CN1552384A - Yilingjing pills and their preparation - Google Patents
Yilingjing pills and their preparation Download PDFInfo
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- CN1552384A CN1552384A CNA031245250A CN03124525A CN1552384A CN 1552384 A CN1552384 A CN 1552384A CN A031245250 A CNA031245250 A CN A031245250A CN 03124525 A CN03124525 A CN 03124525A CN 1552384 A CN1552384 A CN 1552384A
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Abstract
A Chinese medicine 'Yilingjing pill' for treating dizziness, tinnitus, insomnia, palpitation, hypertension, etc is an improvement to existing relative medicine in the form of oral liquid. 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 Yilingjing pill and preparation method.
Background technology
Pill is a kind of traditional form of Chinese drug, because the velocity of sound of modern science and technology development, pharmaceutical machine, equipment are brought in constant renewal in and are regenerated, the appearance of novel pellet processing machine, and the extensive use of new adjuvant, for this ancient dosage form of medicine pill has shone youthful vigor, it has changed the traditional prejudice of people to medicine pill " black, big, thick ", advantage such as 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, good looking appearance.According to the relevant drug act of China, change dosage form as a kind of new drug research.The former dosage form YILINGJING KOUFUYE of Yilingjing pill has been listed in the 6th of the Drug Standard of Ministry of Public Health of the Peoples Republic of China " Chinese traditional patent formulation preparation ", is made up of 7 flavor Chinese medicines.The technology of original oral liquid is: whole medical material water extract-alcohol precipitations, filter, and filtrate recycling ethanol adds refined honey, antiseptic through being prepared from.Oral liquid carries the inconvenient easy precipitation that produces of stablizing inadequately in storage, and this dosage form employing alcohol precipitation process, some easily losses of effective one-tenth, and target level of product quality is low, no quantitative target, and this product forms is single simultaneously, far can not satisfy people's medication demand.We use the modern pharmaceutical technology this product technology are done necessary the improvement based on this, form new preparation, improve the quality standard of product simultaneously, guarantee the quality of product, improve curative 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 Yilingjing pill and preparation method, improve the quality of products and curative effect, increase the stability of product, make that people are more pleased to take to satisfy needs of medical treatment better.
The objective of the invention is such realization:
1. Yilingjing pill and preparation method comprise the steps:
1.1 the prescription of Yilingjing pill is formed
Radix Polygoni Multiflori Preparata 420-2400g Fructus Rosae Laevigatae meat 210-1200g Fructus Mori 210-1200g
Fructus Ligustri Lucidi (wine steaming) 105-600g Herba Siegesbeckiae (mulse steaming) 52.5-300g
Radix Cyathulae (wine steaming) 52.5-300g Semen Cuscutae (wine steaming) 105-600g
Right amount of auxiliary materials is made 500g altogether.
Optimum formula is: Radix Polygoni Multiflori Preparata 600-1800g Fructus Rosae Laevigatae meat 300-900g
Fructus Mori 300-900g Fructus Ligustri Lucidi (wine steaming) 150-450g Herba Siegesbeckiae (mulse steaming) 75-225g
Radix Cyathulae (wine steaming) 75-225g Semen Cuscutae (wine steaming) 150-450g
Right amount of auxiliary materials is made 500g altogether.
1.2 Yilingjing pill preparation technology
Technology one cleans seven flavor medicine respectively, removes impurity, and it is standby to be up to the standards; Seven flavor medicine is ground into coarse powder/be cut into decoction pieces, decocts with water 2-4 time, and each 1-3 hour, decocting liquid merged, and filtered, and filtrate is condensed into thick paste/concentrate drying and makes dried cream powder, with appropriate amount of auxiliary materials mixing, pill, drying, promptly.
Technology two cleans seven flavor medicine respectively, removes impurity, and it is standby to be up to the standards; Get seven flavors and be ground into coarse powder/be cut into decoction pieces, decoct with water 2-4 time, 1-3 hour at every turn, collecting decoction filters, and filtrate is concentrated into and adds ethanol in right amount and make and contain the alcohol amount and be 40-70%, precipitate with ethanol leaves standstill, and filters, filtrate recycling ethanol, be condensed into thick paste/concentrate drying and make dried cream powder, add the appropriate amount of auxiliary materials mixing, pill, drying, promptly.
