CN1552375A - Chronic hepatitis yin nourishing pills and their preparation - Google Patents
Chronic hepatitis yin nourishing pills and their preparation Download PDFInfo
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- CN1552375A CN1552375A CNA031245161A CN03124516A CN1552375A CN 1552375 A CN1552375 A CN 1552375A CN A031245161 A CNA031245161 A CN A031245161A CN 03124516 A CN03124516 A CN 03124516A CN 1552375 A CN1552375 A CN 1552375A
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Abstract
A Chinese medicine 'Mangan Yangyin pill' for treating metastatic hepatitis, chronic hepatitis and hepatitis sequelae is an improvement to existing relative medicine in the form of capsule. Its preparing process is also disclosed. Its advantages are high curative effect, high release speed and high biologic utilization rate.
Description
Technical field
This invention relates to the processing technology technical field of Chinese patent medicine pill, relates in particular to chronic hepatitis yin nourishing bolus and preparation method.
Background technology
Pill is a kind of conventional dosage forms, because quick development of modern science and technology, pharmaceutical machine equipment is brought in constant renewal in and is regenerated, the extensive use of the appearance of novel pellet processing machine and new adjuvant, for this ancient dosage form of medicine pill has shone youthful vigor, it has changed people to the traditional prejudice of traditional pill " black, big, thick ", advantages such as the pill that makes it to produce has that drug release rate is fast, bioavailability is high, divided dose is accurate, takes, easy to carry, good looking appearance.According to the relevant drug act of China, changing dosage form needs as a kind of new drug research, the original dosage form of chronic hepatitis yin nourishing bolus is: the chronic hepatitis yin-nourishing capsule, and listed China's Drug Standard of Ministry of Public Health of the Peoples Republic of China (in " Chinese traditional patent formulation preparation " the 9th) in, form by ten flavor medicines.The technology features of former dosage form is that Radix Angelicae Sinensis, Fructus Schisandrae Chinensis, the Ramulus Cinnamomi in the prescription is ground into fine powder, and seven flavor decocting liquid such as all the other Radix Glehniaes are condensed into thick paste, and with above-mentioned fine powder mixing, drying is pulverized encapsulated.Volatile ingredient loses easily in this capsule technology, and in its quality standard, a few indefiniteness quantitative targets, this pharmaceutically dosage form is single simultaneously, far can not satisfy people's medication demand.We use the modern pharmaceutical technology and reflect the improvement of survey means to this product technology work necessity based on this, form new preparation, and the standard of improving the quality of products, quality to product is carried out overall monitor, thereby assurance product quality, benefit the common people, this is significant to inheriting and develop motherland's medicine legacy.
Summary of the invention
The purpose of this invention is to provide a kind of chronic hepatitis yin nourishing bolus and preparation method, improve the quality of products, satisfy needs of medical treatment better.
The objective of the invention is such realization:
1. chronic hepatitis yin nourishing bolus and preparation method comprise the steps:
1.1 the prescription of chronic hepatitis yin nourishing bolus is formed:
Radix Glehniae 180-360g Fructus Lycii 200-400g 180-360g Radix Ophiopogonis
Fructus Toosendan 180-360g Fructus Schisandrae Chinensis 180-360g Radix Angelicae Sinensis 180-360g
Radix Rehmanniae 220-440g Radix Codonopsis 220-440g Ramulus Cinnamomi 100-200g
Radix Ginseng 30-60g right amount of auxiliary materials is made 1000g altogether.
Its optimum formula is:
Radix Glehniae 298g Fructus Lycii 438g 298g Radix Ophiopogonis Fructus Toosendan 298g
Fructus Schisandrae Chinensis 298g Radix Angelicae Sinensis 298g Radix Rehmanniae 578g Radix Codonopsis 578g
Ramulus Cinnamomi 158g Radix Ginseng 70g right amount of auxiliary materials is made 1000g altogether.
