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CN104398657A - Preparation method of calyx seu fructus physalis dispersing tablet - Google Patents

Preparation method of calyx seu fructus physalis dispersing tablet Download PDF

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CN104398657A
CN104398657A CN201410610709.3A CN201410610709A CN104398657A CN 104398657 A CN104398657 A CN 104398657A CN 201410610709 A CN201410610709 A CN 201410610709A CN 104398657 A CN104398657 A CN 104398657A
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dispersible tablet
seu fructus
calyx seu
fructus physalis
microcrystalline cellulose
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王晓林
钟方丽
薛健飞
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Jilin Institute of Chemical Technology
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/81Solanaceae (Potato family), e.g. tobacco, nightshade, tomato, belladonna, capsicum or jimsonweed
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2059Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/30Extraction of the material
    • A61K2236/33Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
    • A61K2236/333Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using mixed solvents, e.g. 70% EtOH
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/30Extraction of the material
    • A61K2236/39Complex extraction schemes, e.g. fractionation or repeated extraction steps

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Abstract

本发明公开了一种具有降血糖作用的锦灯笼分散片的制备方法。该分散片是以锦灯笼经提取、纯化制得的浸膏为原料,稀释剂为乳糖、微晶纤维素、硫酸钙,崩解剂为交联聚乙烯吡咯烷酮、羧甲基淀粉钠、低取代羟丙基纤维素,润滑剂为微粉硅胶,矫味剂为甜菊糖苷,粘合剂为5-10%聚乙烯吡咯烷酮K30的乙醇溶液或95%乙醇制成,该分散片在3min内完全崩解且达到均匀分散状态,该分散片具有崩解溶出速度快、生物利用度高、制备工艺较为简单的特点,适合工业化大生产。The invention discloses a preparation method of Jindenglong dispersible tablets with hypoglycemic effect. The dispersible tablet is made from the extract obtained by extracting and purifying Jindenglong, the diluent is lactose, microcrystalline cellulose, calcium sulfate, and the disintegrating agent is cross-linked polyvinylpyrrolidone, sodium carboxymethyl starch, low-substituted Hydroxypropyl cellulose, the lubricant is micro powdered silica gel, the flavoring agent is steviol glycoside, the binder is made of 5-10% polyvinylpyrrolidone K30 ethanol solution or 95% ethanol, and the dispersible tablet disintegrates completely within 3 minutes And reach a uniformly dispersed state, the dispersible tablet has the characteristics of fast disintegration and dissolution speed, high bioavailability, and relatively simple preparation process, and is suitable for industrialized large-scale production.

Description

一种锦灯笼分散片的制备方法A kind of preparation method of Jindenglan dispersible tablet

技术领域 technical field

本发明涉及医药技术领域,具体涉及一种锦灯笼分散片的制备方法。 The invention relates to the technical field of medicine, in particular to a preparation method of Jindenglong dispersible tablets.

背景技术 Background technique

锦灯笼为茄科植物酸浆的干燥宿萼或带果实的宿萼,是中华人民共和国药典收录的常用中药材。锦灯笼具有清热解毒、利咽化痰和利尿之功效, 用于治疗咽痛、音哑、痰热咳嗽、小便不利等,外治天疱疮、湿疹,民间常用于治疗急、慢性气管炎和咽炎及糖尿病等。锦灯笼的化学成分复杂,主要含有甾类、黄酮、生物碱、氨基酸、矿物元素及维生素。另外,还含有玉蜀黍黄素,树脂、果胶质、鞣质、粘液质、多糖、有机酸类及香豆素类等。锦灯笼具有众多药理作用,如:抗菌作用、降血糖作用、强心作用、兴奋子宫的作用、利尿作用、抗癌作用。另外,锦灯笼还具有抗炎、避孕、调节免疫功能、解热镇痛作用等药理作用。 Jindeng is the dry persistent calyx or the persistent calyx with fruit of Physalis Physalis of Solanaceae plant, which is a commonly used Chinese medicinal material included in the Pharmacopoeia of the People's Republic of China. Brocade lanterns have the effects of clearing heat and detoxification, relieving pharynx and phlegm, and diuresis. It is used to treat sore throat, hoarseness, phlegm-heat cough, dysuria, etc. It is also used for external treatment of pemphigus and eczema. It is commonly used by folks to treat acute and chronic bronchitis and Pharyngitis and diabetes etc. The chemical composition of brocade lanterns is complex, mainly containing steroids, flavonoids, alkaloids, amino acids, mineral elements and vitamins. In addition, it also contains zeaxanthin, resin, pectin, tannin, mucus, polysaccharide, organic acid and coumarin. Brocade lanterns have many pharmacological effects, such as: antibacterial effect, hypoglycemic effect, cardiotonic effect, excitatory effect of uterus, diuretic effect, anticancer effect. In addition, brocade lanterns also have pharmacological effects such as anti-inflammatory, contraceptive, immune function regulation, antipyretic and analgesic effects.

目前,锦灯笼的开发速度还较慢,研究内容还不全面,这极大地制约了锦灯笼的广泛应用与开发,锦灯笼资源丰富,每年均可采收,原料易得、价廉,且含有多种丰富活性成分,如果能将锦灯笼制成活性成分较高的提取物,再将提取物制成分散片,可充分地利用自然资源,对提高其经济效益和促进吉林省北药基地建设具有深远的意义。 At present, the development speed of brocade lanterns is still relatively slow, and the research content is not comprehensive, which greatly restricts the wide application and development of brocade lanterns. Brocade lanterns are rich in resources and can be harvested every year. The raw materials are easy to get, cheap, and contain A variety of rich active ingredients, if brocade lanterns can be made into extracts with high active ingredients, and then the extracts can be made into dispersible tablets, which can make full use of natural resources, improve its economic benefits and promote the construction of Beiyao base in Jilin Province has far-reaching significance.

