CN1548090A - Eyesight improving and kidney-nourishing bolus and its prepn - Google Patents

Eyesight improving and kidney-nourishing bolus and its prepn Download PDF

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Publication number
CN1548090A
CN1548090A CNA031244289A CN03124428A CN1548090A CN 1548090 A CN1548090 A CN 1548090A CN A031244289 A CNA031244289 A CN A031244289A CN 03124428 A CN03124428 A CN 03124428A CN 1548090 A CN1548090 A CN 1548090A
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time
drying
kidney
pill
powder
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毛友昌
毛小敏
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Abstract

The present invention discloses eyesight improving and kidney nourishing bolus and its preparation. The present invention relates to preparation form innovation on the basis of available tablet, and the medicine has the advantages of fast release speed, high bioavailability, less irritation, etc. The medicine has the functions of nourishing liver and kidney, benefiting life essence and improving eyesight, and is used in treating deficiency liver and kidney Yin, poor eyesight, dizziness, etc. with high curative effect.

Description

Pill for Replenishing the Kidney-yin and preparation method make eye bright
Technical field
This invention relates to the processing technology technical field of Chinese patent medicine pill, relates in particular to make eye bright Pill for Replenishing the Kidney-yin 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, the former dosage form nourishing kidney sheet that makes eye bright has been listed country of National Drug Administration standard for traditional Chinese medicines compilation terrestrial reference in and has been risen in the GB tentative standard.The technology features of this dosage form is that three flavors such as Radix Rehmanniae decoct with water in the prescription, is condensed into clear paste; The lixiviate of Flos Chrysanthemi hot water is condensed into clear paste; Fructus Lycii 60% ethanol percolate extraction gets clear paste, and Fructus Ligustri Lucidi is beaten powder and above-mentioned three kinds of clear paste and sucrose mixing, granulates, and tabletting, sugar coating are promptly.This medicine Fructus Lycii adopts 60% ethanol extraction, and effective ingredient such as polysaccharide are difficult to propose, and secondly, this medicine is a coated tablet, coating is loaded down with trivial details, prolonged disintegration, and this medicine dose is big, one time 6, dysphagia, aged debility person especially, simultaneously, its quality standard still can further improve.Based on this, we use the modern pharmaceutical technology this product technology are necessarily 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.This is significant to inheriting and develop motherland's medicine legacy.
Summary of the invention
The purpose of this invention is to provide make eye bright Pill for Replenishing the Kidney-yin and preparation method, improve the quality and the curative effect of product, enrich medicine variety, satisfy better and guarantee people medication demand.
The object of the present invention is achieved like this
1. the prescription of Pill for Replenishing the Kidney-yin of making eye bright is formed
Radix Rehmanniae 250~500g Fructus Ligustri Lucidi 300~750g Fructus Lycii 400~1000g
Flos Chrysanthemi 250~500g Semen Cassiae 250~500g Radix Achyranthis Bidentatae 150~450g
Right amount of auxiliary materials is made 1000g altogether
Its optimum formula is:
Radix Rehmanniae 300-400g Fructus Ligustri Lucidi 450-600g Fructus Lycii 600-800g
Flos Chrysanthemi 300-400g Semen Cassiae 300-400g Radix Achyranthis Bidentatae 300-400g
Right amount of auxiliary materials is made 1000g altogether
2. Pill for Replenishing the Kidney-yin preparation technology makes eye bright
Technology one, will write out a prescription in the Six-element medicine be up to the standards standby respectively; Get Radix Rehmanniae, Radix Achyranthis Bidentatae, Semen Cassiae powder and be broken into coarse powder/be cut into decoction pieces to decoct with water 2-3 time, each 1-3 hour, collecting decoction filtered, and filtrate is condensed into clear paste; Flos Chrysanthemi soaks 2-3 time with hot water, and each 0.5-3 hour, merge immersion, filter, filtrate is condensed into clear paste; Fructus Lycii 40-95% ethanol extraction, extracting solution reclaims ethanol and is condensed into clear paste; Other gets Fructus Ligustri Lucidi powder and is broken into fine powder, adds above-mentioned three kinds of clear paste mixings, and drying is pulverized, and with appropriate amount of auxiliary materials, mixing, makes ball, drying, promptly.
Technology two, will write out a prescription in the Six-element medicine inspection test qualified standby; Get Radix Rehmanniae, Radix Achyranthis Bidentatae, Semen Cassiae powder and be broken into coarse powder/be cut into decoction pieces to decoct with water 2-3 time, each 1-3 hour, collecting decoction filtered, and filtrate is concentrated in right amount; Flos Chrysanthemi soaks 2-3 time with hot water, and each 0.5-3 hour, merge immersion, filter, filtrate is concentrated in right amount; Fructus Lycii 40-95% ethanol extraction, extracting solution reclaims ethanol and is concentrated in right amount; Above-mentioned concentrated solution mixing, being condensed into thick paste or concentrate drying, to make dried cream powder standby; Other gets Fructus Ligustri Lucidi powder and is broken into fine powder, adds above-mentioned thick paste/dried cream powder and appropriate amount of auxiliary materials mixing, makes ball, drying, promptly.
