CN101579428A - Zhuhuang Chuihou preparation and preparation technology thereof - Google Patents
Zhuhuang Chuihou preparation and preparation technology thereof Download PDFInfo
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- CN101579428A CN101579428A CNA2008101065953A CN200810106595A CN101579428A CN 101579428 A CN101579428 A CN 101579428A CN A2008101065953 A CNA2008101065953 A CN A2008101065953A CN 200810106595 A CN200810106595 A CN 200810106595A CN 101579428 A CN101579428 A CN 101579428A
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Abstract
The invention discloses a traditional Chinese medicine preparation, in particular a Zhuhuang Chuihou preparation prepared by adopting an ultrafine grinding technology, belonging to the field of traditional Chinese medicines. The prescription of the preparation originates from the prior Zhuhuang Chuihou powder, and raw materials are prepared into needed preparation by the conventional technology after being ground by the ultrafine grinding technology. Compared with the prior art, the obtained product has little toxic side effect, maintains active ingredients to the maximum, keeps the compound grinding homogenization, fully embodies the traditional Chinese medicine features and greatly enhances the curative effect. The invention also discloses a preparation technology of the Zhuhuang Chuihou preparation.
Description
Technical field
The present invention relates to a kind of Chinese medicine preparation and preparation technology thereof, particularly a kind of is crude drug and new Zhuhuangchuizhou preparation and the preparation technology thereof that adopt superfine communication technique to make with Chinese medicine " Zhuhuangchuizhou loose " prescription, belongs to the field of Chinese medicines.
Background technology
Current, along with the raising of people's living standard, the variation of dietary structure and dietary habit, diseases such as the throat dispute is swollen and ache, erosion become the frequently-occurring disease and the commonly encountered diseases of puzzlement people's orthobiosis or work gradually.
Zhuhuangchuizhou looses and now to record in " 553 pages of Chinese pharmacopoeia versions in 2005 are used for that the throat dispute is swollen and ache, erosion, are to separate to poison rotten classics recipe.Its prescription consists of:
Margarita 50g Calculus Bovis 30g Borax (forging) 250g watermelon crystal 80g Realgar 40g
Catechu 100g Rhizoma Coptidis 100g Cortex Phellodendri 150g Borneolum Syntheticum 50g
Its preparation method is: above nine flavors, and except that Calculus Bovis, Borneolum Syntheticum, watermelon crystal, Margarita water flies or is ground into impalpable powder; Realgar water flies into impalpable powder; Four flavors such as all the other Boraxs are ground into fine powder; With Calculus Bovis, Borneolum Syntheticum porphyrize, with above-mentioned powder and watermelon crystal
Facing-up sieves, mixing, promptly.
When taking, external is blown in the affected part, 3～5 times on the one.
As everyone knows, the pulverizing of medical material is thin more, and specific surface area is big more, and its effective ingredient is easy more to be absorbed by the body; By contrast, the defective of pill is just apparent: most of medical material bioavailability is low, and the herb resource waste is serious; The pill dose is big, takes extremely inconvenience, also is not easy to carry, and the patient is difficult to be accepted.
Superfine communication technique is the machining process that makes the fine and super-refinement of material, provides one of important means of ultrafine powder.Micronizing is a new and high technology that grows up over nearly 20 years, refers to utilize machinery or hydromechanical approach that material is crushed to particle diameter less than the process below the 10 μ m.Ultramicro powder is the final products of micronizing, has some special physicochemical properties that general granule does not have, as fine solubility, dispersibility, adsorptivity etc.; For Chinese crude drug, the histiocyte sporoderm-broken rate improves greatly, and up to 90%, each effective constituents is release conditions, and dissolution and bioavailability are multiplied; And mineral drug or animal drugs.Since the nineties in 20th century, superfine communication technique is applied to Chinese medicine gradually, has given the more modern high section of Chinese medicine content, and the broken technology of Chinese medicine ultra-fine powder is as the constantly development of a new technology.