分散片既可口服,也可分散于水中作为溶液剂服用,具有口服方便、崩解时间短、分散均匀、药物溶出迅速、吸收快、生物利用度高、不良反应小等优点。尤其对吞咽困难的儿童和老人更加方便。本发明研究设计了以锦灯笼提取物为主要活性成分的中药分散片,可方便地应用于高血糖患者的防治。 Dispersible tablets can be taken orally or dispersed in water and taken as a solution. They have the advantages of convenient oral administration, short disintegration time, uniform dispersion, rapid drug dissolution, fast absorption, high bioavailability, and small adverse reactions. It is especially convenient for children and the elderly who have difficulty swallowing. The present invention studies and designs a traditional Chinese medicine dispersible tablet with the extract of brocade lanterns as the main active ingredient, which can be conveniently applied to the prevention and treatment of patients with hyperglycemia.

发明内容 Contents of the invention

本发明的目的在于,提供一种锦灯笼分散片的制备方法。该分散片是以锦灯笼经提取制得的浸膏为原料,稀释剂为乳糖、微晶纤维素、硫酸钙,崩解剂为交联聚乙烯吡咯烷酮、羧甲基淀粉钠、低取代羟丙基纤维素,润滑剂为微粉硅胶,矫味剂为甜菊糖苷,粘合剂为5-10%聚乙烯吡咯烷酮K30的乙醇溶液或95%乙醇制成,该分散片在3 min内完全崩解且达到均匀分散状态,该分散片具有崩解溶出速度快、生物利用度高、制备工艺较为简单的特点,适合工业化大生产。 The object of the present invention is to provide a preparation method of brocade lantern dispersible tablets. The dispersible tablet is made from the extract obtained by extracting Jindenglong, the diluent is lactose, microcrystalline cellulose, calcium sulfate, and the disintegrating agent is cross-linked polyvinylpyrrolidone, sodium carboxymethyl starch, low-substituted hydroxypropyl base cellulose, the lubricant is micropowder silica gel, the flavoring agent is steviol glycoside, and the binder is made of 5-10% polyvinylpyrrolidone K30 ethanol solution or 95% ethanol. The dispersible tablet disintegrates completely within 3 minutes and Evenly dispersed, the dispersible tablet has the characteristics of fast disintegration and dissolution, high bioavailability, and relatively simple preparation process, and is suitable for industrialized large-scale production.

本发明所述的锦灯笼分散片,该分散片以1000片为基数,原料锦灯笼2000g,稀释剂微晶纤维素100-150g、乳糖50-100g,崩解剂交联聚乙烯吡咯烷酮30-60g,润滑剂微粉硅胶5-20g,矫味剂甜菊糖苷1.5-3.0g,粘合剂为5-10%聚乙烯吡咯烷酮的乙醇溶液50-200mL制成。 The brocade lantern dispersible tablet of the present invention, the dispersible tablet is based on 1000 tablets, raw material brocade lantern 2000g, diluent microcrystalline cellulose 100-150g, lactose 50-100g, disintegrant cross-linked polyvinylpyrrolidone 30-60g , 5-20g of fine powdered silica gel as lubricant, 1.5-3.0g of steviol glycoside as flavoring agent, and 50-200mL of 5-10% polyvinylpyrrolidone ethanol solution as binder.

本发明所述的锦灯笼分散片,该分散片以1000片为基数,原料锦灯笼2000g,稀释剂微晶纤维素100-150g、硫酸钙50-100g,崩解剂交联羧甲基淀粉钠20-40g、低取代羟丙纤维素10-40g,润滑剂微粉硅胶3-10g,矫味剂甜菊糖苷1.5-3.0g,粘合剂为5-10%聚乙烯吡咯烷酮的乙醇溶液50-200mL制成。 Brocade lantern dispersible tablet according to the present invention, the dispersible tablet is based on 1000 tablets, raw material brocade lantern 2000g, diluent microcrystalline cellulose 100-150g, calcium sulfate 50-100g, disintegrant cross-linked sodium carboxymethyl starch 20-40g, low-substituted hydroxypropyl cellulose 10-40g, lubricant micro-powder silica gel 3-10g, flavoring agent steviol glycoside 1.5-3.0g, binder 50-200mL of 5-10% polyvinylpyrrolidone ethanol solution become.

本发明所述的锦灯笼分散片,该分散片以1000片为基数,原料锦灯笼2000g,稀释剂微晶纤维素100-150g、硫酸钙50-100g,崩解剂交联羧甲基淀粉钠20-40g、低取代羟丙纤维素10-40g,润滑剂微粉硅胶5-20g,矫味剂甜菊糖苷1.5-3.0g,粘合剂为95%乙醇溶液50-200mL制成。 Brocade lantern dispersible tablet according to the present invention, the dispersible tablet is based on 1000 tablets, raw material brocade lantern 2000g, diluent microcrystalline cellulose 100-150g, calcium sulfate 50-100g, disintegrant cross-linked sodium carboxymethyl starch 20-40g, 10-40g of low-substituted hydroxypropyl cellulose, 5-20g of micro-powdered silica gel as a lubricant, 1.5-3.0g of steviol glycoside as a flavoring agent, and 50-200mL of 95% ethanol solution as a binder.

本发明所述的锦灯笼分散片,该分散片以1000片为基数,原料锦灯笼2000g,稀释剂微晶纤维素100-150g、乳糖50-100g,崩解剂交联聚乙烯吡咯烷酮30-60g,润滑剂微粉硅胶3-10g,矫味剂甜菊糖苷1.5-3.0g,粘合剂为95%乙醇溶液50-200mL制成。 The brocade lantern dispersible tablet of the present invention, the dispersible tablet is based on 1000 tablets, raw material brocade lantern 2000g, diluent microcrystalline cellulose 100-150g, lactose 50-100g, disintegrant cross-linked polyvinylpyrrolidone 30-60g , 3-10g of micro-powdered silica gel as lubricant, 1.5-3.0g of steviol glycoside as flavoring agent, and 50-200mL of 95% ethanol solution as the adhesive.

