CN1698772A - Method for preparing Chinese medicinal preparation of whiteback thundergodvine by water decoction alcohol precipitation - Google Patents
Method for preparing Chinese medicinal preparation of whiteback thundergodvine by water decoction alcohol precipitation Download PDFInfo
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- 230000001506 immunosuppresive effect Effects 0.000 description 4
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- LPTRNLNOHUVQMS-UHFFFAOYSA-N epicatechin Natural products Cc1cc(O)cc2OC(C(O)Cc12)c1ccc(O)c(O)c1 LPTRNLNOHUVQMS-UHFFFAOYSA-N 0.000 description 1
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- UHVMMEOXYDMDKI-JKYCWFKZSA-L zinc;1-(5-cyanopyridin-2-yl)-3-[(1s,2s)-2-(6-fluoro-2-hydroxy-3-propanoylphenyl)cyclopropyl]urea;diacetate Chemical compound [Zn+2].CC([O-])=O.CC([O-])=O.CCC(=O)C1=CC=C(F)C([C@H]2[C@H](C2)NC(=O)NC=2N=CC(=CC=2)C#N)=C1O UHVMMEOXYDMDKI-JKYCWFKZSA-L 0.000 description 1
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- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
The invention discloses a method for preparing Chinese medicinal preparation of whiteback thundergodvine by water decoction alcohol precipitation, wherein the effective compositions are extracted through a water grilling and alcohol settling method instead of the conventional ethanol inverse flow extraction process. The prepared medicament has reliable curative effect and reduced toxicity, the production cost is reduced substantially.
Description
Technical field
The present invention relates to a kind of preparation method of Chinese medicine immunosuppressant, particularly a kind of is the preparation method of the Chinese medicine immunosuppressant whiteback thundergodvine by water decoction alcohol precipitation of primary raw material with the Tripterygium hypoglaucum.
Background technology
Tripterygium hypoglaucum be a kind of be the Chinese medicine immunosuppressant that primary raw material is made with the Chinese herbal medicine Tripterygium hypoglaucum, because of it has good antiinflammatory, immunosuppressive effect, clinically by extensively as the various autoimmune diseasees of Chinese medicine immunosuppressant treatment, as: rheumatoid arthritis, chronic nephritis, lupus erythematosus, vasculitis, psoriasis etc.The preparation method of Tripterygium hypoglaucum adopts ethanol extraction method mostly at present, as Tripterygium Hypoglaucum Hutch Tablet.But this method not only cost is higher, and the medicament toxicity of preparation is bigger, takes organs such as liver to the patient, kidney, gonad for a long time and all can cause in various degree infringement; Especially have tangible gonad inhibitory action, cause women's spanomenorrhea or amenorrhea, man's oligospermia or disappearance; Inhibitory action to bone marrow can cause leukocyte, thrombocytopenia.
Summary of the invention
The purpose of this invention is to provide a kind of preparation method that not only can reduce production costs but also can reduce toxic whiteback thundergodvine by water decoction alcohol precipitation, may further comprise the steps successively: (1): get Tripterygium hypoglaucum, thinly slice, decoct with water; (2): decocting liquid after will decocting merges and filters, and to be concentrated into relative density be 1.05～1.07 clear paste in heating then; (3): add ethanol and make and contain alcohol amount and reach 50～80%, stir evenly, leave standstill, filter; (4): reclaiming ethanol and heating, to be concentrated into relative density be 1.30～1.35 thick paste; (5): add starch, Pulvis Talci, magnesium stearate, mixing, drying is made said dosage form on any pharmaceutics as required.
The raw materials used Tripterygium hypoglaucum of the present invention, starch, Pulvis Talci, magnesium stearate all can be from buying on the market.The weight proportion of Tripterygium hypoglaucum, starch, Pulvis Talci, magnesium stearate is 500～1278: 58: 2: 1.Decocting number of times can be 3 times, and wherein decocting time is 1.5 hours for the first time, and second and third time decocting time respectively is 1 hour.Wherein step (2) and step (4) temperature when heating concentrates can not surpass 60 ℃, and scope is controlled at 40 ℃～60 ℃ better.
