T/SHZX 0004-2022 Abolished Group standards

T/SHZX 0004-2022 Customized ointment formula processing quality management specifications

Publish Date: 2022-12-21 Implement Date: 2023-01-01 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 0004-2022

Standard Type: Group standards

Standard Status: Abolished

is_force_gb: no

CCS Name: -

ICS Name: Drugs

Publish Date: 2022-12-21

Implement Date: 2023-01-01

Scope

Scope: This document specifies the requirements for customized paste preparation sites, facilities, utensils, and staff, as well as pre-processing preparations, production processes, management, and self-discipline in the industry. This document applies to traditional Chinese medicine (TCM) decoction pieces production and retail enterprises in Shanghai that have obtained drug production or sales licenses. The paste referred to in this document is an oral preparation. Main technical content: 6. Process requirements 6.1 For decoction pieces, the soaking (decoction) water should meet the requirements of GB 5749 (it is recommended to use water below 40°C for soaking). The decoction pieces should be completely submerged in 6-8 times their own volume of water, with the water level exceeding the surface of the decoction pieces by 10-20 cm. Soaking time: For open-air decoction (using traditional copper pots, etc.), the soaking time should be ≥6 hours; for closed-pressure decoction machines, the soaking time should be ≥8 hours. 6.2 Handling of auxiliary materials and glue materials For auxiliary materials and glue materials required by the prescription, soak and stir them in yellow wine or a suitable solvent until they are completely melted, then filter them through an 80-100 mesh sieve for standby use. 6.3 Decoction 6.3.1 The decoction pieces should be decocted twice (juice). For open-air decoction (using traditional copper pots, etc.), the first decoction time should be ≥1 hour, and the second decoction time should be ≥0.5 hour (the above times refer to the time after boiling starts). Finally, squeeze the juice; for closed-pressure decoction machines, the decoction time after boiling should be ≥1 hour. For prescriptions with large amounts of medicine and equipment volumes that cannot achieve simultaneous decoction, the decoction pieces should be mixed well after preparation and decocted in separate pots (machines), and the decoction liquids should be comb