CN104398657A - Preparation method of calyx seu fructus physalis dispersing tablet - Google Patents
Preparation method of calyx seu fructus physalis dispersing tablet Download PDFInfo
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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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- 238000002360 preparation method Methods 0.000 title claims abstract description 15
- 241001164374 Calyx Species 0.000 title claims description 16
- 244000064622 Physalis edulis Species 0.000 title 1
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims abstract description 85
- 239000007919 dispersible tablet Substances 0.000 claims abstract description 43
- OSGAYBCDTDRGGQ-UHFFFAOYSA-L calcium sulfate Chemical compound [Ca+2].[O-]S([O-])(=O)=O OSGAYBCDTDRGGQ-UHFFFAOYSA-L 0.000 claims abstract description 42
- 239000001267 polyvinylpyrrolidone Substances 0.000 claims abstract description 36
- 229920000036 polyvinylpyrrolidone Polymers 0.000 claims abstract description 36
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- 229920000168 Microcrystalline cellulose Polymers 0.000 claims abstract description 31
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- 239000000284 extract Substances 0.000 claims abstract description 29
- 229940031703 low substituted hydroxypropyl cellulose Drugs 0.000 claims abstract description 28
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 claims abstract description 27
- 239000003085 diluting agent Substances 0.000 claims abstract description 27
- 239000000314 lubricant Substances 0.000 claims abstract description 27
- 239000000741 silica gel Substances 0.000 claims abstract description 27
- 229910002027 silica gel Inorganic materials 0.000 claims abstract description 27
- 239000011734 sodium Substances 0.000 claims abstract description 27
- 229910052708 sodium Inorganic materials 0.000 claims abstract description 27
- 235000019202 steviosides Nutrition 0.000 claims abstract description 27
- GUBGYTABKSRVRQ-QKKXKWKRSA-N lactose group Chemical group OC1[C@H](O)[C@@H](O)[C@H](O[C@H]2[C@H](O)[C@@H](O)[C@@H](O)[C@H](O2)CO)[C@H](O1)CO GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 claims abstract description 23
- 239000011230 binding agent Substances 0.000 claims abstract description 21
- 239000008101 lactose Substances 0.000 claims abstract description 21
- 239000003795 chemical substances by application Substances 0.000 claims abstract description 11
- 230000002218 hypoglycaemic effect Effects 0.000 claims abstract description 3
- 238000001179 sorption measurement Methods 0.000 claims description 29
- 239000008187 granular material Substances 0.000 claims description 26
- 239000002994 raw material Substances 0.000 claims description 25
- 239000003814 drug Substances 0.000 claims description 19
- DGAQECJNVWCQMB-PUAWFVPOSA-M Ilexoside XXIX Chemical compound C[C@@H]1CC[C@@]2(CC[C@@]3(C(=CC[C@H]4[C@]3(CC[C@@H]5[C@@]4(CC[C@@H](C5(C)C)OS(=O)(=O)[O-])C)C)[C@@H]2[C@]1(C)O)C)C(=O)O[C@H]6[C@@H]([C@H]([C@@H]([C@H](O6)CO)O)O)O.[Na+] DGAQECJNVWCQMB-PUAWFVPOSA-M 0.000 claims description 18
- 125000002057 carboxymethyl group Chemical group [H]OC(=O)C([H])([H])[*] 0.000 claims description 17
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 17
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- GUBGYTABKSRVRQ-XLOQQCSPSA-N Alpha-Lactose Chemical compound O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@H]1O[C@@H]1[C@@H](CO)O[C@H](O)[C@H](O)[C@H]1O GUBGYTABKSRVRQ-XLOQQCSPSA-N 0.000 claims description 4
