| 摘要: |
| 目的：调查与分析零售药店销售的儿童非处方药（OTC）口服液体制剂分剂量的情况，以提高儿童合理用药水平，同时为国家有关管理部门制订法规提供参考。方法：将儿童OTC药品信息如品名、规格、种类、剂型等录入Excel 2007，分类汇总统计相关信息。分剂量的方法参考《欧洲药典9.0》多剂量包装制剂分剂量重量均一性检查方法，分析15种多剂量包装儿童OTC口服液体制剂分剂量的准确性。随机抽取5种单剂量包装儿童OTC口服液体制剂分析分剂量的准确性。结果：药品说明书“用法用量”项未明确标明儿童用药剂量的占43.5%。药品说明书“用法用量”项对于儿童用词的表述影响剂量的确定。15种多剂量包装品种中，未能通过多剂量包装制剂分剂量重量均一性检查的有氢溴酸右美沙芬口服溶液和对乙酰氨基酚滴剂（应用量杯或滴管量取）以及按照包装瓶内、外刻度量取。同厂家同品种，按照包装瓶内、外刻度量取的RSD均大于应用量杯量取。单剂量包装品种23种，需要分剂量的22种，包装中均未配备分剂量用具，从中随机抽取的5种均未能通过多剂量包装制剂分剂量重量均一性检查。结论：OTC药品说明书“用法用量”项对于儿童用词亟需规范。建议监管部门制订规范确保多剂量包装用量具分剂量准确性。单剂量包装需要分剂量的包装应匹配相应的量具。 |
| 关键词: 儿童 非处方药 口服 液体制剂 分剂量 |
| DOI：10.13407/j.cnki.jpp.1672-108X.2021.01.013 |
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| 基金项目: |
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| Investigation and Analysis of 30 Kinds of Divided Doses of Orally Ingested Over the Counter Liquid Preparations for Children |
| Liu Yuanjiang1, Li Cuicui2 |
| (1. Qingyuan Polytechnic, Guangdong Qingyuan 511510, China; 2. Qingyuan People’s Hospital, Guangdong Qingyuan 511518, China) |
| Abstract: |
| Objective: To investigate and analyze the status of divided doses of orally ingested over the counter drug (OTC) liquid preparations for children sold in retail pharmacies, so as to improve the level of rational drug use for children and provide reference for the relevant national administrative departments to formulate regulations. Methods: OTC drug information for children such as product name, specification, type, dosage form were inputted into Excel 2007, and relevant information was classified and summarized. The method of divided doses was based on the European Pharmacopoeia 9.0, which was used to check the uniformity of dosing weight of multi-dose packaged preparations. The accuracy of divided doses of 15 multi-dose packaged OTC oral liquid preparations for children was analyzed. Five single-dose packaged OTC oral liquid preparations for children were randomly selected to analyze the accuracy of divided doses. Results: The item of “usage and dosage” in the drug instructions did not clearly indicate the dosage for children, accounting for 43.5%. The description of the “usage and dosage” in the drug instructions for children affected the determination of dosage. Among the 15 kinds of multi-dose packaging products, dextromethorphan hydrobromide oral solution and paracetamol drops (dosage cups or droppers) were not passed by uniformity of mass of divided doses from multi-dose container, and were measured by dosage scaling according to the outer surface or inner label of packaging bottles. With the same manufacturer and varieties, the RSD taken according to the outer surface or inner label of packaging bottles was greater than that taken according to the dosage cups. There were 23 kinds of single-dose packaging, and 22 needed to be divided into different doses. None of the packaging was equipped with the divided doses, and the five randomly selected products failed to pass the test of multi-dose packaging preparation for different doses and weights. Conclusion: The term “usage and dosage” in the OTC drug instructions for children urgently needs to be standardized. It is suggested that the regulatory authorities should formulate regulations to ensure the accuracy of multi-dose packaging dosage. Single-dose packaging liquid preparations that require divided doses need to be packaged instruments. |
| Key words: children over the counter orally liquid preparations divided doses |
