CN1456243A - Preparation of double coptis root dispersed tablets - Google Patents

Preparation of double coptis root dispersed tablets Download PDF

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Publication number
CN1456243A
CN1456243A CN 03118639 CN03118639A CN1456243A CN 1456243 A CN1456243 A CN 1456243A CN 03118639 CN03118639 CN 03118639 CN 03118639 A CN03118639 A CN 03118639A CN 1456243 A CN1456243 A CN 1456243A
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ethanol
water
relative density
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毛友昌
毛晓敏
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Abstract

A process for preparing Chinese medicine "Shuanghuanglian dispersing tablet" for treating cold includes suchs steps as decocting scutellaria root, depositing in acid, decocting honeysuckle, flower and forsythia fruit, concentrating, drying, adding additive, mixing all together, and preparing dispersing tablets. Its advantages are high curative effect and safety, and high disintegrating speed.

Description

The preparation method of Shuang Huang Lian ' dispersible tablet
Technical field
This invention relates to the processing technology technical field of Chinese patent medicine dispersible tablet, relates in particular to the preparation method of Shuang Huang Lian ' dispersible tablet.
Background technology
Dispersible tablet is a kind of new form of Chinese drug, according to the relevant drug act of China, change dosage form as a kind of new drug research, SHUANGHUANLIAN has multiple dosage form, the SHUANGHUANGLIAN KELI of one of former dosage form, SHUANGHUANGLIAN KOUFUYE have been listed version in 2000 in, and " Chinese pharmacopoeia (an one) is made up of three flavor Chinese medicines.Former particulate technology is: Radix Scutellariae is made Radix Scutellariae extract, makes dried cream behind Flos Lonicerae, the Fructus Forsythiae decocting in water precipitate with ethanol, and add adjuvant after the mixing and granulate, drying, packing forms.This product is children's's preparation, and behind the granule impulsive motion, children's easily obeys.Every bag of 5g of SHUANGHUANGLIAN KELI agent is with to divide to children's below 3 years old again and takes, and divides process dosage inaccurate again, and is also inconvenient; The oral liquid pediatric pharmaceuticals is convenient, but in water some composition instability, and place problems such as can occurring precipitation long afterwards; Using for this reason that the modern pharmaceutical technology changes its agent into can be oral, can be scattered in rapidly again to form fragrant and sweet good to eat solution in the water, and the sheet intermediate score, is beneficial to the dispersible tablet of divided dose, satisfies the needs of children better.
Summary of the invention
The preparation method that the purpose of this invention is to provide a kind of Shuang Huang Lian ' dispersible tablet makes things convenient for child administration to satisfy needs of medical treatment better.
The objective of the invention is such realization:
The preparation method of Shuang Huang Lian ' dispersible tablet comprises the steps:
One, the prescription of Shuang Huang Lian ' dispersible tablet is formed
Flos Lonicerae 1500-4500g Radix Scutellariae 1500-4500g Fructus Forsythiae 3000-9000g
Right amount of auxiliary materials is made 1000 altogether.
Best prescription is:
Flos Lonicerae 2500g Radix Scutellariae 2500g Fructus Forsythiae 5000g
Right amount of auxiliary materials is made 1000 altogether.
Two, Shuang Huang Lian ' dispersible tablet preparation technology
Three flavor medicines are cleaned respectively, remove impurity, it is standby to be up to the standards; More than three flavors, Radix Scutellariae section or be ground into coarse powder, water decocts three times, 2 hours for the first time, second and third time each 1 hour, collecting decoction, filter, filtrate is concentrated into relative density 1.05~1.10 (80 ℃), adds the 2mol/L hydrochloric acid solution and regulate pH value to 1.0~2.0 in the time of 80 ℃, be incubated 1 hour, left standstill 24 hours, filter, precipitation washes with water to pH value 5.0, continuing and being washed till pH value with 70% ethanol is 7.0, and cold drying is standby; Flos Lonicerae, after Fructus Forsythiae adds water temperature and soaks half an hour, decoct each 1.5 hours 2 times, gradation filters, merging filtrate, and being concentrated into relative density is the clear paste of 1.20~1.25 (70~80 ℃), when being chilled to 40 ℃, stirring down and slowly adds ethanol, make to contain the alcohol amount and reach 75%, fully stir, left standstill the leaching supernatant 12 hours, it is an amount of that residue adds 75% ethanol, stirs evenly, and left standstill 12 hours, filter, merge ethanol liquid, reclaim ethanol to there not being the alcohol flavor, and being condensed into the clear paste that relative density is 1.30~1.32 (60~65 ℃), drying under reduced pressure is ground into fine powder with Radix Scutellariae extract, add appropriate amount of auxiliary materials, mixing is made granule, drying adds right amount of auxiliary materials, mixing again, tabletting, promptly.
Three, prepared by above-mentioned technology is dispersible tablet.
Added supplementary product consumption before granulating in the technology: 5-20% microcrystalline Cellulose, 3-10% low-substituted hydroxypropyl cellulose, 1-5% carboxymethylstach sodium, 2-10% polyvinylpolypyrrolidone, optimum amount is: 9% microcrystalline Cellulose, 5% low-substituted hydroxypropyl cellulose, 1.5% carboxymethylstach sodium, 5% polyvinylpolypyrrolidone.Adjuvant and consumption used during granulation are: the 2-10% 30 POVIDONE K 30 BP/USP 30, be made into the alcoholic solution of 5-12%.Optimum amount and concentration are: 6% 30 POVIDONE K 30 BP/USP 30, be made into 8% alcoholic solution; Added adjuvant and consumption before the tabletting: 0.5-2% micropowder silica gel, 1-5% carboxymethylstach sodium, 0.1-1% Herba Menthae essence (powder).Optimum amount is: 1% micropowder silica gel, 2% carboxymethylstach sodium, 0.3% Herba Menthae essence (powder).
