CN1456271A - Preparation of south isatis root effervescent tablets - Google Patents
Preparation of south isatis root effervescent tablets Download PDFInfo
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- CN1456271A CN1456271A CN 03118673 CN03118673A CN1456271A CN 1456271 A CN1456271 A CN 1456271A CN 03118673 CN03118673 CN 03118673 CN 03118673 A CN03118673 A CN 03118673A CN 1456271 A CN1456271 A CN 1456271A
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Abstract
A process for preparing Chinese medicine "Effervascent particles of southern isatis root" for treating cold, epidemic encephalitis B, hepatitis, parotitis, etc includes such steps as decocting 2 Chinese-medicinal materials, concentrating, spray drying, mixing with effervascent agent and additive, and granulating. Its advantages are high dissolving speed, agreeable taste and high curative effect and safety.
Description
Technical field
This invention relates to the processing technology technical field of Chinese patent medicine effervescent granule, relates in particular to the preparation method of Rhizoma Et Radix Baphicacanthis Cusiae effervescent granule.
Background technology
Effervescent granule 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, the former dosage form Rhizoma Et Radix Baphicacanthis Cusiae of Rhizoma Et Radix Baphicacanthis Cusiae electuary has been listed the 9th of Ministry of Health of the People's Republic of China's " Chinese traditional patent formulation preparation " in, is made up of two flavor Chinese medicines.The technology of former dosage form is: two decoction liquor that decoct with water of flavor are condensed into precipitate with ethanol behind the thick paste, reclaim ethanol after, concentrate, drying is pulverized, and granulates or is pressed into bulk, packing forms.This product is carried, produces all convenient, and suitable adult takes, and child, children's also need divided dose, take inconvenience, and mouthfeel is also relatively poor.The quality standard of controlling product quality simultaneously is extremely low, does not set up qualitative, quantitative target as yet.Have shortcoming based on electuary, we use the modern pharmaceutical technology this production technology is improved, and change its agent into children's more is ready to accept a kind of and bubble in fusion process, and are not only fragrant but also sweet and dissolve effervescent granule faster, benefit the common people.
Summary of the invention
The preparation method that the purpose of this invention is to provide a kind of Rhizoma Et Radix Baphicacanthis Cusiae effervescent granule, children's is more pleased to take to satisfy needs of medical treatment better.
The objective of the invention is such realization:
The preparation method of Rhizoma Et Radix Baphicacanthis Cusiae effervescent granule comprises the steps:
One, the prescription of Rhizoma Et Radix Baphicacanthis Cusiae effervescent granule is formed
Rhizoma Et Radix Baphicacanthis Cusiae 2000-5000g Folium Isatidis 3000-6500g
Right amount of auxiliary materials is made 1000 bags altogether.
Best prescription is:
Rhizoma Et Radix Baphicacanthis Cusiae 3000g Folium Isatidis 4500g
Right amount of auxiliary materials is made 1000 bags altogether.
Two, Rhizoma Et Radix Baphicacanthis Cusiae effervescent granule preparation technology
Technology one cleans two flavor medicines respectively, removes impurity, and it is standby to be up to the standards; Get two flavor medicated powder and be broken into coarse powder, decoct with water 2-3 time, each 1-3 hour, collecting decoction, filter, filtrate is concentrated into the concentrated solution that relative density is 1.15-1.25 (60 ℃), adds 3 times of amount ethanol, stirs evenly, placed 12-24 hour, and filtered, filtrate recycling ethanol, and concentrated relative density is the clear paste of 1.28-1.30 (50 ℃), drying under reduced pressure becomes dried cream, is ground into fine powder, adds an amount of effervescent and auxiliary materials and mixing, granulate drying, packing, quality inspection, packing, promptly.
Technology two cleans two flavor medicines respectively, removes impurity, and it is standby to be up to the standards; Get two flavor medicated powder and be broken into coarse powder, decoct with water 2-3 time, each 1-3 hour, collecting decoction, filter, filtrate is concentrated into the concentrated solution that relative density is 1.15-1.25 (60 ℃), adds 3 times of amount ethanol, stirs evenly, placed 12-24 hour, and filtered filtrate recycling ethanol, and concentrated relative density is the concentrated solution of 1.05-1.15 (50 ℃), is spray dried to dried cream powder, adds an amount of effervescent and auxiliary materials and mixing, granulate drying, packing, quality inspection, packing, promptly.