Technology three, will write out a prescription in the Six-element medicine inspection test qualified standby; Fructus Lycii, Fructus Ligustri Lucidi, Flos Chrysanthemi 40-95% ethanol extraction 2-3, extracting solution filters, and reclaims ethanol, is concentrated into an amount of; Medicinal residues and Radix Rehmanniae, Radix Achyranthis Bidentatae, Semen Cassiae decoct with water, and decocting liquid filters, and are concentrated in right amount, merge with above-mentioned alcohol extract, are condensed into thick paste or concentrate drying is made dried cream powder, add the appropriate amount of auxiliary materials mixing, make ball, drying, promptly.
Technology four, will write out a prescription in the Six-element medicine be up to the standards standby respectively; The prescription Chinese crude drug is ground into coarse powder, uses 40-95% ethanol extraction 2-3 time, merge extractive liquid,, filter, reclaim ethanol, be concentrated into an amount of, medicinal residues decoct with water 1-3 time, and collecting decoction filters, filtrate is concentrated in right amount, merges with above-mentioned alcohol extract, and concentrate drying is made dried cream powder, add the appropriate amount of auxiliary materials mixing, make ball, drying, promptly.
3. the ball that makes by technology one, two, three, four is the Pill for Replenishing the Kidney-yin that makes eye bright.
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-, 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 condition that decocting boils in the technology is: decoct 2-3 time, amount of water is doubly measured for the 6-12 of dose for the first time, and second and third time doubly measured for the 4-10 of dose, and decocting time is 1-3 hour.Decocting the bests such as Radix Rehmanniae are: decoct 2 times, amount of water is 10 times of amounts of dose for the first time, is 8 times of amounts of dose for the second time, 2 hours for the first time, and 1.5 hours for the second time; Add during decocting such as Fructus Lycii boils and can fry in shallow oil the second time of Radix Rehmanniae etc. in the technology three and decoct together, it is best for decocting 2 times that the medicinal residues decocting after the technology tetrol is carried boils, and amount of water is 8 times of amounts, each 1 hour of time.
Adopt the ethanol extraction of 40-95% can adopt percolation or heating reflux method in the technology, the best is 60% ethanol percolate extraction in the technology one, two; The best is with 75% alcohol reflux in the technology three, four.
Technology one, two ZHONGJUHUA hot water extracting conditions are: extract 2-3 time, amount of water is doubly measured for the 6-12 of dose for the first time, and second and third time doubly measured time 1-3 hour for the 4-10 of dose.Best amount of water is 10 times of amounts of dose for the first time in order to extract 2 times, is 8 times of amounts of dose for the second time, 1.5 hours for the first time, and 1 hour for the second time.
Being ground into coarse powder/be cut into decoction pieces in the technology was 5-30 purpose coarse powder, was preferably 10 purpose coarse powder.
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 ℃.
The relative density of clear paste is 1.10-1.35 (60 ℃) in the technology, and best relative density is 1.28 (60 ℃).
The relative density of thick paste is 1.15-1.45 (60 ℃) in the technology, and best relative density is 1.36 (60 ℃).
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.
4. the quality control standard of Pill for Replenishing the Kidney-yin of making eye bright among the present invention further improves on the basis of original nourishing kidney sheet that makes eye bright, former dosage form has the thin layer of Semen Cassiae, Fructus Ligustri Lucidi, Fructus Lycii to differentiate on differentiating, now kept, and increased the thin layer of Flos Chrysanthemi has been differentiated, former dosage form does not have the limit examine of arsenic salt, heavy metal on checking, now increased heavy metal limit and must not cross 10/1000000ths, arsenic salt must not cross 2/1000000ths; Former dosage form has carried out quantitatively now being kept to Semen Cassiae on the assay, and increased to Fructus Ligustri Lucidi quantitatively.
This invention is dosage form technological innovation on the basis of existing tablet, produces easylier, and technology is more reasonable, and quality standard has new raising again, to improving the quality of products significant meaning is arranged, and has enriched medicine variety, and is satisfied and ensured people's medication demand.
The specific embodiment
The optimum implementation of this invention is to test Six-element medicine inspection in the prescription qualified standby; Get Radix Rehmanniae, Radix Achyranthis Bidentatae, Semen Cassiae powder and be broken into coarse powder and decoct with water 2 times, 2 hours for the first time, 1.5 hours for the second time, collecting decoction filtered, and filtrate is concentrated into relative density 1.08-1.10 (60 ℃); Flos Chrysanthemi soaks 2 times with hot water, and 1.5 hours for the first time, 1 hour for the second time, merge immersion, filter, filtrate is concentrated into relative density 1.08-1.10 (60 ℃); Fructus Lycii 60% ethanol extraction, extracting solution reclaims ethanol and concentrates relative density 1.08-1.10 (60 ℃); Above-mentioned concentrated solution merges mixing, and it is standby that spray drying is made dried cream powder; Other gets Fructus Ligustri Lucidi powder and is broken into fine powder, adds above-mentioned dried cream powder and appropriate amount of auxiliary materials mixing, makes ball, drying, promptly.