Radix scutellariae medicinal materials is ground into coarse powder and was generally 5~30 purpose coarse powder or was cut into decoction pieces in the technology, is preferably 10 order coarse powder or is cut into decoction pieces.
The preparation condition of Radix Scutellariae extract in the technology: decoct with water 3 times, amount of water is 6~12 times of amounts of dose for the first time, and second and third time is 4~10 times of amounts of dose, and the time is 2~6 hours for the first time, and second and third time is 1~3 hour.The best is: amount of water is 10 times of amounts of dose for the first time, and second and third time is 6 times of amounts of dose, and best decocting time is for being 2 hours for the first time, and second and third time is 1 hour.
To be condensed into relative density be 1.02~1.12 (80 ℃) to three decocting liquid of Radix Scutellariae in the technology, and best relative density is 1.05~1.10 (80 ℃).Add 1~3mol/L hydrochloric acid solution and regulate pH value to 1.0~2.0 in the time of 80 ℃, be incubated 0.5~2 hour, left standstill 24~48 hours, filter, precipitation washes with water to pH value 5.0, continues and washes pH value 7.0, drying for standby with 60~80% ethanol; The best is: add the 2mol/L hydrochloric acid solution and regulate pH value to 1.0 in the time of 80 ℃, be incubated 1 hour, left standstill 24 hours, filter, precipitation washes with water to pH value 5.0, continues and washes pH value 7.0, drying for standby with 70% ethanol.
Being prepared as of Flos Lonicerae, Fructus Forsythiae dried cream powder in the technology: the condition that (1) Flos Lonicerae and Fructus Forsythiae decoct with water secondary is: after adding 40~50 ℃ warm water and soaking 30~60 minutes, add for the first time 8~16 times of amounts that water is dose, be 5~10 times of amounts of dose for the second time, decocting time is 1~3 hour at every turn; The best is: after adding 45 ℃ warm water and soaking 30 minutes, adding 12 times of amounts that water is dose for the first time, is 6 times of amounts of dose for the second time, and decocting time is 1.5 hours at every turn.(2) the secondary decocting liquid of Flos Lonicerae and Fructus Forsythiae is concentrated into the clear paste that relative density is 1.15~1.30 (70~80 ℃), stir and slowly to add ethanol down and make and contain the alcohol amount and reach 70~80%, fully stir, left standstill 12~24 hours, the leaching supernatant, it is an amount of that residue adds 70~80% ethanol, stir evenly, left standstill 12~24 hours, and filtered, merge ethanol liquid, reclaim ethanol to there not being the alcohol flavor, and be concentrated into the concentrated solution of relative density 1.05~1.15 (60~65 ℃), and being spray dried to dried cream powder/be concentrated into the clear paste of relative density 1.25~1.35 (60~65 ℃), drying under reduced pressure becomes dried cream powder.The best is: decocting liquid is concentrated into the clear paste that relative density is 1.20~1.25 (70~80 ℃), stir and slowly to add ethanol down and make and contain the alcohol amount and reach 75%, fully stir, left standstill 12 hours, the leaching supernatant, it is an amount of that residue adds 75% ethanol, stir evenly, left standstill 12 hours, and filtered, merge ethanol liquid, reclaim ethanol to there not being the alcohol flavor, and be concentrated into the concentrated solution of relative density 1.08~1.10 (60~65 ℃), and being spray dried to dried cream powder/be concentrated into the clear paste of relative density 1.30~1.32 (60~65 ℃), drying under reduced pressure becomes dried cream powder.
The temperature of drying under reduced pressure is 50~80 ℃ in the technology, preferably is controlled at 60 ℃;
The spray drying inlet temperature is 100~200 ℃ in the technology, and leaving air temp is 50~150 ℃, and best inlet temperature is 160 ℃, and leaving air temp is 90 ℃.
The temperature of particle drying is controlled at 60~80 ℃ in the technology, is preferably 60 ℃.
This invention with have its superiority of dosage form comparison now and be: be that a kind of child administration is convenient, produce, a kind of dosage form easy to carry.
The specific embodiment
The optimum implementation of this invention is that three flavor medicines are cleaned respectively, removes impurity, and it is standby to be up to the standards; More than three flavors, Radix Scutellariae section or be ground into coarse powder, water decocts three times, 2 hours for the first time, second and third time each 1 hour, collecting decoction, filter, filtrate is concentrated into relative density 1.05~1.10 (80 ℃), adds the 2mol/L hydrochloric acid solution and regulate pH value to 1.0~2.0 in the time of 80 ℃, be incubated 1 hour, left standstill 24 hours, filter, precipitation washes with water to pH value 5.0, continuing and being washed till pH value with 70% ethanol is 7.0, and cold drying is standby; Flos Lonicerae, after Fructus Forsythiae adds water temperature and soaks half an hour, decoct each 1.5 hours 2 times, gradation filters, merging filtrate, and being concentrated into relative density is the clear paste of 1.20~1.25 (70~80 ℃), when being chilled to 40 ℃, stirring down and slowly adds ethanol, make to contain the alcohol amount and reach 75%, fully stir, left standstill the leaching supernatant 12 hours, it is an amount of that residue adds 75% ethanol, stirs evenly, and left standstill 12 hours, filter, merge ethanol liquid, reclaim ethanol to there not being the alcohol flavor, and being condensed into the clear paste that relative density is 1.30~1.32 (60~65 ℃), drying under reduced pressure is ground into fine powder with Radix Scutellariae extract, add appropriate amount of auxiliary materials, mixing is made granule, drying adds right amount of auxiliary materials, mixing again, tabletting, promptly.

