剂; 5. Oral emulsions can ensure accurate dosage and are convenient to take. Oil-in-water emulsions can cover the bad smell of fat-soluble drugs, and can also add flavoring agents;

6、乳剂可使药物定位于油水界面膜或油滴核中, 避免药物直接与胃肠道接触, 从而减少药物对胃肠道的刺激性,避免一般药物口服所常见的胃肠道反应,如恶心、呕吐、胃烧灼、上腹疼痛、严重者可导致极性胃肠道出血及胃溃疡等现象发生。 6. The emulsion can locate the drug in the oil-water interface film or the nucleus of the oil droplet, avoiding the direct contact of the drug with the gastrointestinal tract, thereby reducing the irritation of the drug to the gastrointestinal tract, and avoiding the common gastrointestinal reactions commonly seen in oral administration of general drugs, such as Nausea, vomiting, stomach burning, epigastric pain, and severe cases can lead to extreme gastrointestinal bleeding and gastric ulcers.

但是,乳剂的制备一般需要运用能够有效降低界面张力的各种类型的表面活性剂,使得乳化所形成的微小液滴表面张力降至足够小,从而使微小液滴的内相不再因界面破裂而与外相中的其它微小液滴的内相融合,这样才能形成一个物理稳定的油水均匀分散的两相或多相体系。因此,乳剂的组成对其稳定性和生物利用度有很大的影响。目前,现有技术中尚未发现有香砂养胃口服乳剂公开。 However, the preparation of emulsions generally requires the use of various types of surfactants that can effectively reduce the interfacial tension, so that the surface tension of the micro-droplets formed by emulsification is reduced enough, so that the internal phase of the micro-droplets is no longer broken by the interface. And the internal phase of other tiny droplets in the external phase is fused, so as to form a physically stable two-phase or multi-phase system in which oil and water are evenly dispersed. Therefore, the composition of an emulsion has a great influence on its stability and bioavailability. At present, there is no disclosure of Xiangsha nourishing stomach oral emulsion in the prior art.

发明内容 Contents of the invention

本发明的目的是提供一种低成本、制备方法简单、具有更高生物利用度的香砂养胃口服乳剂,用于治疗胃阳不足、湿阻气滞所致的胃痛、痞满,症见胃痛隐隐、脘闷不舒、呕吐酸水、嘈杂不适、不思饮食、四肢倦怠。 The purpose of the present invention is to provide a low-cost, simple preparation method and higher bioavailability Xiangsha Nourishing Stomach Oral Emulsion, which is used for the treatment of stomach pain, fullness caused by deficiency of stomach yang, dampness and stagnation of Qi. Stomach pain, nausea, vomiting, sour water, noisy discomfort, lack of appetite, fatigue of limbs.

本发明通过以下的技术方案来实现上述技术目的。 The present invention achieves the above-mentioned technical purpose through the following technical solutions.

一种香砂养胃口服乳剂,含有如下成分: An oral emulsion for nourishing the stomach with fragrant sand, which contains the following ingredients:

(i) 60-85%香砂养胃药液和0.5-1.2%挥发油; (i) 60-85% Xiangsha Nourishing Stomach Liquid and 0.5-1.2% volatile oil;

(ii) 1.0-15%药用油; (ii) 1.0-15% medicinal oil;

(iii) 3.0-25%乳化剂; (iii) 3.0-25% emulsifier;

(iv) 0-10%辅助乳化剂; (iv) 0-10% auxiliary emulsifier;

(v) 0.005-1.0%抗氧剂; (v) 0.005-1.0% antioxidant;

(vi) 0-1.5%防腐剂; (vi) 0-1.5% preservatives;

余量的水; remaining water;

所述香砂养胃药液和挥发油的制备方法为:取木香70g、砂仁70 g、白术100 g、陈皮100 g、茯苓100 g、半夏(制)100 g、香附(醋制)70 g 、枳实(炒)70 g、豆蔻(去壳)70 g、厚朴(姜制)70 g、广藿香70 g、甘草30 g、生姜30 g和大枣50 g一并提取挥发油,挥发油收集备用,剩余药渣加水煎煮2-3次,每次45-75分钟,合并煎液,滤过,滤液浓缩至75℃相对密度为1.14~1.18的清膏,加乙醇使含醇量为70-85%,静置40-50小时,取上清液回收乙醇,剩余药液加水适量,调pH值为3.5-4.5,静置40-50小时,滤过,即得香砂养胃药液。 The preparation method of the fragrant sand nourishing stomach medicine liquid and volatile oil is as follows: take 70 g of woody root, 70 g of amomum, 100 g of Atractylodes macrocephala, 100 g of tangerine peel, 100 g of poria cocos, 100 g of pinellia (made by) cyperus cyperi (made of vinegar) ) 70 g, citrus aurantium (fried) 70 g, cardamom (shelled) 70 g, magnolia officinalis (ginger) 70 g, patchouli 70 g, licorice 30 g, ginger 30 g and jujube 50 g Volatile oil, collect the volatile oil for later use, add water to decoct the remaining medicinal residues 2-3 times, 45-75 minutes each time, combine the decoction, filter, and concentrate the filtrate to a clear paste with a relative density of 1.14-1.18 at 75°C, add ethanol to make the paste containing The alcohol content is 70-85%, let it stand for 40-50 hours, take the supernatant to recover ethanol, add appropriate amount of water to the remaining liquid medicine, adjust the pH value to 3.5-4.5, let it stand for 40-50 hours, filter, and get the fragrant sand Stomach nourishing liquid.

其中,上述百分比的单位是%(g/100ml)。 Wherein, the unit of the above percentage is % (g/100ml).

优选地,所述药用油选自天然植物油、油酸乙酯、油酸丁酯、长链甘油三酯或中链甘油三酯中的一种或几种。 Preferably, the medicinal oil is selected from one or more of natural vegetable oil, ethyl oleate, butyl oleate, long-chain triglycerides or medium-chain triglycerides.