Claims (10)

1. make eye bright Pill for Replenishing the Kidney-yin and preparation method is characterized in that:
(1) will write out a prescription in Radix Rehmanniae, Radix Achyranthis Bidentatae, Semen Cassiae, Fructus Ligustri Lucidi, Fructus Lycii, Flos Chrysanthemi Six-element medicine be up to the standards standby respectively; Get Radix Rehmanniae, Radix Achyranthis Bidentatae, Semen Cassiae powder and be broken into coarse powder/be cut into decoction pieces to decoct with water 2-3 time, each 1-3 hour, collecting decoction filtered, and filtrate is condensed into clear paste; Flos Chrysanthemi soaks 2-3 time with hot water, and each 0.5-3 hour, merge immersion, filter, filtrate is condensed into clear paste; Fructus Lycii 40-95% ethanol extraction, extracting solution reclaims ethanol and is condensed into clear paste; Other gets Fructus Ligustri Lucidi powder and is broken into fine powder, adds three kinds of clear paste mixings, and drying is pulverized, and with appropriate amount of auxiliary materials, mixing, makes ball, drying, promptly.
(2) will write out a prescription in Radix Rehmanniae, Radix Achyranthis Bidentatae, Semen Cassiae, Fructus Ligustri Lucidi, Fructus Lycii, the medicine inspection of Flos Chrysanthemi Six-element test qualified standby; Get Radix Rehmanniae, Radix Achyranthis Bidentatae, Semen Cassiae powder and be broken into coarse powder/be cut into decoction pieces to decoct with water 2-3 time, each 1-3 hour, collecting decoction filtered, and filtrate is concentrated in right amount; Flos Chrysanthemi soaks 2-3 time with hot water, and each 0.5-3 hour, merge immersion, filter, filtrate is concentrated in right amount; Fructus Lycii 40-95% ethanol extraction, extracting solution reclaims ethanol and is concentrated in right amount; The concentrated solution mixing, being condensed into thick paste/concentrate drying, to make dried cream powder standby; Other gets Fructus Ligustri Lucidi powder and is broken into fine powder, adds thick paste/dried cream powder and appropriate amount of auxiliary materials mixing, makes ball, drying, promptly.
(3) will write out a prescription in Radix Rehmanniae, Radix Achyranthis Bidentatae, Semen Cassiae, Fructus Ligustri Lucidi, Fructus Lycii, the medicine inspection of Flos Chrysanthemi Six-element test qualified standby; Fructus Lycii, Fructus Ligustri Lucidi, Flos Chrysanthemi 40-95% ethanol extraction 2-3, extracting solution filters, and reclaims ethanol, is concentrated into an amount of; Medicinal residues and Radix Rehmanniae, Radix Achyranthis Bidentatae, Semen Cassiae decoct with water, and decocting liquid filters, and are concentrated in right amount, merge with alcohol extract, are condensed into thick paste/concentrate drying and make dried cream powder, add the appropriate amount of auxiliary materials mixing, make ball, drying, promptly.
(4) will write out a prescription in Radix Rehmanniae, Radix Achyranthis Bidentatae, Semen Cassiae, Fructus Ligustri Lucidi, Fructus Lycii, Flos Chrysanthemi Six-element medicine be up to the standards standby respectively; The prescription Chinese crude drug is ground into coarse powder, uses 40-95% ethanol extraction 2-3 time, merge extractive liquid,, filter, reclaim ethanol, be concentrated into an amount of, medicinal residues decoct with water 1-3 time, and collecting decoction filters, filtrate is concentrated in right amount, merges with alcohol extract, and concentrate drying is made dried cream powder, add the appropriate amount of auxiliary materials mixing, make ball, drying, promptly.
2. Pill for Replenishing the Kidney-yin and the preparation method of making eye bright according to claim 1, 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. Pill for Replenishing the Kidney-yin and the preparation method of making eye bright according to claim 1 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.
