CN1565486A - Leucocyte increasing pills and its preparation method - Google Patents
Leucocyte increasing pills and its preparation method Download PDFInfo
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- CN1565486A CN1565486A CN 03124503 CN03124503A CN1565486A CN 1565486 A CN1565486 A CN 1565486A CN 03124503 CN03124503 CN 03124503 CN 03124503 A CN03124503 A CN 03124503A CN 1565486 A CN1565486 A CN 1565486A
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Abstract
The invention discloses a Leucocyte increasing pills and its preparation method, wherein the pills have the advantages of quick release rate, high biological availability, non-irritating, accurate dosage, and convenient in use.
Description
Technical field
This invention relates to the processing technology technical field of Chinese patent medicine pill, relates in particular to filler ball and preparation method.
Background technology
Pill is a kind of conventional dosage forms, 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, original dosage form of filler ball is the filler granule, 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: eight flavor medicines in the prescription, decoct with water, and be condensed into clear paste, add sucrose, dextrin mixed pelletization, be drying to obtain.This granule supplementary product consumption is big, and dose is big, and the sugar content height be not suitable for the people who suffers from diabetes and take, and this pharmaceutically dosage form is single, far can not satisfy people's medication demand, and its quality standard still can further improve simultaneously.We use the modern pharmaceutical technology this product technology are done necessary improvement based on this, form new preparation, and control criterion simultaneously improves the quality, guarantee the quality monitoring of product, 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 filler ball 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. filler ball and preparation method comprise the steps:
1.1 the prescription of filler ball is formed
Fructus Psoraleae 75-800g Semen Lablab Album 120-1320g Herba Epimedii 75-800g
Radix Salviae Miltiorrhizae 75-800g Radix Bupleuri 75-800g Semen sojae atricolor 250-2680g
Semen Phaseoli 250-2680g Radix Sophorae Flavescentis 75-800g right amount of auxiliary materials is made 300g altogether.
Its optimum formula is:
Fructus Psoraleae 200-500g Semen Lablab Album 330-825g Herba Epimedii 200-500g
Radix Salviae Miltiorrhizae 200-500g Radix Bupleuri 200-500g Semen sojae atricolor 670-1675g
Semen Phaseoli 670-1675g Radix Sophorae Flavescentis 200-500g right amount of auxiliary materials is made 300g altogether.
1.2 the preparation technology of filler ball
Technology one, will write out a prescription in eight the flavor medicines be up to the standards standby respectively; Eight flavor medicated powder are broken into coarse powder/be cut into decoction pieces to decoct with water 2-3 time in the prescription, and decoction liquor merges, filtration, 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, will write out a prescription in eight the flavor medicines be up to the standards standby respectively; Fructus Psoraleae, Radix Salviae Miltiorrhizae, Radix Bupleuri, Herba Epimedii are ground into coarse powder, use the 50-95% ethanol extraction, and extracting solution reclaims ethanol, be concentrated in right amount, four flavors such as medicinal residues and all the other Semen Lablab Albums are ground into coarse powder/be cut into decoction pieces to decoct with water 2-3 time the decoction liquor merging, filter, filtrate is concentrated in right amount, merges with above-mentioned alcohol extract, is condensed into thick paste/concentrate drying and makes dried cream powder, with the appropriate amount of auxiliary materials mixing, pill, drying, promptly.
1.3 the ball by the technology gained is the filler ball.
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, one or more mixing of methylcellulose to use.
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 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 condition that decocting boils in the technology is: amount of water is that 6-15 doubly measures for the first time, and second and third time doubly measured for 4-10, decocts each 1-3 hour 2-3 time.Best amount of water is 10 times of amounts for the first time in order to decoct secondary, is 8 times of amounts for the second time, is 1.5 hours for the first time, 1 hour for the second time.
The alcohol extraction condition is in the technology: with 50-95% ethanol is solvent, adopts and refluxes or the percolation extraction, best for being solvent with 70-75% ethanol, adds 8 times of amount solvent refluxings and extracts secondary, each 1.5 hours.
The technology pulverizing medicinal materials becomes coarse powder, is generally 5-40 order coarse powder, and the best was a 10-20 order coarse powder.
