GB/T 44036-2024Technical specification for automatic dispensing system of Chinese herbal pieces (English PDF)

Foreword

This document is in accordance with the provisions of GB/T 1:1-2020 "Guidelines for standardization work Part 1: Structure and drafting rules for standardization documents" Drafting: Please note that some of the contents of this document may involve patents: The issuing organization of this document does not assume the responsibility for identifying patents: This document was proposed and coordinated by the National Technical Committee for Standardization of Pharmaceutical Equipment (SAC/TC356): This document was drafted by: Zhejiang Houda Intelligent Technology Co:, Ltd:, Beijing Donghuayuan Medical Equipment Co:, Ltd:, Beijing Heli Kangyuan Medical Technology Co:, Ltd:, Jiangsu Provincial Hospital of Traditional Chinese Medicine, Guangdong Provincial Hospital of Traditional Chinese Medicine, Shanxi Provincial Hospital of Traditional Chinese Medicine, Guang'anmen Hospital of China Academy of Chinese Medical Sciences, Zhejiang Jiangxi Provincial Hospital of Traditional Chinese Medicine, Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, People's Hospital Affiliated to Fujian University of Traditional Chinese Medicine, Hong Kong Baptist University, Kangmei Pharmaceutical Co:, Ltd: Co:, Ltd:, Shanghai Medicinal Materials Co:, Ltd:, Zhejiang Chinese Medical University Chinese Medicine Pieces Co:, Ltd:, Beijing University of Chinese Medicine, Capital Medical University Affiliated to Beijing Hospital of Traditional Chinese Medicine, Shanghai Tongjitang Pharmaceutical Co:, Ltd:, Tongjuntang Pharmaceutical Co:, Ltd:, and the Second People's Hospital of Fujian University of Traditional Chinese Medicine Hospital, Xiamen Traditional Chinese Medicine Hospital, Henan Provincial Traditional Chinese Medicine Hospital, Tianjin Institute of Traditional Chinese Medicine Affiliated Hospital, Wuhan Traditional Chinese Medicine Hospital, Zhejiang Huachuan Sanxitang Traditional Chinese Medicine Hospital Pharmaceutical Co:, Ltd:, Zhejiang Zuoli Baicao Chinese Medicine Pieces Co:, Ltd:, and Shanghai Kangqiao Chinese Medicine Pieces Co:, Ltd: The main drafters of this document are: Cai Yongchao, Li Kun, Wan Rongchun, Yuan Changgong, Nan Yuan, Yuan Minghong, Yu Riyue, Song Weijun, Shu Yachun, Wu Shiheng, Hu Li, Wang Shiwei, Jin Min, Wu Jiannong, Xi Yan, Jiang Chuan, Liang Jiahao, Deng Guanghai, Wang Tong, Song Yan, Zhang Long, Zhai Huaqiang, Wu Jiankun, Huang Zhangxin, Wang Yujun, Zeng Maogui, Peng Liangong, Wang Kun, Yang Xinjian, Zhang Yisheng, Guan Lingling, Fan Zhiqin, Chen Weirong, Yang Yuzhou: Technical specification for automatic dispensing system of Chinese herbal medicines

1 Scope

GB/T 44036-2024 specifies the machines that dispense traditional Chinese herbal prescriptions. A TCM prescription is not a packaged product: it is a set of a dozen or more herbs, each weighed to a stated quantity and combined per dose, and dispensing it by hand is slow, physically demanding and - because the herbs are dry plant material of varying density and particle size - prone to weighing errors that nobody detects. Automating it is attractive for the same reasons hospital pharmacy automation elsewhere is, but the material makes it difficult: herbs bridge and stick in hoppers, they vary between batches, some are hygroscopic, and cross-contamination between them matters both clinically and for patients with sensitivities. Accuracy is the safety-critical property, since the dose relationships within a formula are the therapy. This document defines the terms and definitions for automatic dispensing systems for Chinese herbal pieces, specifies the requirements for them, and describes the corresponding test methods. Under ICS 11.120.30 and CCS C93, it is written for equipment manufacturers, for TCM hospitals and pharmacies, and for the drug administration authorities supervising dispensing.

This document defines the terms and definitions of the automatic dispensing system for Chinese herbal medicines, specifies the requirements for the automatic dispensing system for Chinese herbal medicines, and describes Experimental methods for automatic dispensing system of Chinese herbal medicines: This document applies to the manufacture and inspection of automatic dispensing systems for Chinese herbal medicines (hereinafter referred to as dispensing systems):

2 Normative references

The contents of the following documents constitute the essential clauses of this document through normative references in this document: For referenced documents without a date, only the version corresponding to that date applies to this document; for referenced documents without a date, the latest version (including all amendments) applies to This document:

GB/T 3768 Acoustics Sound Pressure Method for Determination of Sound Power Level and Sound Energy Level of Noise Source Using a Simple Measurement of the Envelope Measurement Surface Above the Reflecting Surface Easy Method

GB/T 36035 General requirements for electrical safety of pharmaceutical machinery Pharmacopoeia of the People's Republic of China (Part I) (National Pharmacopoeia Committee)

3 Terms and definitions

The following terms and definitions apply to this document: 3:1 A system for receiving, reviewing, automatically adjusting and verifying prescriptions for Chinese herbal medicines: 3:2 dispensing The process of preparing Chinese herbal medicines into prescriptions according to the doctor's prescription: 3:

3 Chinese herbal bucket A container for loading Chinese herbal medicine slices for preparation: 3:

4 Vehicle A container for transporting prepared Chinese herbal medicine slices: 3:

5 The method of arranging Chinese herbal medicine pieces in a certain order in a medicine bowl:

4 Requirements

1 Materials Check the material quality certification data: If the material quality cannot be verified, conduct the test according to the test method of the corresponding material: