CN102973644A - Drug for treating acute or chronic hepatitis, and preparation method thereof - Google Patents
Drug for treating acute or chronic hepatitis, and preparation method thereof Download PDFInfo
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- CN102973644A CN102973644A CN 201210493569 CN201210493569A CN102973644A CN 102973644 A CN102973644 A CN 102973644A CN 201210493569 CN201210493569 CN 201210493569 CN 201210493569 A CN201210493569 A CN 201210493569A CN 102973644 A CN102973644 A CN 102973644A
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Abstract
The invention relates to the field of drug preparation and discloses a drug for treating acute or chronic hepatitis, and a preparation method thereof. The preparation method is characterized by comprising the following steps: extracting, concentrating and purifying active ingredients to radix sophorae tonkinensis, drying, and granulating to prepare into tablets or granules or hard capsules through filling. The preparation method is simple to operate, low in cost, easy for the process to control, and pollution-free. The prepared drug is obvious in curative effect on patients with acute or chronic hepatitis, and can fast lower aminotransferase.
Description
Technical field
The present invention relates to field of pharmaceutical preparations, be specifically related to a kind of medicine for the treatment of acute hepatitis, chronic hepatitis and preparation method thereof.
Background technology
Liver is the indispensable organ of human body.Along with the continuous improvement of China people material life, the sickness rate of hepatitis presents the trend that rises gradually.Hepatitis, typically refer to by multiple paathogenic factor--such as virus, antibacterial, parasite, chemical toxicant, medicine and poisonous substance, ethanol etc., the infringement liver, so that the cell of liver is damaged, the function of liver suffers damage, it can cause a series of malaise symptoms of health, and liver function index is unusual.Hepatitis can be divided into multiple different type usually: divide according to the cause of disease, can be divided into viral hepatitis, drug induced hepatitis, alcoholic hepatitis, toxic hepatitis etc.; Divide according to course of disease length, can be divided into acute hepatitis, chronic hepatitis etc.; According to severe extent, chronic hepatitis can be divided into again slightly, moderate, severe etc.According to existing dissimilar hepatitis 1.4 hundred million people of analysis of clinical China, be badly in need of the liver disease drug of good effect, few side effects.
At present, being used for the treatment of commonly usedly in the medicine of acute, chronic hepatitis has bifendate, glycyrrhizic acid diamidogen etc., but these medicines generally have certain side effect, the phenomenon such as often follow that therapeutic effect at a specified future date is poor, recur after the Strain drug resistance, drug withdrawal.Along with the curative effect of Chinese traditional treatment hepatitis B is proved by a large amount of clinical trials, Radix Sophorae Tonkinensis uses in continuous exploitation as a kind of effective Chinese crude drug for the treatment of hepatitis.Radix Sophorae Tonkinensis, it is the root of leguminous plant sophora subprostrata, mainly originate in the provinces such as Guangxi, Guangdong, Guizhou, the nature and flavor bitter cold is returned lung meridian, have heat-clearing and toxic substances removing, throat, the loose effect that swells and ache, main component is that alkaloids comprises matrine, oxymatrine, anagyrine etc., and flavonoid comprises that Chinese scholartree is fixed, Chinese scholartree ketone, sophoradochromene, Chinese scholartree promise chromene.Use Radix Sophorae Tonkinensis extract treatment hepatitis to be of long duration, ultimate attainment but the drug effect of how Radix Sophorae Tonkinensis being treated the effective ingredient of hepatitis performs to, and again the toxicity of extract is down to minimumly, be the problem that numerous medical experts explore always.
Summary of the invention
The object of the invention provides a kind of medicine for the treatment of acute hepatitis, chronic hepatitis and preparation method thereof, is intended to alleviate acute hepatitis, chronic hepatitis patient's symptom, and the fast reducing transaminase, and medicine of the present invention is evident in efficacy and not yet find toxic and side effects for treatment hepatitis.
The inventor for achieving the above object, a kind of medicine for the treatment of acute hepatitis, chronic hepatitis and preparation method thereof, its specific embodiments is as follows:
A kind of medicine for the treatment of acute hepatitis, chronic hepatitis of the present invention and preparation method thereof is characterized in that this drug main will add suitable adjuvant by matrine, oxymatrine, organic glycosides again and form.
A kind of medicine for the treatment of acute hepatitis, chronic hepatitis of the present invention and preparation method thereof, the effective ingredient that it is characterized in that this medicine is one or more products in the Radix Sophorae Tonkinensis extract, and its used Radix Sophorae Tonkinensis is selected, wash, cut medicine, extraction, concentrated, purification and dry gained.