1.3 by technology one, two prepared balls is Yilingjing pill.
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, methylcellulose etc., and one or more mix 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, and the best is 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 purpose coarse powder/be cut into decoction pieces, is preferably 10-20 order coarse powder.
The condition that decocting boils in the technology is: decoct 2-4 time, amount of water is that the 4-12 of dose doubly measures, each 1-3 hour; The best is: decoct 3 times, amount of water is 10 times of amounts of dose for the first time, and the time is 2 hours, and second and third time amount of water is 8 times of amounts of dose, each 2 hours of time.
The relative density that is condensed into thick paste in the technology is 1.10-1.45 (55-60 a ℃), and best relative density is 1.30-1.35 (55-60 a ℃).
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 (55-60 a ℃) 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 (55-60 a ℃), and inlet temperature is 150-170 ℃, and leaving air temp is 80-100 ℃.
The water extract is concentrated into and adds ethanol in right amount and make the alcohol amount of containing be 40-70%, precipitate with ethanol in the technology; Best for being concentrated into about 1.08 (80-95 ℃) of relative density, add the ethanol of 1.5 times of amounts.
Filter in the technology to adopt and conventionally filter, centrifugal, ultrafiltration, add filtration/centrifugal/methods such as ultrafiltration behind the clarifier.
2. the quality control of this product mainly contains discriminating, inspection, three aspects of assay.
This product is dosage form technological innovation on the basis of former dosage form YILINGJING KOUFUYE, and former dosage form has only three physicochemical identification on differentiating, existing having increased differentiated the thin layer of Radix Polygoni Multiflori Preparata, Fructus Ligustri Lucidi; On checking, increased to heavy metal must not cross 10/1000000ths, arsenic salt must not cross 2/1000000ths limit examine; On assay, former dosage form does not have quantitative target, now Radix Polygoni Multiflori Preparata has been carried out quantitatively.
This invention its superiority compared with the prior art is: production technology is easier, and is easy to carry, and product is more stable, and quality standard has new raising again, makes product that the qualitative, quantitative control method of science be arranged, and makes the quality of product that guarantee arranged.
The specific embodiment
Embodiment 1: seven flavor medicine is cleaned respectively, remove impurity, it is standby to be up to the standards; The seven flavor medicine mixed powder is broken into coarse powder, decocts with water 3 times, and each 2 hours, decocting liquid merged, and filtered, and filtrate is concentrated into 1.08-1.10 (55-60 ℃), and spray drying is made dried cream powder, with appropriate amount of auxiliary materials mixing, pill, drying, promptly.
Embodiment 2: seven flavor medicine is cleaned respectively, remove impurity, it is standby to be up to the standards; Get seven flavors and be ground into coarse powder, decoct with water each 2 hours 3 times, collecting decoction filters, and filtrate is concentrated into about 1.08 (80-95 ℃) of relative density, add 1.5 times of amount ethanol, precipitate with ethanol leaves standstill, filter, filtrate recycling ethanol is concentrated into 1.08-1.10 (55-60 ℃), spray drying is made dried cream powder, adds the appropriate amount of auxiliary materials mixing, pill, drying, promptly.
Claims (10)
1. Yilingjing pill and preparation method is characterized in that:
(1) Radix Polygoni Multiflori Preparata, Fructus Rosae Laevigatae meat, Fructus Mori, Fructus Ligustri Lucidi, Herba Siegesbeckiae, Radix Cyathulae, Semen Cuscutae seven flavor medicine are cleaned respectively, remove impurity, it is standby to be up to the standards; The seven flavor medicine mixed powder is broken into coarse powder/be cut into decoction pieces, decocts with water 2-4 time, and each 1-3 hour, decocting liquid merged, and filtered, and filtrate is condensed into thick paste/concentrate drying and makes dried cream powder, with appropriate amount of auxiliary materials mixing, pill, drying, promptly.