优选地,所述乳化剂选自脂肪酸山梨坦类、聚氧乙烯脂肪酸酯类、聚氧乙烯脂肪醇醚类、聚氧乙烯-聚氧丙烯共聚物类、聚氧乙烯-聚氧丙烯嵌段共聚物类、单甘油脂肪酸酯、三甘油脂肪酸酯、聚甘油脂肪酸酯、蔗糖脂肪酸酯、单硬脂酸甘油酯、硬脂酸钠、硬脂酸钾、油酸钠、油酸钾、硬脂酸钙、十二烷基硫酸钠、十六烷基硫酸化蓖麻油、阿拉伯胶、西黄蓍胶、明胶或磷脂中的一种或几种。 Preferably, the emulsifier is selected from fatty acid sorbitan, polyoxyethylene fatty acid ester, polyoxyethylene fatty alcohol ether, polyoxyethylene-polyoxypropylene copolymer, polyoxyethylene-polyoxypropylene block copolymer Species, monoglyceride fatty acid ester, triglyceride fatty acid ester, polyglycerol fatty acid ester, sucrose fatty acid ester, glyceryl monostearate, sodium stearate, potassium stearate, sodium oleate, potassium oleate , calcium stearate, sodium lauryl sulfate, cetyl sulfated castor oil, gum arabic, gum tragacanth, gelatin or phospholipids.

优选地,所述辅助乳化剂选自甲基纤维素、羧甲基纤维素钠、羧丙基纤维素、海藻酸钠、琼脂、西黄蓍胶、阿拉伯胶、黄原胶、瓜尔胶、果胶、皂土、鲸蜡醇、蜂蜡、单硬脂酸甘油酯、硬脂酸、硬脂醇、甘油、聚乙二醇、聚甘油酯或聚维酮中的一种或几种。 Preferably, the auxiliary emulsifier is selected from the group consisting of methyl cellulose, sodium carboxymethyl cellulose, carboxypropyl cellulose, sodium alginate, agar, gum tragacanth, gum arabic, xanthan gum, guar gum, One or more of pectin, bentonite, cetyl alcohol, beeswax, glyceryl monostearate, stearic acid, stearyl alcohol, glycerin, polyethylene glycol, polyglycerol esters or povidone.

优选地,所述抗氧剂选自亚硫酸钠、亚硫酸氢钠、硫代硫酸钠、焦亚硫酸钠、抗坏血酸、没食子酸丙酯、抗坏血酸棕榈酸酯、叔丁基对羟基茴香醚、二叔丁基对甲酚、维生素E或维生素E醋酸酯中的一种或几种。 Preferably, the antioxidant is selected from sodium sulfite, sodium bisulfite, sodium thiosulfate, sodium metabisulfite, ascorbic acid, propyl gallate, ascorbyl palmitate, tert-butyl p-hydroxyanisole, di-tert-butyl p- One or more of cresol, vitamin E or vitamin E acetate.

优选地,所述防腐剂选自苯甲酸、山梨酸钙、尼泊金乙酯、尼泊金丙酯、苯甲酸钠或山梨酸钾中的一种或几种。 Preferably, the preservative is selected from one or more of benzoic acid, calcium sorbate, ethylparaben, propylparaben, sodium benzoate or potassium sorbate.

优选地,所述水为去离子水或注射用水。 Preferably, the water is deionized water or water for injection.

更优选地,本发明中的药用油为大豆油、蓖麻油、花生油、芝麻油、玉米油、橄榄油、茶油、油酸乙酯、油酸丁酯、长链甘油三酯或中链甘油三酯中的一种或几种,用量为2.5-9.0%。其中,所述的长链甘油三酯是指碳原子数为14~22的脂肪酸的甘油三酯,所述的中链甘油三酯是指碳原子数为8~12的脂肪酸的甘油三酯。 More preferably, the medicinal oil in the present invention is soybean oil, castor oil, peanut oil, sesame oil, corn oil, olive oil, tea oil, ethyl oleate, butyl oleate, long-chain triglyceride or medium-chain glycerol One or more of the triesters, the dosage is 2.5-9.0%. Wherein, the long-chain triglycerides refer to triglycerides of fatty acids with 14-22 carbon atoms, and the medium-chain triglycerides refer to triglycerides of fatty acids with 8-12 carbon atoms.

更优选地,本发明中的乳化剂为吐温80、聚乙二醇-12-羟基硬脂酸酯(HS-15)、泊洛沙姆188、大豆磷脂、十二烷基硫酸钠、聚氧乙烯氢化蓖麻油(RH40)或聚氧乙烯-35-蓖麻油(EL-35)中的一种或几种,用量为3.0-11.0%。 More preferably, the emulsifier in the present invention is Tween 80, polyethylene glycol-12-hydroxystearate (HS-15), poloxamer 188, soybean lecithin, sodium lauryl sulfate, poly One or more of oxyethylene hydrogenated castor oil (RH40) or polyoxyethylene-35-castor oil (EL-35), the dosage is 3.0-11.0%.

更优选地,本发明中的辅助乳化剂选自羧甲基纤维素钠、单硬脂酸甘油酯或聚维酮中的一种或几种,用量为0.05-3.5%。 More preferably, the auxiliary emulsifier in the present invention is selected from one or more of sodium carboxymethylcellulose, glyceryl monostearate or povidone, and the dosage is 0.05-3.5%.

更优选地,本发明中的抗氧剂选自亚硫酸钠、亚硫酸氢钠、硫代硫酸钠、焦亚硫酸钠、抗坏血酸、没食子酸丙酯、抗坏血酸棕榈酸酯、叔丁基对羟基茴香醚、二丁甲苯酚、维生素E或维生素E醋酸酯中的一种或几种,用量为0.01-0.5%。 More preferably, the antioxidant in the present invention is selected from sodium sulfite, sodium bisulfite, sodium thiosulfate, sodium metabisulfite, ascorbic acid, propyl gallate, ascorbyl palmitate, tert-butyl p-hydroxyanisole, dibutyl One or more of cresol, vitamin E or vitamin E acetate, the dosage is 0.01-0.5%.

