Quality Control Method of Ganoderma Lucidum Two-dimensional Methionine Capsules

A quality control method, the technology of methionine, applied in the direction of measuring devices, instruments, scientific instruments, etc., can solve the problems of no reasonable and accurate indicators for product quality, difficulty in effectively controlling the quality of finished products, and huge impact on clinical treatment, so as to ensure Clinical use is safe, the curative effect is stable and accurate, and the effect of the production process is guaranteed

Active Publication Date: 2021-01-08
中科谱研(广州)检测有限公司
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Problems solved by technology

For this reason, the existing methods are difficult to effectively control the quality of finished products in production. There is no reasonable and accurate indicator to measure the quality of different batches of products, and it is impossible to ensure the efficacy of the products, which has a huge impact on clinical treatment.

Method used

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  • Quality Control Method of Ganoderma Lucidum Two-dimensional Methionine Capsules
  • Quality Control Method of Ganoderma Lucidum Two-dimensional Methionine Capsules
  • Quality Control Method of Ganoderma Lucidum Two-dimensional Methionine Capsules

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Embodiment Construction

[0025] Study on quality control method of Ganoderma lucidum two-dimensional methionine capsules

[0026] Ganoderma lucidum two-dimensional methionine capsules from company A (batch numbers C10003, C10004, C10005, T50001) and company B (batch numbers 1101211, 1101201, 1101171) were selected as samples in this study.

[0027] TLC identification of Ganoderma lucidum

[0028] The proposed method is as follows: take 3g of the content of this product, grind it finely, add 20ml of methanol, heat and reflux for 20 minutes, let it cool, filter, evaporate the filtrate to dryness, add 1ml of methanol to dissolve the residue, and use it as the test solution; 2g, prepare the reference medicinal material solution in the same way; according to the thin-layer chromatography (Chinese Pharmacopoeia General Rule 0502) test, draw 10 μl each of the above-mentioned need testing solution and the reference medicinal material solution, respectively spot on the same silica gel G thin-layer plate, and u...

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Abstract

The invention discloses a quality control method of lucid ganoderma two-dimensional methionine capsules. According to the method, the problems of an existing quality detection method for related preparations of the lucid ganoderma two-dimensional methionine capsules are improved; thin layer chromatography, a content uniformity test and a dissolution test of lucid ganoderma are mainly increased and the content determination of three components is carried out by adopting an HPLC (High Performance Liquid Chromatography) method. The quality control method disclosed by the invention has the advantages of reasonable design, accuracy and reliability, strong specificity and simplicity in operation; novel quality control standards of the lucid ganoderma two-dimensional methionine capsules are established according to the quality control method, the quality of medicines in lucid ganoderma two-dimensional methionine capsule production, circulation and utilization links can be effectively controlled and the quality level of the medicines is improved, so that a production technology is controllable, the clinical utilization safety is ensured and reliable guarantees are provided for a stable and accurate curative effect of products.

Description

technical field [0001] The invention belongs to the technical field of medicine quality control, and in particular relates to a quality control method of Ganoderma lucidum two-dimensional methionine capsules. Background technique [0002] Ganoderma lucidum two-dimensional methionine capsules are methionine, ganoderma extract, vitamin B 1 , vitamin B2 and capsules composed of auxiliary materials are mainly used for weakness after illness, loss of appetite, weight loss, excessive use of the brain, neurasthenia, etc., and for coronary heart disease, chronic hepatitis, bronchial asthma, anemia, rheumatoid arthritis, Adjuvant treatment of chronic diseases such as gastric ulcer. The current standard of this variety is recorded in the 15th volume of the national standard of local standards of chemical drugs in the "National Drug Standards", which is not recorded in foreign pharmacopoeias such as USP33 version, BP2010 version and JP15. [0003] The inspection items included in the...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/90G01N30/02G01N30/06
CPCG01N30/02G01N30/06G01N30/90
Inventor 卢日刚朱健萍孙煜谭菊英朱荣邓鸣
Owner 中科谱研(广州)检测有限公司
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