CN101049366A - Drop pills of general glycosides of picrorhiza rhizome, and preparation method - Google Patents
Drop pills of general glycosides of picrorhiza rhizome, and preparation method Download PDFInfo
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- CN101049366A CN101049366A CN 200610043418 CN200610043418A CN101049366A CN 101049366 A CN101049366 A CN 101049366A CN 200610043418 CN200610043418 CN 200610043418 CN 200610043418 A CN200610043418 A CN 200610043418A CN 101049366 A CN101049366 A CN 101049366A
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Abstract
A dripping pill of general picroside for protecting liver and preventing and treating hepatitis is prepared from the general picroside extracted from figwortflower picrorhiza rhizome and the medicinal matrix chosen from polyethanediol, sodium stearate, glycerin and gelatin. Its preparing process is also disclosed.
Description
Technical field
A kind of drop pills of general glycosides of picrorhiza rhizome and preparation method thereof belongs to field of traditional Chinese.
Background technology
Hepatitis B virus (HBV) infects has become a kind of global harm.In 6,000,000,000 populations of the whole world, about 2,000,000,000 people have HBV to infect, and 3.5 hundred million people be chronic HBV infection, wherein 25%～40% finally will die from liver cirrhosis or hepatocarcinoma, and annual number because of the death of hepatitis B relevant disease is up to more than 100 ten thousand examples.15%～20% has the active chronic viral hepatitis B patient who duplicates of virus in 5 years liver cirrhosis to take place, and 5 years survival rates of chronic patient with liver cirrhosis only are 55%.The more non-hepatitis B patient of danger that hepatocarcinoma takes place hepatitis B patient has raise 200 times.China is hepatitis B big country, and is the same based on viral hepatitis and acquired immune deficiency syndrome (AIDS), pulmonary tuberculosis, the schistosomicide of hepatitis B, become one of four the most serious big infectious disease of current harm, so chronic viral hepatitis B is a serious public health problem.
The anti-hbv drug untoward reaction of using clinically at present is more, as nucleoside medicines such as lamivudine, ganciclovirs, has stronger anti-HBV effect, but life-time service produces drug resistance, particularly lamivudine can produce serious bounce-back after the drug withdrawal, is easy to generate explosive jaundice.Therefore, the development chronic hepatitis B medicine that therapeutic effect is good, toxic and side effects is little has important society and economic implications.
Summary of the invention
The purpose of this invention is to provide the chronic hepatitis B medicine drop pills of general glycosides of picrorhiza rhizome that a kind of therapeutic effect is good, toxic and side effects is little.
The preparation method that the purpose of this invention is to provide the chronic hepatitis B medicine drop pills of general glycosides of picrorhiza rhizome that a kind of therapeutic effect is good, toxic and side effects is little.
The present invention realizes like this, drop pills of general glycosides of picrorhiza rhizome comprises Rhizoma Picrorhizae total glucosides and medicinal substrate composition, the consumption weight ratio of Rhizoma Picrorhizae total glucosides and medicinal substrate is 1: 1～5, medicinal substrate can adopt Polyethylene Glycol, sodium stearate, glycerin gelatine, stearic acid, Cera Flava, insect wax, hydrogenated vegetable oil, can a kind of independent use also can severally unite use.The drop pills of general glycosides of picrorhiza rhizome specification is 10～30mg/ grain, clinically takes 10 at every turn, contains picroside-II and must not be less than the 24mg/10 grain, contains total glycosides and must not be less than every 30mg/10 grain in picroside-II.
The preparation method of drop pills of general glycosides of picrorhiza rhizome is, with the Rhizoma Picrorhizae ethanol extraction, concentration of ethanol is 50%～100%, the method that adopts has: dipping, percolation, reflux etc., obtain Rhizoma Picrorhizae alcohol extraction thing, adopt the method for column chromatography to make with extra care again, chromatographic column is made with extra care with silicagel column, polyamide column, several post couplings of macroporous resin column, adopt crystallization then, the method of recrystallization makes the higher degree picrorhiza rhizome total glycoside extract, and the content of the picroside-II in the picrorhiza rhizome total glycoside extract is no less than 80%.Add substrate then, adopt dropping preparation method, in liquid coolant, cool off, make drop pill.
The liquid coolant that adopts is liquid paraffin, vegetable oil, methyl-silicone oil, kerosene, water, Different concentrations of alcohol, can a kind of independent use also can severally unite use.