In with Chinese medicine conventional art and the bonded process of superfine communication technique, be existing Chinese patent medicine, especially classical side's medicine provides suitable superfine grinding method, the important content that become and improve the medical material utilization rate, promotes Chinese patent medicine research and development level.Because the different in kind of each flavor Chinese crude drug, the characteristic of the prescriptions of Chinese medicine of being made up of Chinese crude drug varies especially, therefore a Chinese patent medicine micronizing preparation to be processed into, except the characteristics that will be familiar with the broken technology of micropowder and each flavor Chinese medicine, also a large amount of practical experiences must be passed through.
Purpose of the present invention by analysis, practice many times, to obtain the practicable micronizing technology of a cover, in the hope of applying it to the herbal pharmaceutical industry, realizes industrialization, scale just at " Zhuhuangchuizhou looses " this classical prescription.
Summary of the invention
First purpose of the present invention is to provide a kind of new Zhuhuangchuizhou preparation, and said preparation is realized by superfine communication technique.
Another object of the present invention provides the preparation technology of this Zhuhuangchuizhou preparation.
The object of the invention mainly is to adopt following dual mode to realize:
Mode one: common micronizing
The inventor provides a kind of Zhuhuangchuizhou preparation that adopts superfine communication technique to make, prescription and ratio are with reference to " " Zhuhuangchuizhou looses " that Chinese pharmacopoeia version in 2005 is an one the 553rd page, pass through superfine communication technique, most of Chinese crude drug is ground into fine grained in will writing out a prescription, and then, these medical material intermediate are made required preparation by routine techniques.Simultaneously, the inventor notices that the Realgar in the crude drug is the toxicity mineral drug, mainly contains realgar (As
2S
2), should go into ball powder according to traditional Chinese medicine principle of medication, should not go into decoct, avoid ironware and high temperature, prevent Yin Gaowen and cause dissociating arsenic and the increase of solubility arsenic salt content, toxicity increases, thereby for avoid the toxic and side effects of preparation of the present invention as far as possible, guarantee patient's drug safety, we have still kept water to the Realgar in the prescription and have flown processing, have effectively removed toxic components such as free arsenic and soluble mercury arsenic salt; In addition, for thoroughly stopping patient's contingent toxic and side effects when using, it can also be the Zhuhuangchuizhou that the deducts Cinnabaris prescription that looses that the prescription of preparation of the present invention is formed.
For remedying the deficiency of existing Zhuhuangchuizhou preparation, farthest utilize the crude drug in the prescription, further improve the curative effect of preparation of the present invention, save the medicine source simultaneously, reduce production costs, the present invention introduces superfine communication technique among the preparation technology.The broken technology of Chinese medicine ultra-fine powder claims broken technology of Chinese medicine cell grade micropowder or Chinese medicine cell wall breaking technology again, and it is meant the broken and cell grade ultrafine Chinese herb preparation to Chinese medicine cell grade micropowder mostly, is to break the comminution process that the Chinese crude drug cell is a purpose.The broken technology of Chinese medicine ultra-fine powder has plurality of advantages: a improves extraction ratio of effective constituents, thereby improves drug bioavailability, and taking dose reduces, and saves Chinese material medicine resource, meets " sustainable development " strategy; B improves compound recipe and pulverizes homogenization, embodies tcm characteristic; C retains biological activity composition improves curative effect of medication; D reduces the oral granule sense; E avoids outside contamination, parasite killing, adjection such as antibacterial.
The broken device category of Chinese medicine ultra-fine powder is various, normal at present use mainly contain three major types: vibration type super micron mill, air-flowing type super micron mill, mechanical type super micron mill.Though air-flowing type equipment does not have the association heat, it is low to pulverize temperature, but capacity usage ratio is low, and energy consumption is big, the production cost height, and be not suitable for the superfine communication technique that adds adjuvant; Mechanical equipment convenience simple to operation, it is big that charging is suitable for particle size range, but equipment easily heats up, the component of machine serious wear, and the direct contaminated material of wear particle, heavy metal exceeds standard greatly, and the granularity of gained micropowder is bigger than normal; And vibration type equipment adopts full alloy material to make abrasive media, and special principle has farthest been avoided the wearing and tearing of parts, crush efficiency height, gained powder granularity (D simultaneously
50) can reach below the 10 μ m, combine with cryogenic technique simultaneously, be equally applicable to low melting point and thermal sensitivity medical material, applied range is present optimal micronizing equipment.So the present invention adopts the vibration type super micron mill to prepare the Zhuhuangchuizhou superfine powder, existing crush efficiency height, the micropowder granularity is little, the advantage that energy consumption is little, can use novel superfine grinding method again---add the method for adjuvant micronizing, better bring into play the curative effect of preparation.
