Quality detection method of Shouhui Tongbian capsule

A quality inspection method, the technology of Shouhui laxative, which is applied in the direction of measuring devices, instruments, scientific instruments, etc.

Active Publication Date: 2020-09-04
LUNAN HOPE PHARM CO LTD
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] Aiming at the deficiencies of the existing Shouhui Laxative Capsules quality detection method, the technical problem to be solved by the present invention is to provide a new method for the quality detection of Shouhui Laxative Capsules

Method used

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  • Quality detection method of Shouhui Tongbian capsule
  • Quality detection method of Shouhui Tongbian capsule
  • Quality detection method of Shouhui Tongbian capsule

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0052] Embodiment 1 high performance liquid chromatography condition optimization

[0053] 1 Selection of extraction method

[0054] The extraction solvents were 70% ethanol, 50% methanol, 70% methanol, pure methanol, etc.; the sample weight was 0.25g, 0.50g, 1.0g; the solvent volume was 25mL, 50mL, 100mL; the ultrasonic treatment time was 30min, 60min, 90min. The preferred extraction method is: accurately weigh 0.50 g of the test product powder, add 50 mL of 50% methanol solution, and ultrasonically treat for 60 min. At this time, the peak area of ​​the chromatogram is the best.

[0055] 2 Selection of column temperature

[0056] This study investigated the peak elution time and content determination accuracy of each component under the same chromatographic conditions and different column temperatures. 25°C, 30°C, and 35°C were investigated respectively. It was found that at 30°C, the separation of each chromatographic peak reached the standard, and the The peak time is app...

Embodiment 2 1

[0063] Example 2 Methodological study on the determination of the content of medicinal ingredients in Shouhui Tongbian Capsules by one standard and multiple testing methods

[0064] 1 Instruments and reagents

[0065] 1.1 Reagents

[0066]2,3,5,4'-tetrahydroxystilbene-2-O-β-D-glucoside (2,3,5,4'-tetrahydroxystilbene-2-O-β-D-glucoside, CAS: 82373 -94-2, purity ≥ 98%), naringin (Naringin, CAS: 10236-47-2, purity ≥ 98%), neohesperidin (Neohesperidin, CAS: 13241-33-3, purity ≥ 98%) ), aloin A (Aloin A, CAS: 1415-73-2, purity ≥ 98%), aloin B (Aloin B, CAS: 28317-16-6, purity ≥ 98%), aloemodin (Aloeemodin, CAS: 481-72-1, purity ≥ 97%), chrysophanol (Chrysophanol, CAS: 481-74-3, purity ≥ 98%), and the above reference substances were provided by Shanghai Yuanye Biotechnology Co., Ltd. Acetonitrile, methanol (chromatographically pure, Thermo Fisher Scientific Co., Ltd.), isopropanol, phosphoric acid (chromatographically pure, Nanjing Chemical Reagent Co., Ltd.), methanol (analytical...

Embodiment 3

[0141] Example 3 Polygonum Polygoni Multiflori TLC Identification in Shouhui Tongbian Capsules

[0142] A. Preparation of the test solution: Take 4g of the contents of Shouhui Laxative Capsules from batch 200201, grind them finely, add 30ml of 50% methanol for the first time, extract by heating and reflux for 30min, add 24ml of 50% methanol for the second time, extract by heating and reflux After 30 minutes, combine the two extracts, centrifuge, take the supernatant, extract 3 times with 60 mL of ether, 20 mL each time, collect the ether layer, combine the extracts, evaporate to dryness, add 2 mL of methanol to dissolve the residue, and use it as the test solution.

[0143] B. Preparation of reference medicinal material solution: take 0.5 g of Radix Polygoni Multiflori as the reference medicinal material, and prepare the reference medicinal material solution in the same way; Emodin methyl ether and emodin reference substances were accurately weighed, dissolved in methanol to p...

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Abstract

The invention belongs to the field of analysis of traditional Chinese medicine preparations, and particularly discloses a quality detection method of Shouhui Tongbian capsule. The method comprises thefollowing steps: identifying polygonum multiflorum in the Shouhui Tongbian capsule by thin-layer chromatography; on the basis of a high performance liquid chromatography technology, detecting the content of 2,3,5,4'-tetrahydroxystilbene-2-O-beta-D-glucoside, naringin, neohesperidin, barbaloin A, barbaloin B, aloe-emodin and chrysophanol in the Shouhui Tongbian capsule is determined by adopting aone-standard multi-measurement analysis method and 2,3,5,4'-tetrahydroxystilbene-2-O-beta-D-glucoside as an internal reference substance. The quality detection method is simple and convenient to operate, stable and reliable, strong in specificity and good in reproducibility, can comprehensively and effectively control the quality of the aloe vera bowel relaxing capsules, is beneficial to stabilizing the product quality, and ensures the safety and effectiveness of clinical medication, thereby better meeting the requirements of medical treatment and markets.

Description

technical field [0001] The invention relates to a quality detection method for Shouhui Tongbian capsules, belonging to the field of analysis of traditional Chinese medicine preparations. Background technique [0002] Chinese invention patent CN100453105C discloses a Shouhui Laxative Capsule, which is made of Polygonum multiflorum, Aloe, Cassia, Lycium barbarum, Ejiao, Ginseng, Atractylodes macrocephala, Citrus aurantium, and has independent knowledge of core technologies such as prescription, process, quality standard and use Property rights. On May 6, 2015, the production approval document (Guoyao Zhunzi Z20150041) and the new drug certificate (Guoyao Zhengzi Z20150005) were obtained, and it has been successfully listed on the market. Shouhui Tongbian Capsules are mainly used for the treatment of functional constipation clinically. It has the effects of moistening the intestines and laxatives, purging turbidity and detoxification, nourishing blood and moistening dryness, n...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/90
CPCG01N30/90
Inventor 张贵民马云关永霞
Owner LUNAN HOPE PHARM CO LTD
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