Because the plurality of active ingredients in the raw material is water-soluble and pure, and toxic component is insoluble in water and is soluble in alcohol.Adopt ethanol extraction method, then toxic component is also sneaked in the extracting solution thereupon, and made Tripterygium hypoglaucum preparation toxicity is also bigger.And the present invention adopts the method effective component extracting of water decoction-alcohol sedimentation, because toxic component is insoluble in water, also just avoided toxic component to sneak in the decoction liquor, gained Tripterygium hypoglaucum preparation toxicity reduces greatly, its alkaloid of the medicament that water decoction-alcohol sedimentation technology and alcohol extraction process are made suitable (the single oral dose alkaloid is 2mg) simultaneously, the consumption of ethanol has reduced more than 38%, has saved production cost.
Adopt the inventive method can make said dosage form on any pharmaceutics as required, as tablet, capsule, pill, micropill, drop pill, granule etc.Wherein every heavy 0.18 in tablet restrains, and every contains Tripterygium hypoglaucum (colguhoumia root) with epicatechin (C
35H
14O
6) meter, must not be less than 0.10 milligram.Oral, one time 3～5,3 times on the one.
Use decocting to boil the toxicity of alcohol precipitating method and the Tripterygium hypoglaucum preparation that uses ethanol extraction method to make and immunosuppressive effect relatively, can be verified through zoopery.
1.LD
50Value relatively
| Extracting method | Mice | ?LD 50Value (crude drug g/kg) |
| The whiteback thundergodvine by water decoction alcohol precipitation preparation | National standard | ?68 |
| Tripterygium hypoglaucum 50% ethanol extraction | National standard | ?39.81 |
Median lethal dose(LD 50) (the LD of whiteback thundergodvine by water decoction alcohol precipitation agent as can be seen from the above table
50) apparently higher than the Tripterygium hypoglaucum ethanol extraction, this toxicity that shows the whiteback thundergodvine by water decoction alcohol precipitation preparation is littler than Tripterygium hypoglaucum ethanol extraction toxicity.
2. subacute toxicity test
Experimental technique: by the per kilogram of body weight dosage rat is divided into groups, took normal saline, Tripterygium Hypoglaucum Hutch Tablet (water decoction-alcohol sedimentation preparation) and Tripterygium hypoglaucum 50% ethanol extraction in continuous respectively one month, the result is as follows:
(1) takes Tripterygium Hypoglaucum Hutch Tablet (water decoction-alcohol sedimentation preparation), normal saline group, get blood during off-test and survey leukocyte, hepatic and renal function, and, there is no obvious pathological change the sick inspection of internal organs such as the heart, liver, spleen, lung, kidney, adrenal gland, intestinal, thymus.The 40g/kg group is not seen yet the overt toxicity reaction.
(2) liver cytoplasm to occur loose for Tripterygium hypoglaucum 50% ethanol extraction 4g/kg group, the hepatocyte particle agglutination appears in 8g/kg, the necrosis of being dispersed in property of minority animal renal cells, hepatocyte diffusivity cloudy swelling appears in the 20g/kg group, karyokinesis increases and visible hepatic necrosis, the necrosis of most of being dispersed in property of animal renal cells, though only administration 4 days of 40g/kg treated animal, also cause most animals hepatocyte diffusivity cloudy swelling, karyokinesis increase and the necrosis of half animal renal cells, and visible muscular degeneration of heart, myocardial necrosis appears in weight person.
Therefore the toxicity of Tripterygium Hypoglaucum Hutch Tablet (water decoction-alcohol sedimentation preparation) is little than Tripterygium hypoglaucum 50% ethanol extraction.