The present invention also provides the preparation technology of employing mode one preparation Zhuhuangchuizhou micronizing preparation, is specially:
Get Zhu Xionghuang and carry out water and fly, dry naturally, standby; 10 mesh sieves are crossed in all the other 8 flavor crude drug flushing coarse pulverizations, and micronizing is 10～80 minutes in the vibration type pulverizing mill, makes ultra-fine pharmaceutical composition, flies the fine powder mix homogeneously with Realgar water, makes required preparation according to pharmaceutics conventional formulation technology.
The prepared preparation of above-mentioned preparation technology can be any one in pill, capsule or the tablet.
Simultaneously, for guaranteeing this preparation curative effect, the ultra-fine pharmaceutical composition that preparation adopted must reach the granularity of regulation: D
50Be not more than 10 μ m and D
90Be not more than 50 μ m, thereby guarantee the sporoderm-broken rate more than 90%, make each interior effective constituents of crude drug cell come out preferably and be release conditions, farthest improve drug bioavailability.
Optimization formula of the present invention is formed in the back and is embodied in the specific embodiment.
Mode two: add the adjuvant micronizing
The inventor provides Zhuhuangchuizhou to add adjuvant micronizing preparation, prescription and ratio are with reference to " " Zhuhuangchuizhou looses " that Chinese pharmacopoeia version in 2005 is an one the 553rd page, and by following proportioning adding pulverizing adjuvant, raw material after adjuvant passes through micronizing, is made required preparation by routine techniques again.The supplementary material proportioning is as follows:
Prescription part 0 part＜dispersant≤20,100 parts of 0 part＜wetting agent≤10 of medical material part
0～10 part of 0～10 portion of efficient disintegrating agent of bioadhesive polymer
Adjuvant used in the present invention is through screening and the final combination of determining, has uniqueness and irreplaceability, and wherein wetting agent is any or the compositions more than two kinds in lecithin, poloxamer, the Polyethylene Glycol; Bioadhesive polymer is the compositions of any or two kinds in chitosan, carbomer and the polyvinylpyrrolidone; Dispersant is any or the compositions more than two kinds in micropowder silica gel, cyclodextrin, starch, the dextrin; Efficient disintegrating agent is that low-substituted hydroxypropyl cellulose, carboxymethyl starch sodium, super carboxymethyl starch sodium, crospolyvinylpyrrolidone, cross-linked carboxymethyl cellulose are received, any or the compositions more than two kinds in the microcrystalline Cellulose.
Bioadhesive polymer chitosan, carbomer and polyvinylpyrrolidone are macromolecular material, have the bio-adhesive performance, but prolong drug significantly improves bioavailability of medicament in the gastrointestinal holdup time.Self is electronegative under the meta-alkalescence condition for carbomer, and intestinal can provide the environment of meta-alkalescence, and carbomer can form hydrophilic high viscosity gel in intestinal, be adsorbed on the intestinal mucosa, strengthen medicine in the holdup time of intestinal, promote the medicine moistening, strengthen absorbing of effective ingredient; Chitosan is natural biodegradable pasting material and the slow-release material of using always, and tool promotes the effect of medicine mucosa absorption, it is the polycation polysaccharide of the only existence of nature, chitosan be N-acetyl-D-glucamine and D-glucamine by the linear long-chain high-polymer molecular that β (1-4) glycosidic bond is formed by connecting, contain in a large number can with other molecules form hydrogen bonds-0H and-NH
2Group ,-NH
2Protonated formation-NH
3 +Make the molecule positively charged, above-mentioned molecular characterization makes chitosan become good bio-adhesive material, under the condition of acidic pH of gastric juice, chitosan forms hydrophilic high viscosity gel, easily be adsorbed on the gastrointestinal tract mucosa, the holdup time of prolong drug promotes the medicine moistening, strengthens absorbing of effective ingredient; And chitosan can also open epithelial tight connection, further promotes drug absorption.
