Current status analysis of production and quality control of opioids and their compound oral preparations
10.19778/j.chp.2025.04.006
- VernacularTitle:阿片及其复方口服制剂质量控制现状分析
- Author:
Ruifeng HAO
1
;
Chao LI
;
Qiuping HUANG
;
Huiyue CHENG
;
Qin FENG
;
Huanhuan YU
;
Linggao ZENG
;
Jianhua WANG
;
Zhu CHEN
Author Information
1. 重庆大学生物工程学院生物流变科学与技术教育部重点实验室,重庆 400044
- Publication Type:Journal Article
- Keywords:
opium;
compound licorice formulations;
compound licorice tablets;
pharmacopoeia standards;
alka-loids;
drug regulation
- From:
Drug Standards of China
2025;26(4):371-379
- CountryChina
- Language:Chinese
-
Abstract:
Opium is obtained by air-drying the milky latex extracted from the unripe capsules of the opium poppy(Papaver somniferum).This latex is rich in benzylisoquinoline alkaloids(BIA),with major active compounds in-cluding morphine,codeine,thebaine,papaverine,and noscapine.Compound licorice oral solution and compound licorice tablets are derivative drugs containing opium.Initially classified as over-the-counter(OTC)medications,both formulations were later reclassified as prescription drugs by the National Medical Products Administration(NMPA),restricting their purchase without proper authorization.Although the national pharmacopeia standards specify the morphine content in the opium raw materials used for compound licorice oral solution and tablets,they lack mandatory requirements for the detection and quantification of the other four major alkaloids.Given the unique nature of opium raw materials and the stringent regulatory requirements for such drugs,it is imperative to enhance and refine simultaneous detection and control methods for all alkaloid components in these products.Furthermore,the establishment of scientific and reasonable detection and control standards for preservatives in compound licorice formulations is crucial to improving overall product quality management and ensuring drug safety and efficacy.This study analyzes and discusses the quality standards,detection methods,and research progress for opium and com-pound licorice preparations,aiming to explore the potential for technological innovation and ensure the safe use of these medications.
