CN100522238C - Pain-relieving and abdominal mass-eliminatnig bolus and its preparation - Google Patents
Pain-relieving and abdominal mass-eliminatnig bolus and its preparation Download PDFInfo
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- CN100522238C CN100522238C CNB031244637A CN03124463A CN100522238C CN 100522238 C CN100522238 C CN 100522238C CN B031244637 A CNB031244637 A CN B031244637A CN 03124463 A CN03124463 A CN 03124463A CN 100522238 C CN100522238 C CN 100522238C
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- 208000002193 Pain Diseases 0.000 title claims abstract description 18
- 238000002360 preparation method Methods 0.000 title claims abstract description 15
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- 239000003814 drug Substances 0.000 claims abstract description 16
- 239000000843 powder Substances 0.000 claims description 30
- 238000005516 engineering process Methods 0.000 claims description 24
- 239000000341 volatile oil Substances 0.000 claims description 17
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 17
- 241000131808 Scolopendra Species 0.000 claims description 13
- 229920000858 Cyclodextrin Polymers 0.000 claims description 11
- 238000001035 drying Methods 0.000 claims description 11
- 238000002156 mixing Methods 0.000 claims description 10
- HFHDHCJBZVLPGP-UHFFFAOYSA-N schardinger α-dextrin Chemical compound O1C(C(C2O)O)C(CO)OC2OC(C(C2O)O)C(CO)OC2OC(C(C2O)O)C(CO)OC2OC(C(O)C2O)C(CO)OC2OC(C(C2O)O)C(CO)OC2OC2C(O)C(O)C1OC2CO HFHDHCJBZVLPGP-UHFFFAOYSA-N 0.000 claims description 10
- 241001489978 Eupolyphaga Species 0.000 claims description 8
- 241000522620 Scorpio Species 0.000 claims description 8
- 239000006071 cream Substances 0.000 claims description 8
- 239000000463 material Substances 0.000 claims description 8
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- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims description 5
- 241000756943 Codonopsis Species 0.000 claims description 4
- 239000009636 Huang Qi Substances 0.000 claims description 4
- 239000007788 liquid Substances 0.000 claims description 4
- 238000000034 method Methods 0.000 claims description 4
- 241000218176 Corydalis Species 0.000 claims description 3
- 241000600871 Euryale <brittle star> Species 0.000 claims description 3
- 235000006487 Euryale ferox Nutrition 0.000 claims description 3
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- UAJTZZNRJCKXJN-UHFFFAOYSA-M sodium;2-dodecoxy-2-oxoethanesulfonate Chemical compound [Na+].CCCCCCCCCCCCOC(=O)CS([O-])(=O)=O UAJTZZNRJCKXJN-UHFFFAOYSA-M 0.000 claims description 3
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- WHGYBXFWUBPSRW-FOUAGVGXSA-N beta-cyclodextrin Chemical compound OC[C@H]([C@H]([C@@H]([C@H]1O)O)O[C@H]2O[C@@H]([C@@H](O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O3)[C@H](O)[C@H]2O)CO)O[C@@H]1O[C@H]1[C@H](O)[C@@H](O)[C@@H]3O[C@@H]1CO WHGYBXFWUBPSRW-FOUAGVGXSA-N 0.000 claims 1
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- 208000005171 Dysmenorrhea Diseases 0.000 abstract 1
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- 208000029082 Pelvic Inflammatory Disease Diseases 0.000 abstract 1
- 230000017531 blood circulation Effects 0.000 abstract 1
- 230000001684 chronic effect Effects 0.000 abstract 1
- 210000003608 fece Anatomy 0.000 abstract 1
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- 238000000108 ultra-filtration Methods 0.000 description 2
- 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 description 1
- 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 description 1
- GUBGYTABKSRVRQ-QKKXKWKRSA-N Lactose Natural products OC[C@H]1O[C@@H](O[C@H]2[C@H](O)[C@@H](O)C(O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@H]1O GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 description 1
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- Medicines Containing Plant Substances (AREA)
Abstract
The present invention discloses pain-relieving and abdominal mass-eliminating bolus of and its preparation. The present invention relates to preparation form innovation on the basis of available capsule, and the medicine has the advantages of fast release speed, high bioavailability, less irritation, etc. The medicine has the functions of promoting blood circulation, regulating menstruation, eliminating abdominal mass, relieving pain, softening the dry feces and dissipating mass, and has obvious curative effect on abdominal mass, dysmenorrhea, amenorrhvea, leucorrhea with reddish discharge, chronic pelvic inflammation, etc.
Description
Technical field
This invention relates to the processing technology technical field of Chinese patent medicine pill, relates in particular to pain-relieving and illness-eliminating ball and preparation method.