Wetting agent lecithin, poloxamer, Polyethylene Glycol have certain surface activity effect, abundant moistening micropowders surface, reduce the surface tension of micropowder greatly, prevent that micropowder is coalescent agglomerating, the raising of micropowders wettability has simultaneously strengthened itself and the coupling ability of gastrointestinal wall, fully contacts, discharge effective ingredient, improve bioavailability.
Dispersant micropowder silica gel, cyclodextrin, microcrystalline Cellulose, starch, dextrin, Polyethylene Glycol etc. provide surface area great carrier for the high degree of dispersion of micropowders, the part microgranule that can neutralize simultaneously institute is electrically charged, eliminate the microparticle surfaces air film, make the surface energy of micropowders reduce greatly, the coalescent agglomerating phenomenon of medicine no longer appears, the mobile enhancing can carry out the preparation of preparations such as tablet, capsule fully, the more important thing is to have strengthened stability of drug.
Efficient disintegrating agent low-substituted hydroxypropyl cellulose, carboxymethyl starch sodium, super carboxymethyl starch sodium, crospolyvinylpyrrolidone, cross-linked carboxymethyl cellulose are received, the adding of microcrystalline Cellulose etc., be beneficial to preparations such as capsule, tablet, pill and discharge medicine rapidly, reach onset concentration in short period, onset rapidly.
The present invention also provides the preparation technology of employing mode two preparation Zhuhuangchuizhou micronizing preparations, is specially:
Get Realgar and carry out water and fly, dry naturally, standby; 10 mesh sieves are crossed in all the other 8 flavor crude drug flushing coarse pulverizations, add pharmaceutical adjunct, and micronizing is 10～80 minutes in the vibration type pulverizing mill, makes ultra-fine pharmaceutical composition, flies the fine powder mix homogeneously with Realgar water, makes required preparation according to pharmaceutics conventional formulation technology.
Among the above-mentioned preparation technology, the pharmaceutical adjunct that is added comprises wetting agent and dispersant, also can contain bioadhesive polymer and/or efficient disintegrating agent simultaneously.
The prepared preparation of above-mentioned preparation technology can be any one in pill, capsule or the tablet.
Simultaneously, for guaranteeing this preparation curative effect, the ultra-fine pharmaceutical composition that preparation adopted must reach the granularity of regulation: D
50Be not more than 10 μ m, D
90Be not more than 50 μ m, thereby guarantee the sporoderm-broken rate more than 90%, make each interior effective constituents of crude drug cell come out preferably and be release conditions, farthest improve drug bioavailability.
Optimization formula of the present invention is formed in the back and is embodied in the specific embodiment.
Beneficial effect
Technical scheme of the present invention is considered from practical angle, adopts innovative technology to make preparation of the present invention in conjunction with superfine communication technique, and concrete advantage is as follows:
1, improve drug bioavailability, improved curative effect: the Zhuhuangchuizhou preparation that adopts this patent invention preparation method to make has significantly improved bioavailability of medicament.Mineral drug, unorganized drug and insoluble drug are after micronizing in the prescription, and granularity reduces, and surface area sharply increases, and absorb to distribute soon the bioavailability height; And the animals and plants medical material is after micronizing, the cell wall breaking rate reaches 90%, and intracellular each effective constituents comes out preferably and is release conditions, and effective ingredient dissolution and bioavailability improve greatly, can reach onset concentration within a short period of time, bring into play curative effect rapidly.
2, reduced toxic and side effects: the inventor fully takes into account the toxicity and the side effect of preparation toxic crude drug, adopts optimum preparation technology to make preparation of the present invention, is reduced to the preparation toxic and side effects minimum.Acute toxicity and 3 months long term toxicity tests are not found any heavy metal accumulate poisoning symptom, point out preparation of the present invention safer, low toxicity.
