目的:揭示止咳中成药的品种特点,为新止咳中成药的开发立项提供参考。方法:以《中华人民共和国药典》和《新编国家中成药》中收载的具有国家标准中成药为对象,收录在功能、主治中出现“止 咳”、“镇咳”、“止嗽”、“咳嗽”、“久咳”等关键字的中成药,开展“止咳中成药的数目、批准文号、民族药品种、儿童用药品种、国家中药保护品种、药味数”的情况统计,分析通用名称和剂型特点。结果:收录止咳中成药684 个,占7 260 个中成药总数的8.60%;共获得7 450 个批准文号,约33%的中成药仅有1 个批准文号,平均每个中成药拥有16.6 个批准文号;民族药品种有藏族验方十五味沉香丸等3 种,蒙古族验方四味土木香散等4 种;儿童用品种数占止咳中成药的14%,涉及9 种剂型;药品通用名称的命名类型多达16种,其中以处方中主要药材缩写来命名者最为常见;处方药味数多为8 味左右,在16 味以内;涉及16 种剂型,其中固体制剂的使用比例大于液体制剂者。结论:止咳中成药具有品种丰富、剂型多样、药味数合理、零售市场份额高和儿童用品种可满足临床需要等特点,存在通用名称不规范、同质化竞争激烈、民族药品种少等问题。
This study was aimed to reveal the species characteristics of Chinese patent medicines for antitussive effect and provide references for developing new drugs. This research targeted Chinese patent medicines for antitussive effect which were included in the Pharmacopoeia of the People's Republic of China and the New National Chinese Patent Medicines as well as those characterized by keywords such as "cough cure", "cough alleviating", "antitussive effect", "cough", "persistent cough". The analysis was made on the species characteristics, such as the number of Chinese patent medicines for antitussive effect, license number, ethnomedicine patent medicines, drugs for children use, protection of varieties of traditional Chinese medicine, the number of drugs, the generic names of drug, and drug forms. The results showed that 684 Chinese patent medicines for antitussive effect collected in this research had accounted for 8.60% of the total 7 260 of Chinese patent medicines. A total of 7 450 license numbers were approved,and 33% of the Chinese patent medicines shares one license number. One Chinese patent medicine owns 16.6 license numbers on average. Ethnomedicine patent medicines had 3 Tibetan prescriptions such as the Shiwuwei Chenxiang pill and 4 Mongolian prescriptions, such as the Siwei Tumuxiang powder. Drugs for children accounted for 14%, including 9 forms. The type of the generic names of drug reached 16 and most of them originate from abbreviations of the main drug in prescription. The number of drugs in prescription ranges from 8 to 16. Chinese patent medicines for antitussive effect involved 16 forms, of which the proportion of the use of solid preparation was higher than the liquid preparation. It was concluded that Chinese patent medicines for antitussive effect were characterized by such advantages such as a variety of species, various forms, the reasonable number of drugs, considerable medicine retail market share and drug for children use which can meet the clinical needs, and meanwhile some problems, such as a lack of criteria for the generic names of drug, the homogenization of fierce competition, and inadequacy of ethnomedicine patent medicines.