中文摘要：

目的 分析中药注射剂研究的现状,探讨超分子结构形式对免疫毒性作用及研究方法.方法 总结中药注射研究,特别是安全性研究现状,分析中药注射剂可能存在的超分子形式,阐述中药注射剂免疫毒性研究中的超分子结构作用及研究方法.结果 中药注射剂的不良反应以致敏与类致敏反应为主,致敏原可能为注射剂中单分子成分及其代谢产物,更可能是由单分子成分组合而成的超分子形式.中药注射剂中的单分子成分可以自身或相互络合、复合、螯合、包合、中和、自组装及化学反应形成超分子物质,其表观分子量、免疫原性会显者性地增加.中药注射给药时这种形式得以最大保留,而在口服给药时,因肠胃道的吸收作用而拆散了这种形式,因此中药给药注射易而口服难产生免疫毒性.结论 中药的物质基础是基于包括单分子在内的超分子群混合物,中药注射给药能最大保留这种形式,而口服给药能显著性地改变这一形式.在进行中药注射剂安全性研究时,应特别重视超分子的作用规律与研究方法,这是中药注射剂区别于单分子注射剂所产生免疫毒性最为本质的地方.

英文摘要：

Objective To analyze the research status of Chinese materia medica injection（CMMI）, and to investigate their immunotoxicities owning to supramolecular structure and the suitable research approach. Methods The research status of the CMMI, especially their safety research was summarized, and possibly existing supramolecular forms in the CMMI were analyzed in order to explain the supramolecular structure actions in the research of the CMMI immunotoxicities, as the research approach as well. Results There were mainly two kinds of immunotoxicity （senstization and homeo-sensitization responses） and the sensitinogens might be unimolecule and their metabolites, especially the supramolecular structures formed from the single compounds that can build the supramolecular structure by complex, composite, chelation, inclusion, neutralization, self-assembly and chemical reaction, which could markedly improve their apparent molecular weight and immunogenicity. The supramolecular structures would be reserved in maximum in injection administration, whereas they would be disassembled in oral administration. Therefore, it was more easily to generate immunotoxicity by injection administration than the oral administration. Conclusion The material foundation of the CMMI consists of the supramolecular group mixtures including single molecules, which can be reserved in maximum by injection administration, but markedly changed by oral administration. The regularities and research approach of supramolecular action should be thought highly during the study of the CMMI safeties, which is the most essential for the CMMI distinguishing from the single ingredient injection.