CN1537598A - Traditional Chinese medicine Conghuang bushen granule for tonifying kidney, and its prepn. method - Google Patents
Traditional Chinese medicine Conghuang bushen granule for tonifying kidney, and its prepn. method Download PDFInfo
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- CN1537598A CN1537598A CNA031183239A CN03118323A CN1537598A CN 1537598 A CN1537598 A CN 1537598A CN A031183239 A CNA031183239 A CN A031183239A CN 03118323 A CN03118323 A CN 03118323A CN 1537598 A CN1537598 A CN 1537598A
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Abstract
An improved Chinese medicine 'Conghuang Bushen granule' for treating the deficiency of vital function and vital essence of the kidney and lumbar sore is prepared through extracting from part of raw materials, decocting the dregs and rehmannia root, concentrating, drying, adding auxiliary and granulating. Its advantages are high curative effect, low dosage, and high safety.
Description
Technical field
This invention relates to the particulate processing technology technical field of Chinese patent medicine, relates in particular to yellow the kidney invigorating granule of desert and preparation method.
Background technology
Granule is the pharmaceutical formulation of using always, according to the relevant drug act of China, change dosage form as a kind of new drug research, the particulate original dosage form of the yellow the kidney invigorating of desert is the yellow the kidney invigorating ball of desert, has listed in national Bureau of Drugs Supervision's country's standard for traditional Chinese medicines compilation (terrestrial reference rises the GB tentative standard).The technology characteristics of former dosage form is: Radix Rehmanniae Preparata is made the water thick paste, and Semen Cuscutae is made pure clear paste, then with the Herba Cistanches that is ground into fine powder, Fructus Schisandrae Chinensis fine powder mixing pill.This pill dose is big, and a 1.5g (8 balls) swallows difficulty, especially to old person, secondly, the pill prolonged disintegration, and this pharmaceutically dosage form is single, and application forms still has only pill, far can not satisfy people's medication demand, its quality standard still can further improve simultaneously, and based on this, we use the modern pharmaceutical technology this product technology is done necessary improvement, form new preparation, the control criterion that improves the quality simultaneously guarantees the quality monitoring of product, improve drug effect, benefit the common people.
Summary of the invention
The purpose of this invention is to provide yellow the kidney invigorating granule of a kind of desert and preparation method, improve the quality of products and curative effect, increase the stability of product, enrich medicine variety, to satisfy and to ensure people's medication demand better.
1, the particulate preparation method of the yellow the kidney invigorating of desert comprises the steps:
1.1 the particulate prescription of the yellow the kidney invigorating of desert is formed
Herba Cistanches 670-1340g Radix Rehmanniae Preparata 670-1340g Semen Cuscutae 670-1340g
Fructus Schisandrae Chinensis (wine steaming) 11-22g
Right amount of auxiliary materials is made 1000 bags altogether.
Optimum formula is:
Herba Cistanches 1005g Radix Rehmanniae Preparata 1005g Semen Cuscutae 1005g
Fructus Schisandrae Chinensis (wine steaming) 16.5g
Right amount of auxiliary materials is made 1000 bags altogether
1.2 the particulate preparation technology of the yellow the kidney invigorating of desert
Technology one, will write out a prescription in four Chinese medicine be up to the standards standby respectively; Radix Rehmanniae Preparata decocts with water 2-3 time, and each 1-3 hour, collecting decoction filtered, and filtrate is concentrated into the thick paste that relative density is 1.20-1.40 (20 ℃); Semen Cuscutae powder is broken into coarse powder and makes solvent with 30-60% ethanol, floods to carry out percolation after 12-48 hour, and is closely colourless to percolate, and percolate reclaims ethanol and is concentrated into the clear paste that relative density is 1.05-1.20 (20 ℃); Herba Cistanches, Fructus Schisandrae Chinensis powder are broken into fine powder; With above-mentioned clear paste and fine powder and right amount of auxiliary materials mixing, granulate, drying, granulate, packing is promptly.