(2) Radix Polygoni Multiflori Preparata, Fructus Rosae Laevigatae meat, Fructus Mori, Fructus Ligustri Lucidi, Herba Siegesbeckiae, Radix Cyathulae, Semen Cuscutae seven flavor medicine are cleaned respectively, remove impurity, it is standby to be up to the standards; Get seven flavors and be ground into coarse powder/be cut into decoction pieces, decoct with water 2-4 time, 1-3 hour at every turn, collecting decoction filters, and filtrate is concentrated into and adds ethanol in right amount and make and contain the alcohol amount and be 40-70%, precipitate with ethanol leaves standstill, and filters, filtrate recycling ethanol, be condensed into thick paste/concentrate drying and make dried cream powder, add the appropriate amount of auxiliary materials mixing, pill, drying, promptly.
2. according to described Yilingjing pill 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.
3. according to described Yilingjing pill of claim 1 and preparation method, it is characterized in that: 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.
4. according to described Yilingjing pill of claim 1 and preparation method, it is characterized in that: the particle diameter of the ball of middle gained is 0.5-6mm, and the best is 1-4mm; The ball of gained can directly use/pack in the capsulae vacuus and use; The ball drying can adopt vacuum drying, fluid bed drying, lyophilization.
5. according to described Yilingjing pill 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 purpose coarse powder/be cut into decoction pieces, and the best was a 10-20 order coarse powder.
6. according to described Yilingjing pill of claim 1 and preparation method, it is characterized in that: the condition that decocting boils is: decoct 2-4 time, amount of water is that the 4-12 of dose doubly measures, each 1-3 hour; The best is: decoct 3 times, amount of water is 10 times of amounts of dose for the first time, and the time is 2 hours, and second and third time amount of water is 8 times of amounts of dose, each 2 hours of time.
7. according to described Yilingjing pill of claim 1 and preparation method, it is characterized in that: the relative density that is condensed into thick paste is 1.10-1.45 (55-60 a ℃), and best relative density is 1.30-1.35 (55-60 a ℃); The drying of extract can adopt vacuum drying/spray drying; 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 (55-60 a ℃) 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 (55-60 a ℃), and inlet temperature is 150-180 ℃, and leaving air temp is 80-100 ℃.
8. according to described Yilingjing pill of claim 1 and preparation method, it is characterized in that: the water extract is concentrated into and adds ethanol in right amount and make the alcohol amount of containing be 40-70%, precipitate with ethanol; Best for being concentrated into about 1.08 (80-95 ℃) of relative density, add the ethanol of 1.5 times of amounts.
9. according to described Yilingjing pill 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/ultrafiltration behind the clarifier.
10. according to described Yilingjing pill 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 Polygoni Multiflori Preparata, Fructus Ligustri Lucidi 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 Radix Polygoni Multiflori Preparata arranged on assay.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA031245250A CN1552384A (en) | 2003-06-03 | 2003-06-03 | Yilingjing pills and their preparation |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA031245250A CN1552384A (en) | 2003-06-03 | 2003-06-03 | Yilingjing pills and their preparation |
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| CN1552384A true CN1552384A (en) | 2004-12-08 |
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| CNA031245250A Pending CN1552384A (en) | 2003-06-03 | 2003-06-03 | Yilingjing pills and their preparation |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110559388A (en) * | 2019-09-10 | 2019-12-13 | 中联正禾(北京)科技有限公司 | Traditional Chinese medicine composition and preparation method and application thereof |
| CN110763642A (en) * | 2018-07-27 | 2020-02-07 | 九芝堂股份有限公司 | Detection method of traditional Chinese medicine preparation |
| CN111289680A (en) * | 2018-12-08 | 2020-06-16 | 九芝堂股份有限公司 | Method for identifying cherokee rose fruit in Yilingjing |
-
2003
- 2003-06-03 CN CNA031245250A patent/CN1552384A/en active Pending
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110763642A (en) * | 2018-07-27 | 2020-02-07 | 九芝堂股份有限公司 | Detection method of traditional Chinese medicine preparation |
| CN111289680A (en) * | 2018-12-08 | 2020-06-16 | 九芝堂股份有限公司 | Method for identifying cherokee rose fruit in Yilingjing |
| CN110559388A (en) * | 2019-09-10 | 2019-12-13 | 中联正禾(北京)科技有限公司 | Traditional Chinese medicine composition and preparation method and application thereof |
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