更优选地,本发明中的所述防腐剂选自尼泊金乙酯、尼泊金丙酯、苯甲酸钠或山梨酸钾中的一种或几种,用量为0.01-0.8%。 More preferably, the preservative in the present invention is selected from one or more of ethylparaben, propylparaben, sodium benzoate or potassium sorbate, and the dosage is 0.01-0.8%.

此外,本发明的乳剂中还包含药学可接受的矫味剂、芳香剂。 In addition, the emulsion of the present invention also contains pharmaceutically acceptable flavoring agents and fragrances.

本发明的香砂养胃口服乳剂可采用下述方法制备,其步骤包括:取挥发油、药用油、抗氧剂和防腐剂混合均匀,制得油相,40~80℃保温备用,取香砂养胃药液、乳化剂、辅助乳化剂和水混合溶解后加入到油相中,40~80℃下磁力搅拌10~60min,以5000-8000转/分的转速剪切1~30min,灌封,灭菌,即得。 The fragrant sand nourishing stomach oral emulsion of the present invention can be prepared by the following method, and the steps include: taking volatile oil, medicinal oil, antioxidant and preservative and mixing uniformly to obtain an oil phase, keeping it warm at 40-80°C for later use, taking the incense Sand nourishing stomach medicinal liquid, emulsifier, auxiliary emulsifier and water are mixed and dissolved, then added to the oil phase, magnetically stirred at 40-80°C for 10-60 minutes, sheared at 5000-8000 rpm for 1-30 minutes, poured Seal, sterilize, and get ready.

或者,可采用下述方法制备,其步骤包括:取挥发油、药用油、抗氧剂和防腐剂混合均匀,制得油相,40~80℃保温备用,取香砂养胃药液、乳化剂、辅助乳化剂和水混合溶解后加入到油相中,经超声波乳化器在100 W~1000 W下分散1~5 min,重复3~4次,灌封,灭菌,即得。 Alternatively, it can be prepared by the following method, the steps of which include: taking volatile oil, medicinal oil, antioxidant and preservative and mixing evenly to obtain an oil phase, keeping it warm at 40-80°C for later use, taking fragrant sand nourishing stomach liquid, emulsifying Add the agent, auxiliary emulsifier and water to the oil phase after mixing and dissolving, disperse at 100 W to 1000 W for 1 to 5 min through an ultrasonic emulsifier, repeat 3 to 4 times, potting, and sterilizing.

本发明的香砂养胃口服乳剂还可采用下述方法制备,其步骤包括:取挥发油、药用油、抗氧剂和防腐剂混合均匀,40~80℃预热,制得油相备用;在缓慢搅拌下,以细射流的方式将40~80 ℃预热的内含香砂养胃药液、乳化剂、辅助乳化剂和水的水相加入到预热的油相中,灌封,灭菌,即得。 The fragrant sand nourishing stomach oral emulsion of the present invention can also be prepared by the following method, the steps of which include: taking volatile oil, medicinal oil, antioxidant and preservative, mixing uniformly, preheating at 40-80°C, and preparing the oil phase for later use; Under slow stirring, add the water phase preheated at 40-80 ℃ containing fragrant sand stomach nourishing liquid, emulsifier, auxiliary emulsifier and water into the preheated oil phase in the form of fine jets, potting, Sterilize, that is.

本发明的技术方案与现有技术相比,具有下述优点: Compared with the prior art, the technical solution of the present invention has the following advantages:

1、本发明将传统香砂养胃丸中的活性成分提取并制成口服乳剂,使得香砂养胃中药组合物中的活性成分的释放更充分、促进了吸收,生物利用度大大提高。 1. The present invention extracts the active ingredients in the traditional Xiangsha Yangwei Pills and makes an oral emulsion, which makes the release of the active ingredients in the Xiangsha Yangwei Chinese medicine composition more sufficient, promotes absorption, and greatly improves bioavailability.

2、本发明通过提取工艺,利用乳剂的特点,有效掩盖了中药成分的不良气味,口味良好,提高了消费者的接受度。 2. The present invention utilizes the characteristics of the emulsion through the extraction process to effectively cover the bad smell of the traditional Chinese medicine components, has a good taste, and improves the acceptance of consumers.

3、本发明通过合理选用药用油、乳化剂等辅料及其它们的配比,所制得的香砂养胃口服乳剂稳定性好,适于贮存。 3. The present invention rationally selects medicinal oils, emulsifiers and other auxiliary materials and their proportions, so that the prepared Xiangsha Nourishing Stomach Oral Emulsion has good stability and is suitable for storage.

具体实施方式 Detailed ways

本发明给出下面的实施例来进一步说明,但本发明的保护范围不限于这些实施例。 The present invention provides the following examples to further illustrate, but the protection scope of the present invention is not limited to these examples.