The pharmaceutical worker's order of cutting of the present invention, the decoction pieces thickness of cutting is between the 0.3mm--10mm, and the decoction pieces baking temperature is 30--60 ℃, and be 2--8 hour drying time,
Abstraction process of the present invention, the mass ratio of decoction pieces and purified water is between the 1:1--1:5 in the leaching process, and extracting temperature is 60--100 ℃, and extracts three times, and each extraction time is 2--8 hour.
Enrichment process of the present invention, concentrator adopt economic benefits and social benefits or multiple-effect vacuum concentrator, concentrated vacuum degree control-below the 0.08Mpa, temperature is 40--100 ℃, the crude extract proportion that concentrates out is between the 1:1---1:1.5.
Purification procedures of the present invention drops into Alcohol-settling tank with enrichment process gained extractum, and adding ethanol, to make it alcohol concentration be 60%--80%, and opens cryogenic system and make it temperature and be down to subzero 5 ℃ of 8--, is incubated 48 hours.
Filtrate behind the purification of the present invention again vacuum concentration to proportion is 1:1--1:1.3, and thickening temperature is 20--50 ℃, and the smart extractum of gained is the Radix Sophorae Tonkinensis effective ingredient.Adopt the spray dried drying prescription dry the smart extractum of gained, the drying machine inlet temperature is 100--300 ℃, and outlet temperature is 60--90 ℃, and dried extractum particle moisture Control is below 3%.At last the extractum particle that drying is good and suitably auxiliary materials and mixing tabletting, or in the fill hard capsule, or use the granule packing.
Suitable adjuvant of the present invention comprises one or more in microcrystalline Cellulose, starch, pregelatinized Starch, hydroxypropyl methylcellulose, Pulvis Talci, carboxymethyl starch sodium, the cross-linking sodium carboxymethyl cellulose.
The present invention has the following advantages:
1, raw material is bought easily, and can promote the development of Chinese medicine.Be convenient to large production.
2, technique is simple, and is easy and simple to handle, and equipment requirements is not high.
3, this product is that oral medicine is easy to use, few side effects.
It is as follows to implement above-mentioned technique detailed process:
1, extract:
1.1 select, wash, cut medicine, drying, extraction
1.1.1 select qualified Radix Sophorae Tonkinensis, medical material and the foreign material removing stem, go mouldy, go bad.
1.1.2 the medical material of select is cleaned up repeatedly with the clear water that flows.
1.1.3 with the medical material cleaned with medicine cutter cut to thickness be between the 0.3mm--10mm.
1.14. the decoction pieces that cuts is placed in the drying baker, 50 ℃, dry 3 hours.
1.15. the decoction pieces that drying is good is weighed, and drops in the extraction pot, and presses 3 times of adding purified water extraction of its quality, extracts three times, each time is 2.5 hours.
2, concentrated
Extracting solution is evacuated in the dual-effect concentrator, opens steam valve, vacuum valve is concentrated, and thickening temperature is controlled at about 70 ℃, and the proportion of concentrated extract (slightly) is about 1.15.
3, purification
Extractum (slightly) is dropped in the Alcohol-settling tank, and it is 80% that adding ethanol makes it alcohol concentration, is cooled to 4 ℃, is incubated 48 hours.It is 1.1 that collection filtrate is concentrated into extractum (essence) proportion.
4, spray drying
Extractum (essence) is dry to the spray dried drying prescription.
5, tabletting, capsule charge, packing
With tabletting or capsule charge or packing after extractum (essence) particle and the auxiliary materials and mixing.
The specific embodiment
Below enforcement only for more detailed description the present invention, but do not limit in any form the present invention.
Embodiment 1:
1, extract:
Select qualified Radix Sophorae Tonkinensis, then medical material and the foreign material removing stem, go mouldy, go bad clean up repeatedly with the clear water that flows.With the medical material cleaned with medicine cutter cut to thickness be between the 5mm.. the decoction pieces that cuts is placed in the drying baker, 50 ℃, dry 3 hours.The decoction pieces that drying is good is weighed as 200kg, drops in the extraction pot, and adds the 600kg purified water extraction 2.5 hours, extracts three times.
2, concentrated
Extracting solution is evacuated in the dual-effect concentrator, opens steam valve, vacuum valve is concentrated, and thickening temperature is controlled at about 70 ℃, and the proportion of concentrated extract (slightly) is about 1.15.Gained extractum (slightly) 10kg.
3, purification
Extractum (slightly) is dropped in the Alcohol-settling tank, and it is 80% that adding ethanol makes it alcohol concentration, is cooled to 4 ℃, is incubated 48 hours.It is 1.1 that collection filtrate is concentrated into extractum (essence) proportion.Gained extractum (essence) 7kg.
4, spray drying
Extractum (essence) is dry to the spray dried drying prescription, get extractum particle 6.5kg.
