CN101032551B - Hepatosis-treating Chinese traditional medicine - Google Patents
Hepatosis-treating Chinese traditional medicine Download PDFInfo
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- CN101032551B CN101032551B CN2007100981568A CN200710098156A CN101032551B CN 101032551 B CN101032551 B CN 101032551B CN 2007100981568 A CN2007100981568 A CN 2007100981568A CN 200710098156 A CN200710098156 A CN 200710098156A CN 101032551 B CN101032551 B CN 101032551B
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Abstract
The Chinese medicine for treating hepatosis is prepared with silymarin 40-80 weight portions, alcohol extractum of five kinds of seed 140-180 weight portions, beta-cyclodextrin 120-160 weight portions and fine silica gel powder 10-20 weight portions. The Chinese medicine with beta-cyclodextrin and fine silica gel powder as supplementary material and prepared through specific production process has raised bioavailability, reduced dosage, easy-to-control production process and stable and reliable quality. The present invention also relates to the preparation process of the Chinese medicine.
Description
Technical field
The present invention relates to the field of Chinese medicines, particularly a kind of Chinese patent medicine for the treatment of hepatopathy.
Background technology
Herba Silybi mariani at present commonly used and schizandrol extractum are as a kind of Chinese patent medicine of treatment hepatopathy, this medicine is called compound liver-benepitino remedy again, and the function of this medicine cures mainly and is liver-benefiting kidney-nourishing, detoxifying, removing dampness.Be used for the hepatic and renal YIN deficiency, the hypochondriac pain poor appetite that noxious dampness does not cause clearly, abdominal distention, the soreness of waist is weak, diseases such as yellowish urine; Or the chronic hepatitis transaminase person of increasing; Compound liver-benepitino remedy is as a liver disease drug, and clinical reflection is respond well, all is better than silybin and schizandrol single preparations of ephedrine aspect not rebounding repairing hepatocyte and fall enzyme, is an outstanding one-tenth side Chinese patent medicine kind in the liver disease medicine in the market.Yet it still has the following disadvantages: dosage is slightly bigger than normal, takes 6～8 at every turn, and adjuvant amount is more than 3 times of principal agent amount in this, if can select novel adjuvant for use, dosage is reduced, and can make things convenient for the patient; Schizandrol extractum does not have the content control criterion in the side, and production technology is wayward, so quality standard is necessary to improve.
Summary of the invention
The technical problem to be solved in the present invention is intended to overcome the deficiency of above-mentioned prior art, and a kind of Chinese patent medicine for the treatment of hepatopathy is provided, and this Chinese patent medicine adjuvant amount reduces, and dosage reduces, and stable curative effect is reliable.
The technical solution used in the present invention is:
A kind of Chinese patent medicine for the treatment of hepatopathy, described Chinese patent medicine are the medicaments of being made by the raw material that contains following mass ratio component: silymarin-40～80; Schizandrol extractum-140～180; Beta cyclodextrin-120～160; Micropowder silica gel-10～20.
Further, described Chinese patent medicine also includes the component of following mass ratio: carboxymethyl starch sodium-10～20.
Further, described schizandrol extractum can be got by following method preparation: get Fructus Schisandrae Chinensis 1000g, remove foreign material such as sandstone, added 6 times of amount soak with ethanol of 30% 24 hours, filtration, filtrate recycling ethanol, crude drug residue drying, be ground into coarse powder, add 75% alcohol reflux three times: 4 times of amount alcohol reflux 3hr for the first time; Measure alcohol reflux 2hr for 3 times for the second time; Measure alcohol reflux 1hr for 3 times for the third time; Merge extractive liquid,, leave standstill 48hr, get supernatant, decompression recycling ethanol is to paste, density 1.25～1.35 (60 ℃ of heat are surveyed), extractum adds 1.5 times of amount 90% alcohol reflux 2hr again, filter, extracting solution leaves standstill 24hr, gets supernatant, reclaim ethanol to density 1.25～1.33 (60 ℃ of heat are surveyed), promptly.