The relative density of thick paste is 1.10-1.45 (60-70 a ℃) in the technology, and best relative density is 1.30-1.35 (60-70 a ℃).
Concentrate drying can adopt vacuum drying or adopt spray drying in the technology, and the vacuum drying temperature is controlled at 50-80 ℃, is preferably 60 ℃.Spray drying is for to be concentrated to the concentrated solution that relative density is 1.05-1.15 (55-60 a ℃) with extracting solution, spray drying, inlet temperature is 100-220 ℃, leaving air temp is 50-150 ℃, best relative density is 1.08-1.10 (55-60 a ℃), inlet temperature is 160-180 ℃, and leaving air temp is 90-110 ℃.
Concentrate in the technology and can adopt concentrating under reduced pressure/thin film concentration/vacuum film to concentrate.
Filter in the technology and can adopt conventional the filtration, centrifugal, ultrafiltration adds filtration/centrifugal/methods such as ultrafiltration behind the clarifier.
2. the quality control standard of filler ball mainly contains discriminating, inspection and three aspects of assay among the present invention.
This product is further to improve on the particulate basis of original filler, former dosage form has the thin layer of Fructus Psoraleae, Radix Salviae Miltiorrhizae, Radix Sophorae Flavescentis to differentiate on differentiating, now kept, and the thin layer that has increased Herba Epimedii, Radix Bupleuri is differentiated; Former dosage form does not have the limit examine of arsenic salt, heavy metal on checking, has now increased heavy metal limit and must not cross 10/1000000ths, and arsenic salt must not cross 2/1000000ths; Former dosage form has carried out quantitatively now being kept to Fructus Psoraleae on the assay.
This invention is dosage form technological innovation on original particulate basis, and quality standard has new raising again, to improving the quality of products significant meaning is arranged, and has enriched medicine variety, satisfies and ensured people's medication demand.
The specific embodiment
Embodiment 1: eight flavor medicines are up to the standards standby respectively in will writing out a prescription; Eight flavor medicines decoct with water 2 times in the prescription, and 1.5 hours for the first time, 1 hour for the second time, decoction liquor merged, and filtered, and it is 1.08-1.10 (60 ℃) that filtrate is concentrated into relative density, and spray drying is made dried cream powder, with appropriate amount of auxiliary materials mixing, pill, drying, promptly.
Embodiment 2: eight flavor medicines are up to the standards standby respectively in will writing out a prescription; Fructus Psoraleae, Radix Salviae Miltiorrhizae, Radix Bupleuri, Herba Epimedii are ground into coarse powder, with 70-75% ethanol is solvent, add 8 times of amount solvent refluxings and extract secondary, each 1.5 hours, extracting solution reclaimed ethanol, be concentrated into an amount of, four flavors such as medicinal residues and all the other Semen Lablab Albums decoct with water 2 times, and 1.5 hours for the first time, 1 hour for the second time, decoction liquor merges, filter, filtrate is concentrated in right amount, merges with above-mentioned alcohol extract, being concentrated into relative density is 1.08-1.10 (60 ℃), spray drying is made dried cream powder, with appropriate amount of auxiliary materials mixing, pill, drying, promptly.
Claims (10)
1. filler ball and preparation method is characterized in that:
(1) Fructus Psoraleae, Semen Lablab Album, Herba Epimedii, Radix Salviae Miltiorrhizae, Radix Bupleuri, Semen sojae atricolor, Semen Phaseoli, the Radix Sophorae Flavescentis eight flavor medicines of will writing out a prescription are up to the standards standby respectively; Eight flavor medicines decoct with water 2-3 time in the prescription, and decoction liquor merges, and filters, 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) Fructus Psoraleae, Semen Lablab Album, Herba Epimedii, Radix Salviae Miltiorrhizae, Radix Bupleuri, Semen sojae atricolor, Semen Phaseoli, the Radix Sophorae Flavescentis eight flavor medicines of will writing out a prescription are up to the standards standby respectively; Fructus Psoraleae, Radix Salviae Miltiorrhizae, Radix Bupleuri, Herba Epimedii are ground into coarse powder, use the 50-95% ethanol extraction, and extracting solution reclaims ethanol, be concentrated in right amount, four flavors such as medicinal residues and all the other Semen Lablab Albums decoct with water 2-3 time, and decoction liquor merges, filter, filtrate is concentrated in right amount, merges with alcohol extract, is condensed into thick paste/concentrate drying and makes dried cream powder, with the appropriate amount of auxiliary materials mixing, pill, drying, promptly.
