CN1456246A - Preparation of tablets against dysmenorrhea - Google Patents
Preparation of tablets against dysmenorrhea Download PDFInfo
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- CN1456246A CN1456246A CN 03118643 CN03118643A CN1456246A CN 1456246 A CN1456246 A CN 1456246A CN 03118643 CN03118643 CN 03118643 CN 03118643 A CN03118643 A CN 03118643A CN 1456246 A CN1456246 A CN 1456246A
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Abstract
A process for preparing Chinese medicine "Zhitonghuazheng tablet" for treating menalgia, amenorhrhoea, leukorrhea with reddish discharge, chronic pelvic inflammation, etc includes such steps as pulverizing 3 Chinese-medicinal materials including centipede, crushing and decocting 16 Chinese-medicinal materials including red sage root for collecting volatile oil, concentrating the decoction, spray drying, adding additive, mixing all together, and tabletting.
Description
Technical field
This invention relates to the processing technology technical field of Chinese patent medicine tablet, relates in particular to the preparation method of pain-relieving and illness-eliminating sheet.
Background technology
Tablet is a kind of pharmaceutical formulation commonly used, according to the relevant drug act of China, changes dosage form as a kind of new drug research, and original dosage form of pain-relieving and illness-eliminating sheet is: the pain-relieving and illness-eliminating capsule.The pain-relieving and illness-eliminating capsule has been listed in the 13rd of the Drug Standard of Ministry of Public Health of the Peoples Republic of China " Chinese traditional patent formulation preparation ".The technology features of former dosage form is that the three flavor medicated powder such as Scolopendra in the prescription are broken into fine powder, all the other ten Six-elements decoct with water thick paste, with above-mentioned fine powder mixing, granulate, divide encapsulated forming.There is the loss of volatile oil component in the processing technology and the quality standard controlling index significant drawbacks that influences quality such as low in this capsule.Have the shortcoming that influences quality based on capsule, we use the modern pharmaceutical technology this product technology are improved, and form new preparation, and the standard that comprehensively improves the quality, and guarantee the quality monitoring of product, to improve drug effect, benefit the common people.
Summary of the invention
The preparation method that the purpose of this invention is to provide a kind of pain-relieving and illness-eliminating sheet is improved the quality of products and curative effect, increases the stability of product, satisfies needs of medical treatment better.
The objective of the invention is such realization:
The preparation method of pain-relieving and illness-eliminating sheet comprises the steps:
One, the prescription of pain-relieving and illness-eliminating sheet is formed
The Radix Codonopsis 50-150g Radix Astragali (processed with honey) the 100-300g Rhizoma Atractylodis Macrocephalae (stir-fry) 30-90g
Radix Salviae Miltiorrhizae 100-300g Radix Angelicae Sinensis 50-150g Caulis Spatholobi 100-300g
Rhizoma sparganic 30-90g Rhizoma Curcumae 30-90g Semen Euryales 50-150g
Rhizoma Dioscoreae 50-150g Rhizoma Corydalis 50-150g Fructus Toosendan 30-90g
Herba Houttuyniae 100-300g Herba Patriniae 100-300g Scolopendra 1.2-3.6g
Scorpio 50-150g Eupolyphaga Seu Steleophaga 50-150g Rhizoma Zingiberis Preparatum 15-45g
Cortex Cinnamomi 10-30g
Right amount of auxiliary materials is made 1000 altogether.
Its optimum formula is:
The Radix Codonopsis 100g Radix Astragali (processed with honey) the 200g Rhizoma Atractylodis Macrocephalae (stir-fry) 60g
Radix Salviae Miltiorrhizae 200g Radix Angelicae Sinensis 100g Caulis Spatholobi 200g
Rhizoma sparganic 60g Rhizoma Curcumae 60g Semen Euryales 100g
Rhizoma Dioscoreae 100g Rhizoma Corydalis 100g Fructus Toosendan 60g
Herba Houttuyniae 200g Herba Patriniae 200g Scolopendra 2.4g
Scorpio 100g Eupolyphaga Seu Steleophaga 100g Rhizoma Zingiberis Preparatum 30g
Cortex Cinnamomi 20g
Right amount of auxiliary materials is made 1000 altogether.
Two, pain-relieving and illness-eliminating sheet preparation technology
Technology one cleans 19 flavor medicines respectively, removes impurity, and it is standby to be up to the standards.Scolopendra, Scorpio, that the Eupolyphaga Seu Steleophaga mixed powder is broken into fine powder is standby; Ten Six-elements such as all the other Radix Salviae Miltiorrhizaes were ground into 5-20 purpose coarse powder, preferably were ground into 10 purpose coarse powder, decocted with water three times, 3 hours for the first time, 2 hours for the second time, 1 hour for the third time, filter, merging filtrate, being condensed into relative density is 1.10-1.45 (80 ℃), the best is the thick paste of relative density 1.30 (80 ℃), adds fine powder and appropriate amount of auxiliary materials such as above-mentioned Scolopendra, mixing, drying, tabletting, coating, quality inspection, packing, promptly.