Background technology
Pill is a kind of conventional dosage forms, because quick development of modern science and technology, the pharmacy structural establishment 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, advantages such as it has changed people to the traditional prejudice of traditional pill " black, big, thick ", and the pill that makes it to produce has that drug release rate is fast, bioavailability is high, zest is little, divided dose is accurate, takes, easy to carry; According to the relevant drug act of China, change dosage form as a kind of new drug research, original dosage form of pain-relieving and illness-eliminating ball 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.Easy loss of this capsule volatile ingredient in manufacturing process and quality standard controlling index thereof are low, and this pharmaceutically dosage form is single simultaneously, far can not satisfy people's medication demand.We use the modern pharmaceutical technology this product technology are improved based on this, 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.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 pain-relieving and illness-eliminating ball and preparation method, improve the quality of products and curative effect, increase the stability of product, satisfy needs of medical treatment better.
The objective of the invention is such realization:
1. pain-relieving and illness-eliminating ball and preparation method comprise the steps:
1.1 the prescription of pain-relieving and illness-eliminating ball is formed
The Radix Codonopsis 150-300g Radix Astragali (processed with honey) the 300-600g Rhizoma Atractylodis Macrocephalae (stir-fry) 90-180g
Radix Salviae Miltiorrhizae 300-600g Radix Angelicae Sinensis 150-300g Caulis Spatholobi 300-600g
Rhizoma sparganic 90-180g Rhizoma Curcumae 90-180g Semen Euryales 150-300g
Rhizoma Dioscoreae 150-300g Rhizoma Corydalis 150-300g Fructus Toosendan 90-180g
Herba Houttuyniae 300-600g Herba Patriniae 300-600g Scolopendra 3.6-7.2g
Scorpio 150-300g Eupolyphaga Seu Steleophaga 150-300g Rhizoma Zingiberis Preparatum 45-90g
Cortex Cinnamomi 30-60g right amount of auxiliary materials is made 1000g altogether.
Its optimum formula is:
The Radix Codonopsis 225g Radix Astragali (processed with honey) the 450g Rhizoma Atractylodis Macrocephalae (stir-fry) 135g
Radix Salviae Miltiorrhizae 450g Radix Angelicae Sinensis 225g Caulis Spatholobi 450g
Rhizoma sparganic 135g Rhizoma Curcumae 135g Semen Euryales 450g
Rhizoma Dioscoreae 450g Rhizoma Corydalis 450g Fructus Toosendan 135g
Herba Houttuyniae 900g Herba Patriniae 900g Scolopendra 5.4g
Scorpio 450g Eupolyphaga Seu Steleophaga 450g Rhizoma Zingiberis Preparatum 67.5g
Cortex Cinnamomi 45g right amount of auxiliary materials is made 1000g altogether.
1.2 pain-relieving and illness-eliminating ball preparation technology
Technology one cleans 19 flavor medicines respectively, removes impurity, and it is standby to be up to the standards.Scolopendra, Scorpio, that Eupolyph aga sinesis Walker is broken into fine powder is standby; Ten Six-elements such as all the other Radix Salviae Miltiorrhizaes are ground into coarse powder/be cut into decoction pieces, decoct with water 2-4 time, and each 1-4 hour, collecting decoction, filter, filtrate is condensed into thick paste or concentrate drying is made dried cream powder, with fine powder and appropriate amount of auxiliary materials such as above-mentioned Scolopendra, mixing, make ball, drying, promptly.
Technology two cleans 19 flavor medicines respectively, removes impurity, and it is standby to be up to the standards.Scolopendra, Scorpio, that Eupolyph aga sinesis Walker is broken into fine powder is standby; Ten Six-elements such as all the other Radix Salviae Miltiorrhizaes are ground into coarse powder/be cut into decoction pieces, add water steaming and decocting 2-4 time, and each 1-4 hour, it was standby to collect volatile oil; Merge cooking liquor, filter, 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 or standby with an amount of anhydrous alcohol solution; Get fine powder, cyclodextrin of volatile oil clathrate and appropriate amount of auxiliary materials mixings such as above-mentioned thick paste/dried cream powder, Scolopendra, make ball, drying, promptly.Or fine powder and appropriate amount of auxiliary materials mixings such as above-mentioned thick paste/dried cream powder, Scolopendra, make ball, drying, spray adds the volatile oil ethanol solution, mixing, promptly.
1.3 by technology one, two prepared balls is the pain-relieving and illness-eliminating ball.
The ball of gained can wrap film-coat in the technology, 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 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, and optimum grain-diameter is 1.5-4mm.
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 for being ground into 5-30 purpose coarse powder/be cut into decoction pieces, and the best is a 10-20 purpose coarse powder.
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 HP-, 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 HP-is: 1:3-10 (ml/g), optimal proportion is: 1:6 (ml/g).
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 second and third time amount of water is that the 4-10 of dose doubly measures, and the time is 1-4 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 drying of extract can adopt vacuum drying or adopt spray drying in the technology, and the vacuum drying temperature is controlled at 50-80 ℃, is preferably 60 ℃.The spray drying inlet temperature is 100-200 ℃, leaving air temp 50-150 ℃; Best relative density is 1.08-1.10 (60 ℃), and inlet temperature is 160-180 ℃, leaving air temp 80-100 ℃.