4. Pill for Replenishing the Kidney-yin and the preparation method of making eye bright according to claim 1, it is characterized in that: the condition that decocting boils is: decoct 2-3 time, amount of water is doubly measured for the 6-12 of dose for the first time, second and third time doubly measured for the 4-10 of dose, and decocting time is 1-3 hour, and decocting the bests such as Radix Rehmanniae are: decoct 2 times, amount of water is 10 times of amounts of dose for the first time, be 8 times of amounts of dose for the second time, 2 hours for the first time, 1.5 hours for the second time; Add together during decoctings such as Fructus Lycii boil and can fry in shallow oil the second time of Radix Rehmanniae etc. and decoct, the medicinal residues decocting after the alcohol extraction boils best for decocting 2 times, and amount of water is 8 times of amounts, each 1 hour of time.
5. Pill for Replenishing the Kidney-yin and the preparation method of making eye bright according to claim 1 is characterized in that: adopt the ethanol extraction of 40-95% can adopt percolation/heating reflux method, the best is 60% ethanol percolate extraction; The best is with 75% alcohol reflux.
6. Pill for Replenishing the Kidney-yin and the preparation method of making eye bright according to claim 1, it is characterized in that: Flos Chrysanthemi hot water extracting condition is: extract 2-3 time, amount of water is doubly measured for the 6-12 of dose for the first time, second and third time doubly measured for the 4-10 of dose, and be time 1-3 hour, best for extracting 2 times, amount of water is 10 times of amounts of dose for the first time, be 8 times of amounts of dose for the second time, 1.5 hours for the first time, 1 hour for the second time.
7. Pill for Replenishing the Kidney-yin and the preparation method of making eye bright according to claim 1, it is characterized in that: the drying of extract can adopt vacuum drying/employing spray drying, and the vacuum drying temperature is controlled at 50-80 ℃, and 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 ℃.
8. Pill for Replenishing the Kidney-yin and the preparation method of making eye bright according to claim 1 is characterized in that: being ground into coarse powder/be cut into decoction pieces was 5-30 purpose coarse powder, and the best was 10 purpose coarse powder; The relative density of clear paste is 1.10-1.35 (60 ℃), and best relative density is 1.28 (60 ℃); The relative density of thick paste is 1.15-1.45 (60 ℃), and best relative density is 1.36 (60 ℃).
9. Pill for Replenishing the Kidney-yin and the preparation method of making eye bright according to claim 1 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. Pill for Replenishing the Kidney-yin and the preparation method of making eye bright according to claim 1, it is characterized in that: this product quality standard is controlled at differentiates the thin layer discriminating that Flos Chrysanthemi is arranged, have that heavy metal must not cross 10/1000000ths, arsenic salt must not be crossed 2/1000000ths limit examine, have on the assay Fructus Ligustri Lucidi quantitatively.
CNA031244289A 2003-05-24 2003-05-24 Eyesight improving and kidney-nourishing bolus and its prepn Pending CN1548090A (en)

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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN103160415A (en) * 2013-03-07 2013-06-19 王玉兰 Tortoise shell cassia tora wine
CN101698026B (en) * 2009-06-01 2013-07-17 张红伟 Method for producing traditional Chinese medicine formula for treating eye disease of amblyopia
CN116920027A (en) * 2023-08-31 2023-10-24 乐泰药业有限公司 Traditional Chinese medicine composition for treating cataract caused by liver-kidney yin deficiency and qi and blood stasis, and preparation method and quality control method thereof

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101698026B (en) * 2009-06-01 2013-07-17 张红伟 Method for producing traditional Chinese medicine formula for treating eye disease of amblyopia
CN103160415A (en) * 2013-03-07 2013-06-19 王玉兰 Tortoise shell cassia tora wine
CN116920027A (en) * 2023-08-31 2023-10-24 乐泰药业有限公司 Traditional Chinese medicine composition for treating cataract caused by liver-kidney yin deficiency and qi and blood stasis, and preparation method and quality control method thereof

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