Technology two cleans 19 flavor medicines respectively, removes impurity, and it is standby to be up to the standards.Scolopendra, Scorpio, Eupolyphaga Seu Steleophaga mixed powder are broken into fine powder, and be standby; Ten Six-elements such as all the other Radix Salviae Miltiorrhizaes were ground into 5-20 purpose coarse powder, preferably were ground into 10 purpose coarse powder, added the water steaming and decocting three times, and it is standby to collect volatile oil and water boiling liquid; Merge three times water boiling liquid, centrifugal, the clear liquid thin film concentration is the concentrated solution of 1.08 (60 ℃) to the best relative density of relative density 1.05-1.15 (60 ℃), spray drying, and it is standby to collect dried cream powder; Above-mentioned volatile oil adds an amount of cyclodextrin, and to make the cyclodextrin of volatile oil clathrate standby or become the volatile oil alcoholic solution standby with an amount of dissolve with ethanol; Get above-mentioned fine powder and dried cream powder and above-mentioned cyclodextrin of volatile oil clathrate or volatile oil alcoholic solution and appropriate amount of auxiliary materials mixing, tabletting, coating, quality inspection, packing, promptly.
Three, be Film coated tablets by technology one, two prepared coated tablet, its film-coat material adopts stomach dissolution type film-coat pre-mixing agent (Opadry).
The technology Chinese crude drug is ground into fine powder, is generally to be ground into 80-160 purpose fine powder, and the best is that superfine powder is broken into 200-300 purpose fine powder.
Cyclodextrin of volatile oil clathrate preparation in the technology: cyclodextrin can adopt a kind of in beta-schardinger dextrin-, the hydroxyl beta-schardinger dextrin-, the ratio of volatile oil and beta-schardinger dextrin-is: 1: 5-15 (ml/g), optimal proportion is: 1: 9 (ml/g), the ratio of volatile oil and hydroxyl beta-schardinger dextrin-is: 1: 3-10 (ml/g), optimal proportion is: 1: 6 (ml/g).
Any or the multiple mixing that adds adjuvant in the technology and can be in beta-schardinger dextrin-, hydroxyl beta-schardinger dextrin-, low-substituted hydroxypropyl cellulose, microcrystalline Cellulose, polyvinylpolypyrrolidone, carboxymethylstach sodium, 30 POVIDONE K 30 BP/USP 30, micropowder silica gel, magnesium stearate, starch, the dextrin is used.
In the technology decocting boil/condition of water steaming and decocting is: amount of water is that the 6-12 of dose doubly measures for the first time, and time 1-4 hour, second and third time amount of water was that the 4-10 of dose doubly measures, and the time is 0.5-3 hour; Best is that amount of water is 10 times of amounts of dose for the first time, and the time is 3 hours, and amount of water is 6 times of amounts of dose for the second time, and the time is 2 hours, and amount of water is 4 times of amounts of dose for the third time, and the time is 1 hour.
The relative density of thick paste is 1.10-1.45 (80 ℃) in the technology, and the best is relative density 1.30 (80 ℃).
The relative density of concentrated solution is 1.05-1.15 (60 ℃) in the technology, and the spray drying inlet temperature is 100-200 ℃, leaving air temp 50-150 ℃; The relative density of best concentrated solution is 1.08 (60 ℃), and spray-dired inlet temperature is 150 ℃, and leaving air temp is 100 ℃.
Volatile ingredient can obtain keeping preferably after process modification, and its quality standard is improved comprehensively, and former dosage form does not have qualitative and quantitative index, has increased Radix Codonopsis, the Radix Astragali, Radix Angelicae Sinensis, the Rhizoma Atractylodis Macrocephalae, the discriminating of Radix Salviae Miltiorrhizae thin layer now; Increase heavy metal limit in the inspection and must not cross 10/1000000ths, arsenic salt must not cross 2/1000000ths; On assay, Radix Salviae Miltiorrhizae, Radix Angelicae Sinensis have been carried out quantitatively.
This invention its superiority compared with the prior art is: production technology more becomes to improving rationally, keep better that stability improves greatly under the volatility active substance prerequisite, effect duration reached more than 2 years, quality standard is much improved, make product that the qualitative, quantitative control method of science be arranged, make the quality of product and curative effect that guarantee arranged.
The specific embodiment
The optimum implementation of this invention is: 19 flavor medicines are cleaned respectively, remove impurity, it is standby to be up to the standards.Scolopendra, Scorpio, Eupolyphaga Seu Steleophaga mixed powder are broken into fine powder, and be standby; Ten Six-elements such as all the other Radix Salviae Miltiorrhizaes were ground into 5-20 purpose coarse powder, preferably were ground into 10 purpose coarse powder, added the water steaming and decocting three times, and it is standby to collect volatile oil and water boiling liquid; Merge three times water boiling liquid, centrifugal, the clear liquid thin film concentration is to the concentrated solution of relative density 1.05-1.15 (60 ℃), spray drying, and it is standby to collect dried cream powder; Above-mentioned volatile oil adds an amount of cyclodextrin, and to make the cyclodextrin of volatile oil clathrate standby or become the volatile oil alcoholic solution standby with an amount of dissolve with ethanol; Get above-mentioned fine powder and dried cream powder and above-mentioned cyclodextrin of volatile oil clathrate or volatile oil alcoholic solution and appropriate amount of auxiliary materials mixing, tabletting, coating, quality inspection, packing, promptly.
