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Quality control method of capsules for curing waist pain

A quality control method and capsule technology, which can be used in capsule delivery, medical preparations containing active ingredients, and measuring devices, etc. It can solve the problem that Yaoxitong capsules should not be taken in large quantities, taken for a long time, microscopic features cannot be seen, and the index components are black. There are no suitable detection methods for Taurine

Active Publication Date: 2008-10-01
江西药都仁和制药有限公司
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  • Summary
  • Abstract
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  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] 3. Yaoxitong capsules should not be taken in large quantities or for a long time
The current quality standard of Yaoxitong Capsules only uses microscopic identification methods to control its quality. Due to reasons such as experimental inspection or processing, sometimes the microscopic characteristics of individual medicinal material tissues cannot be seen, and it is difficult to determine whether it does not meet the requirements. It is judged that because Aconitum is a highly toxic drug, there is no suitable detection method for the index component aconitine in the finished capsule, and there is no qualitative detection method in the quality standard; these are the deficiencies in the current standard
[0030] The original quality standard of Yaoxitong Capsules only has qualitative methods, and there is no quantitative analysis method, which is also a current deficiency

Method used

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  • Quality control method of capsules for curing waist pain
  • Quality control method of capsules for curing waist pain

Examples

Experimental program
Comparison scheme
Effect test

experiment example 1

[0044] Five batches of Yaoxitong capsules were randomly selected (batch numbers: 20070712-1, 20070824-1, 20070911-1, 20071015-1, 20071112-1).

[0045] Take 6.0g of the contents of the above 5 batches of capsules, put them in a 500ml Erlenmeyer flask with a stopper, add 60ml of concentrated ammonia test solution to make it wet, add 200ml of ether, ultrasonicate for 40 minutes, let cool, and divide the ether solution , Evaporate to dryness, add absolute ethanol to the residue to dissolve and dilute to 2 ml, as the test solution. In addition, accurately weigh an appropriate amount of aconitine reference substance, add absolute ethanol to make a solution containing 1 mg per 1 ml, and use it as the reference substance solution. Test according to the thin-layer chromatography (Appendix VIB of the Chinese Pharmacopoeia in 2005), draw each 5 microliters of the above-mentioned need testing solution and the reference solution, and point respectively on the same silica gel G thin film wi...

experiment example 2

[0050] Five batches of Yaoxitong capsules were randomly selected (batch numbers: 20070712-1, 20070824-1, 20070911-1, 20071015-1, 20071112-1).

[0051] Determination according to high performance liquid chromatography (Chinese Pharmacopoeia 2005 edition appendix VID).

[0052] Chromatographic conditions and system suitability test use octadecylsilane bonded silica gel as filler, acetonitrile-0.05% phosphoric acid aqueous solution (14:86) as mobile phase, detection wavelength 230nm, flow rate: 1.0 ml / min, theoretical plate number press Paeoniflorin peak calculation should not be less than 3000.

[0053] Preparation of reference substance solution Take an appropriate amount of paeoniflorin reference substance dried under reduced pressure to constant weight, accurately weigh it, add 50% methanol to make a solution containing 60 micrograms per 1 ml, and obtain it.

[0054] Preparation of the test solution Take an appropriate amount of the content of the Yaoxitong Capsules under th...

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Abstract

The invention relates to a lumbago relieving capsule which can relax tendons and activate collaterals, remove blood stasis, relieve pain, activate blood and remove rheumatism. The lumbago relieving capsule can be applied to rheumatoid arthritis, hypertrophic ixomyelitis, hypertrophic thoracic inflammation, cervical inflammation, sciatica and lumbar muscle strain. Since the lumbago relieving capsule contains toxic kusnezoff monkshood root, carefulness is needed during clinical use. The quality standard of current lumbago relieving capsules cannot totally meet the purpose of drug safety supervision. The lumbago relieving capsule of the invention aims at providing more perfect quality control method from qualitative and rational aspects.

Description

【Technical field】 [0001] The invention belongs to the technical field of traditional Chinese medicines, in particular to a quality control method for Yaoxitong capsules. 【Background technique】 [0002] The functions and indications of Yaoxitong Capsules include relaxing tendons and activating collaterals, dispelling blood stasis and relieving pain, promoting blood circulation and expelling wind. For rheumatoid arthritis, hypertrophic lumbar spondylitis, hypertrophic thoracic spondylitis, cervical spondylitis, sciatica, lumbar muscle strain. Its usage and dosage is oral, 2 capsules at a time, 3 times a day, after meals. [0003] The following three items should be paid attention to clinically for Yaoxitong Capsules: [0004] 1. Take it with caution for those with heart disease and gastrointestinal discomfort. [0005] 2. If nausea, vomiting, abdominal pain, dizziness, numbness of tongue, limbs and whole body, cold stomach, followed by dilated pupils, blurred vision, dyspne...

Claims

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Application Information

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IPC IPC(8): A61K36/8945A61K9/48A61P29/00G01N30/02G01N30/90A61K31/167
Inventor 杨文龙
Owner 江西药都仁和制药有限公司
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