  所述的锦灯笼分散片的制备方法,按以下步骤进行: The preparation method of described brocade lantern dispersible tablet, carry out according to the following steps:

a、中药制取过程:取锦灯笼2000g,加8倍量80%乙醇回流提取2次,每次3 h,滤过,滤液备用,合并滤液,回收乙醇,浓缩至相对密度为1.14-1.20 (60℃)的清膏,加蒸馏水分散成浓度为0.25-0.35 g/mL (相当于原生药),药液pH值调为10,经过D-101型大孔吸附树脂吸附时间30 min,吸附速率为1-2 BV/h,吸附后用3 BV蒸馏水洗脱,再用3-5 BV 的70%乙醇以1-2 BV/h的流速洗脱,收集洗脱液,浓缩,真空干燥成干膏,将上述干膏粉碎成细粉; a. Preparation process of traditional Chinese medicine: Take 2000g of brocade lanterns, add 8 times the amount of 80% ethanol to reflux and extract twice, each time for 3 hours, filter, the filtrate is set aside, combine the filtrate, recover ethanol, concentrate to a relative density of 1.14-1.20 ( 60℃) clear ointment, add distilled water to disperse to a concentration of 0.25-0.35 g/mL (equivalent to the original drug), adjust the pH value of the liquid to 10, after the D-101 macroporous adsorption resin adsorption time of 30 minutes, the adsorption rate 1-2 BV/h, eluted with 3 BV distilled water after adsorption, then eluted with 3-5 BV of 70% ethanol at a flow rate of 1-2 BV/h, collected the eluate, concentrated, and dried in vacuum paste, the above-mentioned dry paste is crushed into fine powder;

b、将原料锦灯笼干浸膏,稀释剂微晶纤维素、硫酸钙、乳糖,崩解剂交联聚乙烯吡咯烷酮、交联羧甲基淀粉钠、低取代羟丙纤维素,润滑剂微粉硅胶,矫味剂甜菊糖苷,粘合剂聚乙烯吡咯烷酮粉碎,过80-100目筛,备用; b. The raw material Jindenglong dry extract, diluent microcrystalline cellulose, calcium sulfate, lactose, disintegrant cross-linked polyvinylpyrrolidone, cross-linked carboxymethyl starch sodium, low-substituted hydroxypropyl cellulose, lubricant micropowder silica gel , the flavoring agent steviol glycoside, and the binder polyvinylpyrrolidone are pulverized, passed through a 80-100 mesh sieve, and set aside;

c、按处方量每1000片为基数,取步骤b的原料锦灯笼干浸膏,稀释剂微晶纤维素125-150g、硫酸钙60-80g或微晶纤维素125-150g、乳糖60-80g或微晶纤维素100-125g、硫酸钙50-60g、乳糖50-60g,崩解剂交联羧甲基淀粉钠15g、低取代羟丙纤维素10g或交联聚乙烯吡咯烷酮20g或交联聚乙烯吡咯烷酮10g、交联羧甲基淀粉钠10g、低取代羟丙纤维素5g,矫味剂甜菊糖苷2g于混合机中混匀,加入粘合剂10%聚乙烯吡咯烷酮的乙醇溶液或95%乙醇160mL,用高速制粒机或摇摆式颗粒机制软材,软材用24目筛制粒,湿颗粒于60℃下干燥; c. According to the prescription quantity per 1000 tablets as the base, take the raw material Jindenglong dry extract of step b, diluent microcrystalline cellulose 125-150g, calcium sulfate 60-80g or microcrystalline cellulose 125-150g, lactose 60-80g Or microcrystalline cellulose 100-125g, calcium sulfate 50-60g, lactose 50-60g, disintegrant cross-linked carboxymethyl starch sodium 15g, low-substituted hydroxypropyl cellulose 10g or cross-linked polyvinylpyrrolidone 20g or cross-linked polyvinylpyrrolidone Vinylpyrrolidone 10g, cross-linked carboxymethyl starch sodium 10g, low-substituted hydroxypropyl cellulose 5g, flavoring agent steviol glycoside 2g, mix in a mixer, add binder 10% polyvinylpyrrolidone ethanol solution or 95% ethanol 160mL, use a high-speed granulator or a oscillating granulator for soft materials, use a 24-mesh sieve to granulate the soft materials, and dry the wet granules at 60°C;

d、湿颗粒干燥后,用24目筛整粒,加入崩解剂交联羧甲基淀粉钠15g、低取代羟丙纤维素10g或交联聚乙烯吡咯烷酮30g或交联聚乙烯吡咯烷酮10g、交联羧甲基淀粉钠10g、低取代羟丙纤维素5g,润滑剂微粉硅胶3-5g,混匀,压片,即得锦灯笼分散片。 d. After the wet granules are dried, use a 24-mesh sieve to size the granules, add 15g of disintegrant cross-linked carboxymethyl starch sodium, 10g of low-substituted hydroxypropyl cellulose or 30g of cross-linked polyvinylpyrrolidone or 10g of cross-linked polyvinylpyrrolidone, cross-linked polyvinylpyrrolidone, Dicarboxymethyl starch sodium 10g, low-substituted hydroxypropyl cellulose 5g, lubricant micropowder silica gel 3-5g, mix well, and compress into tablets to obtain brocade lantern dispersible tablets.

 本发明所述的锦灯笼分散片中含有有效治疗剂量的锦灯笼干浸膏和适合制备分散片的药用载体,所述的药用载体选自:稀释剂乳糖、微晶纤维素、硫酸钙,崩解剂交联聚乙烯吡咯烷酮、交联羧甲基淀粉钠、低取代羟丙纤维素,润滑剂微粉硅胶,矫味剂甜菊糖苷,粘合剂为5-10%聚乙烯吡咯烷酮的乙醇溶液或95%乙醇。 The Jindenglong dispersible tablet of the present invention contains an effective therapeutic dose of Jindenglong dry extract and a pharmaceutical carrier suitable for preparing a dispersible tablet, and the pharmaceutical carrier is selected from: diluent lactose, microcrystalline cellulose, calcium sulfate , disintegrant cross-linked polyvinylpyrrolidone, cross-linked sodium carboxymethyl starch, low-substituted hydroxypropyl cellulose, lubricant micropowder silica gel, flavoring agent steviol glycoside, binder is 5-10% ethanol solution of polyvinylpyrrolidone or 95% ethanol.

