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The Research Of The Standard Uniform And Standardization Of Yiqing Series Preparations

Posted on:2015-01-14Degree:MasterType:Thesis
Country:ChinaCandidate:X YangFull Text:PDF
GTID:2284330431960903Subject:Drug Analysis
Abstract/Summary:PDF Full Text Request
Yiqing series of formulations is the active ingredient of avariety of traditional Chinesemedicines for heat—clearing, detoxifying and the effect of circulation cooling bleeding, it is the drugs treat on real fire permit, from Zhang ZhongJing’s Xie Xin Tang of "Golden Chamber". Yiqing series preparations include in granules, tablets, dripping Pills, capsules/soft capsules four formulations, hard capsules, granules standards contained in a2010edition of Chinese Pharmacopoeia,they are the national essential drug varieties;tablets, dripping pills, capsules are the implementation of registration standards. But the dosage form quality standard is not unified.Content control indicators is singleness and exist differences. In order to make Yiqing series of formulations standard unified and quality can be controlled,According to the requirement of the2015edition pharmacopeia research commitments,we are carried out on Yiqing series of formulations quality standard of comprehensive research, developed a series of preparation of general quality standards. The following contents have been completed1.We have unified the TLC identification method of rheum officinale. We use of silica gel G as an adsorbent,petroleum ether-ethyl formate-formic acid (15:5:1) of the upper solution as solvent,examine at the UV lamp365nm, reexamin in the sun after exposured to fumes of ammonia.2. We have unified the TLC identification method of Scutellaria baicalensis Georgi.We use of unifiedpolyamide as adsorbent, toluene-ethyl acetate-methanol-formic acid (10:3:1:2) as developing agent,2%iron trichloride ethanol solution was used as chromogenic agent, examine after chromogenic in daylight.3. We have unified the TLC identification method of Rhizoma Coptidis. We use of silica gel G as an adsorbent, toluene-ethyl acetate-isopropyl alcohol-methanol-water (4:2:1:1:1:0.2) as solvent, examine at the UV lamp365nm4. To establish a general method for the determination of baicalin. The etermination of baicalin content of HPLC by high performance liquid chromatography (HPLC) in the prescription. The C18column (250mmX4.6mm,5u m);0.05mol/L sodium dihydrogen phosphate (pH value was adjusted to2.7with phosphoric acid): methanol-0. l%phosphoric acid(40:60) as mobile phase, isocratic elution; column temperature of30℃; the flow rate is1. OmL/min; the detection wavelength was275nm; injection volume was10μL.5. To increase the content determination of isoquinoline alkaloids in Coptis chinensis Franch. In this study, berberine hydrochloride is as control sample, At the same time determin the content of berberine, palmatine,Coptisine, epiberberine (used as a method of QMSA). The C18column(250mmX4.6mm,5μm);acetonitrile-0.05mol/L potassium dihydrogen phosphate (45:55)(per100mL plus0.4g twelve sodium alkyl sulfate, pH value is adjusted to4with phosphoric acid) as mobile phase, isocratic elution; column temperature of30℃; the flow rate is1. OmL/min; the detection wavelength is345nm; injection volume is10μL6. To established a general method for the content in Rhubarb determination of HPLC by high performance liquid chromatography (HPLC). The C18column (250mmX4.6mm,5u m);0.1%phosphoric acid: methanol(22:78) as mobile phase, isocratic elution; column temperature of30℃; the flow rate was1. OmL/min; the detection wavelength was254nm; injection volume was10μL7.To set limit method for the determination of the content of the index composition.
Keywords/Search Tags:Yiqing seriers of preparation, Quality Standard, TLC, HPLC
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