1.2 chronic hepatitis yin nourishing bolus preparation technology
Technology one, with ten the flavor medicines clean respectively, remove impurity, it is standby to be up to the standards; With Radix Angelicae Sinensis, Fructus Schisandrae Chinensis, that Ramulus Cinnamomi is ground into fine powder is standby; Seven flavor medicines such as all the other Radix Glehniaes are ground into coarse powder/be cut into decoction pieces, decoct with water 2-3 time, and collecting decoction filters, and filtrate is condensed into thick paste/concentrate drying and makes dried cream powder; Add above-mentioned fine powder and appropriate amount of auxiliary materials, make ball, drying, promptly.
Technology two, with ten the flavor medicines clean respectively, remove impurity, it is standby to be up to the standards; With Radix Angelicae Sinensis, Fructus Schisandrae Chinensis, Ramulus Cinnamomi, that the Radix Ginseng powder is broken into fine powder is standby; Six-element medicated powder such as all the other Radix Glehniaes are broken into coarse powder/be cut into decoction pieces, decoct with water 2-3 time, and collecting decoction filters, and filtrate is condensed into thick paste/concentrate drying and makes dried cream powder; Add above-mentioned fine powder and appropriate amount of auxiliary materials, make ball, drying, promptly.
Technology three cleans ten flavor medicines respectively, removes impurity, and it is standby to be up to the standards; Get Radix Angelicae Sinensis, Fructus Schisandrae Chinensis, Ramulus Cinnamomi mixed powder and be broken into coarse powder, distillating extracting oil is standby; Seven flavor medicines such as medicinal residues and all the other Radix Glehniaes decoct with water 2-3 time, and decoction liquor merges, and filter, and filtrate is condensed into thick paste/concentrate drying, and to make dried cream powder standby; Above-mentioned volatile oil adds an amount of cyclodextrin and makes cyclodextrin of volatile oil clathrate/standby with an amount of anhydrous alcohol solution; Get above-mentioned thick paste/dried cream powder, cyclodextrin of volatile oil clathrate and appropriate amount of auxiliary materials mixing, make ball, drying, promptly.Or above-mentioned thick paste/dried cream powder and appropriate amount of auxiliary materials mixing, make ball, drying sprays into the volatile oil ethanol solution, promptly.
Technology four cleans ten flavor medicines respectively, removes impurity, and it is standby to be up to the standards; Ten flavor medicated powder are broken into coarse powder/be cut into decoction pieces in the prescription, add the water steaming and decocting and extract 2-3 time, and collection volatile oil is standby; Merge secondary water and steam extract, filter, filtrate is condensed into thick paste/concentrate drying, and to make dried cream powder standby; Said extracted volatile oil adds an amount of cyclodextrin and makes cyclodextrin of volatile oil clathrate or standby with an amount of ethanol solution dissolving; Get above-mentioned thick paste/dried cream powder, cyclodextrin of volatile oil clathrate and appropriate amount of auxiliary materials mixing, make ball, drying, promptly.Or above-mentioned thick paste/dried cream powder and appropriate amount of auxiliary materials mixing, make ball, drying, spray adds the volatile oil ethanol solution, promptly.
1.3 by technology one, two, three, four prepared balls is the chronic hepatitis yin nourishing bolus.
The ball of gained can wrap film-coat in the technology, and the film-coat material adopts stomach dissolution type film-coat pre-mixing agent (Opadry), hydroxypropyl cellulose, polyvinylpyrrolidone, hydroxypropyl emthylcellulose, polyvinyl alcohol, one or more mixing of methylcellulose to use.
Used adjuvant can be that one or more mixing such as sucrose, lactose, starch, beta-schardinger dextrin-, HP-, microcrystalline Cellulose, hydroxypropyl cellulose, carboxymethylstach sodium, Aspartane, polyvinylpolypyrrolidone, 30 POVIDONE K 30 BP/USP 30 are used in the technology.
The particle diameter of the ball of gained is 0.5-6mm in the technology, is preferably 1-4mm.
In the technology ball of gained can directly use or the capsulae vacuus of packing in use.
The ball drying can adopt vacuum drying, fluid bed drying, lyophilization etc. in the technology.
The technology Chinese crude drug is ground into coarse powder/be cut into decoction pieces, is generally 5～30 order coarse powder/be cut into decoction pieces, is preferably 10-20 order coarse powder.
The technology Chinese crude drug is ground into fine powder, is generally to be ground into 80-160 purpose fine powder, and it is standby that the best is that superfine powder is broken into 200-300 purpose fine powder.
