Quality Control Method of Phenylalanine Tablets

Abstract

The invention discloses a quality control method of phenprobamate tablets. The method improves the problems existing in current quality detection methods of related preparations of phenprobamate tablets; the determination of content is conducted by mainly adding IR identification, inspection of related substances, examination of dissolution rate and adopting an HPLC method. The quality control method is reasonable in design, accurate and reliable, strong in specificity and simple in operation, and establishes a new quality control standard of the phenprobamate tablets, can help people to control the drug quality in various links of production, circulation and use of the phenprobamate tablets, improves the quality level, ensures that the production process is controllable, ensures the safety of clinical use, and provides reliable guarantee for stable and definite curative effects of products.

Description

technical field [0001] The invention belongs to the technical field of medicine quality control, in particular to a quality control method for phenylalanine tablets. Background technique [0002] Phenprobamate is a central skeletal muscle relaxant with a sedative effect. It was first successfully synthesized by Siegfried in 1960 and was first marketed in Japan and Germany. Tianjin Zhongxin Pharmaceutical Group Co., Ltd. first obtained the approval document for raw materials in 1981; in the same year, Tianjin Lisheng Pharmaceutical Co., Ltd. obtained the approval document for tablets. This product has only one dosage form of tablet in China, the specification is 200mg. Clinically, it is often used for abnormal muscle tension such as muscle spasm and rigidity, muscle pain and neuralgia. It can also be used for shoulder and neck periarthritis, rheumatoid arthritis, ligament injury, tendonitis, and also for children with Lennox-Gastaut syndrome. adjuvant therapy. [0003] The...

AI Technical Summary

Problems solved by technology

The current standard testing items are relatively simple, with many omissions and lack of quality control items for key indicators such as related substances and dissolution rate; the setting of testing items is unreasonable, and the testing methods are unreasonable. For example, the content determination method is ultraviolet spectrophotometry or nitrogen determination. , poor specificity

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.

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