CN1312077A - Composite component comprising the effective extracts of licorice and lightyellow sophora and its application - Google Patents
Composite component comprising the effective extracts of licorice and lightyellow sophora and its application Download PDFInfo
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- CN1312077A CN1312077A CN 01105106 CN01105106A CN1312077A CN 1312077 A CN1312077 A CN 1312077A CN 01105106 CN01105106 CN 01105106 CN 01105106 A CN01105106 A CN 01105106A CN 1312077 A CN1312077 A CN 1312077A
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- sophorae flavescentis
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Abstract
The present invention adopts percolation method to extract effective components of licorice and flavescent sophora root, and utilizes their effective components to form compound composition whose main components are glycyrrhizic acid and sophocarpidine and their content ratio is 1:(0.25-4). Said composition can be made into oral preparation or injection for curing the diseases of hepatopathy and immunologic dysfunction and resisting inflammation. The tests show that its therapeutic effect is good, and its side effect is less.
Description
The present invention relates to compound recipe component and the application thereof formed by Chinese medicine Radix Glycyrrhizae (Glycyrrhiza Uralensis Fish) and Radix Sophorae Flavescentis (Sopharaflavescens Ait) effective extract.
Hepatic disease is a kind of frequently-occurring disease and commonly encountered diseases in China.Its cause of disease and pathogeny are very complicated, do not have definite effective control medicine at present.The clinical differential diagnosis in tcm opinion that adopts is controlled more, and adds with some ancillary drug raising curative effects.But many patients' prognosis is very poor, brings harmful effect for society and family.
Immunologic function is the important defense mechanism of human body opposing virus and bacterial infection, removing cancerous tumor cell.The reason that causes the reduction of human immune system's function is a lot, and pathophysiological change is very complicated, does not have effective medicine.The inflammatory reaction that is caused by immune dysfunction lacks effective treatment means equally.
Though Radix Glycyrrhizae, Radix Sophorae Flavescentis and effective extract thereof can be used as the ancillary drug of treatment hepatic disease, oral or its effective extract has serious adverse reactions such as retention of sodium and water, hypertension and hypokalemia for a long time.Intravenous administration, because of the course of treatment oversize, the patient is difficult to accept.And the clinical efficacy of Radix Sophorae Flavescentis and effective extract thereof is imprecise, and side effect such as diuresis are arranged.
The objective of the invention is to develop the compound recipe component that a kind of effective extract that extracts is formed from Radix Glycyrrhizae and Radix Sophorae Flavescentis.
The objective of the invention is to study the application of compound recipe component in preparation treatment hepatic disease medicine of Radix Glycyrrhizae and Radix Sophorae Flavescentis effective extract.
The objective of the invention is to study the application of compound recipe component in preparation treatment mediator body immunity function medicine of Radix Glycyrrhizae and Radix Sophorae Flavescentis effective extract.
The objective of the invention is to study the application of compound recipe component in preparation treatment inflammatory reaction disease medicine of Radix Glycyrrhizae and Radix Sophorae Flavescentis effective extract.
The present invention is from the compound recipe component of Radix Glycyrrhizae and Radix Sophorae Flavescentis effective extract composition, and wherein Main Ingredients and Appearance is glycyrrhizic acid and matrine (generally can claim Radix Sophorae Flavescentis total alkaloids), and glycyrrhizic acid comprises glycyrrhizin and enoxolone etc., and matrine comprises matrine and oxymatrine etc.Glycyrrhizic acid and content of matrine ratio is 1 in the compound recipe component: (0.25～4).
Above-mentioned compound recipe component can be made oral agents such as tablet, capsule, unguentum or injection injection.The glycyrrhizic acid of per unit preparation and content of matrine can be as required or animal test results amplify according to the above ratio to concentrate and make, make things convenient for the patient to use.
The present invention's weight ratio is 1: the Radix Glycyrrhizae of (0.1～10) and Radix Sophorae Flavescentis coarse powder extract active ingredient with percolation, make percolate earlier, and the ammonification scaleization is got precipitation then and added organic solvent extraction, promptly obtains the compound recipe component of effective extract.