3. the comparison of immunosuppressive effect
(1) to the influence of mice DNCB SDH
| Preparation | Dosage (g/kg/ day * 5) | Mus ear weightening finish (mg) |
| Normal saline | ??-- | ??6.93±0.91 |
| Tripterygium Hypoglaucum Hutch Tablet (water decoction-alcohol sedimentation) | ??30 | ??1.23±0.30 |
| Tripterygium hypoglaucum 50% ethanol extraction | ??10 | ??3.75±0.39 |
(2) influence of mice reticuloendothelial system RES phagocytic function
| Preparation | Dosage (g/kg/ day * 4) | Mus ear weightening finish (mg) |
| Normal saline | ??-- | ??0.0559±0.0128 |
| Tripterygium Hypoglaucum Hutch Tablet (water decoction-alcohol sedimentation) | ??30 | ??0.0259±0.0065 |
| Tripterygium hypoglaucum 50% ethanol extraction | ??5 | ??0.0312±0.0065 |
By last two tables as seen: Tripterygium Hypoglaucum Hutch Tablet (water decoction-alcohol sedimentation) all has certain inhibitory action with Tripterygium hypoglaucum 50% ethanol extraction to the pathologic immunoreation.And under toxic agent amount such as approximately, the immunosuppressive effect of Tripterygium Hypoglaucum Hutch Tablet (water decoction-alcohol sedimentation preparation) is more eager to excel in whatever one does than Tripterygium hypoglaucum 50% ethanol extraction.
4. Tripterygium Hypoglaucum Hutch Tablet (water decoction-alcohol sedimentation preparation) and Tripterygium Hypoglaucum Hutch Tablet (ethanol extraction method makes) are at antiinflammatory, to the comparison of aspects such as the inhibition of granulation hyperplasia, antagonism that capillary permeability increases, analgesia:
(1) to the influence of Freund ' s adjuvant-induced arthritis: Tripterygium Hypoglaucum Hutch Tablet (water decoction-alcohol sedimentation preparation) (5.0g/kg, 10g/kg group) all has very obvious suppression effect to Freund ' s adjuvant-induced arthritis, and under same dose (10g/kg), the inhibitory action of Tripterygium Hypoglaucum Hutch Tablet (water decoction-alcohol sedimentation preparation) slightly is better than Tripterygium Hypoglaucum Hutch Tablet (ethanol extraction method makes).
(2) influence of rat paw edema due to the on Carrageenan: the two all has inhibitory action, and inhibitory action is suitable under same dose.
(3) to the influence of granuloma induced by implantation of cotton pellets: Tripterygium Hypoglaucum Hutch Tablet (water decoction-alcohol sedimentation preparation) has very obvious suppression effect to granuloma induced by implantation of cotton pellets, and under same dose (10g/kg), the inhibitory action of Tripterygium Hypoglaucum Hutch Tablet (water decoction-alcohol sedimentation preparation) slightly is better than Tripterygium Hypoglaucum Hutch Tablet (ethanol extraction method makes).
(4) to the influence of mouse peritoneal capillary permeability: the two all has antagonism to increasing of mouse peritoneal capillary permeability, and inhibitory action is suitable down at same dose (10g/kg).
(5) analgesic activity: the two all has tangible antagonism to 0.7% acetic acid induced mice writhing response, and inhibitory action is suitable down at same dose (10g/kg).
Comparison by above-mentioned every index can be reached a conclusion: the toxicity of Tripterygium hypoglaucum (water decoction-alcohol sedimentation preparation) is lower than Tripterygium hypoglaucum (ethanol extraction), and antiinflammatory, immunosuppressant, analgesic activity then are better than Tripterygium hypoglaucum (ethanol extraction).
Specific embodiment (totally 3 examples)
Embodiment 1
Preparation Chinese medicine preparation Tripterygium hypoglaucum carries out successively according to the following steps:
(1): get Tripterygium hypoglaucum 900 grams, thinly slice, decoct with water three times, 1.5 hours for the first time, second and third time decocted 1 hour;
(2): decocting liquid after will decocting merges after-filtration, and to be concentrated into relative density be 1.05～1.07 clear paste in heating then, and temperature is controlled at 60 ℃;
(3): add ethanol and make and contain alcohol amount and reach 50%, stir evenly, leave standstill 12 hours after-filtration;
(4): reclaiming ethanol and heating, to be concentrated into relative density be 1.30～1.35 thick paste, and temperature is controlled at 60 ℃;
(5): add starch 105 grams, Pulvis Talci 3.6 grams, magnesium stearate 1.8 grams, mixing, drying, tabletting is made tablet.Every heavy 0.18 gram.