实施例1:香砂养胃药液和挥发油的制备Example 1: Preparation of fragrant sand nourishing stomach medicinal liquid and volatile oil

取木香70g、砂仁70 g、白术100 g、陈皮100 g、茯苓100 g、半夏(制)100 g、香附(醋制)70 g 、枳实(炒)70 g、豆蔻(去壳)70 g、厚朴(姜制)70 g、广藿香70 g、甘草30 g、生姜30 g和大枣50 g一并提取挥发油,挥发油收集备用,剩余药渣加水煎煮2次,每次50分钟,合并煎液,滤过,滤液浓缩至75℃相对密度为1.16的清膏,加乙醇使含醇量为80%,静置45小时,取上清液回收乙醇,剩余药液加水适量,调pH值为4.0,静置45小时,滤过,即得香砂养胃药液。 Take 70g Muxiang, 70g Amomum, 100g Atractylodes Atractylodes, 100g Chenpi, 100g Poria, 100g Pinellia (made from vinegar), 70g Cyperus cyperi (made from vinegar), 70g Zhishi (stir-fried), cardamom (removed) shell) 70 g, magnolia officinalis (made from ginger) 70 g, patchouli 70 g, licorice 30 g, ginger 30 g and jujube 50 g to extract volatile oil together, collect the volatile oil for later use, and decoct the remaining medicinal residue with water twice, 50 minutes each time, combine the decoction, filter, concentrate the filtrate to a clear paste with a relative density of 1.16 at 75°C, add ethanol to make the alcohol content 80%, let it stand for 45 hours, take the supernatant to recover the ethanol, and the remaining liquid Add appropriate amount of water, adjust the pH value to 4.0, let it stand for 45 hours, and filter to obtain the fragrant sand nourishing stomach liquid.

实施例2:香砂养胃药液和挥发油的制备Example 2: Preparation of fragrant sand nourishing stomach medicinal liquid and volatile oil

取木香70g、砂仁70 g、白术100 g、陈皮100 g、茯苓100 g、半夏(制)100 g、香附(醋制)70 g 、枳实(炒)70 g、豆蔻(去壳)70 g、厚朴(姜制)70 g、广藿香70 g、甘草30 g、生姜30 g和大枣50 g一并提取挥发油,挥发油收集备用,剩余药渣加水煎煮3次,每次60分钟,合并煎液,滤过,滤液浓缩至75℃相对密度为1.18的清膏,加乙醇使含醇量为80%,静置48小时,取上清液回收乙醇,剩余药液加水适量,调pH值为4.2,静置48小时,滤过,即得香砂养胃药液。 Take 70g Muxiang, 70g Amomum, 100g Atractylodes Atractylodes, 100g Chenpi, 100g Poria, 100g Pinellia (made from vinegar), 70g Cyperus cyperi (made from vinegar), 70g Zhishi (stir-fried), cardamom (removed) shell) 70 g, magnolia officinalis (made from ginger) 70 g, patchouli 70 g, licorice 30 g, ginger 30 g and jujube 50 g to extract volatile oil together, collect the volatile oil for later use, and decoct the remaining medicinal residue with water for 3 times, 60 minutes each time, combine the decoction, filter, concentrate the filtrate to a clear paste with a relative density of 1.18 at 75°C, add ethanol to make the alcohol content 80%, let it stand for 48 hours, take the supernatant to recover the ethanol, and the remaining liquid medicine Add an appropriate amount of water to adjust the pH to 4.2, let it stand for 48 hours, and filter to obtain the fragrant sand nourishing stomach liquid.

实施例3:香砂养胃口服乳剂的制备Example 3: Preparation of Xiangsha Nourishing Stomach Oral Emulsion

处方: prescription:

实施例1的香砂养胃药液The fragrant sand stomach nourishing medicinal liquid of embodiment 1 80%(g/100ml)80% (g/100ml) 实施例1的挥发油The volatile oil of embodiment 1 0.9%(g/100ml)0.9% (g/100ml) 长链甘油三酯long chain triglycerides 3%(g/100ml)3% (g/100ml) 大豆磷脂Soy lecithin 9%(g/100ml)9% (g/100ml) 叔丁基对羟基茴香醚tert-butyl p-hydroxyanisole 0.5%(g/100ml)0.5% (g/100ml) 尼泊金乙酯Ethylparaben 0.05%(g/100ml)0.05% (g/100ml) 尼泊金丙酯Propylparaben 0.05%(g/100ml)0.05% (g/100ml) 注射用水Water for Injection 余量margin

制备方法:将挥发油、长链甘油三酯、叔丁基对羟基茴香醚、尼泊金乙酯和尼泊金丙酯混合均匀,制得油相,60℃保温备用;将香砂养胃药液、大豆磷脂和注射用水混合溶解后加入到油相中,60℃下磁力搅拌30分钟,用高速剪切机以6000转/分的转速剪切15min,灌封,灭菌,即得口服乳剂。 Preparation method: Mix volatile oil, long-chain triglycerides, tert-butyl-p-hydroxyanisole, ethylparaben and propylparaben evenly to obtain an oil phase, keep warm at 60°C for later use; Liquid, soybean lecithin and water for injection are mixed and dissolved, then added to the oil phase, magnetically stirred at 60°C for 30 minutes, cut with a high-speed shearer at a speed of 6000 rpm for 15 minutes, potted and sterilized to obtain an oral emulsion .

实施例4:香砂养胃口服乳剂的制备 Example 4: Preparation of Xiangsha Nourishing Stomach Oral Emulsion

处方: prescription:

实施例1的香砂养胃药液The fragrant sand stomach nourishing medicinal liquid of embodiment 1 60%(g/100ml)60% (g/100ml) 实施例1的挥发油The volatile oil of embodiment 1 0.7%(g/100ml)0.7% (g/100ml) 大豆油Soybean oil 5%(g/100ml)5% (g/100ml) 聚乙二醇-12-羟基硬脂酸酯Polyethylene glycol-12-hydroxystearate 6%(g/100ml)6% (g/100ml) 吐温-80Tween 80 2%(g/100ml)2% (g/100ml) 维生素E醋酸酯Vitamin E Acetate 0.5%(g/100ml)0.5% (g/100ml) 尼泊金乙酯Ethylparaben 0.2%(g/100ml)0.2% (g/100ml) 香精essence 0.15%(g/100ml)0.15% (g/100ml) 注射用水Water for Injection 余量margin

制备方法: Preparation:

将挥发油、大豆油、维生素E醋酸酯和尼泊金乙酯混合均匀,制得油相,50℃保温备用;将香砂养胃药液、聚乙二醇-12-羟基硬脂酸酯、吐温-80、香精和注射用水混合溶解后加入到油相中,50℃下磁力搅拌40分钟,用高速剪切机以7000转/分的转速剪切12min,灌封,灭菌,即得口服乳剂。 Mix volatile oil, soybean oil, vitamin E acetate and ethylparaben evenly to obtain an oil phase, and keep it warm at 50°C for later use; mix fragrant sand stomach nourishing liquid, polyethylene glycol-12-hydroxystearate, Tween-80, essence and water for injection are mixed and dissolved, then added to the oil phase, magnetically stirred at 50°C for 40 minutes, cut with a high-speed shearer at a speed of 7000 rpm for 12 minutes, potted and sterilized to obtain Oral emulsion.