To suitably concentrate after the compound recipe component Quality Identification of above-mentioned effective extract, purification is made oral formulations or ejection preparation by the compound Chinese medicinal preparation requirement.
The compound recipe component that effective extract of the present invention is formed according to Pharmacopoeia of the People's Republic of China regulation all with glycyrrhizic acid and matrine as quality control standard, therefore its active ingredient of compound recipe component of the present invention all illustrates with glycyrrhizic acid and matrine (GS).
Our experiments show that the compound recipe component of above-mentioned effective extract is applied to the treatment of hepatitis or hepatocarcinoma, obtained good effect.This compound recipe component can obviously reduce the sickness rate of hepatitis or hepatocarcinoma disease, have the effect of working in coordination with hepatitis virus resisting with interference.Its gastrointestinal absorption, bioavailability, untoward reaction etc. all obtain gratifying effect.
Acetaminophen hepatic injury model is one of the most frequently used model method of research and screening hepatic.Its mechanism be the toxic dose acetaminophen under the effect of liver CYP450 oxidase, generate active intermediate product, the liver reduced glutathion is exhausted, and is combined with biomacromolecule, produce a large amount of TNF-α, cause hepatic necrosis." GS " can obviously reduce the mouse death rate due to the toxic dose acetaminophen, and the liver reduced glutathion that Abensanil causes is exhausted also obvious protective effect.Not only there were significant differences with matched group in this effect, also is better than the single medicinal material extract.This result shows that " GS " has obvious liver-protective effect, and its curative effect is higher than Radix Glycyrrhizae or Radix Sophorae Flavescentis single medicinal material extract.
Diethylnitrosamine has been proved to be and can have brought out the humans and animals tumor, also is carcinogen common in food and the environment.The present invention adopts diethylnitrosamine to bring out the rat liver cercinoma prophase pathologic change, has verified the protective effect on cancer risk that protects the liver of " GS ".The result shows, compound recipe component of the present invention " GS " decapacitation reduces outside rats'liver/weight ratio that diethylnitrosamine causes increases, and it is (individual/cm obviously to suppress the number of γ-Gu Anxiantai enzyme positive kitchen range
2), make the positive kitchen range area (mm of unit volume
2/ cm
2) and the average area of positive kitchen range (mm2/) also obviously dwindle.Illustrate that " GS " can not only the liver protecting, and the rat liver precancerous lesion that diethylnitrosamine brings out is had obvious preventive and therapeutic effect; This effect of " GS " also is better than Radix Glycyrrhizae or Radix Sophorae Flavescentis single medicinal material extract.
Compound recipe component of the present invention is applied to mediator's body immunity function and has also obtained good effect.The present invention adopts low cytometric analysis, measures CD4/CD8 immune t-cell subgroup and ratio thereof, and conventional simultaneously counting blood leukocytes quantity last week, has observed " GS " protection and adjusting to the cyclophosphamide immunosuppressive action.The result shows that " GS " has protective effect to the cyclophosphamide immunosuppressive action, and its ratio that makes cd4 t cell subgroup and cd8 t cell subgroup is near the normal control group, and the peripheral white blood cell amount is also apparently higher than positive controls.Be not difficult to find out that by embodiment the immunoregulation effect of " GS " obviously is better than Radix Glycyrrhizae or Radix Sophorae Flavescentis single medicinal material extract.
The compound recipe component of above-mentioned effective extract is applied to the inflammatory reaction disease and has also obtained good effect.Ovum Gallus domesticus album causes the common model that rat pawl swelling test is the research anti-inflammatory drug, its not only easy, easy row, and also the test period is short, can dynamic observe reliable results.The present invention adopts cortisone acetate as positive control, water for injection is as negative control, has observed " GS " causes the swelling of rat pawl to Ovum Gallus domesticus album influence.The result shows that " GS " causes the swelling of rat pawl to Ovum Gallus domesticus album obvious inhibitory action, and its action intensity illustrates that apparently higher than Radix Glycyrrhizae or Radix Sophorae Flavescentis single medicinal material extract " GS " has non-specific antiinflammatory action.