5, tabletting, capsule charge, packing.
With tabletting or capsule charge or packing after extractum (essence) particle and the auxiliary materials and mixing.
Embodiment 2:
1, extract:
Select qualified Radix Sophorae Tonkinensis, medical material and the foreign material removing stem, go mouldy, go bad.Then repeatedly clean up with the clear water that flows.With the medical material cleaned with medicine cutter cut to thickness be between the 10mm.The decoction pieces that cuts is placed in the drying baker, 50 ℃, dry 3 hours.The decoction pieces that drying is good is weighed as 200kg, drops in the extraction pot, and adds the 600kg purified water extraction 2 hours, extracts three times.
2, concentrated
Extracting solution is evacuated in the dual-effect concentrator, opens steam valve, vacuum valve is concentrated, and thickening temperature is controlled at about 70 ℃, and the proportion of concentrated extract (slightly) is about 1.15.Gained extractum (slightly) 9kg.
3, purification
Extractum (slightly) is dropped in the Alcohol-settling tank, and it is 80% that adding ethanol makes it alcohol concentration, is cooled to 4 ℃, is incubated 48 hours.It is 1.1 that collection filtrate is concentrated into extractum (essence) proportion.Gained extractum (essence) 6.5kg.
4, spray drying
Extractum (essence) is dry to the spray dried drying prescription, get extractum particle 5.7kg.
5, tabletting, capsule charge, packing
With tabletting or capsule charge or packing after extractum (essence) particle and the auxiliary materials and mixing.
Claims (9)
1. treat medicine of acute hepatitis, chronic hepatitis and preparation method thereof for one kind, it is characterized in that this drug main will add suitable adjuvant by matrine, oxymatrine, organic glycosides again and form, preparation method be Radix Sophorae Tonkinensis selected, wash, cut medicine, extraction, concentrated, purification, drying, granulating with suitable adjuvant forms.
2. the described pharmaceutical worker's order of cutting according to claim 1, the decoction pieces thickness of cutting is between the 0.3mm--10mm, and the decoction pieces baking temperature is 30--60 ℃, and be 2--8 hour drying time.
3. according to claim 1 described extraction is characterized in that the mass ratio of decoction pieces and purified water is between the 1:1--1:5 in the leaching process, and extracting temperature is 60--100 ℃, and extracts three times, and each extraction time is 2--8 hour.
4. described enrichment process according to claim 1, concentrator adopts economic benefits and social benefits or multiple-effect vacuum concentrator, concentrated vacuum degree control-below the 0.08Mpa, temperature is 40--100 ℃, the crude extract proportion that concentrates out is between the 1:1---1:1.5.
5. described purification procedures according to claim 1 drops into Alcohol-settling tank with enrichment process gained extractum, and adding ethanol, to make it alcohol concentration be 60%--80%, and opens cryogenic system and make it temperature and be down to subzero 5 ℃ of 8--, is incubated 48 hours.
According to claim 5 the filtrate behind the purification again vacuum concentration to proportion be 1:1--1:1.3, thickening temperature is 20--50 ℃, the smart extractum of gained is the Radix Sophorae Tonkinensis effective ingredient.
7. the described smart extractum of claim 6 adopts the spray dried drying prescription dry, and the drying machine inlet temperature is 100--300 ℃, and outlet temperature is 60--90 ℃, and dried extractum particle moisture Control is below 3%.
8. according to claim 7 dry good extractum particle and suitable auxiliary materials and mixing tabletting, or in the fill hard capsule, or use the granule packing.
9. suitable adjuvant according to claim 9 comprises one or more in microcrystalline Cellulose, starch, pregelatinized Starch, hydroxypropyl methylcellulose, Pulvis Talci, carboxymethyl starch sodium, the cross-linking sodium carboxymethyl cellulose.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 201210493569 CN102973644A (en) | 2012-11-28 | 2012-11-28 | Drug for treating acute or chronic hepatitis, and preparation method thereof |
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| Application Number | Priority Date | Filing Date | Title |
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| CN 201210493569 CN102973644A (en) | 2012-11-28 | 2012-11-28 | Drug for treating acute or chronic hepatitis, and preparation method thereof |
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| CN102973644A true CN102973644A (en) | 2013-03-20 |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN114425060A (en) * | 2020-10-29 | 2022-05-03 | 康普药业股份有限公司 | Preparation method of high-stability stomach-strengthening tablet |
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2012
- 2012-11-28 CN CN 201210493569 patent/CN102973644A/en active Pending
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN114425060A (en) * | 2020-10-29 | 2022-05-03 | 康普药业股份有限公司 | Preparation method of high-stability stomach-strengthening tablet |
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Application publication date: 20130320 |