本发明所述的锦灯笼分散片符合中国药典2010版关于分散片的相关规定:该分散片在3 min内完全崩解且达到均匀分散状态。 The Jindenglong dispersible tablet of the present invention complies with the relevant provisions of the Chinese Pharmacopoeia 2010 edition on dispersible tablets: the dispersible tablet disintegrates completely within 3 minutes and reaches a uniformly dispersed state.

下面结合实例进一步说明本发明,但本发明要求保护的范围并不局限于下列实施方式。 The present invention is further described below in conjunction with examples, but the scope of protection of the present invention is not limited to the following embodiments.

实施例1 Example 1

a、中药制取过程:取锦灯笼2000g,加8倍量80%乙醇回流提取2次,每次3 h,滤过,滤液备用,合并滤液,回收乙醇,浓缩至相对密度为1.14-1.20 (60℃)的清膏,加蒸馏水分散成浓度为0.25-0.35 g/mL (相当于原生药),药液pH值调为10,经过D-101型大孔吸附树脂吸附时间30 min,吸附速率为1-2 BV/h,吸附后用3 BV蒸馏水洗脱,再用3-5 BV 的70%乙醇以1-2 BV/h的流速洗脱,收集洗脱液,浓缩,真空干燥成干膏,将上述干膏粉碎成细粉; a. Preparation process of traditional Chinese medicine: Take 2000g of brocade lanterns, add 8 times the amount of 80% ethanol to reflux and extract twice, each time for 3 hours, filter, the filtrate is set aside, combine the filtrate, recover ethanol, concentrate to a relative density of 1.14-1.20 ( 60℃) clear ointment, add distilled water to disperse to a concentration of 0.25-0.35 g/mL (equivalent to the original drug), adjust the pH value of the liquid to 10, after the D-101 macroporous adsorption resin adsorption time of 30 minutes, the adsorption rate 1-2 BV/h, eluted with 3 BV distilled water after adsorption, then eluted with 3-5 BV of 70% ethanol at a flow rate of 1-2 BV/h, collected the eluate, concentrated, and dried in vacuum paste, the above-mentioned dry paste is crushed into fine powder;

b、将原料锦灯笼干浸膏,稀释剂微晶纤维素、乳糖,崩解剂交联聚乙烯吡咯烷酮,润滑剂微粉硅胶,矫味剂甜菊糖苷,粘合剂聚乙烯吡咯烷酮粉碎,过80-100目筛,备用; b. Grind the raw material Jindenglong dry extract, diluent microcrystalline cellulose, lactose, disintegrant cross-linked polyvinylpyrrolidone, lubricant micropowder silica gel, flavoring agent steviol glycoside, binder polyvinylpyrrolidone, and pass 80- 100 mesh sieve, spare;

c、按处方量每1000片为基数,取步骤b的原料锦灯笼干浸膏,稀释剂微晶纤维素125-150g、乳糖60-80g,崩解剂交联聚乙烯吡咯烷酮20g,矫味剂甜菊糖苷2g于混合机中混匀,加入粘合剂10%聚乙烯吡咯烷酮的乙醇溶液160mL,用高速制粒机或摇摆式颗粒机制软材,软材用24目筛制粒,湿颗粒于60℃条件下烘干干燥; c. According to the prescription quantity per 1000 tablets as the base, take the raw material Jindenglong dry extract of step b, diluent microcrystalline cellulose 125-150g, lactose 60-80g, disintegrant cross-linked polyvinylpyrrolidone 20g, flavoring agent Mix 2 g of steviol glycosides in a mixer, add 160 mL of ethanol solution of 10% polyvinylpyrrolidone as a binder, use a high-speed granulator or a swinging granulator to make soft materials, use a 24-mesh sieve to granulate the soft materials, and wet the granules at 60 Drying at ℃;

d、湿颗粒干燥后,用24目筛整粒,加入崩解剂交联聚乙烯吡咯烷酮30g,润滑剂微粉硅胶3-5g,混匀,压片,即得锦灯笼分散片。 d. After the wet granules are dried, use a 24-mesh sieve to sieve the granules, add 30g of disintegrating agent cross-linked polyvinylpyrrolidone, and 3-5g of lubricant micropowder silica gel, mix well, and press into tablets to obtain brocade lantern dispersible tablets.

实施例2 Example 2

a、中药制取过程:取锦灯笼2000g,加8倍量80%乙醇回流提取2次,每次3 h,滤过,滤液备用,合并滤液,回收乙醇,浓缩至相对密度为1.14-1.20 (60℃)的清膏,加蒸馏水分散成浓度为0.25-0.35 g/mL (相当于原生药),药液pH值调为10,经过D-101型大孔吸附树脂吸附时间30 min,吸附速率为1-2 BV/h,吸附后用3 BV蒸馏水洗脱,再用3-5 BV 的70%乙醇以1-2 BV/h的流速洗脱,收集洗脱液,浓缩,真空干燥成干膏,将上述干膏粉碎成细粉; a. Preparation process of traditional Chinese medicine: Take 2000g of brocade lanterns, add 8 times the amount of 80% ethanol to reflux and extract twice, each time for 3 hours, filter, the filtrate is set aside, combine the filtrate, recover ethanol, concentrate to a relative density of 1.14-1.20 ( 60℃) clear ointment, add distilled water to disperse to a concentration of 0.25-0.35 g/mL (equivalent to the original drug), adjust the pH value of the liquid to 10, after the D-101 macroporous adsorption resin adsorption time of 30 minutes, the adsorption rate 1-2 BV/h, eluted with 3 BV distilled water after adsorption, then eluted with 3-5 BV of 70% ethanol at a flow rate of 1-2 BV/h, collected the eluate, concentrated, and dried in vacuum paste, the above-mentioned dry paste is crushed into fine powder;