Claims (1)

1, the preparation method of Shuang Huang Lian ' dispersible tablet is characterized in that it may further comprise the steps:
(1) radix scutellariae medicinal materials is ground into coarse powder and was generally 5~30 purpose coarse powder or was cut into decoction pieces in the technology, is preferably 10 order coarse powder or is cut into decoction pieces.
(2) decocting of preparation Radix Scutellariae extract boils condition in the technology: decoct with water 3 times, amount of water is 6~12 times of amounts of dose for the first time, and second and third time is 4~10 times of amounts of dose, and the time is 2~4 hours for the first time, and second and third time is 1~3 hour.The best is: amount of water is 10 times of amounts of dose for the first time, and second and third time is 6 times of amounts of dose, and best decocting time is for being 2 hours for the first time, and second and third time is 1 hour.
(3) in the technology three decocting liquid of Radix Scutellariae to be condensed into relative density be 1.02~1.12 (80 ℃), best relative density is 1.05~1.10 (80 ℃).Add 1~3mol/L hydrochloric acid solution and regulate pH value to 1.0~2.0 in the time of 80 ℃, be incubated 0.5~2 hour, left standstill 24~48 hours, filter, precipitation washes with water to pH value 5.0, continues and washes pH value 7.0, drying for standby with 60~80% ethanol; The best is: add the 2mol/L hydrochloric acid solution and regulate pH value to 1.0 in the time of 80 ℃, be incubated 1 hour, left standstill 24 hours, filter, precipitation washes with water to pH value 5.0, and continuing is washed till pH value 7.0, drying for standby with 70% ethanol.
(4) being prepared as of Flos Lonicerae, Fructus Forsythiae dried cream powder in the technology: 1. Flos Lonicerae and Fructus Forsythiae decoct with water the condition of secondary and are: after adding 40~50 ℃ warm water and soaking 30~60 minutes, add for the first time 8~16 times of amounts that water is dose, be 5~10 times of amounts of dose for the second time, decocting time is 1~3 hour at every turn; The best is: after adding 45 ℃ warm water and soaking 30 minutes, adding 12 times of amounts that water is dose for the first time, is 6 times of amounts of dose for the second time, and decocting time is 1.5 hours at every turn.2. the secondary decocting liquid of Flos Lonicerae and Fructus Forsythiae is concentrated into the clear paste that relative density is 1.15~1.30 (70~80 ℃), stir and slowly to add ethanol down and make and contain the alcohol amount and reach 70~80%, fully stir, left standstill 12~24 hours, the leaching supernatant, it is an amount of that residue adds 70~80% ethanol, stir evenly, left standstill 12~24 hours, and filtered, merge ethanol liquid, reclaim ethanol to there not being the alcohol flavor, and be concentrated into the concentrated solution of relative density 1.05~1.15 (60~65 ℃), and being spray dried to dried cream powder/be concentrated into the clear paste of relative density 1.25~1.35 (60~65 ℃), drying under reduced pressure becomes dried cream powder.The best is: decocting liquid is concentrated into the clear paste that relative density is 1.20~1.25 (70~80 ℃), stir and slowly to add ethanol down and make and contain the alcohol amount and reach 75%, fully stir, left standstill 12 hours, the leaching supernatant, it is an amount of that residue adds 75% ethanol, stir evenly, left standstill 12 hours, and filtered, merge ethanol liquid, reclaim ethanol to there not being the alcohol flavor, and be concentrated into the concentrated solution of relative density 1.08~1.10 (60~65 ℃), and being spray dried to dried cream powder/be concentrated into the clear paste of relative density 1.30~1.32 (60~65 ℃), drying under reduced pressure becomes dried cream powder.