Embodiment 2
Preparation Chinese medicine preparation Tripterygium hypoglaucum carries out successively according to the following steps:
(1): get Tripterygium hypoglaucum 2300 grams, thinly slice, decoct with water secondary, 1.5 hours for the first time, decocted 1 hour for the second time;
(2): decocting liquid after will decocting merges after-filtration, is concentrated into relative density then and is 1.05～1.07 clear paste, and temperature is controlled at 40 ℃;
(3): add ethanol and make and contain alcohol amount and reach 70%, stir evenly, leave standstill 12 hours after-filtration;
(4): reclaiming ethanol and being concentrated into relative density is 1.30～1.35 thick paste, and temperature is controlled at 40 ℃;
(5): add starch 105 grams, Pulvis Talci 3.6 grams, magnesium stearate 1.8 grams, mixing, drying is made granule.
Embodiment 3
Preparation Chinese medicine preparation Tripterygium hypoglaucum carries out successively according to the following steps:
(1): get Tripterygium hypoglaucum 1620 gram, thinly slice, decoct with water five times, 1.5 hours for the first time, second and third, respectively decocted for four, five times 1 hour;
(2): decocting liquid after will decocting merges after-filtration, is concentrated into relative density then and is 1.05～1.07 clear paste, and temperature is controlled at 50 ℃;
(3): add ethanol and make and contain alcohol amount and reach 80%, stir evenly, leave standstill 12 hours after-filtration;
(4): reclaiming ethanol and being concentrated into relative density is 1.30～1.35 thick paste, and temperature is controlled at 50 ℃;
(5): add starch 105 grams, Pulvis Talci 3.6 grams, magnesium stearate 1.8 grams, mixing, drying is made granule.
Claims (10)
1, a kind of preparation method of Chinese medicine preparation whiteback thundergodvine by water decoction alcohol precipitation may further comprise the steps successively:
(1): by following weight proportion 500～1278: get Tripterygium hypoglaucum, starch, Pulvis Talci, magnesium stearate at 58: 2: 1, wherein Tripterygium hypoglaucum is thinly sliced, and decocts with water 2～5 times;
(2): decocting liquid after will decocting merges and filters, then under 40 ℃～60 ℃ temperature heating to be concentrated into relative density be 1.05～1.07 clear paste;
(3): add ethanol and make and contain alcohol amount and reach 50～80%, stir evenly, leave standstill, filter;
(4): reclaim ethanol and under 40 ℃～60 ℃ temperature heating to be concentrated into relative density be 1.30～1.35 thick paste;
(5): add starch, Pulvis Talci, magnesium stearate, mixing, drying is made said dosage form on any pharmaceutics as required.
2, the preparation method of the described Chinese medicine preparation whiteback thundergodvine by water decoction alcohol precipitation of claim 1, the weight proportion of raw materials used Tripterygium hypoglaucum, starch, Pulvis Talci, magnesium stearate is 500: 58: 2: 1.
3, the preparation method of Chinese medicine preparation whiteback thundergodvine by water decoction alcohol precipitation as claimed in claim 1, the weight proportion of raw materials used Tripterygium hypoglaucum, starch, Pulvis Talci, magnesium stearate are 1278: 58: 2: 1.
4, the preparation method of Chinese medicine preparation whiteback thundergodvine by water decoction alcohol precipitation as claimed in claim 1, the weight proportion of raw materials used Tripterygium hypoglaucum, starch, Pulvis Talci, magnesium stearate are 900: 58: 2: 1.
