Fingerprint building method and quality control method of Shenxiong glucose injection raw material, Shenxiong glucose injection midbody and Shenxiong glucose injection preparation

A technology of ginseng glucose and fingerprint spectrum, which is applied in the field of establishment method and quality control of traditional Chinese medicine fingerprint spectrum, and can solve problems such as difficulty in comprehensively reflecting the characteristics of chemical components of preparations.

Active Publication Date: 2013-06-12
GUIZHOU JINGFENG INJECTION
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The current quality standard of Shenxiong Glucose Injection (WS-10001-(HD-1136)-2002) content determination items only quantitatively control Danshensu and Ligustrazine Hydrochloride, which is difficult to fully reflect the chemical composition characteristics of the preparation

Method used

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  • Fingerprint building method and quality control method of Shenxiong glucose injection raw material, Shenxiong glucose injection midbody and Shenxiong glucose injection preparation
  • Fingerprint building method and quality control method of Shenxiong glucose injection raw material, Shenxiong glucose injection midbody and Shenxiong glucose injection preparation
  • Fingerprint building method and quality control method of Shenxiong glucose injection raw material, Shenxiong glucose injection midbody and Shenxiong glucose injection preparation

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Experimental program
Comparison scheme
Effect test

preparation example Construction

[0060] Two, the preparation of reference substance solution

[0061] Accurately weigh the appropriate amount of danshensu sodium, ligustrazine hydrochloride, protocatechualdehyde, salvianolic acid D, rosmarinic acid, salvianolic acid B, and salvianolic acid A, add methanol to dissolve, and dilute to make the concentrations 1mg·mL respectively -1 of the reference substance solution.

[0062] Three, the preparation of test solution

[0063] 1. Preparation of Salvia miltiorrhiza medicinal material test solution

[0064] Take about 0.5g of Salvia miltiorrhiza powder (raw material) through a 40-mesh sieve, weigh it accurately, add 25ml of water precisely, weigh it, heat and reflux for extraction for 2 hours, let it cool and weigh it again, make up the lost weight with water, shake well, The supernatant was filtered with a microporous membrane (0.45 μm), and the filtrate was taken to obtain the test solution of Danshen medicinal material.

[0065] 2. Preparation of Salvia miltior...

Embodiment 1

[0083] Embodiment 1: Determination of Fingerprint Spectrum of Salvia Miltiorrhiza

[0084] (1) Source of medicinal materials

[0085] The samples of Salvia miltiorrhiza came from Sichuan, Shandong, Henan, Shaanxi and Jiangsu, etc. The details are shown in Table 1, and were identified by the Department of Medicinal Plants and Pharmacognosy of Guiyang Medical College.

[0086] Table 118 batches of Danshen medicinal materials source and origin

[0087]

[0088] (2) Chromatographic conditions

[0089] DiamonsilC18 column (4.6mm×250mm, 5μm); mobile phase acetonitrile (A)-0.05% phosphoric acid (B), flow rate 1mL min -1 , gradient elution, 0~7min, A2%~4%; 7~12min, A4%~18%; 12~15min, A18%~20%; 15~22min, A20%~23%; 22~32min, A23 %~32%; 32~42min, A32%~35%; 42~50min, A35%~90%; 50~60min, A90%. The column temperature is 40°C, the detection wavelength is 230nm, the injection volume is 10μL, and the chromatogram is recorded for 60min.

[0090] (3) Investigation on the preparation meth...

Embodiment 2

[0107] Embodiment 2: The fingerprint chromatogram of semi-finished product of Danshen root is measured

[0108] (1) Chromatographic conditions

[0109] DiamonsilC18 column (4.6mm×250mm, 5μm); mobile phase acetonitrile (A)-0.05% phosphoric acid (B), flow rate 1mL min -1 , gradient elution, 0~7min, A2%~4%; 7~12min, A4%~18%; 12~15min, A18%~20%; 15~22min, A20%~23%; 22~32min, A23 %~32%; 32~42min, A32%~35%; 42~50min, A35%~90%; 50~60min, A90%. The column temperature is 40°C, the detection wavelength is 230nm, the injection volume is 10μL, and the chromatogram is recorded for 60min.

[0110] (2) Preparation of the test solution

[0111] Take about 0.15g of the semi-finished product of Salvia miltiorrhiza, weigh it accurately, dissolve and dilute it with water, set the volume to 50mL, shake well, filter the supernatant with a microporous membrane (0.45μm), and take the subsequent filtrate to obtain the test solution of the semi-finished product of Salvia miltiorrhiza ;

[0112] (3...

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Abstract

The invention discloses a fingerprint building method and a quality control method of Shenxiong glucose injection raw material, a Shenxiong glucose injection midbody and Shenxiong glucose injection preparation. Fingerprint detection is conducted on the raw material, the midbody and the preparation of the raw material and the midbody under the condition of the same chromatograph. Octadecylsilane chemically bonded silica is used as chromatographic column filling agent, acetonitrile-phosphate aqueous solution is used as mobile phase, gradient elution is conducted, a test sample fingerprint and a contrasted fingerprint have good relevance, similarity is larger than 0.90, a fingerprint of the Shenxiong glucose injection raw material, a fingerprint of the Shenxiong glucose injection midbody and a fingerprint of the Shenxiong glucose injection preparation have good relevance, and each characteristic peak in the preparation fingerprint can be tracked in the raw material and the midbody. The fingerprint building method and the quality control method of the Shenxiong glucose injection raw material, the Shenxiong glucose injection midbody and the Shenxiong glucose injection preparation can be used for controlling conditions and quality of the preparation technology of Shenxiong glucose injection products and ensure stability of the preparation technology and the quality of the products. A fingerprint detecting method has the advantages of being simple and convenient to operate, accurate, reliable, and suitable for controlling the quality of Shenxiong glucose injection.

Description

technical field [0001] The invention relates to the technical field of a method for establishing fingerprints of traditional Chinese medicines and a method for quality control. Specifically, the invention relates to a method for establishing fingerprints and a method for quality control of Shenxiong glucose injection raw materials, intermediates and preparations thereof. Background technique [0002] The composition of traditional Chinese medicine compound is complex, and the traditional method of quality control based on a single component as an index is increasingly unable to meet the current requirements of quality control of traditional Chinese medicine. In the process of modernization of traditional Chinese medicine, the fingerprint of traditional Chinese medicine, which has two basic characteristics of integrity and fuzziness, has become an effective means to reflect the internal quality of traditional Chinese medicine more comprehensively at this stage. Shenxiong gluc...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/88
Inventor 叶湘武郑林王永林兰燕宇
Owner GUIZHOU JINGFENG INJECTION
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