(5) temperature of drying under reduced pressure is 50~80 ℃ in the technology, preferably is controlled at 60 ℃.
(6) the spray drying inlet temperature is 100~200 ℃, and leaving air temp is 50~150 ℃, and best inlet temperature is 160 ℃, and leaving air temp is 90 ℃.
(7) temperature of particle drying is controlled at 60~80 ℃ in the technology, is preferably 60 ℃.
(8) the preceding added supplementary product consumption of granulation in the technology: 5-20% microcrystalline Cellulose, 3-10% low-substituted hydroxypropyl cellulose, 1-5% carboxymethylstach sodium, 2-10% polyvinylpolypyrrolidone, optimum amount is: 9% microcrystalline Cellulose, 5% low-substituted hydroxypropyl cellulose, 1.5% carboxymethylstach sodium, 5% polyvinylpolypyrrolidone.Adjuvant and consumption used during granulation are: the 2-10% 30 POVIDONE K 30 BP/USP 30, be made into the alcoholic solution of 5-12%.Optimum amount and concentration are: 6% 30 POVIDONE K 30 BP/USP 30, be made into 8% alcoholic solution; Added adjuvant and consumption before the tabletting: 0.5-2% micropowder silica gel, 1-5% carboxymethylstach sodium, 0.1-1% Herba Menthae essence (powder).Optimum amount is: 1% micropowder silica gel, 2% carboxymethylstach sodium, 0.3% Herba Menthae essence (powder).
(9) after being converted by requirements of national standard prescription, the standby material of (1), (2), (3), (4), (5), (6), (7), (8) feeds intake, mixing, and tabletting promptly gets Shuang Huang Lian ' dispersible tablet.
CN 03118639 2003-02-18 2003-02-18 Preparation of double coptis root dispersed tablets Pending CN1456243A (en)

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Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101612197B (en) * 2009-07-15 2012-05-23 曲敬来 Baikal skullcap root composition with activity of anti-enteroviruses and/or influenza virus A type agent
CN103652950A (en) * 2013-12-31 2014-03-26 陈慧婷 Coix seed and Chinese date dispersible tablet and preparing method thereof
CN105816529A (en) * 2016-05-26 2016-08-03 江西京通美联药业有限公司 Method for preparing traditional Chinese medicine preparation for clearing away heat and toxic materials and resisting bacteria and diminishing inflammation
CN110302166A (en) * 2019-07-19 2019-10-08 杨慧慧 A kind of swap buffers tablet and preparation method thereof
CN112569281A (en) * 2020-12-26 2021-03-30 迪沙药业集团有限公司 Yiqing composition and preparation method thereof

Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101612197B (en) * 2009-07-15 2012-05-23 曲敬来 Baikal skullcap root composition with activity of anti-enteroviruses and/or influenza virus A type agent
CN103652950A (en) * 2013-12-31 2014-03-26 陈慧婷 Coix seed and Chinese date dispersible tablet and preparing method thereof
CN103652950B (en) * 2013-12-31 2015-04-22 陈慧婷 Coix seed and Chinese date dispersible tablet and preparing method thereof
CN105816529A (en) * 2016-05-26 2016-08-03 江西京通美联药业有限公司 Method for preparing traditional Chinese medicine preparation for clearing away heat and toxic materials and resisting bacteria and diminishing inflammation
CN110302166A (en) * 2019-07-19 2019-10-08 杨慧慧 A kind of swap buffers tablet and preparation method thereof
CN112569281A (en) * 2020-12-26 2021-03-30 迪沙药业集团有限公司 Yiqing composition and preparation method thereof
CN112569281B (en) * 2020-12-26 2022-02-08 迪沙药业集团有限公司 Yiqing composition and preparation method thereof

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