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Impurity fingerprint spectrum analysis method of sinomenine hydrochloride bulk drug

A technology of sinomenine hydrochloride and fingerprint spectrum, which is applied in the detection field of raw materials, can solve the problems of neglect and unfavorable quality of raw materials of sinomenine hydrochloride, etc.

Pending Publication Date: 2022-03-29
HUNAN ZHENGQING PHARM GRP CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The reported detection methods focus on detecting the content of sinomenine hydrochloride, but ignore the impurities in it, which is not conducive to fully reflecting the quality of sinomenine hydrochloride raw materials

Method used

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  • Impurity fingerprint spectrum analysis method of sinomenine hydrochloride bulk drug
  • Impurity fingerprint spectrum analysis method of sinomenine hydrochloride bulk drug
  • Impurity fingerprint spectrum analysis method of sinomenine hydrochloride bulk drug

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Experimental program
Comparison scheme
Effect test

Embodiment Construction

[0060] The impurity fingerprint analysis method of sinomenine hydrochloride crude drug comprises the following steps:

[0061] (3) Preparation of the test solution

[0062] Weigh 20mg of sinomenine hydrochloride crude drug, put it in a 5mL volumetric flask, use 5% acetonitrile to make up to volume, fully dissolve, oscillate evenly, filter with a 0.22μm filter membrane, or centrifuge at 12000rpm for 10min to obtain the product.

[0063] (4) Run liquid chromatography under specified conditions

[0064] Specified conditions refer to: Column: Waters ACQUITY UPLC BEH C 18 Chromatographic column (2.1mm×100 mm, 1.7μm); mobile phase: Phase A is 1.0mmol / L ammonium formate solution, adjusted to pH=9.3 with ammonia water, phase B is 1.0mmol / L ammonium formate dissolved in 80% acetonitrile Solution, adjusted to pH=8.5 with ammonia water; injection volume: 2.0μL; detection wavelength: 210nm; column temperature: 35°C; flow rate: 0.300mL / min. See the table below for gradient conditions. ...

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Abstract

The invention provides an impurity fingerprint spectrum analysis method of sinomenine hydrochloride bulk drug, which comprises the following steps: preparing a test solution and operating liquid chromatography under specified conditions to obtain an impurity fingerprint spectrum, two main impurity peaks (Z2 and Z1 #) of the sinomenine hydrochloride bulk drug at tR = 15.16 min and 18.25 min; and the two secondary impurity peaks (C2 and C1) are in tR = 5.32 min and 11.28 min. Compared with the existing sinomenine hydrochloride method, the method provided by the invention can more comprehensively reflect the quality of the sinomenine hydrochloride bulk drug.

Description

technical field [0001] The invention belongs to the technical field of detection of raw materials, and in particular relates to an impurity fingerprint analysis method of sinomenine hydrochloride raw materials. Background technique [0002] Qingfengteng tastes bitter, pungent, and neutral in nature. It belongs to the liver and spleen meridian and is included in the 2020 edition of "Chinese Pharmacopoeia". Qingfengteng has the functions of expelling wind and dampness, promoting blood circulation and detoxification. It is mostly used clinically to treat rheumatism and rheumatoid arthritis, ankylosing spondylitis and arrhythmia. The main active ingredients of Qingfengteng are alkaloids, including sinomenine, magnolanine and dauricine. Among them, sinomenine is the index active ingredient of Qingfengteng, which has a wide range of pharmacological activities, including analgesia, sedation, immunosuppression, antihypertensive, anti-inflammation, and anti-arrhythmia. [0003] Sin...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/06G01N30/86
CPCG01N30/02G01N30/06G01N30/8679G01N2030/065
Inventor 仇萍龚行楚张建颉佳乐邰艳妮谷丽红许李彭祖仁朱永波姚本军贺兴立
Owner HUNAN ZHENGQING PHARM GRP CO LTD
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