According to " specification requirement of new Chinese medicine quality standard research " physicochemical property and the quality standard of Rhizoma Picrorhizae total glucosides, drop pills of general glycosides of picrorhiza rhizome are studied:
(1) physicochemical property research comprises: the 1. quality research of Rhizoma Picrorhizae medical material; 2. the examination of the content of Rhizoma Picrorhizae extract, moisture, dissolubility, hygroscopicity etc.; 3. to the examination of the roundness of drop pills of general glycosides of picrorhiza rhizome, moisture, content, weight differential, dissolve scattered time limit, microbial limit etc.
(2) quality standard research comprises: character, discriminating, inspection (moisture, weight differential, dissolve scattered time limit, arsenic salt, heavy metal, microbial limit etc.), assay (chromatographic condition, mensuration wavelength, linear relationship, the response rate, repeatability etc.) are studied.
The study on the stability of Rhizoma Picrorhizae total glucosides, drop pills of general glycosides of picrorhiza rhizome, main approaches is:
(1) influence factor's test:
1. the hot test sample was placed 5 days, 10 days under 60 ℃ of conditions of high temperature, and sampling detects relevant index, the basic no changes of project such as appearance character, pH value, assay;
2. the exposure experiments to light sample is put under the 4500LX daylight lamp and was placed 5 days, 10 days, and sampling detects relevant index, the basic no changes of project such as appearance character, pH value, assay;
3. the high humidity test specimen is put in the environment of RH92.5% and was placed 5 days, 10 days, and sampling detects relevant index, and certain deliquescence is arranged.
(2) preliminary stability test: sample was placed 6 months under the RH75% condition 40 ℃ of temperature, and sampling regularly detects relevant index, and every index does not have significant change.
(3) stability test: sample was placed 12 months under the RH60% condition 25 ℃ of temperature, and sampling regularly detects relevant index, face shaping, pH value, assay.
Compared with the prior art drop pills of general glycosides of picrorhiza rhizome has the following advantages:
1, Rhizoma Picrorhizae total glucosides has the effect of significant hepatic cholagogic, and its hepatoprotective effect intensity and safety are suitable with the at present commercially available class medicine that protects the liver preferably, have the effect that other protect the liver the hepatitis virus resisting of the unexistent moderate strength of class medicine simultaneously.
2, drop pills of general glycosides of picrorhiza rhizome agent, because the dispersion of medicine in substrate is molecularity, colloidal state or the crystallization of micropowder shape, be the high degree of dispersion state, and substrate is water miscible, then can increase or improve the dissolubility of medicine, accelerate the dissolution rate and the infiltration rate of medicine, the bioavailability height.
3, lower to the requirement of production equipment, adapt to the present situation of present domestic Chinese medicine manufacturer.The workshop does not have dust, helps labor protection, the automaticity height, and production cost is low.
The specific embodiment
Embodiment one:
Get Rhizoma Picrorhizae 1000g, add concentration and be 75% alcohol reflux 2 times, each 2 hours, merge extractive liquid,, decompression recycling ethanol, 2 ℃ of cold preservation 24 hours filters, and the filtrate thin up is to 500ml, last macroporous resin column, water, 10% ethanol, 60% ethanol difference eluting, the colour band of collecting 60% ethanol elution part reclaims ethanol than the deep branch, be diluted to 100ml, last silicagel column, use methanol: chloroform (1: 9) eluting, collect eluent, decompression and solvent recovery, use acetone recrystallization, obtain light yellow crystal, be picrorhiza rhizome total glycoside extract.
The picrorhiza rhizome total glycoside extract that this technology obtains, yield is no less than 0.5%, and content should be not less than 80% in Picroside II Amphicoside 6-Vanilloylcatalpol.
Get picrorhiza rhizome total glycoside extract 50g, add Polyethylene Glycol 4000 100g, heating and melting, mix homogeneously drips and makes ball, promptly.
Embodiment two:
Get Rhizoma Picrorhizae 1000g, add concentration and be 80% alcohol reflux 2 times, each 2 hours, merge extractive liquid,, decompression recycling ethanol, 4 ℃ of cold preservation 24 hours filters, and the filtrate thin up is to 600ml, last macroporous resin column, water, 15% ethanol, 70% ethanol difference eluting, the colour band of collecting 70% ethanol elution part reclaims ethanol than the deep branch, be diluted to 100ml, last silicagel column, use methanol: chloroform (2: 8) eluting, collect eluent, decompression and solvent recovery, use acetone recrystallization, obtain light yellow crystal, be picrorhiza rhizome total glycoside extract.
The picrorhiza rhizome total glycoside extract that this technology obtains, yield is no less than 0.5%, and content should be not less than 80% in Picroside II Amphicoside 6-Vanilloylcatalpol.