In the technology decocting boil/condition of water steaming and decocting is: decoction/steaming and decocting 2-3 time, for the first time amount of water be dose 6-12 doubly, the time is 2-4 hour, second and third time amount of water be dose 3-8 doubly, the time is 1-4 hour; The best is: decoction/steaming and decocting 2 times, and for the first time amount of water is 10 times of dose, and the time is 3 hours, and amount of water is 8 times of dose for the second time, and the time is 2 hours.
The cyclodextrin clathrate of volatile oil preparation in the technology: cyclodextrin can adopt any in beta-schardinger dextrin-or the HP-; The ratio of volatile oil and beta-schardinger dextrin-is 1: 7-13ml/g, optimal proportion are 1: 9 (ml/g); The ratio of volatile material and HP-is 1: 3-10ml/g, optimal proportion are 1: 6 (ml/g).
The relative density of thick paste is 1.15～1.45 (60 ℃) in the technology, and optimal proportion is 1.25-1.30 (60 ℃).
The drying of extract can adopt vacuum drying or spray drying in the technology.The vacuum drying temperature is controlled at 50-80 ℃, and the best is 60 ℃.Spray drying is for to be condensed into the concentrated solution that relative density is 1.05-1.15 (60 ℃) with extracting solution, and spray drying, inlet temperature are 100-200 ℃, and leaving air temp is 50-150 ℃.Best relative density is 1.08-1.10 (60 ℃), and inlet temperature is 150-170 ℃, and leaving air temp is 80-100 ℃.
Filter in the technology to adopt and conventionally filter, centrifugal, ultrafiltration, add filtration/centrifugal/methods such as ultrafiltration behind the clarifier.
2. quality control of the present invention mainly is discriminating, inspection, three aspects of assay.
This product has the thin layer of Radix Rehmanniae, Radix Ginseng, Fructus Schisandrae Chinensis, Fructus Lycii, Radix Angelicae Sinensis, Radix Codonopsis to differentiate on differentiating; Have in the inspection that heavy metal must not cross 10/1000000ths, arsenic salt must not be crossed 2/1000000ths limit examine; The quantitative of Fructus Schisandrae Chinensis, Radix Angelicae Sinensis arranged on the assay.
This invention its superiority compared with the prior art is: production technology more becomes fully rationally, quality standard improves greatly, makes product that the qualitative, quantitative control method of science be arranged, and makes the quality of product that guarantee arranged.
The specific embodiment
The optimum implementation of this invention is: ten flavor medicines are cleaned respectively, remove impurity, it is standby to be up to the standards; With Radix Angelicae Sinensis, Fructus Schisandrae Chinensis, Ramulus Cinnamomi, that the Radix Ginseng powder is broken into fine powder is standby; Six-element medicated powder such as all the other Radix Glehniaes are broken into coarse powder, decoct with water 3 hours for the first time 2 times, 2 hours for the second time, collecting decoction filtered, filtrate is concentrated into relative density 1.08-1.10 (60 ℃), spray drying is made dried cream powder, adds above-mentioned fine powder and appropriate amount of auxiliary materials, mixing, pill, drying, coating, promptly.
Claims (10)
1. chronic hepatitis yin nourishing bolus and preparation method is characterized in that:
(1) Radix Glehniae, Fructus Lycii, Radix Ophiopogonis, Fructus Toosendan, Fructus Schisandrae Chinensis, Radix Angelicae Sinensis, Radix Rehmanniae, Radix Codonopsis, Ramulus Cinnamomi, Radix Ginseng ten flavor medicines are cleaned respectively, remove impurity, it is standby to be up to the standards; With Radix Angelicae Sinensis, Fructus Schisandrae Chinensis, that Ramulus Cinnamomi is ground into fine powder is standby; Seven flavor medicines such as all the other Radix Glehniaes are ground into coarse powder/be cut into decoction pieces, decoct with water 2-3 time, and collecting decoction filters, and filtrate is condensed into thick paste/concentrate drying and makes dried cream powder; Add fine powder and appropriate amount of auxiliary materials, make ball, drying, promptly.
