CN1548094A - Head-wind syndrome treating gastrodia tuber bolus and its prepn - Google Patents
Head-wind syndrome treating gastrodia tuber bolus and its prepn Download PDFInfo
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- CN1548094A CN1548094A CNA031244327A CN03124432A CN1548094A CN 1548094 A CN1548094 A CN 1548094A CN A031244327 A CNA031244327 A CN A031244327A CN 03124432 A CN03124432 A CN 03124432A CN 1548094 A CN1548094 A CN 1548094A
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Abstract
The present invention discloses head-wind syndrome treating gastrodia tuber bolus 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 nourishing Yin, suppressing the sthenic Yang, expelling wind evil and strengthening physique, and is used in treating refractory headache, numbness of limbs, chronic lumbago and scelalgia, etc. with high curative effect.
Description
Technical field
This invention relates to the processing technology technical field of Chinese patent medicine pill, relates in particular to head-wind syndrome treating gastrodia tuber bolus 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, it has changed people to the traditional prejudice of traditional pill " black; big; thick ", it is fast that the pill that makes it to produce has drug release rate, the bioavailability height, zest is little, divided dose is accurate, take, advantage such as 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 head-wind syndrome treating gastrodia tuber bolus is: the medicine containing gastrodia tuber for curing wind syndrome of head capsule, and listed the 5th in China's the Sanitation Ministry medicine standard Chinese traditional patent formulation preparation in.The technology features of former dosage form is that the medical material (ten flavors) in the prescription is that Rhizoma Gastrodiae fine powder and all the other nine flavor decoctings boil the thick paste mixing, and the drying and crushing packing forms.This capsule volatile ingredient aborning easily loses, thereby influences drug effect, and is low with this dosage form quality standard controlling index, and it is few to detect data, 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 carried out necessary improvement based on this, form new preparation, improve the quality standard of product simultaneously, guarantee the quality monitoring of product, and the raising drug effect is benefited 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 head-wind syndrome treating gastrodia tuber bolus 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. head-wind syndrome treating gastrodia tuber bolus and preparation method comprise the steps:
1.1 the prescription of head-wind syndrome treating gastrodia tuber bolus is formed
Rhizoma Gastrodiae 150-300g Radix Achyranthis Bidentatae 150-300g Radix Scrophulariae 150-300g
Radix Rehmanniae 450-900g Radix Angelicae Sinensis 645-1290g Cortex Eucommiae 129-158g
Rhizoma Chuanxiong 150-300g Herba Visci 645-1290g Flos Chrysanthemi Indici 150-300g
Ramulus Uncariae Cum Uncis 150-300g
Need be ground into the medical material of fine powder in the technology, can routine be ground into 80-160 purpose fine powder, or superfine powder be broken into 200-300 purpose fine powder.
In the prescription decocting boil/condition of water steaming and decocting is: amount of water is doubly measured for 6-12 for the first time, and second and third time doubly measured for 4-10, decoction/steaming and decocting 2-4 time, each 1-3 hour, best for amount of water is 10 times of amounts for the first time, second and third time was 8 times of amounts, decoction/steaming and decocting 3 times, each 2 hours.
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: 8 (ml/g), the ratio of volatile oil and HP-is: 1: 2-10 (ml/g), optimal proportion is: 1: 5 (ml/g).
The relative density of thick paste is 1.10-1.45 (60 ℃) in the technology one, three, and best relative density is 1.25 (60 ℃).
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 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 also can adopt centrifugal, the conventional filtration, ultrafiltration filters after adding clarifier, method such as ultrafiltration again after adding clarifier and filtering.
2. the control of the quality standard of this product mainly is: discriminating, inspection and three aspects of assay.
