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The developer of Product Quality Standards

 

Chinese herbal extracts have greatly facilitated the use of herbal medicine, promoted the Chinese medicine industry and enhanced public health. As Chinese herbal extracts are relatively new, it is crucial to adopt comprehensive, systematic, multi-united, and overall controlled production methods and strategies, and to establish perfect national quality control standards that are complemented by studies of characteristics of Chinese herbal extracts, thus ensuring the safety, effectiveness, and controllability of the products.

 

1. Participation in the formulation of national Chinese herbal extracts standard. In 2010, the State Administration of Traditional Chinese Medicine has appraised and affirmed the work done by Tianjiang Pharmaceutical in the standardization of Chinese herbal extracts and designated Tianjiang as the leader for standard development.

 

At present, Tianjiang is establishing a comprehensive quality control system in accordance with the National Drug Administration’s regulations. The document it is based on is "Technical Requirements for Research and Development of Chinese Herbal Extracts Quality Standards” by the State Pharmacopoeia Commission. Tianjiang has invested a large amount of human and material resources to the research on the national level and plans to devote 100 million Yuan in the next three years to research on setting national standards for nearly 700 varieties of Chinese herbal extracts. In 2017, the company completed the draft of 33 national standards, which is the most in the industry.

 

This research on the national standard is carried out by Tianjiang under the expert guidance of the National Pharmacopoeia Commission, and regular conferences are held with experts to further ensure the research on the quality standard are scientifically and practically sound. The ultimate goal is to guarantee the stability, controllability, and uniformity of Chinese herbal extracts, and thus the safety and efficacy.

 

2. Tianjiang participates in the formulating of provincial level quality standards for Chinese herbal extracts.

 

3. Tianjiang participates in the formulating of international level quality standards for Chinese herbal extracts. Standards development plays a pivotal role in international trade. To be in a favorable position in international trade and competition, Tianjiang has carried out preliminary research on the production process and quality control international standards of Chinese herbal extracts. In 2017, Tianjiang proposed “The General Requirements of Chinese Herbal Extracts Production and Quality Control” and passed the review by international standard organization/TCC technical committee (ISO/TC249) and its domestic technology counterparts. The proposal is listed as the preliminary research project for ISO International Standards of Traditional Chinese Medicine. This proposal is to establish an international standard for Chinese herbal extracts. It incorporates years of research and production experience together with international standardization requirements, and with thorough preparation and detailed demonstration. It is Tianjiang’s contribution to promoting Chinese herbal extracts further into the international market.

 

4. Tianjiang participates in formulating quality standards for Chinese herbal extracts in US Pharmacopoeia. In 2017, Tianjiang started the research on the quality standard of the United States Pharmacopoeia of the herbal extract of coptis roots and Lonicera flowers for United States Pharmacopoeia. The draft satisfied the technical requirements of the US Pharmacopoeia Commission so that the quality standards of coptis roots extract and Lonicera flowers extract will be listed in the US Pharmacopoeia. This is significant because it marks Tianjiang's leading position in the research of international quality standards and its outstanding contribution in promoting Chinese herbal extracts into the international market.

 

5. Publications--Chinese Traditional Medicine Formula Granules Thin Layer Chromatography Color Atlas.

Tianjiang has established a thin-layer identification authenticity standard for commonly used 410 Chinese herbal extracts and published two series of "Chinese Herbal Extracts Atlas". This is the only collection of TLC identification for Chinese herbal extracts in the world and a contribution from Tianjiang.

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6. Independent quality reviews by the provincial drug administration. According to the regulations of the Food and Drug Administration, from 2002 to 2015 we entrusted Jiangsu Food and Drug Inspection Institute, Tianjin Food, and Drug Inspection Institute and Guizhou Food and Drug Inspection Institute to review the quality standards of 579 products of Chinese herbal extracts. For each specimen, 3 batches were checked, and inspection reports were issued and were collected in a total of 12 books. Among the 579 meditional materials, 280 were reviewed by Jiangsu Provincial Institute of Food and Drug Administration, 289 were reviewed by Guizhou Provincial Institute of Food and Drug Administration, and 10 were reviewed by Tianjin Institute of Food and Drug Administration.

 

7. Certificate of Analysis for every batch of product. To ensure the safety and quality of the products, every batch of the herbs including bulk order herbs comes with the product's Certificate of Analysis (COA) from the national lab. Certificates of Analysis provided for every batch include Identification, Authentication, Heavy-metal, and Microbiological Analysis.