Natural drug is different with chemical synthetic drug.The place of production, acquisition time, medicinal part and concocting method etc. are very big to its active constituent content influence.The present invention had once compared glycyrrhizic acid and matrine content in Radix Glycyrrhizae that ground such as Gansu, Kweiyang, Sichuan, Shaanxi produce and the Radix Sophorae Flavescentis, find its active constituent content differ be up to 10 surplus times.Different Extraction Method gained yield is also obviously different.Sometimes, differ more than 50%.The optimization of obvious raw-material selection and extracting method is most important.Quality control standard is a key issue of Chinese medicine preparation.The present invention is according to nineteen ninety-five version Pharmacopoeia of the People's Republic of China regulation, and with reference to relevant bibliographical information, methods analysts such as employing high performance liquid chromatography and high performance capillary electrophoresis have been measured glycyrrhizic acid and content of matrine in the compound recipe component.And determine dosage on this basis, and make experimental result stable, reliable, have good reproduction.
The compound recipe component that zoopery of the present invention fully proves Radix Glycyrrhizae and Radix Sophorae Flavescentis effective extract for the liver protecting, prevent and treat hepatocarcinoma, improve in the application of immunologic function and inflammatory reaction disease and all obtained good effect, and reduced the untoward reaction that brings by single composition.
Long-term a large amount of oral Radix Glycyrrhizaes or Radix Glycyrrhizae effective extract often cause serious adverse reactions such as retention of sodium and water, hypertension and hypokalemia.It has limited the clinical practice of Radix Glycyrrhizae class preparation.The main adverse reaction of Radix Sophorae Flavescentis and matrine is a diuresis row sodium.So the too much patient of urine amount should not use Radix Sophorae Flavescentis class medicine.The present invention has compared " GS " and Radix Glycyrrhizae or Radix Sophorae Flavescentis single medicinal material extract to the mouse retention amount, the influence of sodium, potassium and chloride ion accumulation excretion.Discovery gives the Radix Glycyrrhizae effective extract after one week, and mice 9h accumulation voided volume obviously reduces, and potassium content increases in the urine, and sodium ions content reduces.And " GS " group mice, no matter urine amount, or sodium, potassium amount and matched group ratio all do not have significant difference.The untoward reaction of " GS " no pool sodium row potassium is described.
Embodiment 1:
The hepatotoxic protective effect of " GS " Abensanil induced mice.60 mices, ♀ ♂ dual-purpose is divided into four groups at random, 15 every group.Radix Glycyrrhizae extracts the thing group: give Radix Glycyrrhizae single medicinal material extract (contain glycyrrhizic acid 1mg/ml/, 25mg/kg, ig); The Radix Sophorae Flavescentis extract group: give Radix Sophorae Flavescentis single extract (contain matrine 1mg/ml, 25mg/kg, ig); " GS " group: give " GS " (contain each 1mg/ml of glycyrrhizic acid and matrine, 0.5ml/20g, ig); Matched group gives equivalent water for injection, ig.Above-mentioned respectively the group is administered once every day, continuous seven days.After the 7th administration, lumbar injection 2% acetaminophen 500mg/kg observes its 48h mortality rate.The results are shown in following table:
" GS " Abensanil causes the toxic protective effect of Mouse Liver
