T/SHZX 0002-2022 Abolished Group standards

T/SHZX 0002-2022, Guidelines for the Quality Management of Decoction Preparation of Traditional Chinese Medicine

T/SHZX 0002-2022

Publish Date: 2022-10-14 Implement Date: 2022-10-20 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

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Basic Information

Standard Code: T/SHZX 0002-2022

Standard Type: Group standards

Standard Status: Abolished

is_force_gb: no

CCS Name: -

ICS Name: Drugs

Publish Date: 2022-10-14

Implement Date: 2022-10-20

Scope

Scope: This document specifies the requirements for the facilities, utensils, and personnel of TCM decoction preparation sites, as well as the requirements for contract decoction preparation, decoction processing, management, and qualification certification of TCM decoction enterprises in Shanghai City. This document applies to the quality management of TCM decoction production and retail enterprises in Shanghai City that have been operating compliantly for more than one year and undertake TCM decoction services commissioned by medical institutions. Main technical content: 7.1.2.1 Each prescription should be decocted twice, and the two decoctions should be mixed and then repacked. The decoction time should be determined according to the function and efficacy of the prescription and the drug. For general drugs, boil for 20 minutes to 30 minutes after boiling; for antipyretic drugs, boil for 15 minutes to 20 minutes after boiling; for tonic drugs, first boil with strong fire and then boil with weak fire for 40 minutes to 60 minutes. The decoction time of the second decoction should be slightly shorter than that of the first decoction. 7.1.2.2 During the decoction process, stir the medicinal materials 2 to 3 times. The stirring utensils should be made of ceramics, stainless steel, copper, etc. After stirring one batch of medicinal materials, the stirring utensils should be cleaned and then used to stir the next batch of medicinal materials. 7.1.2.3 For TCM decoction materials with special requirements such as first decoction, last decoction, packaged decoction, separate decoction, melting into soup to replace water, etc., they shall be operated in accordance with the requirements of the "Shanghai Pill-making Regulations" or medical instructions, and meet the following requirements: a) First decoction: Boil the first-decocted medicinal materials for 10 minutes to 15 minutes, and then decoct with other medicinal materials. b) Last decoction: When the first-decocted med