b、将原料锦灯笼干浸膏,稀释剂微晶纤维素、乳糖,崩解剂交联聚乙烯吡咯烷酮,润滑剂微粉硅胶,矫味剂甜菊糖苷,过80-100目筛,备用; b. The raw material Jindenglong dry extract, diluent microcrystalline cellulose, lactose, disintegrant cross-linked polyvinylpyrrolidone, lubricant micropowder silica gel, flavoring agent steviol glycoside, pass through a 80-100 mesh sieve, and set aside;

c、按处方量每1000片为基数,取步骤b的原料锦灯笼干浸膏,稀释剂微晶纤维素125-150g、乳糖60-80g,崩解剂交联聚乙烯吡咯烷酮20g,矫味剂甜菊糖苷2g于混合机中混匀,加入粘合剂95%乙醇溶液160mL,用高速制粒机或摇摆式颗粒机制软材,软材用24目筛制粒,湿颗粒于60℃下烘干干燥; c. According to the prescription quantity per 1000 tablets as the base, take the raw material Jindenglong dry extract of step b, diluent microcrystalline cellulose 125-150g, lactose 60-80g, disintegrant cross-linked polyvinylpyrrolidone 20g, flavoring agent Mix 2 g of steviol glycosides in a mixer, add 160 mL of 95% ethanol solution of the binder, use a high-speed granulator or a swinging granulator to make soft materials, use a 24-mesh sieve to granulate the soft materials, and dry the wet granules at 60°C dry;

d、湿颗粒干燥后,用24目筛整粒,加入崩解剂交联聚乙烯吡咯烷酮30g,润滑剂微粉硅胶3-5g,混匀,压片,即得锦灯笼分散片。 d. After the wet granules are dried, use a 24-mesh sieve to sieve the granules, add 30g of disintegrating agent cross-linked polyvinylpyrrolidone, and 3-5g of lubricant micropowder silica gel, mix well, and press into tablets to obtain brocade lantern dispersible tablets.

实施例3 Example 3

a、中药制取过程:取锦灯笼2000g,加8倍量80%乙醇回流提取2次,每次3 h,滤过,滤液备用,合并滤液,回收乙醇,浓缩至相对密度为1.14-1.20(60℃)的清膏,加蒸馏水分散成浓度为0.25-0.35 g/mL (相当于原生药),药液pH值调为10,经过D-101型大孔吸附树脂吸附时间30 min,吸附速率为1-2 BV/h,吸附后用3 BV蒸馏水洗脱,再用3-5 BV 的70%乙醇以1-2 BV/h的流速洗脱,收集洗脱液,浓缩,真空干燥成干膏,将上述干膏粉碎成细粉; a. Preparation process of traditional Chinese medicine: Take 2000g of brocade lanterns, add 8 times the amount of 80% ethanol to reflux and extract twice, each time for 3 hours, filter, the filtrate is set aside, combine the filtrate, recover ethanol, concentrate to a relative density of 1.14-1.20( 60℃) clear ointment, add distilled water to disperse to a concentration of 0.25-0.35 g/mL (equivalent to the original drug), adjust the pH value of the liquid to 10, after the D-101 macroporous adsorption resin adsorption time of 30 minutes, the adsorption rate 1-2 BV/h, eluted with 3 BV distilled water after adsorption, then eluted with 3-5 BV of 70% ethanol at a flow rate of 1-2 BV/h, collected the eluate, concentrated, and dried in vacuum paste, the above-mentioned dry paste is crushed into fine powder;

b、将原料锦灯笼干浸膏,稀释剂微晶纤维素、硫酸钙,崩解剂交联羧甲基淀粉钠、低取代羟丙纤维素,润滑剂微粉硅胶,矫味剂甜菊糖苷,粘合剂聚乙烯吡咯烷酮粉碎,过80-100目筛,备用; b. The raw material Jindenglong dry extract, diluent microcrystalline cellulose, calcium sulfate, disintegrant croscarmellose sodium starch, low-substituted hydroxypropyl cellulose, lubricant micropowder silica gel, flavoring agent steviol glycoside, viscose Mixture polyvinylpyrrolidone is crushed, passed through 80-100 mesh sieve, and set aside;

c、按处方量每1000片为基数,取步骤b的原料锦灯笼干浸膏,稀释剂微晶纤维素125-150g、硫酸钙60-80g,崩解剂交联羧甲基淀粉钠15g、低取代羟丙纤维素10g,矫味剂甜菊糖苷2g于混合机中混匀,加入粘合剂10%聚乙烯吡咯烷酮的乙醇溶液160mL,用高速制粒机或摇摆式颗粒机制软材,软材用24目筛制粒,湿颗粒于60℃下烘干干燥; c, according to the prescription quantity per 1000 tablets as the base, take the raw material Jindenglong dry extract of step b, diluent microcrystalline cellulose 125-150g, calcium sulfate 60-80g, disintegrant cross-linked sodium carboxymethyl starch 15g, Low-substituted hydroxypropyl cellulose 10g, flavoring agent steviol glycoside 2g, mix in a mixer, add binder 10% polyvinylpyrrolidone ethanol solution 160mL, use high-speed granulator or oscillating granulation machine to make soft material, soft material Granulate with a 24-mesh sieve, and dry the wet granules at 60°C;

d、湿颗粒干燥后,用24目筛整粒,加入崩解剂交联羧甲基淀粉钠15g、低取代羟丙纤维素10g,润滑剂微粉硅胶3-5g,混匀,压片,即得锦灯笼分散片。 d. After the wet granules are dried, use a 24-mesh sieve to sieve the granules, add 15g of disintegrant cross-linked carboxymethyl starch sodium, 10g of low-substituted hydroxypropyl cellulose, 3-5g of lubricant micropowder silica gel, mix well, and press into tablets, that is, Get brocade lantern dispersible tablets.