(2) Radix Glehniae, Fructus Lycii, Radix Ophiopogonis, Fructus Toosendan, Fructus Schisandrae Chinensis, Radix Angelicae Sinensis, Radix Rehmanniae, Radix Codonopsis, Ramulus Cinnamomi, Radix Ginseng ten flavor medicines are cleaned respectively, remove impurity, it is standby to be up to the standards; With Radix Angelicae Sinensis, Fructus Schisandrae Chinensis, Ramulus Cinnamomi, that the Radix Ginseng powder is broken into fine powder is standby; Six-element medicated powder such as all the other Radix Glehniaes are broken into coarse powder/be cut into decoction pieces, decoct with water 2-3 time, and collecting decoction filters, and filtrate is condensed into thick paste/concentrate drying and makes dried cream powder; Add fine powder and appropriate amount of auxiliary materials, make ball, drying, promptly.
(3) Radix Glehniae, Fructus Lycii, Radix Ophiopogonis, Fructus Toosendan, Fructus Schisandrae Chinensis, Radix Angelicae Sinensis, Radix Rehmanniae, Radix Codonopsis, Ramulus Cinnamomi, Radix Ginseng ten flavor medicines are cleaned respectively, remove impurity, it is standby to be up to the standards; Get Radix Angelicae Sinensis, Fructus Schisandrae Chinensis, Ramulus Cinnamomi mixed powder and be broken into coarse powder, distillating extracting oil is standby; Seven flavor medicines such as medicinal residues and all the other Radix Glehniaes decoct with water 2-3 time, and decoction liquor merges, and filter, and filtrate is condensed into thick paste/concentrate drying, and to make dried cream powder standby; Volatile oil adds an amount of cyclodextrin and makes cyclodextrin of volatile oil clathrate/standby with an amount of anhydrous alcohol solution; Get thick paste/dried cream powder, cyclodextrin of volatile oil clathrate and appropriate amount of auxiliary materials mixing, make ball, drying, promptly; Or thick paste/dried cream powder and appropriate amount of auxiliary materials mixing, make ball, drying sprays into the volatile oil ethanol solution, promptly.
(4) Radix Glehniae, Fructus Lycii, Radix Ophiopogonis, Fructus Toosendan, Fructus Schisandrae Chinensis, Radix Angelicae Sinensis, Radix Rehmanniae, Radix Codonopsis, Ramulus Cinnamomi, Radix Ginseng ten flavor medicines are cleaned respectively, remove impurity, it is standby to be up to the standards; Ten flavor medicated powder are broken into coarse powder/be cut into decoction pieces in the prescription, add the water steaming and decocting and extract 2-3 time, and collection volatile oil is standby; Merge secondary water and steam extract, filter, filtrate is condensed into thick paste/concentrate drying, and to make dried cream powder standby; Extracting volatile oil adds an amount of cyclodextrin and makes cyclodextrin of volatile oil clathrate/dissolve standby with an amount of ethanol solution; Get thick paste/dried cream powder, cyclodextrin of volatile oil clathrate and appropriate amount of auxiliary materials mixing, make ball, drying, promptly; Or thick paste/dried cream powder and appropriate amount of auxiliary materials mixing, make ball, drying, spray adds the volatile oil ethanol solution, promptly.
2. according to described chronic hepatitis yin nourishing bolus of claim 1 and preparation method, it is characterized in that: the ball of gained can wrap film-coat, the film-coat material adopt stomach dissolution type film-coat pre-mixing agent (Opadry), hydroxypropyl cellulose, polyvinylpyrrolidone, hydroxypropyl emthylcellulose, polyvinyl alcohol, methylcellulose a kind of/multiple mixing uses; Used adjuvant can be sucrose, lactose, starch, beta-schardinger dextrin-, microcrystalline Cellulose, hydroxypropyl cellulose, carboxymethylstach sodium, Aspartane, polyvinylpolypyrrolidone, 30 1 kinds/multiple mixing use of 30 POVIDONE K 30 BP/USP.
3. according to described chronic hepatitis yin nourishing bolus of claim 1 and preparation method, it is characterized in that: the particle diameter of the ball of gained is 0.5-6mm, and the best is 1-4mm; The ball drying can adopt vacuum drying, fluid bed drying, lyophilization; The ball of gained can directly use/pack in the capsulae vacuus and use.