Get picrorhiza rhizome total glycoside extract 50g, add Polyethylene Glycol 6000 100g, heating and melting, mix homogeneously drips and makes ball, promptly.
Claims (5)
1, a kind of drop pills of general glycosides of picrorhiza rhizome is characterized in that comprising Rhizoma Picrorhizae total glucosides and medicinal substrate composition, and the consumption weight ratio of Rhizoma Picrorhizae total glucosides and medicinal substrate is 1: 1～5.
2, drop pills of general glycosides of picrorhiza rhizome according to claim 1 is characterized in that medicinal substrate can adopt Polyethylene Glycol, sodium stearate, glycerin gelatine, stearic acid, Cera Flava, insect wax, hydrogenated vegetable oil, can a kind of independent use also can severally unite use.
3, drop pills of general glycosides of picrorhiza rhizome according to claim 1 is characterized in that Rhizoma Coptidis drop pills of general glycosides specification is 10～30mg/ grain.
4, a kind of preparation method of drop pills of general glycosides of picrorhiza rhizome, it is characterized in that the Rhizoma Picrorhizae ethanol extraction, concentration of ethanol is 50%～100%, the method that adopts has: dipping, percolation, reflux etc., obtain Rhizoma Picrorhizae alcohol extraction thing, adopt the method for column chromatography to make with extra care again, the chromatographic column silicagel column, polyamide column, several post couplings of macroporous resin column are made with extra care, and adopt crystallization then, the method of recrystallization makes the higher degree picrorhiza rhizome total glycoside extract, the content of picroside-II in the picrorhiza rhizome total glycoside extract is no less than 80%, adds substrate then, adopts dropping preparation method, in liquid coolant, cool off, make drop pill.
5, drop pills of general glycosides of picrorhiza rhizome preparation method according to claim 4 is characterized in that the liquid coolant that adopts is liquid paraffin, vegetable oil, methyl-silicone oil, kerosene, water, Different concentrations of alcohol, can a kind of independent use also can severally unite use.
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| Application Number | Priority Date | Filing Date | Title |
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| CN 200610043418 CN101049366A (en) | 2006-04-04 | 2006-04-04 | Drop pills of general glycosides of picrorhiza rhizome, and preparation method |
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| CN 200610043418 CN101049366A (en) | 2006-04-04 | 2006-04-04 | Drop pills of general glycosides of picrorhiza rhizome, and preparation method |
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| CN101049366A true CN101049366A (en) | 2007-10-10 |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20120148569A1 (en) * | 2009-09-04 | 2012-06-14 | Munisekhar Medasani | Picrorhiza kurroa extract for prevention, elimination and treatment of infection diseases |
| CN102920831A (en) * | 2012-11-20 | 2013-02-13 | 济南康众医药科技开发有限公司 | Preparation method of rhizoma picrorhizae total saponins |
| CN103601769A (en) * | 2013-11-27 | 2014-02-26 | 扬子江药业集团有限公司 | Preparation process for extracting, separating and purifying picroside I and picroside II from Picrorrhiza Kurrooa Royleex Benth |
-
2006
- 2006-04-04 CN CN 200610043418 patent/CN101049366A/en active Pending
Cited By (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20120148569A1 (en) * | 2009-09-04 | 2012-06-14 | Munisekhar Medasani | Picrorhiza kurroa extract for prevention, elimination and treatment of infection diseases |
| US9125921B2 (en) * | 2009-09-04 | 2015-09-08 | Munisekhar Medasani | Picrorhiza extract for prevention, elimination and treatment of infection diseases |
| US9603885B2 (en) | 2009-09-04 | 2017-03-28 | Munisekhar Medasani | Picrorhiza extract for prevention, elimination and treatment of infection diseases |
| CN102920831A (en) * | 2012-11-20 | 2013-02-13 | 济南康众医药科技开发有限公司 | Preparation method of rhizoma picrorhizae total saponins |
| CN102920831B (en) * | 2012-11-20 | 2014-07-23 | 济南康众医药科技开发有限公司 | Preparation method of rhizoma picrorhizae total saponins |
| CN103601769A (en) * | 2013-11-27 | 2014-02-26 | 扬子江药业集团有限公司 | Preparation process for extracting, separating and purifying picroside I and picroside II from Picrorrhiza Kurrooa Royleex Benth |
| CN103601769B (en) * | 2013-11-27 | 2015-08-19 | 扬子江药业集团有限公司 | A kind of preparation technology of extraction separation and purification picroside Ⅰ and Picroside II from Rhizoma Picrorhizae |
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