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Construction method for HPLC fingerprint of bone-invigorating injection

A technology of fingerprint spectrum and construction method, which is applied in the field of construction of HPLC fingerprint of Jiangu injection to achieve the effect of strong precision and specificity

Active Publication Date: 2018-03-06
GUANGXI NANNING BAIHUI PHARMA GRP +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, there is no fingerprint quality detection method for standard Jiangu injection

Method used

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  • Construction method for HPLC fingerprint of bone-invigorating injection
  • Construction method for HPLC fingerprint of bone-invigorating injection
  • Construction method for HPLC fingerprint of bone-invigorating injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] Example 1 Determination of Jiangu Injection HPLC Fingerprint

[0025] 1 Instruments and reagents

[0026] 1.1 Instruments: Ultimate 3000DGLC high performance liquid chromatography (DGP-3600SD double ternary pump, SRD-3600 degasser, WPS-3000SL autosampler, TCC-3000RS column thermostat, DAD-3000 detector, Chromeleon7.2 data processing software); Japan Hitachi HITACHIChromaster5430 high performance liquid chromatography (CM5110 quaternary pump, CM ORG degasser, CM5310 column oven, CM5210 sampler, CM5430DAD detector); chromatographic column: WelchUltimate XB- C 18 (4.6×250mm, 5μm).

[0027] 1.2 Test drug: 10 batches of finished products, all provided by Guangxi Nanning Baihui Pharmaceutical Group Co., Ltd. The reagent acetonitrile used in the liquid chromatography in the experiment is chromatographically pure, the other reagents used are analytically pure, and the water is ultrapure water.

[0028] Reference substance: Schaftoside (source: China National Institutes for ...

Embodiment 2

[0060] Example 2 Detection of Jiangu Injection Using HPLC Fingerprint

[0061] 1 instrument and reagent: with embodiment 1.

[0062] 2 methods:

[0063] 2.1 Preparation of solution: same as Example 1.

[0064] Preparation of the test solution: Take 1ml of this product under the difference in loading amount, put it in a 10ml volumetric flask, add 20% acetonitrile to make it up to the mark, shake well, filter, and take the filtrate to get final product.

[0065] Preparation of reference substance solution: Take an appropriate amount of schaftoside reference substance, add 20% acetonitrile to make a solution containing 150 μg per 1 ml; take an appropriate amount of Weicaining-2 reference substance, add 20% acetonitrile to make a solution containing 230 μg per 1 ml ; Take an appropriate amount of Wei Cai Ning-3 reference substance, add 20% acetonitrile to make a solution containing 70 μg per 1 ml, that is, too.

[0066] Take 21507001, 1603003, 1608002, 1611001, 1611002, TDe-021...

Embodiment 3

[0073] Example 3 Using HPLC Fingerprint to Detect the Correlation of Finished Products, Intermediates, and Medicinal Materials

[0074] 1 instrument and reagent: with embodiment 1.

[0075] 2 methods:

[0076] 2.1 Preparation of solution:

[0077] Jiangu injection need testing solution: same as embodiment 1.

[0078] Intermediate test solution: Accurately measure 0.1ml of this product, put it in a 10ml volumetric flask, add 20% acetonitrile to make it up to the mark, shake well, filter, and take the subsequent filtrate to get final product.

[0079] War bone medicinal material test solution: same as Example 1

[0080] 2.2 High Performance Liquid Chromatography and Analysis Method: Same as Example 1.

[0081] 2.3 Correlation research on samples, intermediates, and medicinal materials: During the experiment, the same batch of Jiangu Injection, intermediates, and medicinal materials were tested, and the similarity coefficients were all greater than 0.96, which proved the prod...

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Abstract

The invention discloses a construction method for an HPLC fingerprint of a bone-invigorating injection and a quality detection method of the bone-invigorating injection. The method takes schaftoside,vicenin-2 and vicenin-3 as reference substances, the chromatographic conditions are that acetonitrile is used as a mobile phase A, and a glacial acetic acid solution of which the concentration is 0.3%is used as a mobile phase B; the elution time is 0 to 7min, correspondingly, the mobile phase A is changed to 10-20% of A, and the mobile phase B is changed to 90 to 80%; the column temperature is 30DEG C; HPLC analysis is carried out under the circumstance that the detection wavelength is 340nm to construct the fingerprint. A common pattern fingerprint is constructed through ten batches or moreof bone-invigorating injection samples, and is compared with a sample to be tested to detect the quality of the bone-invigorating injection. The method disclosed by the invention can monitor the quality of a bone-invigorating injection finished or semi-finished product, and provide a scientific basis for standardization study of the bone-invigorating injection, and is further strong in repeatability, precision and specificity.

Description

technical field [0001] The invention relates to a method for constructing the HPLC fingerprint of Jiangu injection. Background technique [0002] Premna fulva craib, a plant of the Verbenaceae family, is a folk medicine of the Zhuang nationality in Guangxi, and its commercial medicinal material is called "war bone". Jiangu Injection is included in the 1997 edition of "Ministry of Health of the People's Republic of China Drug Standards for Traditional Chinese Medicine Prescriptions" and is made from Zhangu. According to the theory of traditional Chinese medicine, the war bone strengthens the tendons and strengthens the bones. The injection made from it has the effects of activating blood and dispelling blood stasis, strengthening tendons and bones, dispelling wind and relieving pain, and is used for hyperosteogeny of the spine. The symptoms include joint pain and stiffness, or joint redness and swelling, limb weakness, or local numbness, etc. However, there is no establishe...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02
CPCG01N30/02
Inventor 苏薇薇王静宇彭文烈幸林广梁玉婷林桥辉彭维李华吴忠
Owner GUANGXI NANNING BAIHUI PHARMA GRP
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