实施例5:香砂养胃口服乳剂的制备Example 5: Preparation of Xiangsha Nourishing Stomach Oral Emulsion

处方: prescription:

实施例1的香砂养胃药液The fragrant sand stomach nourishing medicinal liquid of embodiment 1 82%(g/100ml)82% (g/100ml) 实施例1的挥发油The volatile oil of embodiment 1 0.8%(g/100ml)0.8% (g/100ml) 油酸丁酯Butyl oleate 4%(g/100ml)4% (g/100ml) 大豆磷脂Soy lecithin 6%(g/100ml)6% (g/100ml) 聚氧乙烯氢化蓖麻油Polyoxyethylene Hydrogenated Castor Oil 3%(g/100ml)3% (g/100ml) 抗坏血酸棕榈酸酯Ascorbyl Palmitate 0.5%(g/100ml)0.5% (g/100ml) 苯甲酸钠sodium benzoate 0.1%(g/100ml)0.1% (g/100ml) 去离子水Deionized water 余量margin

制备方法: Preparation:

将挥发油、油酸丁酯、抗坏血酸棕榈酸酯和苯甲酸钠混合均匀,制得油相,70℃保温备用;将香砂养胃药液、大豆磷脂、聚氧乙烯氢化蓖麻油和去离子水混合溶解后加入到油相中,经超声波乳化器在800W下分散5 min,重复3次,灌封,灭菌,即得。 Mix the volatile oil, butyl oleate, ascorbyl palmitate and sodium benzoate evenly to obtain the oil phase, keep it warm at 70°C for later use; mix the fragrant sand stomach nourishing liquid, soybean lecithin, polyoxyethylene hydrogenated castor oil and deionized water After dissolving, add it to the oil phase, disperse it at 800W for 5 minutes through an ultrasonic emulsifier, repeat 3 times, potting, and sterilizing it.

实施例6:香砂养胃口服乳剂的制备Example 6: Preparation of Xiangsha Nourishing Stomach Oral Emulsion

处方: prescription:

实施例1的香砂养胃药液The fragrant sand stomach nourishing medicinal liquid of embodiment 1 75%(g/100ml)75% (g/100ml) 实施例1的挥发油The volatile oil of embodiment 1 1.0%(g/100ml)1.0% (g/100ml) 中链甘油三酯medium chain triglycerides 8%(g/100ml)8% (g/100ml) 聚氧乙烯-35-蓖麻油Polyoxyethylene-35-castor oil 3.5%(g/100ml)3.5% (g/100ml) 没食子酸丙酯Propyl gallate 0.5%(g/100ml)0.5% (g/100ml) 山梨酸钾Potassium sorbate 0.8%(g/100ml)0.8% (g/100ml) 注射用水Water for Injection 余量margin

制备方法: Preparation:

将挥发油、中链甘油三酯、没食子酸丙酯和山梨酸钾混合均匀,制得油相,80℃保温备用;将香砂养胃药液、聚氧乙烯-35-蓖麻油和注射用水混合溶解后加入到油相中,80℃下磁力搅拌20分钟,用高速剪切机以8000转/分的转速剪切10min,灌封,灭菌,即得口服乳剂。 Mix the volatile oil, medium-chain triglyceride, propyl gallate and potassium sorbate evenly to obtain the oil phase, and keep it warm at 80°C for later use; mix the fragrant sand stomach nourishing liquid, polyoxyethylene-35-castor oil and water for injection After dissolving, add it to the oil phase, stir magnetically at 80°C for 20 minutes, cut with a high-speed shearer at a speed of 8000 rpm for 10 minutes, fill and sterilize to obtain an oral emulsion.

实施例7:香砂养胃口服乳剂的制备Example 7: Preparation of Xiangsha Nourishing Stomach Oral Emulsion

处方: prescription:

实施例1的香砂养胃药液The fragrant sand stomach nourishing medicinal liquid of embodiment 1 85%(g/100ml)85% (g/100ml) 实施例1的挥发油The volatile oil of embodiment 1 0.6%(g/100ml)0.6% (g/100ml) 玉米油Corn oil 7%(g/100ml)7% (g/100ml) 大豆磷脂Soy lecithin 5%(g/100ml)5% (g/100ml) 泊洛沙姆188Poloxamer 188 0.1(g/100ml)0.1 (g/100ml) 焦亚硫酸钠Sodium metabisulfite 0.1 %(g/100ml)0.1 % (g/100ml) 去离子水Deionized water 余量margin

制备方法: Preparation:

将挥发油、玉米油和焦亚硫酸钠混合均匀,制得油相,60℃保温备用;将香砂养胃药液、大豆磷脂、泊洛沙姆188和去离子水混合溶解后加入到油相中,60℃下磁力搅拌40分钟,用高速剪切机以6000转/分的转速剪切20min,灌封,灭菌,即得口服乳剂。 Mix the volatile oil, corn oil and sodium metabisulfite evenly to prepare the oil phase, and keep it warm at 60°C for later use; mix and dissolve Xiangsha nourishing stomach liquid, soybean lecithin, poloxamer 188 and deionized water and add it to the oil phase. Stir magnetically at 60°C for 40 minutes, cut with a high-speed shearer at a speed of 6,000 rpm for 20 minutes, potting, and sterilizing to obtain an oral emulsion.