Group n death toll (only) mortality rate (%) Radix Glycyrrhizae extract group 15 8 53.3 Radix Sophorae Flavescentis extract groups 15 9 60.0 " GS " group 15 5* 33.3 matched groups 15 12 80.0* and matched group ratio, P＜0.05
Embodiment 2:
" GS " is to mouse retention amount and K
+, Na
+, Cl
-The influence of accumulation excretion.40 mices, ♀ ♂ dual-purpose is divided into four groups at random, 10 every group.Handle by " embodiment 1 " described dosage and method.After the 7th administration, mice is placed metabolic cage respectively, collect the 9h urine, measure K in its volume and the urine
+, Na
+, Cl
-Content.The results are shown in following table
" GS " is to mouse retention amount and k
+, Na
+, Cl
-The influence of accumulation excretion (n=10, X ± SD, mg)
Group urine amount Na
+K
+Cl
-Radix Glycyrrhizae extract group 1.5 ± 0.47
*2.7 ± 0.6
*7.3 ± 2.2 18.9 ± 4.1 Radix Sophorae Flavescentis extract groups 2.3 ± 0.76 3.9 ± 1.4 5.1 ± 1.8 16.7 ± 4.7 " GS " organizes 2.0 ± 0.70 3.7 ± 1.2 5.0 ± 2.1 15.8 ± 5.7 matched group 2.1 ± 0.62 3.6 ± 1.1 4.7 ± 1.6 16.2 ± 5.1 and matched group ratio, P＜0.05
Embodiment 3:
" GS " Abensanil causes the protective effect that the sweet peptide of mouse liver reduced form paddy is exhausted.50 mices, ♀ ♂ half-and-half is divided into 5 groups at random, 10 every group.Handle by " embodiment 1 " described dosage and method.After the 7th administration, the Radix Glycyrrhizae extract group, Radix Sophorae Flavescentis extract group, " GS " group and matched group lumbar injection 0.8% acetaminophen 200mg/kg, normal group gives equivalent water for injection.Behind the 45min, dissect liver, measure its reduced glutathion (GSH) content.The results are shown in following table:
" GS " Abensanil causes the protective effect that the mouse liver reduced glutathion is exhausted
(n=10, μ mol/g liver organization, x ± SD)
Rank liver GSH content
Radix Glycyrrhizae extract group 84.3 ± 19.2
Radix Sophorae Flavescentis extract group 68.1 ± 15.3
" GS " group 123.0 ± 24.4
*
Matched group 41.6 ± 8.2
Normal group 204.5 ± 42.8
*With Radix Glycyrrhizae extract or Radix Sophorae Flavescentis extract group ratio, P＜0.01
Embodiment 4:
" GS " causes the protective effect that mouse immune suppresses to cyclophosphamide.50 mices, ♀ ♂ half-and-half is divided into 5 groups at random, 10 every group.After adapting to a week, handle by " embodiment 1 " described dosage and method.Successive administration is 13 days altogether.In administration the 4th day, give 0.125% cyclophosphamide 25mg/kg; Ip; Successive administration seven days, normal group gives equivalent water for injection.Get blood behind the 14th day socket of the eye, adopt low cytometric analysis to detect peripheral blood CD4/CD8T cell subsets number and ratio thereof, and conventional counting quantity of leucocyte.The results are shown in following table:
" GS " to cyclophosphamide cause the protective effect that mouse immune suppresses (n=10, x=SD)
Group leukocyte (10
9/ L) CD4/CD8
Normal group 9.4 ± 1.8
*1.97 ± 0.38
*
Matched group 4.6 ± 0.9 1.03 ± 0.21
Radix Glycyrrhizae extract group 5.7 ± 1.1 1.31 ± 0.28
If conopsea extraction group 5.5 ± 1.2 1.23 ± 0.27
" GS " group 8.2 ± 1.7
*1.77 ± 0.34
* *With matched group ratio, P＜0.01
Embodiment 5:
" GS " causes the inhibitory action that rat grabs swelling to Ovum Gallus domesticus album.40 SD rats, ♀ ♂ dual-purpose is divided into 5 groups at random, 10 every group.Glycyrrhizic acid extract group, matrine extract group and the used dosage of " GS " group are with " embodiment 1 ".Positive controls gives cortisone acetate 50mg/kg; Ip.Negative control group gives equivalent water for injection.Behind the administration 1h,, adopt drainage to measure behind its albumen injection 0.5,1,2,3,4 and the stereomutation of 5h in left back pawl subcutaneous injection fresh albumen 0.05ml/ pawl.Mus grabs swelling percentage rate (%)