Compared with the prior art the Chinese patent medicine of treatment hepatopathy of the present invention has following good effect: adopt beta-schardinger dextrin-and micropowder silica gel as adjuvant, the amount of adjuvant reduces, and therefore makes patient's taking dose reduce; The Chinese patent medicine that adopts specific adjuvant and specific production technology to make makes the flowability of material obtain very big change; Adopt specific schizandrol production technology, make the content standard of schizandrol extractum be easy to control, and its production technology is easy to control.
Another technical problem that the present invention will solve provides a kind of preparation method for the treatment of the Chinese patent medicine of hepatopathy, this method comprises the steps: to take by weighing beta-schardinger dextrin-and micropowder silica gel, join in the schizandrol extractum, mix thoroughly, dry, pulverize and with the silymarin and the carboxymethyl starch sodium of recipe quantity, sieve mixing, system soft material, granulate drying.
Further, get by following method preparation at schizandrol extractum described in the described method: get Fructus Schisandrae Chinensis 1000g, remove foreign material such as sandstone, added 6 times of amount soak with ethanol of 30% 24 hours, filtration, filtrate recycling ethanol, crude drug residue drying, be ground into coarse powder, add 75% alcohol reflux three times: 4 times of amount alcohol reflux 3hr for the first time; Measure alcohol reflux 2hr for 3 times for the second time; Measure alcohol reflux 1hr for 3 times for the third time; Merge extractive liquid,, leave standstill 48hr, get supernatant, decompression recycling ethanol is to paste, density 1.25～1.35 (60 ℃ of heat are surveyed), extractum adds 1.5 times of amount 90% alcohol reflux 2hr again, filter, extracting solution leaves standstill 24hr, gets supernatant, reclaim ethanol to density 1.25～1.33 (60 ℃ of heat are surveyed), promptly.
Further, the mass ratio of each raw material is as follows in described method: silymarin-60; Schizandrol extractum-160; Beta-schardinger dextrin--140; Micropowder silica gel-15; Carboxymethyl starch sodium-15.
Compound liver-benepitino remedy commonly used, adopt schizandrol extractum and silymarin and adjuvant directly to granulate, the adjuvant amount will add 3 times of about principal agent amount, the ability molding, and each dose is about 2000mg and is pressed into 6～8 coated tablets, dose is big, have only reshaping after the schizandrol extractum drying in order to reduce dose, so the present invention has selected specific drying technology for use.
Because the schizandrol extractum main component is water insoluble, oiliness is heavy, and is more sticking.If do not add adjuvant, directly adopt spraying, microwave, vacuum, the lyophilization all can't be dry through prerun.And take extractum add beta-schardinger dextrin-and micropowder silica gel mix carry out vacuum drying and pulverize after, the humidity of schizandrol extractum is very dried, mobile general, powder viscosity is not sticking, and the schizandrol extractum after handling changes wettability in time and also big amplification can not take place, stable relatively in 24 hours, next step production technology there is not influence.Therefore, can greatly reduce the adjuvant amount by adding beta-schardinger dextrin-and micropowder silica gel mixing, and add beta-schardinger dextrin-and the schizandrol extractum of micropowder silica gel and the combination of Herba Silybi mariani, promptly be suitable for tablet and be suitable for capsule again.
Further, add carboxymethyl starch sodium and can obviously improve the capsule disintegrating property as disintegrating agent, the back flowability of granulating is all better, can no longer add fluidizer.
Further, the present invention adopts specific schizandrol production technology, makes the content standard of schizandrol extractum be easy to control, and its production technology is easy to control, and drug quality is more reliable and more stable.Wherein the extraction ratio of schizandrol is about 11%, and schisandrin B content is no less than 9.0% in the schizandrol.
Because schizandrol extractum viscosity is strong in the material, all waters of wetting agent are found in prerun, use ethanol water as adhesive only.Wherein, choosing 80% ethanol, to make the made mobility of particle of adhesive best, and bulk density reaches the filling requirement.In sum, above-mentioned technology makes material fluidity obtain very big change.