3, preparation technology's efficient height, energy consumption is little: it is big to be compared to air-flowing type super micron mill energy consumption, and capacity usage ratio is low, the deficiency that production cost is high, preparation technology of the present invention improves, and adopts the vibration type pulverizing mill that energy consumption is little, efficient is high to carry out micronizing, granule D
50Can reach below the 10 μ m, and also can add adjuvants such as necessary dispersant and wetting agent among the preparation technology of the present invention, micropowder is reunited, adsorption phenomena is solved, and further strengthens drug effect, and this is that any micronizing mode is beyond one's reach.
4, promoted the application of superfine communication technique in pharmaceuticals industry to a certain extent: preparation unique preparation process of the present invention provides a practical way for similar technological innovation; along with updating of superfine communication technique; obtain the approval of numerous pharmaceutical researchers surely, the scale of the broken technology of Chinese medicine ultra-fine powder, industrialization are pointed the day and await for it.
As seen, the present invention has obtained outstanding technique effect, has reached goal of the invention.
The specific embodiment
Enumerate embodiment below, further specify the present invention, each embodiment only is used to illustrate the present invention, does not limit the present invention:
Embodiment 1
Prescription:
Margarita 50g Calculus Bovis 30g Borax (forging) 250g watermelon crystal 80g Realgar 40g
Catechu 100g Rhizoma Coptidis 100g Cortex Phellodendri 150g Borneolum Syntheticum 50g
Method for making: get Realgar and carry out water and fly, dry naturally, standby; All the other 8 flavor crude drug flushing coarse pulverizations, cross 10 mesh sieves, micronizing is 80 minutes in the vibration type pulverizing mill, makes ultra-fine pharmaceutical composition, fly the fine powder mix homogeneously with Realgar water, make Zhuhuangchuizhou powder, pill, capsule and tablet according to pharmaceutics conventional formulation technology.
Embodiment 2
Prescription:
Margarita 50g Calculus Bovis 30g Borax (forging) 250g watermelon crystal 80g Realgar 40g
Catechu 100g Rhizoma Coptidis 100g Cortex Phellodendri 150g Borneolum Syntheticum 50g
Method for making: get 9 flavor crude drug flushing coarse pulverizations, cross 10 mesh sieves, micronizing is 10 minutes in the vibration type pulverizing mill, makes ultra-fine pharmaceutical composition, makes Zhuhuangchuizhou powder, pill, capsule and tablet according to pharmaceutics conventional formulation technology.
Embodiment 3
Prescription:
Margarita 50g Calculus Bovis 30g Borax (forging) 250g watermelon crystal 80g Realgar 40g
Catechu 100g Rhizoma Coptidis 100g Cortex Phellodendri 150g Borneolum Syntheticum 50g
Method for making: get Realgar and carry out water and fly, dry naturally, standby; All the other 8 flavor crude drug flushing coarse pulverizations, cross 10 mesh sieves, add lecithin 40g, micropowder silica gel 60g, micronizing is 40 minutes in the vibration type pulverizing mill, make ultra-fine pharmaceutical composition, fly the fine powder mix homogeneously with Realgar water, make Zhuhuangchuizhou powder, pill, capsule or tablet according to pharmaceutics conventional formulation technology.
Embodiment 4
Prescription:
Margarita 25g Calculus Bovis 15g Borax (forging) 125g watermelon crystal 40g Realgar 20g
Catechu 50g Rhizoma Coptidis 50g Cortex Phellodendri 75g Borneolum Syntheticum 25g
Method for making: get 9 flavor crude drug flushing coarse pulverizations, cross 10 mesh sieves, add poloxamer 30g, cyclodextrin 35g, super carboxymethyl starch sodium 5g and crospolyvinylpyrrolidone 15g, micronizing is 80 minutes in the vibration type pulverizing mill, make ultra-fine pharmaceutical composition, make Zhuhuangchuizhou powder, pill, capsule or tablet according to pharmaceutics conventional formulation technology.
Claims (10)
1, a kind of Chinese medicine preparation, its raw materials of effective components medicine looses with Zhuhuangchuizhou, it is characterized in that making said preparation is handled crude drug by superfine communication technique after.
2, Chinese medicine preparation according to claim 1 is characterized in that the grain graininess D of the crude drug intermediate after superfine communication technique is handled
50Be not more than 10 μ m and D
90Be not more than 50 μ m.