Experimental result sees the following form:
" GS " causes the inhibitory action (n=8 of rat pawl swelling to Ovum Gallus domesticus album; X ± SD)
Group 0.5 12345 water for injection groups 0.96 ± 0.19 0.90 ± 0.20 0.83 ± 0.19 0.71 ± 0.15 0.65 ± 0.13 0.58 ± 0.12 cortisone group 0.58 ± 0.14
*0.50 ± 0.12
*0.46 ± 0.09
*0.40 ± 0.10
*0.33 ± 0.07
*0.27 ± 0.06
*" GS " group 0.70 ± 0.16
*0.62 ± 0.13
*0.58 ± 0.13
*0.49 ± 0.10
*0.414 ± 0.10
*0.36 ± 0.08
*Radix Glycyrrhizae extract group 0.78 ± 0.18
*0.72 ± 0.15
*0.65 ± 0.14
*0.58 ± 0.12
*0.501 ± 0.12
*0.41 ± 0.10
*Radix Sophorae Flavescentis extract group 0.98 ± 0.20 0.90 ± 0.20 0.81 ± 0.19 0.73 ± 0.15 0.68 ± 0.13 0.60 ± 0.13 and injection water group ratio,
*P＜0.05;
*P＜0.01
Embodiment 6:
" GS " brings out the preventive and therapeutic effect of rat liver cancer to diethylnitrosamine.40 Waster rats, ♀ ♂ dual-purpose is divided into 4 groups at random, 10 every group.After adapting to a week, by " embodiment 1 " described dosage and method administration, matched group gives equivalent water for injection.While lumbar injection diethylnitrosamine (DEN) 100mg/kg; Give DEN after two weeks, raise diacetylamino fluorenes (2-AAF) two weeks of feedstuff to contain 0.015%.Stop using 2-AAF after one week, a row left side and middle period hepatectomy.Postoperative was dissected liver with the rat sacrificed by decapitation on the 3rd day, unified sampling, 4 ℃ of acetone: ethanol (1: 1v/v) fixing.The list of references method is measured the positive kitchen range face of gamma glutamyl transpeptidase (GGT) kitchen range, and it is (individual/cm to calculate on every square centimeter of liver section the positive kitchen range number of GGT then
2), area (mm
2/ cm
2) and the average area (m of kitchen range
2/).
The results are shown in following table:
" GS " brings out preventive and therapeutic effect (n=10, the x ± SD) of rat liver cancer to diethylnitrosamine
With the matched group ratio,
*P＜0.05;
*P＜0.01
| Group | Liver/body weight (g/100g) is individual/cm 2 | The positive situation Mm of GGT 2/cm 2????????????mm 2/ | ||
| Matched group Radix Glycyrrhizae extract Radix Sophorae Flavescentis extract group " GS " group | ?3.0±0.5 ?2.6±0.4 ?3.1±0.6 ?2.3±0.5 * | ?21.7±17?3 ?15.5±10.4 ?20.3±15.8 ?7.1±3.9 ** | ??3.6±2.7 ??2.4±1.6 ??3.2±2.2 ??0.9±0.7 * | ???0.21±0.18 ???0.16±0.12 ???0.20±0.23 ???0.10±0.11 ** |
Embodiment 7:
The preparation of " GS " is got the Radix Glycyrrhizae of 1: 10 weight and Radix Sophorae Flavescentis coarse powder → percolation and is prepared percolate → ammonification scaleization → get precipitation → organic solvent extraction → total effective extract (1) → mensuration Quality Control component content → preparation oral liquid or add adjuvant → preparation tablet or capsule.(2) → heating concentrates → column chromatography → collection purpose component → preparation injection.
Claims (6)
1, the compound recipe component of a kind of Radix Glycyrrhizae and Radix Sophorae Flavescentis effective extract, Main Ingredients and Appearance is glycyrrhizic acid and matrine, it is characterized in that glycyrrhizic acid and content of matrine ratio is 1: (0.25～4).
2, the compound recipe component of Radix Glycyrrhizae according to claim 1 and Radix Sophorae Flavescentis effective extract composition is characterized in that this compound recipe component is oral formulations or injection.