The specific embodiment
Below will be described in detail the specific embodiment of the present invention.
(Silybin, Silymarin LEGALON), are the fruit of Compositae Silybum plant Herba Silybi mariani (Silybum mariaum Gaertn.) to silymarin, extract the loose sprills of gained through the processing degrease.Its main effective ingredient is silibinin (being a stereoisomer), belongs to flavanolignan's compounds, is the off-white color crystalline powder, odorless, mildly bitter flavor is puckery, have draw moist; Be dissolved in acetone, ethyl acetate, methanol, ethanol, be insoluble in chloroform, water insoluble; Easily molten in dilute alkaline soln.
Schizandrol extractum: by the extractum of Fructus Schisandrae Chinensis [be the dry mature fruit of magnoliaceae schisandra Schisandra chinensis (Turcz.) Baill, practise title " Radix Schisandrae Bicoloris "] through the alcohol extraction gained.Radix Schisandrae Bicoloris mainly contains deoxyschizandrin, schisandrin B, schisandrin C, schisandrin, schisantherin B, schisantherin A, schizantherin the second grade chemical compound.
The combination of above-mentioned silymarin and schizandrol extractum and Chinese patent medicine have following effect and characteristics: alleviate all kinds of hepatitis symptoms rapidly, improve liver function comprehensively; The protection hepatocyte is stablized liver plasma membrane, repairs impaired hepatic tissue, can resist hepatic necrosis; Enhance hepatocyte microgranule enzymatic activity improves the liver detoxification ability; Rapid transaminase lowering, curative effect is reliable; Alleviate steatosis, suppress the rising of serum GPT levels, make damaging of liver cell mitochondria and endoplasmic reticulum through recovering, and choleretic effect is arranged.In addition, contain multiple schizandrin in the schizandrol, wherein schisandrin B and schizantherin are first-class can significantly reduce serum glutamic pyruvic transminase, and effect is stablized soon.
And the present invention adopts beta-schardinger dextrin-and micropowder silica gel to make desiccant on the basis of above-mentioned silymarin and schizandrol extractum combination.Below be that example specifies with the silymarin that contains 70% mass content silibinin, as shown in table 1, take by weighing the beta-schardinger dextrin-and the micropowder silica gel of mass ratio shown in the table, join in the schizandrol extractum, mix thoroughly, dry, pulverize and with the silymarin and the carboxymethyl starch sodium of mass ratio shown in the table, sieve, mixing, the system soft material is granulated, drying, the Chinese patent medicine that must the present invention relates to.The Chinese patent medicine that the present invention relates to can be used for for example multiple dosage form such as tablet or capsule, only needs when being used for tablet dried semi-finished product tabletting, sugar coating are got final product; When being used for capsule, need be with dried semi-finished product granulate, capsule is filled, and packing gets final product.
In addition, the schizandrol extractum 1 that the Chinese patent medicine that the present invention relates to can extract with common method is as raw material, also Fructus Schisandrae Chinensis can be extracted the schizandrol extractum 2 that obtain through following method as raw material: take by weighing Fructus Schisandrae Chinensis, choose foreign material such as silt, added 6 times of amount soak with ethanol of 30% 24 hours, and filtered, extractum discards behind the filtrate recycling ethanol, filtering residue adds 75% ethanol (4,3,3) doubly measure reflux, extract, three times (3,2,1) hour, filters.Merge three times filtrate, left standstill 48 hours, draw supernatant, decompression recycling ethanol is condensed into relative density 1.28-1.35 (60 ℃ of heat are surveyed), measured 90% alcohol reflux 2 hours for 1.5 times that add the thick paste amount again, filter, filtrate was left standstill 24 hours, drew supernatant, decompression recycling ethanol promptly gets schizandrol extractum to relative density 1.25-1.30 (heat is surveyed).
