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Quality analysis method of Thesium chinense tablets

A quality analysis technology of Bairui tablets, applied in the field of quality analysis of Bairui tablets, can solve the problems of limited quality control of Bairui tablets and achieve remarkable results

Inactive Publication Date: 2018-11-13
HONG KONG JOWA & HUAYUAN GRP CHUZHOU PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The purpose of the present invention is to overcome the above-mentioned deficiencies of the prior art, to provide a quality analysis method for Bairui tablets, aiming at solving the technical problem that the quality control effect of the existing Bairui tablets is limited

Method used

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  • Quality analysis method of Thesium chinense tablets

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0033] Determination method of Bairui tablet

[0034] Chromatographic conditions: octadecylsilane bonded silica gel as filler; methanol-0.5% phosphoric acid solution (62:38) as mobile phase; detection wavelength: 368nm; column temperature: 30°C; flow rate: 1.0ml / min. The number of theoretical plates should not be less than 4000 based on the kaempferol peak.

[0035] Preparation of standard solution: Take an appropriate amount of kaempferol reference substance dried under reduced pressure by phosphorus pentoxide for 48 hours, weigh it accurately, add methanol to make a solution containing 40 μg of kaempferol per 1 ml, shake well, and obtain.

[0036] Need testing solution preparation: Grind A sample, B and C sample to powder respectively, take 1g, accurately weigh, add 10ml distilled water, heat to dissolve, let cool, slowly add ethanol 80ml, leave standstill for 30 minutes, filter, The residue was washed twice with a small amount of 85% ethanol, the filtrate and washing liqui...

Embodiment 2

[0039] Interference test:

[0040] According to the chromatographic conditions of Example 1, take kaempferol standard solution and 10 microliters each of A sample solution, B sample solution and C sample solution, inject a sample, record the chromatogram, the result is that the separation degree of kaempferol peak and other peaks is good , without interfering with the measurement results. The results of separation determination are shown in Table 1.

Embodiment 3

[0042] Linear relationship investigation:

[0043] According to the chromatographic conditions of Example 1, the kaempferol standard solution of 1, 5, 10, 15, and 20 microliters was respectively injected with an autosampler, and the chromatogram was recorded. The injection content (microgram) is the abscissa, and the chromatographic peak area value is the ordinate, and linear regression is performed to calculate the injection amount of the kaempferol standard solution and the peak area has a good linear relationship. The linear relationship results are shown in Table 1.

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Abstract

The invention belongs to the technical field of pharmacy and particularly relates to a quality analysis method of Thesium chinense tablets. The quality analysis method includes: providing the standardsolution of kaempferol and the test solution of the Thesium chinense tablets; performing liquid chromatography on the standard solution and the test solution, wherein chromatographic conditions include: octadecyl silane bonded silica gel is used as the filling agent, methanol-0.5% phosphoric acid solution with the volume ratio being 62:38 is used as the flowing phase, detection wavelength is 368nanometers, column temperature is 30 DEG C, flow rate is 1.0ml / minute, and theoretical plate number calculated according to kaempferol peak is not lower than 4000; performing quality analysis on the standard solution and the test solution. The quality analysis method has the advantages that the method is good in effect as compared with existing Thesium chinense particle standards, pharmacopeia standards and Thesium chinense tablet standards, the chromatographic conditions are improved, and the quality of the Thesium chinense tablets can be evidently controlled.

Description

technical field [0001] The invention belongs to the technical field of pharmacy, and in particular relates to a method for analyzing the quality of Bairui tablets. Background technique [0002] Bairui Tablet has the functions of clearing away heat and reducing inflammation, relieving cough and resolving phlegm. It is mainly used for acute and chronic pharyngitis, cold and fever, bronchitis, pneumonia and rhinitis. [0003] The active ingredients, disintegration time limit and other quality indicators of Bairui Tablets are very important for drug preparation and clinical use, and can provide an important basis for the safety of clinical medication of Bairui Tablets. However, the existing quality standard of Bairui Tablets is relatively simple and cannot satisfy the comprehensive control of the quality of Bairui Tablets. Contents of the invention [0004] The object of the present invention is to overcome the above-mentioned deficiency of prior art, provide a kind of qualit...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02
CPCG01N30/02
Inventor 管悦琴罗雪峰
Owner HONG KONG JOWA & HUAYUAN GRP CHUZHOU PHARMA CO LTD
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