3, Radix Glycyrrhizae according to claim 1 and Radix Sophorae Flavescentis are effectively put forward the preparation method of the compound recipe component of forming with thing, it is characterized in that with weight ratio it being that the Radix Glycyrrhizae and the Radix Sophorae Flavescentis coarse powder of 1 (0.1～10) extracts active ingredient with percolation, then the concentrated preparation of making of purification.
4, the compound recipe component of Radix Glycyrrhizae according to claim 1 and 2 and Radix Sophorae Flavescentis effective extract composition is characterized in that this compound recipe component is applied to hepatopathy.
5, the compound recipe component of Radix Glycyrrhizae according to claim 1 and 2 and Radix Sophorae Flavescentis effective extract composition is characterized in that this compound recipe component is applied to mediator's body immunity function.
6, the compound recipe component of Radix Glycyrrhizae according to claim 1 and 2 and Radix Sophorae Flavescentis effective extract composition is characterized in that this compound recipe component is applied to suppress inflammatory reaction.
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|---|---|---|---|
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|---|---|---|---|
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|---|---|---|---|---|
| CN100457112C (en) * | 2004-05-12 | 2009-02-04 | 江苏恒瑞医药股份有限公司 | Combination of medication of containing kurarinone and glycyrrhetic acid, and application |
| CN101564420B (en) * | 2009-06-04 | 2012-09-26 | 成都拜特尔药业有限公司 | Chinese medicinal herb composition for treating skin disease |
| CN106074681A (en) * | 2016-06-17 | 2016-11-09 | 中国人民解放军第四军医大学 | A kind of dispersible tablets of Chinese medicine of anti-hepatic fibrosis and preparation method thereof |
| CN106474138A (en) * | 2016-08-31 | 2017-03-08 | 河南农业大学 | A kind of compound traditional Chinese medicine composite of anti-PRRSV virus and preparation |
| CN108836997A (en) * | 2018-08-31 | 2018-11-20 | 周成华 | A kind of drug and preparation method for cancer rehabilitation treatment |
| WO2021082889A1 (en) * | 2019-10-30 | 2021-05-06 | 上海珈凯生物科技有限公司 | Environmentally-friendly method of preparing composition containing anti-inflammatory active ingredient and application thereof |
| CN115010689A (en) * | 2022-07-14 | 2022-09-06 | 贵州医科大学 | Compound kurarinol A and preparation method and application thereof |
-
2001
- 2001-01-04 CN CN 01105106 patent/CN1312077A/en active Pending
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN100457112C (en) * | 2004-05-12 | 2009-02-04 | 江苏恒瑞医药股份有限公司 | Combination of medication of containing kurarinone and glycyrrhetic acid, and application |
| CN101564420B (en) * | 2009-06-04 | 2012-09-26 | 成都拜特尔药业有限公司 | Chinese medicinal herb composition for treating skin disease |
| CN106074681A (en) * | 2016-06-17 | 2016-11-09 | 中国人民解放军第四军医大学 | A kind of dispersible tablets of Chinese medicine of anti-hepatic fibrosis and preparation method thereof |
| CN106474138A (en) * | 2016-08-31 | 2017-03-08 | 河南农业大学 | A kind of compound traditional Chinese medicine composite of anti-PRRSV virus and preparation |
| CN108836997A (en) * | 2018-08-31 | 2018-11-20 | 周成华 | A kind of drug and preparation method for cancer rehabilitation treatment |
| WO2021082889A1 (en) * | 2019-10-30 | 2021-05-06 | 上海珈凯生物科技有限公司 | Environmentally-friendly method of preparing composition containing anti-inflammatory active ingredient and application thereof |
| CN115010689A (en) * | 2022-07-14 | 2022-09-06 | 贵州医科大学 | Compound kurarinol A and preparation method and application thereof |
| CN115010689B (en) * | 2022-07-14 | 2023-10-03 | 贵州医科大学 | Compound kurarinol A and preparation method and application thereof |
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