 实施例4 Example 4

a、中药制取过程:取锦灯笼2000g,加8倍量80%乙醇回流提取2次,每次3 h,滤过,滤液备用,合并滤液,回收乙醇,浓缩至相对密度为1.14-1.20(60℃)的清膏,加蒸馏水分散成浓度为0.25-0.35 g/mL (相当于原生药),药液pH值调为10,经过D-101型大孔吸附树脂吸附时间30 min,吸附速率为1-2 BV/h,吸附后用3 BV蒸馏水洗脱,再用3-5 BV 的70%乙醇以1-2 BV/h的流速洗脱,收集洗脱液,浓缩,真空干燥成干膏,将上述干膏粉碎成细粉; a. Preparation process of traditional Chinese medicine: Take 2000g of brocade lanterns, add 8 times the amount of 80% ethanol to reflux and extract twice, each time for 3 hours, filter, the filtrate is set aside, combine the filtrate, recover ethanol, concentrate to a relative density of 1.14-1.20( 60℃) clear ointment, add distilled water to disperse to a concentration of 0.25-0.35 g/mL (equivalent to the original drug), adjust the pH value of the liquid to 10, after the D-101 macroporous adsorption resin adsorption time of 30 minutes, the adsorption rate 1-2 BV/h, eluted with 3 BV distilled water after adsorption, then eluted with 3-5 BV of 70% ethanol at a flow rate of 1-2 BV/h, collected the eluate, concentrated, and dried in vacuum paste, the above-mentioned dry paste is crushed into fine powder;

b、将原料锦灯笼干浸膏,稀释剂微晶纤维素、硫酸钙,崩解剂交联羧甲基淀粉钠、低取代羟丙纤维素,润滑剂微粉硅胶,矫味剂甜菊糖苷,过80-100目筛,备用; b. The raw material Jindenglong dry extract, diluent microcrystalline cellulose, calcium sulfate, disintegrant croscarmellose sodium starch, low-substituted hydroxypropyl cellulose, lubricant micropowder silica gel, flavoring agent steviol glycoside, over 80-100 mesh sieve, spare;

c、按处方量每1000片为基数,取步骤b的原料锦灯笼干浸膏,稀释剂微晶纤维素125-150g、硫酸钙60-80g,崩解剂交联羧甲基淀粉钠15g、低取代羟丙纤维素10g,矫味剂甜菊糖苷2g于混合机中混匀,加入粘合剂95%乙醇溶液200mL,用高速制粒机或摇摆式颗粒机制软材,软材用24目筛制粒,湿颗粒于60℃下烘干干燥; c, according to the prescription quantity per 1000 tablets as the base, take the raw material Jindenglong dry extract of step b, diluent microcrystalline cellulose 125-150g, calcium sulfate 60-80g, disintegrant cross-linked sodium carboxymethyl starch 15g, Low-substituted hydroxypropyl cellulose 10g, flavoring agent steviol glycoside 2g, mix in a mixer, add binder 95% ethanol solution 200mL, use high-speed granulator or oscillating granulation machine to make soft material, use 24 mesh sieve for soft material Granulating, drying wet granules at 60°C;

d、湿颗粒干燥后,用24目筛整粒,加入崩解剂交联羧甲基淀粉钠15g、低取代羟丙纤维素10g,润滑剂微粉硅胶3-5g,混匀,压片,即得锦灯笼分散片。 d. After the wet granules are dried, use a 24-mesh sieve to sieve the granules, add 15g of disintegrant cross-linked carboxymethyl starch sodium, 10g of low-substituted hydroxypropyl cellulose, 3-5g of lubricant micropowder silica gel, mix well, and press into tablets, that is, Get brocade lantern dispersible tablets.

 实施例5 Example 5

a、中药制取过程:取锦灯笼2000g,加8倍量80%乙醇回流提取2次,每次3 h,滤过,滤液备用,合并滤液,回收乙醇,浓缩至相对密度为1.14-1.20(60℃)的清膏,加蒸馏水分散成浓度为0.25-0.35 g/mL (相当于原生药),药液pH值调为10,经过D-101型大孔吸附树脂吸附时间30 min,吸附速率为1-2 BV/h,吸附后用3 BV蒸馏水洗脱,再用3-5 BV 的70%乙醇以1-2 BV/h的流速洗脱,收集洗脱液,浓缩,真空干燥成干膏,将上述干膏粉碎成细粉; a. Preparation process of traditional Chinese medicine: Take 2000g of brocade lanterns, add 8 times the amount of 80% ethanol to reflux and extract twice, each time for 3 hours, filter, the filtrate is set aside, combine the filtrate, recover ethanol, concentrate to a relative density of 1.14-1.20( 60℃) clear ointment, add distilled water to disperse to a concentration of 0.25-0.35 g/mL (equivalent to the original drug), adjust the pH value of the liquid to 10, after the D-101 macroporous adsorption resin adsorption time of 30 minutes, the adsorption rate 1-2 BV/h, eluted with 3 BV distilled water after adsorption, then eluted with 3-5 BV of 70% ethanol at a flow rate of 1-2 BV/h, collected the eluate, concentrated, and dried in vacuum paste, the above-mentioned dry paste is crushed into fine powder;

b、将原料锦灯笼干浸膏,稀释剂微晶纤维素、硫酸钙、乳糖,崩解剂交联聚乙烯吡咯烷酮、交联羧甲基淀粉钠、低取代羟丙纤维素,润滑剂微粉硅胶,矫味剂甜菊糖苷,粘合剂聚乙烯吡咯烷酮粉碎,过80-100目筛,备用; b. Raw material Jindenglong dry extract, diluent microcrystalline cellulose, calcium sulfate, lactose, disintegrant cross-linked polyvinylpyrrolidone, cross-linked sodium carboxymethyl starch, low-substituted hydroxypropyl cellulose, lubricant micro-powder silica gel , the flavoring agent steviol glycoside, and the binder polyvinylpyrrolidone are pulverized, passed through a 80-100 mesh sieve, and set aside;