Table 1
| Embodiment 1 | Embodiment 2 | Embodiment 3 | Embodiment 4 | Embodiment 5 | Embodiment 6 | Embodiment 7 | Embodiment 8 | Embodiment 9 | Embodiment 10 | |
| Silymarin | 40 | 60 | 80 | 60 | 40 | 80 | 40 | 80 | 60 | 60 |
| Schizandrol extractum 1 | 180 | 160 | 140 | 0 | 0 | 0 | 0 | 0 | 160 | 0 |
| Schizandrol extractum 2 | 0 | 0 | 0 | 160 | 180 | 140 | 180 | 140 | 0 | 160 |
| Beta-schardinger dextrin- | 120 | 160 | 140 | 120 | 160 | 140 | 120 | 160 | 140 | 140 |
| Micropowder silica gel | 20 | 10 | 15 | 20 | 10 | 15 | 20 | 10 | 15 | 15 |
| Carboxymethyl starch sodium | 0 | 0 | 0 | 0 | 0 | 10 | 15 | 20 | 15 | 15 |
Sieve, make operational approach commonly used and the condition control that soft material, granulation and drying process can adopt those skilled in the art in the above-mentioned preparation method, further, the preferred Chinese patent medicine that adopts following method to the present invention relates to: after mixing thoroughly in beta-schardinger dextrin-, micropowder silica gel and the schizandrol extractum with preparation, employing boulton process drying, sieve and be operating as 100 mesh sieves, 80% an amount of ethanol system soft material is adopted in the operation of system soft material, the operation of granulating adopts 24 orders to granulate, and the baking temperature after the granulation adopts 60 ± 5 ℃.Wherein, preferred further employing Chinese patent medicine of the present invention is made capsule formulation.
Chinese patent drug of the present invention has the following advantages: 1. drug bioavailability height, can bring into play quickly drug effect, and curative effect is more reliable and more stable; 2. gloss appearance is attractive in appearance, can cover the adverse drug smell, is convenient to take; 3. be shaped easily, supplementary product consumption can reduce, and patient's single dose reduces; 4. adopt capsule formulation, can avoid the taboo of diabetic to take sugar coated tablet.
Claims (7)
1. a Chinese patent medicine for the treatment of hepatopathy is characterized in that described Chinese patent medicine is the medicament of being made by the raw material that contains following mass ratio component: silymarin 40～80; Schizandrol extractum 140～180; Beta-schardinger dextrin-120～160; Micropowder silica gel 10～20; Carboxymethyl starch sodium 10～20; Described schizandrol extractum is got by following method preparation: get Fructus Schisandrae Chinensis 1000g, remove foreign material such as sandstone, added 6 times of amount soak with ethanol of 30% 24 hours, filtration, filtrate recycling ethanol, crude drug residue drying, be ground into coarse powder, add 75% alcohol reflux three times: 4 times of amount alcohol reflux 3hr for the first time; Measure alcohol reflux 2hr for 3 times for the second time; Measure alcohol reflux 1hr for 3 times for the third time; Merge extractive liquid, leaves standstill 48hr, gets supernatant, and decompression recycling ethanol is to paste, 60 ℃ of heat are surveyed density 1.25～1.35, and extractum adds 1.5 times of amount 90% alcohol reflux 2hr again, filters, and extracting solution leaves standstill 24hr, get supernatant, reclaim ethanol to 60 ℃ heat and survey density 1.25～1.33, promptly.
2. the Chinese patent medicine of treatment hepatopathy according to claim 1 is characterized in that described Chinese patent medicine is the medicament of being made by the raw material that contains following mass ratio component: silymarin 60; Schizandrol extractum 160; Beta-schardinger dextrin-140; Micropowder silica gel 15; Carboxymethyl starch sodium 15.
3. the Chinese patent medicine of treatment hepatopathy according to claim 1 and 2 is characterized in that described Chinese patent medicine is capsule or tablet.
4. the Chinese patent medicine of treatment hepatopathy according to claim 3 is characterized in that described Chinese patent medicine is a capsule.