实施例8:香砂养胃口服乳剂的制备Example 8: Preparation of Xiangsha Nourishing Stomach Oral Emulsion

处方: prescription:

实施例2的香砂养胃药液The fragrant sand nourishing stomach medicinal liquid of embodiment 2 80%(g/100ml)80% (g/100ml) 实施例2的挥发油The volatile oil of embodiment 2 0.9%(g/100ml)0.9% (g/100ml) 茶油tea oil 3%(g/100ml)3% (g/100ml) 聚乙二醇-12-羟基硬脂酸酯Polyethylene glycol-12-hydroxystearate 7%(g/100ml)7% (g/100ml) 亚硫酸氢钠sodium bisulfite 0.2%(g/100ml)0.2% (g/100ml) 羧甲基纤维素钠Sodium carboxymethyl cellulose 0.15%(g/100ml)0.15% (g/100ml) 注射用水Water for Injection 余量margin

制备方法: Preparation:

将挥发油、茶油和亚硫酸氢钠混合均匀,制得油相,70℃保温备用;将香砂养胃药液、聚乙二醇-12-羟基硬脂酸酯、羧甲基纤维素钠和注射用水混合溶解后加入到油相中,70℃下磁力搅拌25分钟,用高速剪切机以5000转/分的转速剪切20min,灌封,灭菌,即得口服乳剂。 Mix the volatile oil, camellia oil and sodium bisulfite evenly to obtain the oil phase, and keep it warm at 70°C for later use; mix the fragrant sand stomach nourishing liquid, polyethylene glycol-12-hydroxystearate, sodium carboxymethyl cellulose Mix and dissolve with water for injection, add to the oil phase, stir magnetically at 70°C for 25 minutes, cut with a high-speed shearer at a speed of 5,000 rpm for 20 minutes, potting, and sterilizing to obtain an oral emulsion.

实施例9:香砂养胃口服乳剂的制备Example 9: Preparation of Xiangsha Nourishing Stomach Oral Emulsion

处方: prescription:

实施例2的香砂养胃药液The fragrant sand nourishing stomach medicinal liquid of embodiment 2 65%(g/100ml)65% (g/100ml) 实施例2的挥发油The volatile oil of embodiment 2 1.2%(g/100ml)1.2% (g/100ml) 油酸乙酯ethyl oleate 4.5%(g/100ml)4.5% (g/100ml) 泊洛沙姆188Poloxamer 188 8.5(g/100ml)8.5 (g/100ml) 吐温-80Tween 80 2%(g/100ml)2% (g/100ml) 单硬脂酸甘油酯Glyceryl monostearate 3.5%(g/100ml)3.5% (g/100ml) 二丁甲苯酚Dibutylcresol 0.01%(g/100ml)0.01% (g/100ml) 注射用水Water for Injection 余量margin

制备方法: Preparation:

将挥发油、油酸乙酯和二丁甲苯酚混合均匀,预热,制得油相备用;在缓慢搅拌下,以细射流的方式将内含香砂养胃药液、泊洛沙姆188、吐温-80、单硬脂酸甘油酯和和注射用水的水相加入到预热的油相中,灌封,灭菌,即得。 Mix the volatile oil, ethyl oleate and butylcresol evenly, and preheat to prepare the oil phase for later use; under slow stirring, use the method of fine jet flow to mix the medicinal liquid containing fragrant sand, poloxamer 188, The water phase of Tween-80, glyceryl monostearate and water for injection is added to the preheated oil phase, filled and sterilized to obtain the product.

实施例10:香砂养胃口服乳剂的制备Example 10: Preparation of Xiangsha Nourishing Stomach Oral Emulsion

处方: prescription:

实施例2的香砂养胃药液The fragrant sand nourishing stomach medicinal liquid of embodiment 2 78%(g/100ml)78% (g/100ml) 实施例2的挥发油The volatile oil of embodiment 2 0.8%(g/100ml)0.8% (g/100ml) 蓖麻油castor oil 8.7%(g/100ml)8.7% (g/100ml) 十二烷基硫酸钠Sodium dodecyl sulfate 2%(g/100ml)2% (g/100ml) 聚乙二醇-12-羟基硬脂酸酯Polyethylene glycol-12-hydroxystearate 1%(g/100ml)1% (g/100ml) 维生素EVitamin E 0.5%(g/100ml)0.5% (g/100ml) 聚维酮Povidone 0.05%(g/100ml)0.05% (g/100ml) 注射用水Water for Injection 余量margin

制备方法: Preparation:

将挥发油、蓖麻油和维生素E混合均匀,制得油相,60℃保温备用;将香砂养胃药液、十二烷基硫酸钠、聚乙二醇-12-羟基硬脂酸酯、聚维酮和注射用水混合溶解后加入到油相中,60℃下磁力搅拌30分钟,用高速剪切机以8000转/分的转速剪切15min,灌封,灭菌,即得口服乳剂。 Mix volatile oil, castor oil and vitamin E evenly to obtain an oil phase, and keep it warm at 60°C for later use; mix fragrant sand stomach nourishing liquid, sodium lauryl sulfate, polyethylene glycol-12-hydroxystearate, poly Mix and dissolve the vitamin ketone and water for injection, add it to the oil phase, stir magnetically at 60°C for 30 minutes, cut with a high-speed shearer at a speed of 8,000 rpm for 15 minutes, fill and sterilize to obtain an oral emulsion.

实施例11:香砂养胃口服乳剂的稳定性试验Example 11: Stability test of Xiangsha nourishing stomach oral emulsion

一、试验样品: 1. Test samples:

如实施例3的方法制备得到的香砂养胃口服乳剂。 The Xiangsha nourishing stomach oral emulsion prepared by the method of Example 3.