Technology two, will write out a prescription in four Chinese medicine be up to the standards standby respectively; Herba Cistanches, Fructus Schisandrae Chinensis powder is broken into coarse powder, extracts 2-3 time each 1-3 hour with the 60-95% alcohol heating reflux, extracting solution reclaims ethanol, is concentrated in right amount, and medicinal residues and Radix Rehmanniae Preparata decoct with water 2-3 time, each 1-3 hour, collecting decoction filtered, filtrate is concentrated in right amount, Semen Cuscutae powder is broken into coarse powder, makes solvent with 30-60% ethanol, floods to carry out percolation after 12-48 hour, closely colourless to percolate, percolate reclaims ethanol and is concentrated in right amount, with above-mentioned alcohol extract, the water extract merges, mixing, vacuum drying/spray drying is made dried cream powder, with the appropriate amount of auxiliary materials mixing, granulate drying, granulate, packing are promptly.
Technology three, will write out a prescription in four flavors be up to the standards standby, Herba Cistanches, Fructus Schisandrae Chinensis, Semen Cuscutae powder is broken into coarse powder, with 60-95% alcohol heating reflux 2-3 time, each 1-3 hour, extracting solution reclaimed ethanol, was concentrated in right amount, and medicinal residues and Radix Rehmanniae Preparata decoct with water 2-3 time, each 1-3 hour, collecting decoction filtered, filtrate is concentrated in right amount, merges with above-mentioned alcohol extract, and vacuum drying/spray drying is made dried cream powder, with the appropriate amount of auxiliary materials mixing, granulate drying, granulate, packing, promptly.
1.3 by the technology gained is granule
The added adjuvant of the yellow the kidney invigorating granule of desert can be: 30 POVIDONE K 30 BP/USP
30, any or multiple mixing in the micropowder silica gel, starch, beta-schardinger dextrin-, dextrin, sucrose, steviosin, Aspartane, magnesium stearate, essence etc. uses.
The technology Chinese crude drug is ground into fine powder and was generally 80-160 purpose fine powder, is preferably superfine powder and is broken into 200-300 order fine powder.
The technology Chinese crude drug is ground into coarse powder and was generally 10-40 purpose coarse powder, is preferably 10-20 order coarse powder.
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 each 1-3 of the time of decoction hour for the 4-10 of dose; The best is: 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, decocts 2 hours at every turn.Medicinal residues after the alcohol extraction can add with frying in shallow oil when frying in shallow oil for the second time.
The relative density that is condensed into thick paste in the technology is 1.20-1.40 (20 ℃), and best relative density is 1.27-1.32 (20 ℃).
The relative density that is condensed into clear paste in the technology is 1.05-1.20 (20 ℃), and best relative density is 1.10-1.15 (20 ℃).
The condition of percolation is in the technology: concentration of alcohol is 30-60%, and consumption is 6-15 a times of medical material amount, and dip time is 12-48 hour, the speed of filtering is 1-10ml/kgmin, and best concentration of alcohol is 45%, and consumption is 9 times of medical material amount, dip time is 24 hours, and the speed of filtering is 3-5ml/kgmin.
The condition of technology reflux is: the ethanol with 60-95% is solvent, and the solubilizer flow control is once doubly measured for 6-14, and second and third time doubly measured for 4-12, reflux 2-3 time, each 1-3 hour.The best thinks that 85% ethanol is solvent, and the solubilizer flow control once is 10 times of amounts, is 8 times of amounts for the second time, refluxes each 2 hours 2 times.
Drying can adopt vacuum drying or spray drying in the technology.The vacuum drying temperature is controlled at 50-90 ℃, and the best is 60 ℃-70.Spray drying is for to be condensed into the concentrated solution that relative density is 1.05-1.15 (60 ℃) with extracting solution, and spray drying, inlet temperature are 100-220 ℃, leaving air temp is 50-150 ℃, best relative density is 1.08-1.10 (60 ℃), and inlet temperature is 160-180 ℃, and leaving air temp is 80-100 ℃.Particle drying adopts vacuum drying.
Concentrate in the technology and can adopt decompression or thin film concentration.
Filter in the technology and also can adopt centrifugation method.