The quality standard of this product is improved comprehensively, former dosage form standard is only made thin layer simply to Radix Achyranthis Bidentatae and differentiated on differentiating, the existing thin layer that has increased Rhizoma Gastrodiae, Rhizoma Chuanxiong, Radix Scrophulariae, Radix Angelicae Sinensis, the Cortex Eucommiae, Ramulus Uncariae Cum Uncis is differentiated; Check right amount of auxiliary materials, make 1000g altogether.
Its optimum formula amount:
Rhizoma Gastrodiae 225g Radix Achyranthis Bidentatae 225g Radix Scrophulariae 225g
Radix Rehmanniae 675g Radix Angelicae Sinensis 968g Cortex Eucommiae 194g
Rhizoma Chuanxiong 225g Herba Visci 968g Flos Chrysanthemi Indici 225g
Ramulus Uncariae Cum Uncis 225g
Right amount of auxiliary materials is made 1000g altogether.
1.2 head-wind syndrome treating gastrodia tuber bolus preparation technology
Technology one cleans ten flavor medicines respectively, removes impurity, and it is standby to be up to the standards.Get Rhizoma Gastrodiae powder and be broken into fine powder, all the other Radix Scrophulariaes etc. nine flavor is ground into coarse powder/be cut into decoction pieces, decocts with water 1-3 hour at every turn 2-4 time, collecting decoction filters, and filtrate is condensed into thick paste or concentrate drying is made dried cream powder, adds Rhizoma Gastrodiae fine powder and appropriate amount of auxiliary materials mixing, make ball, drying, promptly.
Technology two cleans ten flavor medicines respectively, removes impurity, and it is standby to be up to the standards.Getting Rhizoma Gastrodiae powder, to be broken into fine powder standby; All the other Radix Achyranthis Bidentataes etc. nine flavor mixed powders are broken into coarse powder/be cut into decoction pieces, add water steaming and decocting 2-4 time, and each 1-3 hour, collection volatile oil and water boiling liquid were standby; Water boiling liquid filters, and the filtrate concentrate drying becomes 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 above-mentioned fine powder, dried cream powder, cyclodextrin of volatile oil clathrate and appropriate amount of auxiliary materials mixing, make ball, drying, promptly.Or above-mentioned fine powder, dried cream powder and appropriate amount of auxiliary materials mixing, make ball, drying, spray adds above-mentioned volatile oil ethanol solution, mixing, promptly.
Technology three cleans ten flavor medicines respectively, removes impurity, and it is standby to be up to the standards.Getting Rhizoma Gastrodiae powder, to be broken into fine powder standby; All the other Radix Achyranthis Bidentataes etc. nine flavor mixed powders are broken into coarse powder and add water and steam and carry 2-4 time, and each 1-3 hour, collection volatile oil was standby; Merge water boiling liquid, filter, it is standby that filtrate is condensed into thick paste; 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 fine powder, thick paste, volatile oil clathrate compound and appropriate amount of auxiliary materials mixing, make ball, drying, promptly.Or above-mentioned fine powder, thick paste and appropriate amount of auxiliary materials mixing, make ball, drying, spray adds above-mentioned volatile oil ethanol solution, mixing, promptly.
1.3 by technology one, two, three prepared balls is head-wind syndrome treating gastrodia tuber bolus.
Need be ground into coarse powder/be cut into the medical material of decoction pieces in the technology, generally be ground into 5-30 purpose coarse powder/be cut into decoction pieces, preferably be ground into 10-20 purpose coarse powder.On increased heavy metal limit and must not cross 10/1000000ths, arsenic salt must not cross 2/1000000ths, assay has increased Radix Achyranthis Bidentatae has been carried out the content regulation.