5. the Chinese patent medicine of treatment hepatopathy according to claim 3, it is characterized in that described Chinese patent medicine is got by following method preparation: take by weighing beta-schardinger dextrin-and micropowder silica gel, join in the schizandrol extractum, mix thoroughly, vacuum drying, pulverizing and with the silymarin and the carboxymethyl starch sodium of recipe quantity, cross 100 mesh sieves, mixing is with 80% an amount of ethanol system soft material, 24 orders are granulated, 60 ± 5 ℃ of dryings.
6. preparation method for the treatment of the hepatopathy Chinese patent medicine, this method comprises the steps: to take by weighing beta-schardinger dextrin-and micropowder silica gel, joins in the schizandrol extractum, mix thoroughly, dry, pulverize and with the silymarin and the carboxymethyl starch sodium of recipe quantity, sieve mixing, the system soft material is granulated drying; After mixing thoroughly in beta-schardinger dextrin-, micropowder silica gel and the schizandrol extractum, employing boulton process drying, described sieving was operating as 100 mesh sieves, 80% an amount of ethanol system soft material is adopted in described system soft material operation, described granulation operation adopts 24 orders to granulate, and the baking temperature after the described granulation adopts 60 ± 5 ℃; Described Chinese patent medicine contains the raw material of following mass ratio component: silymarin 40～80; Schizandrol extractum 140～180; Beta-schardinger dextrin-120～160; Micropowder silica gel 10～20; Carboxymethyl starch sodium 10～20.
7. the preparation method of the Chinese patent medicine of treatment hepatopathy according to claim 6, it is characterized in that getting by following method preparation: get Fructus Schisandrae Chinensis 1000g at schizandrol extractum described in the described method, remove foreign material such as sandstone, added 6 times of amount soak with ethanol of 30% 24 hours, filtration, filtrate recycling ethanol, crude drug residue drying, be ground into coarse powder, add 75% alcohol reflux three times: 4 times of amount alcohol reflux 3hr for the first time; Measure alcohol reflux 2hr for 3 times for the second time; Measure alcohol reflux 1hr for 3 times for the third time; Merge extractive liquid, leaves standstill 48hr, gets supernatant, and decompression recycling ethanol is to paste, 60 ℃ of heat are surveyed density 1.25～1.35, and extractum adds 1.5 times of amount 90% alcohol reflux 2hr again, filters, and extracting solution leaves standstill 24hr, get supernatant, reclaim ethanol to 60 ℃ heat and survey density 1.25～1.33, promptly.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2007100981568A CN101032551B (en) | 2007-04-17 | 2007-04-17 | Hepatosis-treating Chinese traditional medicine |
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| CN2007100981568A CN101032551B (en) | 2007-04-17 | 2007-04-17 | Hepatosis-treating Chinese traditional medicine |
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| CN101032551A CN101032551A (en) | 2007-09-12 |
| CN101032551B true CN101032551B (en) | 2011-01-12 |
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| CN2007100981568A Active CN101032551B (en) | 2007-04-17 | 2007-04-17 | Hepatosis-treating Chinese traditional medicine |
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Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1660188A (en) * | 2004-12-27 | 2005-08-31 | 陆友新 | Capsule of Chinese traditional medicine for enriching liver and nourishing kidney, detoxification and eliminating damp |
| CN1853675A (en) * | 2005-04-26 | 2006-11-01 | 北京济通天宇科技有限公司 | Compound Silybum drip balls and preparation thereof |
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Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1660188A (en) * | 2004-12-27 | 2005-08-31 | 陆友新 | Capsule of Chinese traditional medicine for enriching liver and nourishing kidney, detoxification and eliminating damp |
| CN1853675A (en) * | 2005-04-26 | 2006-11-01 | 北京济通天宇科技有限公司 | Compound Silybum drip balls and preparation thereof |
Non-Patent Citations (1)
| Title |
|---|
| 中华人民共和国卫生部药典委员会.卫生部颁药品标准（中药成药制剂第十二册）.1997,Z12-126. * |
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| CN101032551A (en) | 2007-09-12 |
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