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Fingerprint of Jialong capsules and its application in quality control and component analysis
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A technique for component analysis, capsules, applied in the field of pharmaceutical analysis
Active Publication Date: 2020-10-23
XIAN C P PHARMA
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However, there is no report on the HPLC fingerprinting of Geranium Capsules
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Embodiment 1
[0040] The establishment of embodiment 1 fingerprint
[0041] 1 Instruments and reagents
[0042] Shimadzu high performance liquid chromatography (LC-2010C HT , LC / Labsoluion chromatographic workstation), Japan Shimadzu Corporation; German sartorius electronic balance, model CPA225D, Germany Sartorius Company; ultrasonic generator, model KQ-5200DE numerical control, Kunshan Ultrasonic Instrument Co., Ltd. Acetonitrile, methanol, chromatographic grade, U.S. Honeywell Company; Ultrapure water, is made by U.S. Millipore pure water instrument, U.S. Millipore Company; 111873-201103, the content is 98.3%), swerticin (batch number 110785-201404, the content is 98.3%), gentiopicroside (batch number 110770-201716, the content is 99.1%), isoorientin (batch number 111974 -201401, with a content of 94.0%) and other reference substances were purchased from China National Institute for the Control of Pharmaceutical and Biological Products; Reference substances such as glucoside (batch nu...
[0053] 3.1 Chromatographic conditions The recording time is 60 minutes, and the rest are the same as 2.1 in Example 1.
[0054] 3.2 Preparation of reference substance solution Accurately weigh a certain amount of shanzhiside methyl ester, swerticroside, swertigin, isoorientin, isovitexin, loganinic acid, 6′-O -β-D-glucosylgentiopicroside, gentiopicroside, configured as a reference substance mixed solution, loganinic acid, shanzhiside methyl ester, 6′-O-β-D- The concentrations of glucosylgentiopicroside, swertiamarin, gentiopicroside, swertiin, isoorientin, and isovitetin reference substances were 2100.00, 320.00, 1500.00, 510.00, 3900.00, 420.00, 220.00, 110μg·mL -1 .
[0055] 3.3 The preparation of the test solution is the same as 2.2.2 in Example 1.
[0056] 3.4 Linear relationship Precisely measure 0.01, 0.05, 0.10, 0.25, 0.50 and 1.00mL of the reference substance mixture prepared in ...
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Abstract
The invention relates to a gentiana macrophylla capsulefingerprint spectrum and an application of the spectrum to quality control and component analysis. According to the spectrum, a HPLC (high-performance liquid chromatography) fingerprint spectrum common mode of a gentiana macrophylla capsule is determined by the aid of a traditional Chinese medicinechromatographic fingerprint spectrum similarity evaluation system (2004A), 23 common peaks are calibrated, similarity is 0.966-0.982, and the content of loganic acid, shanzhiside methyl ester, 6'-O-beta-D-glucose gentiopicroside, swertiamarin,gentiopicroside, sweroside, isoorientin and isovitexin in 10 preparations is measured. According to the spectrum, a HPLC fingerprint spectrum method of the gentiana macrophylla capsule and a content measuring method are built, the method has good analysis evaluation ability and the advantages of accuracy, convenience, stability, reliability and the like, so that the method can serve as an effective evaluation method for the quality of the preparation.
Description
technical field [0001] The invention belongs to the field of drug analysis, and in particular relates to the fingerprint of Geranium capsules and its application in quality control and component analysis. Background technique [0002] The main ingredient of Gentiana Capsules is the extract of natural plant medicinal material Gentiana chinensis. It is mainly used to clear the liver and expel heat. It is used for functional dyspepsia with liver and stomach stagnation heat syndrome. [1] . Gentiana macrophylla is a plant of Gentianaceae (Gentianaceae). Its root is one of the important traditional Chinese medicinal materials in my country. It was first recorded in "Shen Nong's Materia Medica". pee. Shaanxi and Gansu are the authentic production areas of Gentiana chinensis [2] . At present, the technological process of Gentiana capsules produced by our company is as follows: Gentiana chinensis is percolated with 80% ethanol, then passed through a D101 macroporous adsorption res...
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