c、按处方量每1000片为基数,取步骤b的原料锦灯笼干浸膏,稀释剂微晶纤维素100-125g、硫酸钙50-60g、乳糖50-60g,崩解剂交联聚乙烯吡咯烷酮10g、交联羧甲基淀粉钠10g、低取代羟丙纤维素5g,矫味剂甜菊糖苷2g于混合机中混匀,加入粘合剂10%聚乙烯吡咯烷酮的乙醇溶液160mL,用高速制粒机或摇摆式颗粒机制软材,软材用24目筛制粒,湿颗粒于60℃条件下烘干干燥; c. According to the prescription quantity per 1000 tablets, take the raw material Jindenglong dry extract of step b, diluent microcrystalline cellulose 100-125g, calcium sulfate 50-60g, lactose 50-60g, disintegrant cross-linked polyethylene Pyrrolidone 10g, cross-linked carboxymethyl starch sodium 10g, low-substituted hydroxypropyl cellulose 5g, flavoring agent steviol glycoside 2g were mixed in a mixer, and binder 10% polyvinylpyrrolidone ethanol solution 160mL was added, and the Granulator or oscillating granulator machine soft materials, soft materials are granulated with 24 mesh sieves, and the wet granules are dried at 60°C;

d、湿颗粒干燥后,用24目筛整粒,加入崩解剂交联聚乙烯吡咯烷酮10g、交联羧甲基淀粉钠10g、低取代羟丙纤维素5g,润滑剂微粉硅胶3-5g,混匀,压片,即得锦灯笼分散片。 d. After the wet granules are dried, use a 24-mesh sieve to sieve the granules, add 10 g of disintegrant cross-linked polyvinylpyrrolidone, 10 g of cross-linked carboxymethyl starch sodium, 5 g of low-substituted hydroxypropyl cellulose, and 3-5 g of lubricant micro-powder silica gel, Mix well, and press into tablets to obtain brocade lantern dispersible tablets.

 实施例6 Example 6

a、中药制取过程:取锦灯笼2000g,加8倍量80%乙醇回流提取2次,每次3 h,滤过,滤液备用,合并滤液,回收乙醇,浓缩至相对密度为1.14-1.20(60℃)的清膏,加蒸馏水分散成浓度为0.25-0.35 g/mL (相当于原生药),药液pH值调为10,经过D-101型大孔吸附树脂吸附时间30 min,吸附速率为1-2 BV/h,吸附后用3 BV蒸馏水洗脱,再用3-5 BV 的70%乙醇以1-2 BV/h的流速洗脱,收集洗脱液,浓缩,真空干燥成干膏,将上述干膏粉碎成细粉; a. Preparation process of traditional Chinese medicine: Take 2000g of brocade lanterns, add 8 times the amount of 80% ethanol to reflux and extract twice, each time for 3 hours, filter, the filtrate is set aside, combine the filtrate, recover ethanol, concentrate to a relative density of 1.14-1.20( 60℃) clear ointment, add distilled water to disperse to a concentration of 0.25-0.35 g/mL (equivalent to the original drug), adjust the pH value of the liquid to 10, after the D-101 macroporous adsorption resin adsorption time of 30 minutes, the adsorption rate 1-2 BV/h, eluted with 3 BV distilled water after adsorption, then eluted with 3-5 BV of 70% ethanol at a flow rate of 1-2 BV/h, collected the eluate, concentrated, and dried in vacuum paste, the above-mentioned dry paste is crushed into fine powder;

b、将原料锦灯笼干浸膏,稀释剂微晶纤维素、硫酸钙、乳糖,崩解剂交联聚乙烯吡咯烷酮、交联羧甲基淀粉钠、低取代羟丙纤维素,润滑剂微粉硅胶,矫味剂甜菊糖苷,过80-100目筛,备用; b. Raw material Jindenglong dry extract, diluent microcrystalline cellulose, calcium sulfate, lactose, disintegrant cross-linked polyvinylpyrrolidone, cross-linked sodium carboxymethyl starch, low-substituted hydroxypropyl cellulose, lubricant micro-powder silica gel , the flavoring agent steviol glycoside, passed through a 80-100 mesh sieve, and set aside;

c、按处方量每1000片为基数,取步骤b的原料锦灯笼干浸膏,稀释剂微晶纤维素100-125g、硫酸钙50-60g、乳糖50-60g,崩解剂交联聚乙烯吡咯烷酮10g、交联羧甲基淀粉钠10g、低取代羟丙纤维素5g,矫味剂甜菊糖苷2g于混合机中混匀,加入粘合剂95%乙醇溶液200mL,用高速制粒机或摇摆式颗粒机制软材,软材用24目筛制粒,湿颗粒于60℃下烘干干燥; c. According to the prescription quantity per 1000 tablets, take the raw material Jindenglong dry extract of step b, diluent microcrystalline cellulose 100-125g, calcium sulfate 50-60g, lactose 50-60g, disintegrant cross-linked polyethylene Pyrrolidone 10g, cross-linked carboxymethyl starch sodium 10g, low-substituted hydroxypropyl cellulose 5g, flavoring agent steviol glycoside 2g and mix in a mixer, add binder 95% ethanol solution 200mL, use a high-speed granulator or shake Type granulation mechanism soft material, soft material is granulated with a 24 mesh sieve, and the wet granules are dried at 60°C;

d、湿颗粒干燥后,用24目筛整粒,加入崩解剂交联聚乙烯吡咯烷酮10g、交联羧甲基淀粉钠10g、低取代羟丙纤维素5g,润滑剂微粉硅胶3-5g,混匀,压片,即得锦灯笼分散片。 d. After the wet granules are dried, use a 24-mesh sieve to sieve the granules, add 10 g of disintegrant cross-linked polyvinylpyrrolidone, 10 g of cross-linked carboxymethyl starch sodium, 5 g of low-substituted hydroxypropyl cellulose, and 3-5 g of lubricant micro-powder silica gel, Mix well, and press into tablets to obtain brocade lantern dispersible tablets.

