Tianshili: scientific and technological innovation to ensure the internal quality of products

[China Pharmaceutical network enterprise news] as an enterprise committed to building a modern Chinese medicine, Tianshi company has been steadily carrying out scientific and technological innovation, improving the quality and safety of drugs, especially in the production of its representative product compound Danshen dropping pills The company has conducted in-depth and systematic research on key technologies such as cultivation of traditional Chinese medicine, quality standardization of traditional Chinese medicine, residue limits of heavy metals and pesticides of traditional Chinese medicine, extraction of traditional Chinese medicine, pharmaceutical preparations, quality standards, basic pharmacology, clinical efficacy, etc., ensuring the safety and effectiveness of products in all links from pharmaceutical research and development, cultivation of traditional Chinese medicine, intermediate extraction, preparation production to market operation Tianshili company innovatively put forward the "one core, two extension" comprehensive quality management mode From the whole process of planting, processing, extraction, preparation and sales of medicinal materials, it creatively established an integrated industrial chain in line with a series of standards and specifications, and implemented specialized operation and integrated management to effectively reduce the safety risk of drugs In the total quality management mode, traditional Chinese medicine planting is the key to ensure the quality of products Because the decentralized management of traditional Chinese medicine can not guarantee the internal quality of traditional Chinese medicine, Tianshi company has established its own planting base On April 20, 2003, the planting base of Salvia miltiorrhiza in Shangluo became a base that passed the gap pilot certification of traditional Chinese medicine, and passed the official certification on November 27 of the same year In 2012, Tianshili company carried out production and control in strict accordance with the production technology control procedures and quality standards of organic Salvia miltiorrhiza, and obtained the EU organic conversion certificate In 2000, Tianshili company applied the international advanced agricultural management system in Wenshan, Yunnan Province, adopted the farm planting management, and successively established more than 2000 mu and 37 planting bases These measures ensure the quality of drugs from the source In the process of building the quality control of the whole industrial chain of Compound Danshen dropping pills, Tianshili company found that the quality control of the extraction link of traditional Chinese medicine was broken Therefore, in October 2001, at the "International Forum on traditional Chinese medicine and botanical medicine", Tianshi company creatively proposed to establish GEP, which is the last time in the history of international pharmaceutical industry that Chinese enterprises proposed to establish industry standards Through 20 years of continuous exploration and innovation, the company has established a relatively mature theoretical system and management system in modern Chinese medicine and modern Chinese medicine industry chain, effectively ensuring the internal quality of products According to the database of national adverse reaction monitoring center, the incidence of adverse reactions / events related to compound Danshen dropping pills is only 0.0018%, which is very rare Adverse reactions / events occurred during the reporting period were mainly gastrointestinal reactions (see the instructions), dizziness, headache, rash, pruritus, etc These events have been reported in the past, and the symptoms can be self-healing or improved Compound Danshen dropping pill has been used for hundreds of millions of times, which shows the safety and effectiveness of the drug This is also the reason that compound Danshen dropping pill has become the first-line drug for cardiovascular disease treatment in China (Jin Yong) original title: scientific and technological innovation creates the internal quality of Danshen Dropping Pills