Three, prepared by technology one, two is effervescent granule.
Added adjuvant can be in the technology: 30 POVIDONE K 30 BP/USP
30, any or multiple mixing in the sucrose, starch, dextrin, aspartame, essence uses.
The technology Chinese crude drug is ground into coarse powder and was generally 5～30 purpose coarse powder or was cut into decoction pieces, is preferably 10 order coarse powder or is cut into decoction pieces.
The condition of decocting liquid is in the technology: decoct 2-3 time, for the first time amount of water is that the 6-12 of dose doubly measures, and doubly measures 1-3 hour at every turn for the second time for the 4-10 of dose; The best is: decoct 2 times, amount of water is 8 times of amounts of dose for the first time, decocts 2 hours; Amount of water is 6 times of amounts of dose for the second time, decocts 1 hour.
The condition of decocting in water precipitate with ethanol is in the technology: it is 1.15-1.25 (50 ℃) that water cooking liquid is concentrated into relative density, adding 3 times of amount ethanol stirs evenly, left standstill 12-48 hour, reclaiming and being concentrated into relative density behind the ethanol is that clear paste/relative density of 1.25-1.35 (50 ℃) is the concentrated solution of 1.00-1.20 (50 ℃).The best is: it is 1.18-1.20 (50 ℃) that water cooking liquid is concentrated into relative density, adds 3 times of amount ethanol and stirs evenly, and leaves standstill 24 hours, and reclaiming and being concentrated into relative density behind the ethanol is that clear paste/relative density of 1.28-1.30 (50 ℃) is the concentrated solution of 1.05-1.15 (50 ℃).
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 50～80 ℃ in the technology, is preferably 60 ℃.
The acid source of effervescent is a kind of or two kinds in citric acid, tartaric acid, the fumaric acid in the prescription, and carbon dioxide source is a kind of in sodium carbonate, sodium bicarbonate, the potassium carbonate or two kinds; Be preferably citric acid and sodium bicarbonate, its ratio is a sodium bicarbonate: citric acid is 0.8～1.1: 1.2～1.5, and getting is 1.0: 1.3, and consumption is that sodium bicarbonate is 3～10%, and citric acid is 5～15%, is preferably sodium bicarbonate 6%, and citric acid is 8%.
The superiority of this invention is: make the dosage form variation, to the child particularly children's a kind of new dosage form of be willing to accepting is provided, to satisfy needs of medical treatment.The quality control of this product mainly is discriminating, inspection, three aspects of assay.On differentiating, former dosage form has only physicochemical identification, and its specificity is not strong, and the thin layer that now increases Rhizoma Et Radix Baphicacanthis Cusiae is differentiated.Increased heavy metal limit and must not cross 10/1000000ths on checking, arsenic salt must not cross 2/1000000ths.On assay, the effective ingredient indirubin in the Rhizoma Et Radix Baphicacanthis Cusiae has been carried out quantitatively.
Preferred forms
The optimum implementation of this invention is that two flavor medicines are cleaned respectively, removes impurity, and it is standby to be up to the standards; Get two flavor medicated powder and be broken into coarse powder, decoct with water 2-3 time, each 1-3 hour, collecting decoction, filter, filtrate is concentrated into the concentrated solution that relative density is 1.15-1.25 (60 ℃), adds 3 times of amount ethanol, stirs evenly, placed 12-24 hour, and filtered, filtrate recycling ethanol, and concentrated relative density is the clear paste of 1.28-1.30 (50 ℃), drying under reduced pressure becomes dried cream, is ground into fine powder, adds an amount of effervescent and auxiliary materials and mixing, granulate drying, packing, quality inspection, packing, promptly.
Claims (2)
1, a kind of preparation method of Rhizoma Et Radix Baphicacanthis Cusiae effervescent granule is characterized in that it may further comprise the steps:
(1) Rhizoma Et Radix Baphicacanthis Cusiae, Folium Isatidis powder were broken into 5～30 purpose coarse powder and became decoction pieces in the technology, were preferably 10 order coarse powder, carried out the decocting in water precipitate with ethanol.