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- UEDUENGHJMELGK-HYDKPPNVSA-N Stevioside Chemical compound O([C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@H]1O[C@]12C(=C)C[C@@]3(C1)CC[C@@H]1[C@@](C)(CCC[C@]1([C@@H]3CC2)C)C(=O)O[C@H]1[C@@H]([C@@H](O)[C@H](O)[C@@H](CO)O1)O)[C@@H]1O[C@H](CO)[C@@H](O)[C@H](O)[C@H]1O UEDUENGHJMELGK-HYDKPPNVSA-N 0.000 claims 6
- 229940013618 stevioside Drugs 0.000 claims 6
- OHHNJQXIOPOJSC-UHFFFAOYSA-N stevioside Natural products CC1(CCCC2(C)C3(C)CCC4(CC3(CCC12C)CC4=C)OC5OC(CO)C(O)C(O)C5OC6OC(CO)C(O)C(O)C6O)C(=O)OC7OC(CO)C(O)C(O)C7O OHHNJQXIOPOJSC-UHFFFAOYSA-N 0.000 claims 6
- 230000001476 alcoholic effect Effects 0.000 claims 5
- 239000006071 cream Substances 0.000 claims 2
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- 239000004383 Steviol glycoside Substances 0.000 abstract description 21
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- 229930182488 steviol glycoside Natural products 0.000 abstract description 21
- 235000019411 steviol glycoside Nutrition 0.000 abstract description 21
- 150000008144 steviol glycosides Chemical group 0.000 abstract description 21
- 238000004090 dissolution Methods 0.000 abstract description 3
- 238000011031 large-scale manufacturing process Methods 0.000 abstract description 2
- 229920006316 polyvinylpyrrolidine Polymers 0.000 abstract description 2
- 239000007884 disintegrant Substances 0.000 description 24
- 229940032147 starch Drugs 0.000 description 21
- 239000003826 tablet Substances 0.000 description 18
- 241001465382 Physalis alkekengi Species 0.000 description 16
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- DPXJVFZANSGRMM-UHFFFAOYSA-N acetic acid;2,3,4,5,6-pentahydroxyhexanal;sodium Chemical compound [Na].CC(O)=O.OCC(O)C(O)C(O)C(O)C=O DPXJVFZANSGRMM-UHFFFAOYSA-N 0.000 description 2
- 206010006451 bronchitis Diseases 0.000 description 2
- ZYGHJZDHTFUPRJ-UHFFFAOYSA-N coumarin Chemical compound C1=CC=C2OC(=O)C=CC2=C1 ZYGHJZDHTFUPRJ-UHFFFAOYSA-N 0.000 description 2
- 229960001681 croscarmellose sodium Drugs 0.000 description 2
- 229920003020 cross-linked polyethylene Polymers 0.000 description 2
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- JKQXZKUSFCKOGQ-JLGXGRJMSA-N (3R,3'R)-beta,beta-carotene-3,3'-diol Chemical compound C([C@H](O)CC=1C)C(C)(C)C=1/C=C/C(/C)=C/C=C/C(/C)=C/C=C/C=C(C)C=CC=C(C)C=CC1=C(C)C[C@@H](O)CC1(C)C JKQXZKUSFCKOGQ-JLGXGRJMSA-N 0.000 description 1
- 206010067484 Adverse reaction Diseases 0.000 description 1
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- WHNWPMSKXPGLAX-UHFFFAOYSA-N N-Vinyl-2-pyrrolidone Chemical compound C=CN1CCCC1=O WHNWPMSKXPGLAX-UHFFFAOYSA-N 0.000 description 1
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- 241000721454 Pemphigus Species 0.000 description 1
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- 241000208292 Solanaceae Species 0.000 description 1
- JKQXZKUSFCKOGQ-LQFQNGICSA-N Z-zeaxanthin Natural products C([C@H](O)CC=1C)C(C)(C)C=1C=CC(C)=CC=CC(C)=CC=CC=C(C)C=CC=C(C)C=CC1=C(C)C[C@@H](O)CC1(C)C JKQXZKUSFCKOGQ-LQFQNGICSA-N 0.000 description 1
- QOPRSMDTRDMBNK-RNUUUQFGSA-N Zeaxanthin Natural products CC(=C/C=C/C=C(C)/C=C/C=C(C)/C=C/C1=C(C)CCC(O)C1(C)C)C=CC=C(/C)C=CC2=C(C)CC(O)CC2(C)C QOPRSMDTRDMBNK-RNUUUQFGSA-N 0.000 description 1
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- JKQXZKUSFCKOGQ-LOFNIBRQSA-N all-trans-Zeaxanthin Natural products CC(=C/C=C/C=C(C)/C=C/C=C(C)/C=C/C1=C(C)CC(O)CC1(C)C)C=CC=C(/C)C=CC2=C(C)CC(O)CC2(C)C JKQXZKUSFCKOGQ-LOFNIBRQSA-N 0.000 description 1
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- 230000001754 anti-pyretic effect Effects 0.000 description 1
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- 208000010668 atopic eczema Diseases 0.000 description 1
- 230000033228 biological regulation Effects 0.000 description 1