Claims (5)

1. one kind has the Calyx Seu Fructus Physalis dispersible tablet of hypoglycemic activity, it is characterized in that this dispersible tablet with 1000 for radix, raw material Calyx Seu Fructus Physalis 2000g, diluents microcrystalline cellulose 100-250g, lactose 50-100g, disintegrating agent crospolyvinylpyrrolidone 30-60g, lubricant micropowder silica gel 3-10g, correctives stevioside 1.5-3.0g, binding agent is that the alcoholic solution 50-200mL of 5-10% polyvinylpyrrolidone makes.
2. Calyx Seu Fructus Physalis dispersible tablet as claimed in claim 1, it is characterized in that this dispersible tablet with 1000 for radix, raw material Calyx Seu Fructus Physalis 2000g, diluents microcrystalline cellulose 100-250g, calcium sulfate 50-100g, disintegrating agent crosslinked carboxymethyl fecula sodium 20-40g, low-substituted hydroxypropyl cellulose 10-40g, lubricant micropowder silica gel 3-10g, correctives stevioside 1.5-3.0g, binding agent is that the alcoholic solution 50-200mL of 5-10% polyvinylpyrrolidone makes.
3. Calyx Seu Fructus Physalis dispersible tablet as claimed in claim 1, it is characterized in that this dispersible tablet with 1000 for radix, raw material Calyx Seu Fructus Physalis 2000g, diluents microcrystalline cellulose 100-250g, calcium sulfate 50-100g, disintegrating agent crosslinked carboxymethyl fecula sodium 20-40g, low-substituted hydroxypropyl cellulose 10-40g, lubricant micropowder silica gel 3-10g, correctives stevioside 1.5-3.0g, binding agent is that 95% alcoholic solution 50-200mL makes.
4. Calyx Seu Fructus Physalis dispersible tablet as claimed in claim 1, it is characterized in that this dispersible tablet with 1000 for radix, raw material Calyx Seu Fructus Physalis 2000g, diluents microcrystalline cellulose 100-250g, lactose 50-100g, disintegrating agent crospolyvinylpyrrolidone 30-60g, lubricant micropowder silica gel 3-10g, correctives stevioside 1.5-3.0g, binding agent is that 95% alcoholic solution 50-200mL makes.
5. the preparation method of the Calyx Seu Fructus Physalis dispersible tablet according to claim 1,2,3,4, is characterized in that carrying out according to the following steps:
A, Chinese medicine producing process: get Calyx Seu Fructus Physalis 2000g, add 8 times amount 80% alcohol reflux 2 times, each 3 h, filter, filtrate is for subsequent use, merging filtrate, reclaim ethanol, be concentrated into the clear paste that relative density is 1.14-1.20 (60 DEG C), it is 0.25-0.35 g/mL (being equivalent to crude drug in whole) that adding distil water is dispersed into concentration, medicinal liquid pH value is adjusted to 10, through D-101 type absorption with macroporous adsorbent resin time 30 min, the rate of adsorption is 1-2 BV/h, with 3 BV distilled water eluting after absorption, use the flow velocity eluting of 70% ethanol with 1-2 BV/h of 3-5 BV again, collect eluent, concentrated, vacuum drying becomes dry cream, above-mentioned dried cream powder is broken into fine powder,
B, by raw material Calyx Seu Fructus Physalis dry extract, diluents microcrystalline cellulose, calcium sulfate, lactose, disintegrating agent crospolyvinylpyrrolidone, crosslinked carboxymethyl fecula sodium, low-substituted hydroxypropyl cellulose, lubricant micropowder silica gel, correctives stevioside, polyvinyl pyrrolidone is pulverized, and crosses 80-100 mesh sieve, for subsequent use;
C, by recipe quantity, every 1000 is radix, get the raw material Calyx Seu Fructus Physalis dry extract of step b, diluents microcrystalline cellulose 125-150g, calcium sulfate 60-80g or microcrystalline Cellulose 125-150g, lactose 60-80g or microcrystalline Cellulose 100-125g, calcium sulfate 50-60g, lactose 50-60g, disintegrating agent crosslinked carboxymethyl fecula sodium 15g, low-substituted hydroxypropyl cellulose 10g or crospolyvinylpyrrolidone 20g or crospolyvinylpyrrolidone 10g, crosslinked carboxymethyl fecula sodium 10g, low-substituted hydroxypropyl cellulose 5g, correctives stevioside 2g mixes in mixer, add alcoholic solution or the 95% ethanol 200mL of binding agent 10% polyvinylpyrrolidone, with high-speed granulator or oscillating granulator soft material, soft material 24 mesh sieves are granulated, wet granular is bake drying at 60 DEG C,
After d, wet grain drying, with 24 mesh sieve granulate, add disintegrating agent crosslinked carboxymethyl fecula sodium 15g, low-substituted hydroxypropyl cellulose 10g or crospolyvinylpyrrolidone 30g or crospolyvinylpyrrolidone 10g, crosslinked carboxymethyl fecula sodium 10g, low-substituted hydroxypropyl cellulose 10g, lubricant micropowder silica gel 3-5g, mixing, tabletting, obtains Calyx Seu Fructus Physalis dispersible tablet.
CN201410610709.3A 2014-11-04 2014-11-04 Preparation method of calyx seu fructus physalis dispersing tablet Pending CN104398657A (en)

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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN107617031A (en) * 2017-10-12 2018-01-23 吉林化工学院 A kind of preparation method of compound stalk ginseng lozenge
CN110624020A (en) * 2019-09-09 2019-12-31 嘉应学院医学院 Compound calyx seu fructus physalis tablet and preparation method thereof
CN116076641A (en) * 2023-01-18 2023-05-09 云南贝泰妮生物科技集团股份有限公司 Physalis flash-release powder and its preparation method and application

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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN107617031A (en) * 2017-10-12 2018-01-23 吉林化工学院 A kind of preparation method of compound stalk ginseng lozenge
CN110624020A (en) * 2019-09-09 2019-12-31 嘉应学院医学院 Compound calyx seu fructus physalis tablet and preparation method thereof
CN116076641A (en) * 2023-01-18 2023-05-09 云南贝泰妮生物科技集团股份有限公司 Physalis flash-release powder and its preparation method and application

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