二、试验方法: 2. Test method:

参照药物制剂稳定性试验指导原则(中国药典2010版二部附录                                                C),对本品进行加速实验考察,为本品的运输、包装、贮藏、有效期等提供科学依据。通则规定口服乳剂宜采用温度30±2℃、湿度65±5%的条件进行实验。 Refer to the guidelines for the stability test of pharmaceutical preparations (Appendix II of the Chinese Pharmacopoeia 2010 Edition C), carry out accelerated experimental investigation on this product, and provide scientific basis for the transportation, packaging, storage, and validity period of this product. The general rules stipulate that the oral emulsion should be tested under the conditions of temperature 30±2°C and humidity 65±5%.

本研究分别制备三批样品,采用45±2℃、湿度65±5%,30±2℃、湿度65±5%,室温为条件进行稳定性考察,于0、1、2、3、6月取样考察性状、pH值、平均粒径和含量。结果见表1。 In this study, three batches of samples were prepared respectively, and the stability was investigated under the conditions of 45±2°C, humidity 65±5%, 30±2°C, humidity 65±5%, and room temperature. Sampling to investigate properties, pH value, average particle size and content. The results are shown in Table 1.

3、试验结果: 3. Test results:

表1 本发明实施例3香砂养胃乳剂的稳定性考察结果 Table 1 The results of the stability investigation of the embodiment of the present invention 3 Xiangsha nourishing stomach emulsion

结果表明,本发明实施例3的香砂养胃乳剂在45±2℃、湿度65±5%,30±2℃、湿度65±5%,室温条件下保存6个月,各项指标无明显变化,表明本发明的乳剂稳定性良好。 The results show that the Xiangsha Nourishing Stomach Emulsion of Example 3 of the present invention was stored at 45±2°C, humidity 65±5%, 30±2°C, humidity 65±5%, and room temperature for 6 months, and the indicators were not obvious. Change, showing that the emulsion of the present invention has good stability.

实施例12:香砂养胃口服乳剂的药效试验Example 12: Drug efficacy test of Xiangsha nourishing stomach oral emulsion

一、试验样品:  1. Test sample:

如实施例3的方法制备得到的香砂养胃口服乳剂。 The Xiangsha nourishing stomach oral emulsion prepared by the method of Example 3.

二、试验方法和结果: 2. Test methods and results:

1、香砂养胃乳剂对大鼠胃液分泌的影响 1. Effect of Xiangsha Nourishing Stomach Emulsion on the secretion of gastric juice in rats

取雄性SD大鼠,40只,随机分为4组,分别为空白对照组、香砂养胃口服乳剂高剂量组、中剂量组和低剂量组,ig给药,每日1次,连续7天,末次给药后禁食12h,用乙醚麻醉,结扎幽门。术后禁食禁水10h后处死动物,剖腹结扎贲门,收集胃液,并测量胃液量、PH值及胃蛋白酶活力。结果见表2。 40 male SD rats were randomly divided into 4 groups, namely blank control group, Xiangsha Yangwei oral emulsion high-dose group, middle-dose group and low-dose group, ig administration, once a day, for 7 consecutive days day, fasted for 12 hours after the last administration, anesthetized with ether, and ligated the pylorus. Animals were sacrificed after fasting for 10 hours after operation, the cardia was ligated by laparotomy, gastric juice was collected, and the gastric juice volume, pH value and pepsin activity were measured. The results are shown in Table 2.

表2 香砂养胃乳剂对大鼠胃液分泌的影响( ± s) Table 2 The effect of Xiangsha nourishing stomach emulsion on the secretion of gastric juice in rats ( ± s)

注*表示与空白对照组比较,P<0.05,**表示与空白对照组比较,P<0.01 Note * means compared with the blank control group, P<0.05, ** means compared with the blank control group, P<0.01

结果表明,香砂养胃乳剂能够显著减少胃液分泌量,升高胃液PH值,并能够提高胃蛋白酶活力,(P<0.01)或(P<0.05)。 The results showed that Xiangsha Nourishing Stomach Emulsion can significantly reduce the secretion of gastric juice, increase the pH value of gastric juice, and increase the activity of pepsin (P<0.01) or (P<0.05).

2、香砂养胃乳剂对小鼠小肠推进的影响 2. Effect of Xiangsha Nourishing Stomach Emulsion on Small Intestine Propulsion in Mice

取雄性昆明小鼠,40只,随机分为4组,分别为空白对照组、香砂养胃乳剂高剂量组、中剂量组和低剂量组,ig给药,每日1次,连续2天,于第2天给药后禁食但不禁水12h并再给药1次,于末次给药后1后ig10%炭末0.2ml,15min后颈椎脱臼处死小鼠。打开腹腔,剪取上端至幽门下端至回盲部肠管,测量肠管长度为“小肠总长度”,从幽门至炭末前沿的距离为“炭末在肠内推进距离”,用下式计算炭末推进百分率。 40 male Kunming mice were randomly divided into 4 groups, namely blank control group, Xiangsha nourishing stomach emulsion high-dose group, middle-dose group and low-dose group, ig administration, once a day, for 2 consecutive days On the 2nd day after the administration, the mice were fasted but not allowed to drink water for 12 hours and administered once more. After the last administration, 0.2ml of 10% charcoal powder was ig 1, and the mice were sacrificed by cervical dislocation 15 minutes later. Open the abdominal cavity, cut the intestinal tube from the upper end to the lower end of the pylorus to the ileocecal, measure the length of the intestinal tube as the "total length of the small intestine", and the distance from the pylorus to the front of the end of the charcoal is the "distance of the end of the charcoal in the intestine", and use the following formula to calculate the end of the charcoal advance percentage.