(2) condition of decocting liquid is in the technology: decoct 2-3 time, for the first time amount of water is that the 6-12 of dose doubly measures, and doubly measures 1-3 hour at every turn for the second time for the 4-10 of dose; The best is: decoct 2 times, amount of water is 8 times of amounts of dose for the first time, decocts 2 hours; Amount of water is 6 times of amounts of dose for the second time, decocts 1 hour.
(3) condition of decocting in water precipitate with ethanol is in the technology: it is 1.15-1.25 (50 ℃) that water cooking liquid is concentrated into relative density, adding 3 times of amount ethanol stirs evenly, left standstill 12-48 hour, reclaiming and being concentrated into relative density behind the ethanol is that clear paste/relative density of 1.25-1.35 (50 ℃) is the concentrated solution of 1.00-1.20 (50 ℃), the best is: it is 1.18-1.20 (50 ℃) that water cooking liquid is concentrated into relative density, adding 3 times of amount ethanol stirs evenly, left standstill 24 hours, reclaiming and being concentrated into relative density behind the ethanol is that clear paste/relative density of 1.28-1.30 (50 ℃) is the concentrated solution of 1.05-1.15 (50 ℃).
(4) temperature of drying under reduced pressure is 50～80 ℃ in the technology, preferably is controlled at 60 ℃;
(5) 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 ℃.
(6) temperature of particle drying is controlled at 50～80 ℃ in the technology, is preferably 60 ℃.
(7) added adjuvant can be in the technology: 30 POVIDONE K 30 BP/USP
30, any/multiple mixing in the sucrose, starch, dextrin, Aspartane, essence uses.
(8) added effervescent in the prescription, its acid source is a kind of in citric acid, tartaric acid, the fumaric acid/two kind, carbon dioxide source is a kind of/two kind in sodium carbonate, sodium bicarbonate, the potassium carbonate, be preferably citric acid and sodium bicarbonate, its ratio is a sodium bicarbonate: citric acid is 0.8～1.1: 1.2～1.5, and getting is 1.0: 1.3, consumption is that sodium bicarbonate is 3～10%, citric acid is 5～15%, is preferably sodium bicarbonate 6%, and citric acid is 8%.
(9) standby composition and the method with (1), (2), (3), (4), (5), (6), (7), (8) feeds intake by national standard prescription consumption standard-required, and mixing is granulated, drying, and the Rhizoma Et Radix Baphicacanthis Cusiae effervescent granule is made in quality inspection.
2, the preparation method of Rhizoma Et Radix Baphicacanthis Cusiae effervescent granule according to claim 1, it is characterized in that on quality control standard Rhizoma Et Radix Baphicacanthis Cusiae having been carried out the thin layer discriminating must not cross 10/1000000ths to heavy metal limit, arsenic salt must not be crossed 2/1000000ths and detect, and on assay the effective ingredient indirubin in the Rhizoma Et Radix Baphicacanthis Cusiae has been carried out quantitatively.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 03118673 CN1456271A (en) | 2003-02-21 | 2003-02-21 | Preparation of south isatis root effervescent tablets |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 03118673 CN1456271A (en) | 2003-02-21 | 2003-02-21 | Preparation of south isatis root effervescent tablets |
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| CN1456271A true CN1456271A (en) | 2003-11-19 |
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| CN 03118673 Pending CN1456271A (en) | 2003-02-21 | 2003-02-21 | Preparation of south isatis root effervescent tablets |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102008556B (en) * | 2009-09-08 | 2012-06-06 | 河南惠通天下动物药业有限公司 | Qiqing Baidu effervescent granule and preparation method thereof |
| CN108524577A (en) * | 2018-06-21 | 2018-09-14 | 广西忠宁制药有限公司 | Zhuang medicine composition for treating chronic granulocytic leukemia and preparation thereof |
-
2003
- 2003-02-21 CN CN 03118673 patent/CN1456271A/en active Pending
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102008556B (en) * | 2009-09-08 | 2012-06-06 | 河南惠通天下动物药业有限公司 | Qiqing Baidu effervescent granule and preparation method thereof |
| CN108524577A (en) * | 2018-06-21 | 2018-09-14 | 广西忠宁制药有限公司 | Zhuang medicine composition for treating chronic granulocytic leukemia and preparation thereof |
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