2, the particulate quality control standard of the yellow the kidney invigorating of desert further improves on the basis of the yellow the kidney invigorating ball of original desert among the present invention, the thin layer that has increased Fructus Schisandrae Chinensis on differentiating is differentiated, now increased heavy metal limit and must not cross 10/1000000ths on checking, arsenic salt must not cross 2/1000000ths; Assay on former dosage form basis, increased to Fructus Schisandrae Chinensis quantitatively.
The present invention's its superiority compared with the prior art is: it is big to have overcome former pill dose, and the deficiency of dysphagia, prolonged disintegration has taking convenience, be easy to take, onset is advantage rapidly, and target level of product quality further improves simultaneously, has better met and ensured people's medication demand.
The specific embodiment
Optimum implementation of the present invention is: in will writing out a prescription four the flavor be up to the standards standby, Herba Cistanches, Fructus Schisandrae Chinensis, Semen Cuscutae powder is broken into coarse powder, with 85% alcohol heating reflux 2 times, each 2 hours, extracting solution reclaimed ethanol, and it is an amount of to be concentrated into relative 1.08 (60 ℃), medicinal residues and Radix Rehmanniae Preparata decoct with water 2 times, each 2 hours, the medicinal residues behind the above-mentioned alcohol reflux added when second fries in shallow oil with frying in shallow oil collecting decoction, filter, filtrate is concentrated in right amount, merges with above-mentioned alcohol extract, and vacuum drying/spray drying is made dried cream powder, with the appropriate amount of auxiliary materials mixing, granulate drying, granulate, packing, promptly.
Claims (9)
1, yellow the kidney invigorating granule of a kind of desert and preparation method is characterized in that:
(1) will write out a prescription in four Chinese medicine be up to the standards standby respectively; Radix Rehmanniae Preparata decocts with water 2-3 time, and each 1-3 hour, collecting decoction filtered, and filtrate is concentrated into the thick paste that relative density is 1.20-1.40 (20 ℃); Semen Cuscutae powder is broken into coarse powder and makes solvent with 30-60% ethanol, floods to carry out percolation after 12-48 hour, and is closely colourless to percolate, and percolate reclaims ethanol and is concentrated into the clear paste that relative density is 1.05-1.20 (20 ℃); Herba Cistanches, Fructus Schisandrae Chinensis powder are broken into fine powder; With above-mentioned clear paste and fine powder and right amount of auxiliary materials mixing, granulate, drying, granulate, packing is promptly.
(2) will write out a prescription in four Chinese medicine be up to the standards standby respectively; Herba Cistanches, Fructus Schisandrae Chinensis powder is broken into coarse powder, extracts 2-3 time each 1-3 hour with the 60-95% alcohol heating reflux, extracting solution reclaims ethanol, is concentrated in right amount, and medicinal residues and Radix Rehmanniae Preparata decoct with water 2-3 time, each 1-3 hour, collecting decoction filtered, filtrate is concentrated in right amount, Semen Cuscutae powder is broken into coarse powder, makes solvent with 30-60% ethanol, floods to carry out percolation after 12-48 hour, closely colourless to percolate, percolate reclaims ethanol and is concentrated in right amount, with above-mentioned alcohol extract, the water extract merges, mixing, vacuum drying/spray drying is made dried cream powder, with the appropriate amount of auxiliary materials mixing, granulate drying, granulate, packing are promptly.
(3) will write out a prescription in four flavors be up to the standards standby, Herba Cistanches, Fructus Schisandrae Chinensis, Semen Cuscutae powder is broken into coarse powder, with 60-95% alcohol heating reflux 2-3 time, each 1-3 hour, extracting solution reclaimed ethanol, was concentrated in right amount, and medicinal residues and Radix Rehmanniae Preparata decoct with water 2-3 time, each 1-3 hour, collecting decoction filtered, filtrate is concentrated in right amount, merges with above-mentioned alcohol extract, and vacuum drying/spray drying is made dried cream powder, with the appropriate amount of auxiliary materials mixing, granulate drying, granulate, packing, promptly.
2, yellow the kidney invigorating granule of desert according to claim 1 and preparation method is characterized in that: the added adjuvant of the yellow the kidney invigorating granule of desert can be: 30 POVIDONE K 30 BP/USP
30, any/multiple mixing in the micropowder silica gel, starch, beta-schardinger dextrin-, dextrin, sucrose, steviosin, Aspartane, magnesium stearate, essence etc. uses.