2. according to described filler ball 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 filler ball of claim 1 and preparation method, it is characterized in that: 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.
4. according to described filler ball of claim 1 and preparation method, it is characterized in that: the particle diameter of the ball of 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 filler ball of claim 1 and preparation method, it is characterized in that: the condition that decocting boils is: amount of water is that 6-15 doubly measures for the first time, second and third time doubly measured for 4-10, decoct 2-3 time, each 1-3 hour, best for decocting secondary, amount of water is 10 times of amounts for the first time, is 8 times of amounts for the second time, is 1.5 hours for the first time, 1 hour for the second time, the alcohol extraction condition is: with 50-95% ethanol is solvent, adopts backflows/percolation to extract, and best is to be solvent with 70-75% ethanol, add 8 times of amount solvent refluxings and extract secondary, each 2 hours.
6. according to described filler ball of claim 1 and preparation method, it is characterized in that: what pulverizing medicinal materials became coarse powder is generally 5-40 order coarse powder, and the best was a 10-20 order coarse powder.
7. according to described filler ball of claim 1 and preparation method, it is characterized in that: the relative density of thick paste is 1.10-1.45 (60-70 a ℃), and best relative density is 1.30-1.35 (60-70 a ℃).
8. according to described filler ball of claim 1 and preparation method, it is characterized in that: concentrate drying can adopt vacuum drying/employing spray drying, the vacuum drying temperature is controlled at 50-80 ℃, the best is 60 ℃, spray drying is for to be concentrated to the concentrated solution that relative density is 1.05-1.15 (60 ℃) with extracting solution, spray drying, inlet temperature is 100-220 ℃, leaving air temp is 50-150 ℃, best relative density is 1.08-1.10 (55-60 a ℃), inlet temperature is 160-180 ℃, and leaving air temp is 90-110 ℃.
9. according to described filler ball of claim 1 and preparation method, it is characterized in that: concentrate and to adopt concentrating under reduced pressure/thin film concentration/vacuum film to concentrate; Filtration can adopt and conventional filter, centrifugal, ultrafiltration, add filter behind the clarifier, the method for centrifugal, ultrafiltration.
10. according to described filler ball of claim 1 and preparation method, it is characterized in that: the quality standard of this product is controlled at the thin layer that Herba Epimedii, Radix Bupleuri are arranged in the discriminating and differentiates; Have heavy metal must not cross 10/1000000ths, arsenic salt must not be crossed 2/1000000ths limit detection; The quantitative of Fructus Psoraleae arranged on the assay.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 03124503 CN1565486A (en) | 2003-06-03 | 2003-06-03 | Leucocyte increasing pills and its preparation method |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 03124503 CN1565486A (en) | 2003-06-03 | 2003-06-03 | Leucocyte increasing pills and its preparation method |
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| CN1565486A true CN1565486A (en) | 2005-01-19 |
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| CN 03124503 Pending CN1565486A (en) | 2003-06-03 | 2003-06-03 | Leucocyte increasing pills and its preparation method |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102512498A (en) * | 2012-01-01 | 2012-06-27 | 山东大学威海分校 | Preparation method for compound salvia miltiorrhiza preparation and antioxidant activity thereof |
-
2003
- 2003-06-03 CN CN 03124503 patent/CN1565486A/en active Pending
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102512498A (en) * | 2012-01-01 | 2012-06-27 | 山东大学威海分校 | Preparation method for compound salvia miltiorrhiza preparation and antioxidant activity thereof |
| CN102512498B (en) * | 2012-01-01 | 2013-10-23 | 山东大学威海分校 | Preparation method for compound salvia miltiorrhiza preparation and antioxidant activity thereof |
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