炭末推进百分率(%)=炭末在肠管内推进距离/小肠总长度×100% Propelling percentage of charcoal powder (%) = propulsion distance of charcoal powder in the intestine / total length of small intestine × 100%

表2 香砂养胃乳剂对小鼠小肠推进的影响( ± s) Table 2 The effect of Xiangsha nourishing stomach emulsion on small intestine propulsion in mice ( ± s)

组别group NN 炭末推进百分率(%)Charcoal propulsion percentage (%) 空白对照组Blank control group 1010 51.23±8.4451.23±8.44 低剂量组low dose group 1010 65.46±12.6265.46±12.62 中剂量组Middle dose group 1010 74.59±15.71**74.59±15.71** 高剂量组high dose group 1010 83.19±17.96**83.19±17.96**

注*表示与空白对照组比较,P<0.05,**表示与空白对照组比较,P<0.01 Note * means compared with the blank control group, P<0.05, ** means compared with the blank control group, P<0.01

本试验的结果见表2。结果提表明,香砂养胃乳剂能够显著提高小肠炭末推进百分率(P<0.01)。 The results of this test are shown in Table 2. The results showed that Xiangsha Nourishing Stomach Emulsion could significantly increase the propulsion percentage of charcoal in the small intestine (P<0.01).

Claims (6)

1. a cyperus-amomum stomach Orally taken emulsion, is characterized in that containing following composition:
(1) 60-85% cyperus-amomum stomach medicinal liquid and 0.5-1.2% volatile oil;
(2) 2.5-9.0% medicinal oil;
(3) 3.0-11.0% emulsifying agent;
(4) 0.05-3.5% coemulsifier;
(5) 0.01-0.5% antioxidant;
(6) 0.01-0.8% antiseptic;
The water of surplus;
The preparation method of described cyperus-amomum stomach medicinal liquid and volatile oil is: get Radix Aucklandiae 70g, Fructus Amomi 70 g, the Rhizoma Atractylodis Macrocephalae 100 g, Pericarpium Citri Reticulatae 100 g, Poria 100 g, Rhizoma Pinelliae Preparata 100 g, Rhizoma Cyperi (processed with vinegar) 70 g, Fructus Aurantii Immaturus (parched) 70 g, Semen Myristicae (shell removed) 70 g, Sichuan Cortex Magnoliae Officinalis (processed with Rhizoma Zingiberis Recens) 70 g, Herba Pogostemonis 70 g, Radix Glycyrrhizae 30 g, Rhizoma Zingiberis Recens 30 g and Fructus Jujubae 50 g extract volatile oil in the lump, volatile oil is collected standby, residue medicinal residues decoct with water 2-3 time, each 45-75 minute, collecting decoction, filter, filtrate is concentrated into the clear paste that 75 ℃ of relative densities are 1.14~1.18, add ethanol make containing alcohol amount be 70-85%, standing 40-50 hour, get supernatant and reclaim ethanol, it is appropriate that residue medicinal liquid adds water, adjust pH is 3.5-4.5, standing 40-50 hour, filter, obtain cyperus-amomum stomach medicinal liquid,
Described medicinal oil is one or more in soybean oil, Oleum Ricini, Semen Maydis oil, Oleum Camelliae, ethyl oleate, butyl oleate, long chain triglyceride or medium chain triglyceride; Described emulsifying agent is one or more in Tween 80, HS15, PLURONICS F87, soybean phospholipid, sodium lauryl sulphate, polyoxyethylene hydrogenated Oleum Ricini or polyoxyethylene-35-Oleum Ricini; Described coemulsifier is selected from one or more in sodium carboxymethyl cellulose, polyvidone or glyceryl monostearate; Described antioxidant is selected from one or more in sodium sulfite, sodium pyrosulfite, propyl gallate, ascorbyl palmitate, butylated hydroxyarisol, two fourth cresols, vitamin E or Vitamin E acetate; Described antiseptic is selected from one or more in ethyl hydroxybenzoate, propylparaben, sodium benzoate or potassium sorbate;
The unit of described percentage ratio is %g/100ml.
2. cyperus-amomum stomach Orally taken emulsion as claimed in claim 1, is characterized in that described water is deionized water or water for injection.
3. a cyperus-amomum stomach Orally taken emulsion, is characterized in that also further comprising the acceptable correctives of pharmacy, aromatic on the basis of the cyperus-amomum stomach Orally taken emulsion described in claim 1 or 2.
4. the preparation method of the described cyperus-amomum stomach Orally taken emulsion of one of claim 1-2, it is characterized in that comprising following steps: get volatile oil, medicinal oil, antioxidant and antiseptic mix homogeneously, make oil phase, 40~80 ℃ of insulations are standby, join in oil phase after getting cyperus-amomum stomach medicinal liquid, emulsifying agent, coemulsifier and water mixed dissolution, and 40~80 ℃ of lower magnetic forces stir 10~60min, rotating speed cutting 1~30min with 5000-8000 rev/min, embedding, sterilizing, obtains.
5. the preparation method of the described cyperus-amomum stomach Orally taken emulsion of one of claim 1-2, it is characterized in that comprising following steps: get volatile oil, medicinal oil, antioxidant and antiseptic mix homogeneously, make oil phase, 40~80 ℃ of insulations are standby, join in oil phase after getting cyperus-amomum stomach medicinal liquid, emulsifying agent, coemulsifier and water mixed dissolution, through ultrasonic emulsator, under 100 W~1000 W, disperse 1~5 min, repeat 3~4 times, embedding, sterilizing, obtains.
6. the preparation method of the cyperus-amomum stomach Orally taken emulsion described in one of claim 1-2, is characterized in that comprising following steps: get volatile oil, medicinal oil, antioxidant and antiseptic mix homogeneously, 40~80 ℃ of preheatings, make oil phase standby; Under slowly stirring, in the mode of thin jet, the water that includes cyperus-amomum stomach medicinal liquid, emulsifying agent, coemulsifier and water of 40~80 ℃ of preheatings is joined in the oil phase of preheating, embedding, sterilizing, obtains.
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