摘要
目的建立金骨莲胶囊的生物活性测定方法。方法将50只昆明小鼠随机分为空白对照组[等量0.5%羧甲基纤维素钠(CMC-Na)],阳性药对照组(阿司匹林36.40 mg/kg),金骨莲胶囊低、中、高剂量组(113.75,227.50,455.00 mg/kg),各10只。各组小鼠分别按每1 kg体质量灌胃10 mL相应药物,连续7 d,再腹腔注射1%醋酸溶液,测定小鼠20 min内的扭体次数,并测定10批金骨莲胶囊的生物活性。结果与空白对照组比较,金骨莲胶囊低、中、高剂量组小鼠20 min内的扭体次数均显著减少(P<0.01);重复性、中间精密度、方法适用性试验结果的RSD均小于8.0%。结论10批金骨莲胶囊样品均显示出了较好的生物活性。建立的金骨莲胶囊生物活性测定方法准确、可靠,可为建立该制剂更系统、全面的质量控制标准提供参考。
Objective To establish a bioactivity assay method for Jingulian Capsules(JGLC).Methods Fifty Kunming mice were randomly divided into the blank control group[equal volume of 0.5%carboxymethyl cellulose sodium(CMC-Na)],the positive drug control group(36.40 mg/kg of aspirin),and the JGLC low-,medium-,and high-dose groups(113.75,227.50,455.00 mg/kg),with 10 mice in each group.Mice in each group were given 10 mL of corresponding drug per 1 kg of body mass by gavage for 7 d,followed by intraperitoneal injection of 1%acetic acid solution.The number of twisting times within 20 min was measured,and the bioactivity of 10 batches of Jingulian Capsules was measured.Results Compared with those in the blank control group,the twisting times within 20 min in the JGLC low-,medium-,and high-dose groups significantly reduced(P<0.01).The RSDs of the repeatability,intra-day precision,and method applicability test results were all lower than 8.0%.Conclusion All 10 batches of Jingulian Capsules showed good bioactivity.The established bioactivity assay for Jingulian Capsules is accurate and reliable,which can provide a reference for establishing a more systematic and comprehensive quality control standard for this preparation.
作者
杨帅
刘慧
周家华
周祖英
朱迪
巩仔鹏
李月婷
郑林
黄勇
ANG Shuai;LIU Hui;ZHOU Jiahua;ZHOU Zuying;ZHU Di;GONG Zipeng;LI Yueting;ZHENG Lin;HUANG Yong(Guizhou Provincial Key Laboratory of Pharmaceutics·National Engineering Research Center of Miao′s Medicines,Guizhou Medical University,Guiyang,Guizhou,China 550004;School of Pharmacy,Guizhou Medical University,Guiyang,Guizhou,China 550004;The First Affiliated Hospital of Guizhou University of Traditional Chinese Medicine,Guiyang,Guizhou,China 550001)
出处
《中国药业》
CAS
2023年第21期47-50,共4页
China Pharmaceuticals
基金
国家自然科学基金[81960763]
贵州省科技计划项目[黔科合平台人才〔2019〕5407,黔科合中引地〔2023〕006]
贵州省高层次创新型人才[黔科合平台人才-GCC〔2022〕031-1]。
关键词
金骨莲胶囊
生物活性测定
镇痛作用
质量控制
Jingulian Capsules
bioactivity assay
analgesic effect
quality control