Filter in the technology and also can adopt centrifugal conventional the filtration, centrifugal, ultrafiltration, add filter behind the clarifier, centrifugal, add the method that filters ultrafiltration again behind the clarifier.
2. the quality control of this product mainly is: discriminating, inspection, three aspects of assay.
The quality standard of this product is improved comprehensively, and former dose of dosage form do 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 10-20 purpose coarse powder, added the water steaming and decocting three times, and 3 hours for the first time, 2 hours for the second time, 1 hour for the third time, it was standby to collect volatile oil and water boiling liquid; Water boiling liquid merges, and is centrifugal, and the clear liquid thin film concentration is to relative density 1.08-1.10 (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; Get fine powder, above-mentioned dried cream powder, above-mentioned cyclodextrin of volatile oil clathrate and appropriate amount of auxiliary materials mixings such as above-mentioned Scolopendra, make ball, drying, promptly.
Claims (4)
1, a kind of preparation method of pain-relieving and illness-eliminating ball, described pain-relieving and illness-eliminating ball is prepared by following Chinese medicine raw materials by weight proportion: Radix Codonopsis 150-300g, Radix Astragali (processed with Mel) 300-600g, Rhizoma Atractylodis Macrocephalae (parched) 90-180g, Radix Salviae Miltiorrhizae 300-600g, Radix Angelicae Sinensis 150-300g, Caulis Spatholobi 300-600g, rhizoma sparganic 90-180g, Rhizoma Curcumae 90-180g, Semen Euryales 150-300g, Rhizoma Dioscoreae 150-300g, Rhizoma Corydalis 150-300g, Fructus Toosendan 90-180g, Herba Houttuyniae 300-600g, Herba Patriniae 300-600g, Scolopendra 3.6-7.2g, Scorpio 150-300g, Eupolyphaga Seu Steleophaga 150-300g, Rhizoma Zingiberis Preparatum 45-90g, Cortex Cinnamomi 30-60g, this raw material of Chinese medicine prepares the 1000g pill; It is characterized in that the following technology of process:
With Scolopendra, Scorpio, that Eupolyph aga sinesis Walker is broken into fine powder is standby; All the other ten Six-elements add decocting in water 2-4 time, and each 1-4 hour, it was standby to collect volatile oil; Merge water cooking liquid, filter, filtrate is condensed into thick paste or concentrate drying, and to make dried cream powder standby; Volatile oil adds beta-schardinger dextrin-and makes cyclodextrin clathrate; Get thick paste or dried cream powder, Scolopendra, Scorpio, Eupolyphaga Seu Steleophaga fine powder, cyclodextrin of volatile oil clathrate and appropriate amount of auxiliary materials mixing, make ball, drying, that is, the ratio of described volatile oil and beta-cyclodextrin inclusion compound is 1ml: 9g.
2, the preparation method of a kind of pain-relieving and illness-eliminating ball according to claim 1 is characterized in that, the particle diameter of the ball of gained is 0.5-6mm.
3, the preparation method of a kind of pain-relieving and illness-eliminating ball according to claim 1 is characterized in that, the condition of decocting in water is: for the first time amount of water is that the 6-12 of dose doubly measures, and second and third time amount of water is that the 4-10 of dose doubly measures, and the time is 1-4 hour.
4, the preparation method of a kind of pain-relieving and illness-eliminating ball according to claim 1 is characterized in that, the volatile oil of extraction gained sprays the method that adds after adopting dissolve with ethanol.
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| CNB031244637A CN100522238C (en) | 2003-05-24 | 2003-05-24 | Pain-relieving and abdominal mass-eliminatnig bolus and its preparation |
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| CNB031244637A CN100522238C (en) | 2003-05-24 | 2003-05-24 | Pain-relieving and abdominal mass-eliminatnig bolus and its preparation |
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| CN100522238C true CN100522238C (en) | 2009-08-05 |
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| CN101019925B (en) * | 2006-02-15 | 2010-12-01 | 上海市计划生育科学研究所 | A method for preparing frozen-thawed embryos for transplanting endometrium and its kit |
| CN104116801A (en) * | 2013-07-15 | 2014-10-29 | 成都科创佳思科技有限公司 | Patent Chinese medicine for treating pelvic congestion syndrome |
| CN103751715A (en) * | 2014-01-11 | 2014-04-30 | 姜丽莎 | Traditional Chinese medicine composition for treating pelvic inflammation |
| CN104127801A (en) * | 2014-06-30 | 2014-11-05 | 魏本雪 | Traditional Chinese medicine preparation for treatment of kidney deficiency anaemia type amenorrhoea |
| CN108445125B (en) * | 2018-05-30 | 2019-12-06 | 吉林大学 | HPLC Fingerprint Detection Method for Zhitong Huazheng Capsules |
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