4. according to described chronic hepatitis yin nourishing bolus of claim 1 and preparation method, it is characterized in that: what pulverizing medicinal materials became coarse powder/be cut into decoction pieces was generally 5～30 order coarse powder/be cut into decoction pieces, and the best was a 10-20 order coarse powder; Pulverizing medicinal materials becomes being generally of fine powder to be ground into 80-160 purpose fine powder, and it is standby that the best is that superfine powder is broken into 200-300 purpose fine powder.
5. according to described chronic hepatitis yin nourishing bolus of claim 1 and preparation method, it is characterized in that: decocting boils/condition of water steaming and decocting is: decoction/steaming and decocting 2-3 time, for the first time amount of water be dose 6-12 doubly, the time is 2-4 hour, second and third time amount of water is 3-8 a times of dose, and the time is 1-4 hour; The best is: decoction/steaming and decocting 2 times, and for the first time amount of water is 10 times of dose, and the time is 3 hours, and amount of water is 8 times of dose for the second time, and the time is 2 hours.
6. according to described chronic hepatitis yin nourishing bolus of claim 1 and preparation method, it is characterized in that: the preparation of the cyclodextrin clathrate of volatile oil: cyclodextrin can adopt any in beta-schardinger dextrin-or the HP-; The ratio of volatile oil and beta-schardinger dextrin-is 1: 7-13ml/g, optimal proportion are 1: 9 (ml/g); The ratio of volatile material and HP-is 1: 3-10ml/g, optimal proportion are 1: 6 (ml/g).
7. according to described chronic hepatitis yin nourishing bolus of claim 1 and preparation method, it is characterized in that: the relative density of thick paste is 1.15～1.45 (60 ℃), and optimal proportion is 1.25-1.30 (60 ℃).
8. according to described chronic hepatitis yin nourishing bolus of claim 1 and preparation method, it is characterized in that: the drying of extract can adopt vacuum drying/spray drying, the vacuum drying temperature is controlled at 50-80 ℃, the best is 60 ℃, spray drying is for to be condensed into the concentrated solution that relative density is 1.05-1.15 (60 ℃) with extracting solution, spray drying, inlet temperature is 100-200 ℃, leaving air temp is 50-150 ℃, best relative density is 1.08-1.10 (60 ℃), inlet temperature is 150-170 ℃, and leaving air temp is 80-100 ℃.
9. according to described chronic hepatitis yin nourishing bolus of claim 1 and preparation method, it is characterized in that: filtration can adopt and conventional filter, centrifugal, ultrafiltration, add the method for filtration/centrifugal/ultra micro behind the clarifier.
10. according to described chronic hepatitis yin nourishing bolus of claim 1 and preparation method, it is characterized in that: the quality standard of this product is controlled at the thin layer that Radix Rehmanniae, Radix Ginseng, Fructus Schisandrae Chinensis, Fructus Lycii, Radix Angelicae Sinensis, Radix Codonopsis are arranged in the discriminating and differentiates; Have that heavy metal must not cross 10/1000000ths, arsenic salt must not be crossed 2/1000000ths limit detection; The quantitative of Fructus Schisandrae Chinensis, Radix Angelicae Sinensis arranged on the assay.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA031245161A CN1552375A (en) | 2003-06-03 | 2003-06-03 | Chronic hepatitis yin nourishing pills and their preparation |
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| Application Number | Priority Date | Filing Date | Title |
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| CNA031245161A CN1552375A (en) | 2003-06-03 | 2003-06-03 | Chronic hepatitis yin nourishing pills and their preparation |
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| CN1552375A true CN1552375A (en) | 2004-12-08 |
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| CNA031245161A Pending CN1552375A (en) | 2003-06-03 | 2003-06-03 | Chronic hepatitis yin nourishing pills and their preparation |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102698063A (en) * | 2012-06-05 | 2012-10-03 | 李承平 | Tablet for nourishing yin and soothing liver |
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2003
- 2003-06-03 CN CNA031245161A patent/CN1552375A/en active Pending
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102698063A (en) * | 2012-06-05 | 2012-10-03 | 李承平 | Tablet for nourishing yin and soothing liver |
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