5, the preparation method of Chinese medicine preparation whiteback thundergodvine by water decoction alcohol precipitation as claimed in claim 1, wherein the spissated temperature of step (2) and step (4) heating is 40 ℃.
6, the preparation method of Chinese medicine preparation whiteback thundergodvine by water decoction alcohol precipitation as claimed in claim 1, wherein the spissated temperature of step (2) and step (4) heating is 60 ℃.
7, the preparation method of Chinese medicine preparation whiteback thundergodvine by water decoction alcohol precipitation as claimed in claim 1, wherein the spissated temperature of step (2) and step (4) heating is 50 ℃.
8, decocting number of times in the preparation method of Chinese medicine preparation whiteback thundergodvine by water decoction alcohol precipitation as claimed in claim 1, step (1) is 3 times, and wherein decocting time is 1.5 hours for the first time, and second and third time decocting time respectively is 1 hour.
9, the preparation method of Chinese medicine preparation whiteback thundergodvine by water decoction alcohol precipitation as claimed in claim 1, gained Tripterygium hypoglaucum medicament is a tablet.
10, the preparation method of Chinese medicine preparation whiteback thundergodvine by water decoction alcohol precipitation as claimed in claim 1, gained Tripterygium hypoglaucum medicament is a granule.
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Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102727558A (en) * | 2012-07-04 | 2012-10-17 | 重庆市中药研究院 | Tripterygium Hypoglaucum Hutch root extract, and bi-layer extended release tablet and application thereof |
| CN105213463A (en) * | 2015-11-18 | 2016-01-06 | 重庆市中药研究院 | A kind of colguhoumia root external preparation for eczema, preparation method and application thereof |
| CN105250349A (en) * | 2015-11-18 | 2016-01-20 | 重庆市中药研究院 | Colquhoumia root cataplasma for rheumatoid arthritis as well as preparation method and application of colquhoumia root cataplasma |
| CN105250348A (en) * | 2015-11-18 | 2016-01-20 | 重庆市中药研究院 | Tripterygium hypoglaucum (level) hutch root external preparation for relieving swelling and pain as well as preparation method and application thereof |
| CN107184633A (en) * | 2017-06-08 | 2017-09-22 | 重庆市药研院制药有限公司 | The alcohol precipitation preparation method of colguhoumia root medicinal extract |
| CN113713005A (en) * | 2020-11-24 | 2021-11-30 | 重庆市药研院制药有限公司 | Preparation method of herba Polygoni chinensis root slice and prepared herba Polygoni chinensis root slice |
-
2005
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Cited By (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102727558A (en) * | 2012-07-04 | 2012-10-17 | 重庆市中药研究院 | Tripterygium Hypoglaucum Hutch root extract, and bi-layer extended release tablet and application thereof |
| CN105213463A (en) * | 2015-11-18 | 2016-01-06 | 重庆市中药研究院 | A kind of colguhoumia root external preparation for eczema, preparation method and application thereof |
| CN105250349A (en) * | 2015-11-18 | 2016-01-20 | 重庆市中药研究院 | Colquhoumia root cataplasma for rheumatoid arthritis as well as preparation method and application of colquhoumia root cataplasma |
| CN105250348A (en) * | 2015-11-18 | 2016-01-20 | 重庆市中药研究院 | Tripterygium hypoglaucum (level) hutch root external preparation for relieving swelling and pain as well as preparation method and application thereof |
| CN105250348B (en) * | 2015-11-18 | 2019-05-14 | 重庆市中药研究院 | It is a kind of for the colguhoumia root external preparation of swelling and pain relieving, preparation method and applications |
| CN107184633A (en) * | 2017-06-08 | 2017-09-22 | 重庆市药研院制药有限公司 | The alcohol precipitation preparation method of colguhoumia root medicinal extract |
| CN113713005A (en) * | 2020-11-24 | 2021-11-30 | 重庆市药研院制药有限公司 | Preparation method of herba Polygoni chinensis root slice and prepared herba Polygoni chinensis root slice |
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| CN100348208C (en) | 2007-11-14 |
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