3, Chinese medicine preparation according to claim 2 is characterized in that adopting following arbitrary preparation method to make:
A, get Realgar in the crude drug and carry out water and fly, dry naturally, standby; 10 mesh sieves are crossed in all the other 8 flavor crude drug flushing coarse pulverizations, and micronizing is 10～80 minutes in the vibration type pulverizing mill, makes ultra-fine pharmaceutical composition, flies the fine powder mix homogeneously with Realgar water, makes required preparation according to pharmaceutics conventional formulation technology;
B, get Realgar in the crude drug and carry out water and fly, dry naturally, standby; 10 mesh sieves are crossed in all the other 8 flavor crude drug flushing coarse pulverizations, add pharmaceutical adjunct, and micronizing is 10～80 minutes in the vibration type pulverizing mill, makes ultra-fine pharmaceutical composition, flies the fine powder mix homogeneously with Realgar water, makes required preparation according to pharmaceutics conventional formulation technology.
4, Chinese medicine preparation according to claim 3 is characterized in that the pharmaceutical adjunct among method b, the d mainly contains wetting agent and dispersant.
5, Chinese medicine preparation according to claim 4 is characterized in that pharmaceutical adjunct also contains bioadhesive polymer and/or efficient disintegrating agent.
6, Chinese medicine preparation according to claim 5 is characterized in that wetting agent is any or the compositions more than two kinds in lecithin, poloxamer, the Polyethylene Glycol; Dispersant is any or the compositions more than two kinds in micropowder silica gel, cyclodextrin, starch, the dextrin; Bioadhesive polymer is any or the compositions more than two kinds in chitosan, carbomer, the polyvinylpyrrolidone; Efficient disintegrating agent is that low-substituted hydroxypropyl cellulose, carboxymethyl starch sodium, super carboxymethyl starch sodium, crospolyvinylpyrrolidone, cross-linked carboxymethyl cellulose are received, any or the compositions more than two kinds in the microcrystalline Cellulose.
7, Chinese medicine preparation according to claim 6, the weight proportion of it is characterized in that writing out a prescription medical material and wetting agent, dispersant, bioadhesive polymer and efficient disintegrating agent is: 100: 0～10: 0～20: 0～10: 0～10.
8,, it is characterized in that being prepared in pill, capsule or the tablet any one according to the arbitrary described Chinese medicine preparation of claim 1 to 7.
9, the preparation method of arbitrary described Chinese medicine preparation in the claim 1 to 7.
10, the preparation method of the described Chinese medicine preparation of claim 8.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA2008101065953A CN101579428A (en) | 2008-05-14 | 2008-05-14 | Zhuhuang Chuihou preparation and preparation technology thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA2008101065953A CN101579428A (en) | 2008-05-14 | 2008-05-14 | Zhuhuang Chuihou preparation and preparation technology thereof |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN101579428A true CN101579428A (en) | 2009-11-18 |
Family
ID=41361833
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CNA2008101065953A Pending CN101579428A (en) | 2008-05-14 | 2008-05-14 | Zhuhuang Chuihou preparation and preparation technology thereof |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN101579428A (en) |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102423387A (en) * | 2011-11-08 | 2012-04-25 | 上海市浦东新区北蔡社区卫生服务中心 | Chinese medicine composition for treating oral ulcers |
| CN106137978A (en) * | 2016-08-19 | 2016-11-23 | 西藏甘露藏药股份有限公司 | A kind of preparation method of mineral drug powder particles agent |
-
2008
- 2008-05-14 CN CNA2008101065953A patent/CN101579428A/en active Pending
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102423387A (en) * | 2011-11-08 | 2012-04-25 | 上海市浦东新区北蔡社区卫生服务中心 | Chinese medicine composition for treating oral ulcers |
| CN102423387B (en) * | 2011-11-08 | 2014-12-10 | 上海市浦东新区北蔡社区卫生服务中心 | Chinese medicine composition for treating oral ulcers |
| CN106137978A (en) * | 2016-08-19 | 2016-11-23 | 西藏甘露藏药股份有限公司 | A kind of preparation method of mineral drug powder particles agent |
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Open date: 20091118 |