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 can reach more than 2 years, quality standard improves greatly, 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: ten flavor medicines are cleaned respectively, remove impurity, it is standby to be up to the standards.Getting Rhizoma Gastrodiae powder, to be broken into fine powder standby; Nine flavor mixed powders such as all the other Radix Achyranthis Bidentataes are broken into coarse powder, add the water steaming and decocting three times, and each 2 hours, it was standby to collect volatile oil and water boiling liquid; Merge water boiling liquid, centrifugal, the clear liquid thin film concentration is to relative density 1.05-1.15 (80 ℃) concentrated solution, spray drying, and it is standby to collect dried cream powder; The volatile oil that extracts adds an amount of cyclodextrin, and to make the cyclodextrin of volatile oil clathrate standby; Get above-mentioned fine powder, dried cream powder, appropriate amount of auxiliary materials, cyclodextrin of volatile oil clathrate mixing, make ball, drying, promptly.
Claims (10)
1, a kind of head-wind syndrome treating gastrodia tuber bolus and preparation method is characterized in that:
(1) Rhizoma Gastrodiae, Radix Achyranthis Bidentatae, Radix Scrophulariae, Radix Rehmanniae, Radix Angelicae Sinensis, the Cortex Eucommiae, Rhizoma Chuanxiong, Herba Visci, Flos Chrysanthemi Indici, Ramulus Uncariae Cum Uncis ten flavor medicines are cleaned respectively, remove impurity, it is standby to be up to the standards, get Rhizoma Gastrodiae powder and be broken into fine powder, all the other Radix Scrophulariaes etc. nine flavor is ground into coarse powder/be cut into decoction pieces, decocts with water 2-4 time, each 1-3 hour, collecting decoction filters, and filtrate is condensed into thick paste/concentrate drying and makes dried cream powder, add Rhizoma Gastrodiae fine powder and appropriate amount of auxiliary materials mixing, make ball, drying, promptly.
(2) Rhizoma Gastrodiae, Radix Achyranthis Bidentatae, Radix Scrophulariae, Radix Rehmanniae, Radix Angelicae Sinensis, the Cortex Eucommiae, Rhizoma Chuanxiong, Herba Visci, Flos Chrysanthemi Indici, Ramulus Uncariae Cum Uncis ten flavor medicines are cleaned respectively, remove impurity, it is standby to be up to the standards, and getting Rhizoma Gastrodiae powder, to be broken into fine powder standby; All the other Radix Achyranthis Bidentataes etc. nine flavor mixed powders are broken into coarse powder/be cut into decoction pieces, add water steaming and decocting 2-4 time, and each 1-3 hour, collection volatile oil and water boiling liquid were standby; Water boiling liquid filters, and the filtrate concentrate drying becomes 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 fine powder, dried cream powder, cyclodextrin of volatile oil clathrate and appropriate amount of auxiliary materials mixing, make ball, drying, promptly; Or fine powder, dried cream powder and appropriate amount of auxiliary materials mixing, make ball, drying, spray adds the volatile oil ethanol solution, mixing, promptly.
(3) Rhizoma Gastrodiae, Radix Achyranthis Bidentatae, Radix Scrophulariae, Radix Rehmanniae, Radix Angelicae Sinensis, the Cortex Eucommiae, Rhizoma Chuanxiong, Herba Visci, Flos Chrysanthemi Indici, Ramulus Uncariae Cum Uncis ten flavor medicines are cleaned respectively, remove impurity, it is standby to be up to the standards, and getting Rhizoma Gastrodiae powder, to be broken into fine powder standby; All the other Radix Achyranthis Bidentataes etc. nine flavor mixed powders are broken into coarse powder and add water and steam and carry 2-4 time, and each 1-3 hour, collection volatile oil was standby; Merge water boiling liquid, filter, it is standby that filtrate is condensed into thick paste; Volatile oil adds an amount of cyclodextrin and makes cyclodextrin of volatile oil clathrate/standby with an amount of anhydrous alcohol solution; Get fine powder, thick paste, volatile oil clathrate compound and appropriate amount of auxiliary materials mixing, make ball, drying, promptly; Or fine powder, thick paste and appropriate amount of auxiliary materials mixing, make ball, drying, spray adds the volatile oil ethanol solution, mixing, promptly.
