Method for detecting quality of Xianing Gubao capsules

A technology of Xianlinggubao and capsules, which is applied in the field of quality detection of traditional Chinese medicine, can solve the problems of low quality standards, and achieve the effects of good reproducibility, simple operation method and excellent precision

Inactive Publication Date: 2013-05-15
GUOYAOJITUAN TONGJITANG (GUIZHOU) PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, so far, the quality standards for Xianling Gubao are relatively low. The current State Food and Drug Administration Drug Standard (Trial) (WS-10269(ZD-0269)-2002) onl...

Method used

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  • Method for detecting quality of Xianing Gubao capsules
  • Method for detecting quality of Xianing Gubao capsules
  • Method for detecting quality of Xianing Gubao capsules

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0062] Example 1. Establishment of Xianling Gubao Capsule Fingerprint

[0063] Take the content of Xianling Gubao Capsules (Guizhou Tongjitang Pharmaceutical Co., Ltd., batch number 100929), accurately weigh about 0.2g, put it in a 10mL volumetric flask, add about 8mL of methanol with a volume fraction of 60%, and ultrasonicate (power 150W , frequency 40kHz) for 30min, take it out, let it cool to room temperature, dilute to 10mL with 60% methanol, shake well, and centrifuge the extract (that is, the supernatant after shaking well and standing) at 9960rpm / min for 1min, pass 0.45 μm microporous membrane, take the continuous filtrate to obtain the test solution of Xianling Gubao Capsules.

[0064] Take an appropriate amount of each reference substance (that is, a mixed reference substance solution formed by mixing 27 kinds of monomer compounds), dissolve it in an appropriate amount of methanol, and prepare a stock solution respectively, and then mix to prepare a mixed reference s...

Embodiment 2

[0066] Embodiment 2. Determine fingerprint spectrum reproducibility:

[0067]Accurately weigh 6 portions of the content of Xianling Gubao Capsules (Guizhou Tongjitang Pharmaceutical Co., Ltd.), 0.2g each, into a 10mL volumetric flask, add about 8mL of methanol with a volume fraction of 60%, and ultrasonically process (power 150W, frequency 40kHz ) for 30 min, take it out, let cool to room temperature, dilute to volume with 60% methanol, shake well, centrifuge the extract at 9960 rpm / min for 1 min, pass through a 0.45 μm microporous membrane, and take the subsequent filtrate. Adopt the liquid phase condition described in embodiment 1 to carry out chromatographic analysis, record chromatogram (see image 3 ). In the obtained HPLC fingerprint, the relative retention times of twenty-seven chromatographic peaks all meet the relevant requirements in Example 1, and the relative deviations of the relative retention times of the 27 main chromatographic peaks in the fingerprint are all...

Embodiment 3

[0071] Enrichment and structural identification of embodiment 3 chromatographic peaks:

[0072] Take 450g of "Xianling Gubao" extract (XLGB), suspend it in 5L distilled water, and separate it through a macroporous adsorption resin HP-20 chromatographic column (Φ9×70cm, balanced with 15L distilled water in advance), and then wash it with water, 30% , 95% (v / v) ethanol-water gradient elution, collect each eluate, recover the solvent under reduced pressure respectively, and obtain 227.2 g of water eluate (XLGB-A, 58.9%), 30% (v / v) Ethanol-water eluate 61.3g (XLGB-B, 13.0%) and 95% (v / v) ethanol-water eluate 109.3g (XLGB-C, 23.2%). XLGB-B was chromatographed on a silica gel column and eluted with a gradient of chloroform-methanol-water to obtain 12 fractions (B1-B12). Among them, chloroform-methanol-water 70:30:5 (V / V / V) eluted part of XLGB-B12 was subjected to ODS column chromatography and repeated high-performance liquid phase separation (35% methanol-water, containing 0.1% for...

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Abstract

The invention provides a method for detecting the quality of Xianing Gubao capsules. The method comprises the following steps of: establishing a standard finger-print of the Xianing Gubao capsules by employing a reversed-phase high-performance liquid chromatography, wherein the standard finger-print contains 22-32 chromatographic peaks, preferably 27 chromatographic peaks; and the sum of the peak area of the chromatographic peaks is larger than 50 percent of the total peak area, preferably the sum of the peak area of the 27 chromatographic peaks accounts for 50-90 percent of the total peak area, preferably 60 to 70 percent, and more preferably 70 percent. The invention also confirms chemical structures of compounds which correspond to the 27 chromatographic peaks. According to the method, the similarity of finger-prints of multi-batch commercial preparations is evaluated and is not less than 0.952. According to the method, the product quality of the traditional Chinese medicine compound preparation Xianing Gubao capsules can be effectively detected, and the method is high in reproducibility, high in stability, excellent in precision and easy and convenient in operation.

Description

technical field [0001] The invention relates to the field of detection of the quality of traditional Chinese medicines, in particular to a method for detection of the quality of compound Xianling Gubao capsules containing six traditional Chinese medicines of Epimedium, Dipsacus, Psoraleae, Salvia Miltiorrhiza, Anemarrhena, and Rehmannia glutinosa. Background technique [0002] The traditional Chinese medicine compound preparation "Xianling Gubao" Capsule was developed by Professor Shi Guangda, a famous orthopedic expert, based on the bone metabolism balance theory of "kidney governing bone" in traditional Chinese medicine, on the basis of Miao folk prescriptions, and after years of clinical verification and screening. become. It is a compound Chinese patent medicine preparation composed of six traditional Chinese medicines of Epimedium, Dipsacus, Salvia, Psoralen, Anemarrhena, and Rehmannia. Epimedium, also known as fairy spleen, is warm in nature, pungent in taste, sweet, ...

Claims

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Application Information

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IPC IPC(8): G01N30/02
Inventor 姚志红戴毅屠凤娟程红王新峦秦岭姚新生王晓春周宁
Owner GUOYAOJITUAN TONGJITANG (GUIZHOU) PHARMA CO LTD
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