3, yellow the kidney invigorating granule of desert according to claim 1 and preparation method, it is characterized in that: the technology Chinese crude drug is ground into fine powder and was generally 80-160 purpose fine powder, best superfine powder is broken into 200-300 order fine powder, the technology Chinese crude drug is ground into coarse powder and was generally 10-40 purpose coarse powder, and the best was a 10-20 order coarse powder.
4, yellow the kidney invigorating granule of desert according to claim 1 and preparation method, it is characterized in that: 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 each 1-3 of the time of decoction hour for the 4-10 of dose; The best is: 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, decocts 2 hours at every turn.Medicinal residues after the alcohol extraction can add with frying in shallow oil when frying in shallow oil for the second time.
5, yellow the kidney invigorating granule of desert according to claim 1 and preparation method, it is characterized in that: the relative density that is condensed into thick paste in the technology is 1.20-1.40 (20 ℃), best relative density is 1.27-1.32 (20 ℃), the relative density that is condensed into clear paste in the technology is 1.05-1.20 (20 ℃), and best relative density is 1.10-1.15 (20 ℃).
6, yellow the kidney invigorating granule of desert according to claim 1 and preparation method, it is characterized in that: the condition of percolation is in the technology: concentration of alcohol is 30-60%, consumption is 6-15 a times of medical material amount, dip time is 12-48 hour, the speed of filtering is 1-10ml/kgmin, and best concentration of alcohol is 45%, and consumption is 9 times of medical material amount, dip time is 24 hours, and the speed of filtering is 3-5ml/kgmin.
7, yellow the kidney invigorating granule of desert according to claim 1 and preparation method, it is characterized in that: the condition of technology reflux is: the ethanol with 60-95% is solvent, the solubilizer flow control is once doubly measured for 6-14, and second and third time doubly measured for 4-12, reflux 2-3 time, each 1-3 hour, the best thinks that 85% ethanol is solvent, and the solubilizer flow control once is 10 times of amounts, is 8 times of amounts for the second time, reflux each 2 hours 2 times.
8, yellow the kidney invigorating granule of desert according to claim 1 and preparation method, it is characterized in that: drying can adopt vacuum drying/spray drying in the technology.The vacuum drying temperature is controlled at 50-90 ℃, and the best is 60 ℃-70.Spray drying is for to be condensed into the concentrated solution that relative density is 1.05-1.15 (60 ℃) with extracting solution, and spray drying, inlet temperature are 100-220 ℃, leaving air temp is 50-150 ℃, best relative density is 1.08-1.10 (60 ℃), and inlet temperature is 160-180 ℃, and leaving air temp is 80-100 ℃.Particle drying adopts vacuum drying.
9, yellow the kidney invigorating granule of desert according to claim 1 and preparation method is characterized in that: have the thin layer of Fructus Schisandrae Chinensis to differentiate that have heavy metal must not cross 10/1000000ths, arsenic salt must not be crossed 2/1000000ths limit detection on quality inspection standard; The quantitative assay of Fructus Schisandrae Chinensis is arranged.
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Cited By (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN103169823A (en) * | 2013-04-18 | 2013-06-26 | 四川农业大学 | Veterinary drug composition for preventing and controlling mycotoxicoses as well as application, preparation and preparation method of veterinary drug composition |
CN108652004A (en) * | 2018-03-29 | 2018-10-16 | 李昀芊 | A kind of Desert Herba Cistanches electuary of high-content and preparation method thereof |
-
2003
- 2003-04-20 CN CNA031183239A patent/CN1537598A/en active Pending
Cited By (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN103169823A (en) * | 2013-04-18 | 2013-06-26 | 四川农业大学 | Veterinary drug composition for preventing and controlling mycotoxicoses as well as application, preparation and preparation method of veterinary drug composition |
CN108652004A (en) * | 2018-03-29 | 2018-10-16 | 李昀芊 | A kind of Desert Herba Cistanches electuary of high-content and preparation method thereof |
CN108652004B (en) * | 2018-03-29 | 2022-08-05 | 李昀芊 | Desert cistanche granule |
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