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- 206010012601 diabetes mellitus Diseases 0.000 description 1
- 239000006185 dispersion Substances 0.000 description 1
- 230000035619 diuresis Effects 0.000 description 1
- 230000001882 diuretic effect Effects 0.000 description 1
- 206010013990 dysuria Diseases 0.000 description 1
- 235000013399 edible fruits Nutrition 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 230000002964 excitative effect Effects 0.000 description 1
- 229930003935 flavonoid Natural products 0.000 description 1
- 235000017173 flavonoids Nutrition 0.000 description 1
- 150000002215 flavonoids Chemical class 0.000 description 1
- 150000004676 glycans Chemical class 0.000 description 1
- 201000001421 hyperglycemia Diseases 0.000 description 1
- 230000036737 immune function Effects 0.000 description 1
- 239000000463 material Substances 0.000 description 1
- 239000002366 mineral element Substances 0.000 description 1
- 210000003097 mucus Anatomy 0.000 description 1
- 150000007524 organic acids Chemical class 0.000 description 1
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- 235000010987 pectin Nutrition 0.000 description 1
- 229920001277 pectin Polymers 0.000 description 1
- 210000003800 pharynx Anatomy 0.000 description 1
- 229920001282 polysaccharide Polymers 0.000 description 1
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- 230000002265 prevention Effects 0.000 description 1
- 150000003431 steroids Chemical class 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
- 230000009747 swallowing Effects 0.000 description 1
- 239000001648 tannin Substances 0.000 description 1
- 229920001864 tannin Polymers 0.000 description 1
- 235000018553 tannin Nutrition 0.000 description 1
- 238000011287 therapeutic dose Methods 0.000 description 1
- KBPHJBAIARWVSC-XQIHNALSSA-N trans-lutein Natural products CC(=C/C=C/C=C(C)/C=C/C=C(C)/C=C/C1=C(C)CC(O)CC1(C)C)C=CC=C(/C)C=CC2C(=CC(O)CC2(C)C)C KBPHJBAIARWVSC-XQIHNALSSA-N 0.000 description 1
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- 229930003231 vitamin Natural products 0.000 description 1
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- 235000010930 zeaxanthin Nutrition 0.000 description 1
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/81—Solanaceae (Potato family), e.g. tobacco, nightshade, tomato, belladonna, capsicum or jimsonweed
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation 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
- A61K2236/30—Extraction of the material
- A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
- A61K2236/333—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using mixed solvents, e.g. 70% EtOH
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation 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
- A61K2236/30—Extraction of the material
- A61K2236/39—Complex extraction schemes, e.g. fractionation or repeated extraction steps
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- Health & Medical Sciences (AREA)
- Natural Medicines & Medicinal Plants (AREA)
- Life Sciences & Earth Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Chemical & Material Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Medicinal Chemistry (AREA)
- Epidemiology (AREA)
- Alternative & Traditional Medicine (AREA)
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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
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.
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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)
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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 |
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