2. head-wind syndrome treating gastrodia tuber bolus according to claim 1 and preparation method is characterized in that: need be ground into coarse powder/be cut into the medical material of decoction pieces, generally be ground into 5-30 purpose coarse powder/be cut into decoction pieces, the best was ground into 10-20 purpose coarse powder; Need be ground into the medical material of fine powder, can routine be ground into 80-160 purpose fine powder, best superfine powder is broken into 200-300 purpose fine powder.
3. head-wind syndrome treating gastrodia tuber bolus according to claim 1 and preparation method, it is characterized in that: in the prescription decocting boil/condition of water steaming and decocting is: amount of water is doubly measured for 6-12 for the first time, second and third time doubly measured for 4-10, decoction/steaming and decocting 2-4 time, each 1-3 hour, best for amount of water is 10 times of amounts for the first time, second and third time was 8 times of amounts, decoction/steaming and decocting 3 times, each 2 hours.
4. head-wind syndrome treating gastrodia tuber bolus according to claim 1 and preparation method, it is characterized in that: cyclodextrin of volatile oil clathrate preparation: 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: 8 (ml/g), the ratio of volatile oil and hydroxyl beta-schardinger dextrin-is: 1: 2-10 (ml/g), optimal proportion is: 1: 5 (ml/g).
5. head-wind syndrome treating gastrodia tuber bolus according to claim 1 and preparation method is characterized in that: 1 (1), the relative density of 1 (3) middle thick paste is 1.10-1.45 (60 ℃), and best relative density is 1.25 (60 ℃).
6. head-wind syndrome treating gastrodia tuber bolus according to 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-, HP-, microcrystalline Cellulose, hydroxypropyl cellulose, carboxymethylstach sodium, Aspartane, polyvinylpolypyrrolidone, 30 1 kinds/multiple mixing use of 30 POVIDONE K 30 BP/USP.
7. head-wind syndrome treating gastrodia tuber bolus according to claim 1 and preparation method is characterized in that: the particle diameter of the ball of gained is 0.5-6mm, and optimum grain-diameter is 1.5-4mm; 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.
8. head-wind syndrome treating gastrodia tuber bolus according to claim 1 and preparation method, it is characterized in that: the drying of extract can adopt vacuum drying or adopt spray drying, the vacuum drying temperature is controlled at 50-80 ℃, the best is 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 ℃.
9. head-wind syndrome treating gastrodia tuber bolus according to claim 1 and preparation method is characterized in that: filter also can adopt centrifugal, the conventional filtration, ultrafiltration filters after adding clarifier, the method for ultrafiltration again after adding clarifier and filtering.
10. head-wind syndrome treating gastrodia tuber bolus according to claim 1 and preparation method is characterized in that: the quality standard aspect has Rhizoma Gastrodiae, Rhizoma Chuanxiong, Radix Scrophulariae, Radix Angelicae Sinensis, the Cortex Eucommiae, Ramulus Uncariae Cum Uncis thin layer to differentiate; Have that heavy metal must not cross 10/1000000ths, arsenic salt must not be crossed 2/1000000ths limit examine; The Radix Achyranthis Bidentatae assay is arranged.
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|---|---|---|---|
| CNA031244327A CN1548094A (en) | 2003-05-24 | 2003-05-24 | Head-wind syndrome treating gastrodia tuber bolus and its prepn |
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| CNA031244327A CN1548094A (en) | 2003-05-24 | 2003-05-24 | Head-wind syndrome treating gastrodia tuber bolus and its prepn |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1293911C (en) * | 2005-08-01 | 2007-01-10 | 湖南敬和堂制药有限公司 | Preparation method of medicine for treating headache |
-
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- 2003-05-24 CN CNA031244327A patent/CN1548094A/en active Pending
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1293911C (en) * | 2005-08-01 | 2007-01-10 | 湖南敬和堂制药有限公司 | Preparation method of medicine for treating headache |
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