Claims (1)
1, the preparation method of pain-relieving and illness-eliminating sheet is characterized in that it may further comprise the steps:
(1) Scolopendra, Scorpio, Eupolyphaga Seu Steleophaga three flavor medicine mixed powders were broken into 80-160 purpose fine powder in the technology, and it is standby that best superfine powder was broken into 200-300 purpose fine powder.
(2) Radix Salviae Miltiorrhizae, Radix Codonopsis, the Radix Astragali, the Rhizoma Atractylodis Macrocephalae, Radix Angelicae Sinensis, Caulis Spatholobi, rhizoma sparganic, Rhizoma Curcumae, Semen Euryales, Rhizoma Dioscoreae, Rhizoma Corydalis, Fructus Toosendan, Herba Houttuyniae, Herba Patriniae, Rhizoma Zingiberis Preparatum, Cortex Cinnamomi ten Six-element medicine mixed powders are broken into 5-20 purpose coarse powder in the technology, and it is standby to be preferably 10 order coarse powder.
(3) Radix Salviae Miltiorrhizae in the technology, Radix Codonopsis, the Radix Astragali, the Rhizoma Atractylodis Macrocephalae, Radix Angelicae Sinensis, Caulis Spatholobi, rhizoma sparganic, Rhizoma Curcumae, Semen Euryales, Rhizoma Dioscoreae, Rhizoma Corydalis, Fructus Toosendan, Herba Houttuyniae, Herba Patriniae, Rhizoma Zingiberis Preparatum, Cortex Cinnamomi ten Six-element medicine coarse powder decoct with water/add the water steaming and decocting, the volatile oil of gained ring paste enclose formation cyclodextrin of volatile oil clathrate/standby with an amount of dissolve with ethanol, water decoction/water boiling liquid, being condensed into relative density is 1.10-1.45 (80 ℃), the thick paste of best relative density 1.30 (80 ℃)/be condensed into relative density is 1.05-1.15 (60 ℃), best relative density is the concentrated solution of 1.08 (60 ℃), and it is standby to be spray dried to dried cream powder.
(4) in the technology decocting boil/method of water steaming and decocting is: amount of water is that the 6-12 of dose doubly measures for the first time, time 1-4 hour, second and third time amount of water is that the 4-10 of dose doubly measures, time is 0.5-3 hour, and best is that amount of water is 10 times of amounts of dose for the first time, and the time is 3 hours, amount of water is 6 times of amounts of dose for the second time, time is 2 hours, and amount of water is 4 times of amounts of dose for the third time, and the time is 1 hour.
(5) cyclodextrin of volatile oil clathrate preparation in the technology: cyclodextrin can adopt a kind of in beta-schardinger dextrin-, the hydroxyl beta-schardinger dextrin-, the ratio of volatile oil and beta-schardinger dextrin-is: 1: 7～13 (ml/g), optimal proportion is: 1: 9 (ml/g), the ratio of volatile oil and hydroxyl beta-schardinger dextrin-is: 1: 3～10 (ml/g), optimal proportion is: 1: 6 (ml/g).
(6) adding adjuvant in the technology can be beta-schardinger dextrin-, hydroxyl beta-schardinger dextrin-, low-substituted hydroxypropyl cellulose, microcrystalline Cellulose, polyvinylpolypyrrolidone, carboxymethylstach sodium, 30 POVIDONE K 30 BP/USP
30, any/multiple mixing in the micropowder silica gel, magnesium stearate, starch, dextrin uses.
(7) coating material of tablet adopts stomach dissolution type film-coat pre-mixing agent Opadry.
(8) with the standby composition of (1), (2), (3), (4), (5), (6), (7) by national standard prescription consumption standard feed intake mixing, tabletting, coating, the pain-relieving and illness-eliminating sheet is made in quality inspection.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 03118643 CN1456246A (en) | 2003-02-18 | 2003-02-18 | Preparation of tablets against dysmenorrhea |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 03118643 CN1456246A (en) | 2003-02-18 | 2003-02-18 | Preparation of tablets against dysmenorrhea |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN1456246A true CN1456246A (en) | 2003-11-19 |
Family
ID=29411350
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 03118643 Pending CN1456246A (en) | 2003-02-18 | 2003-02-18 | Preparation of tablets against dysmenorrhea |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN1456246A (en) |
-
2003
- 2003-02-18 CN CN 03118643 patent/CN1456246A/en active Pending
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