摘要
目的:考察中国科学技术大学附属第一医院(安徽省立医院)常用中药注射剂参麦、血必净和参附注射液与临床常用溶媒调配后成品输液的稳定性,以期为临床安全合理用药提供技术指导。方法:参照《中国药典》(2020年版)通用技术要求,将参麦、血必净和参附注射液与不同溶媒调配成临床常用浓度的成品输液,分别于0,2,4,6,8,12,24 h时间点取样,考察其成品输液的pH值、渗透压和不溶性微粒数。结果:(1)pH:在0~24 h内,参麦、血必净、参附注射液与不同溶媒调配后成品输液的pH范围在4.03~8.98,接近人体pH(5~8),且随着时间的推移变化不大,成品输液pH变化差值均<1.0。(2)渗透压:在0~24 h内,参麦、血必净、参附注射液与0.9%氯化钠注射液(0.9%sodium chloride injection,0.9%NS)和5%葡萄糖注射液(5%glucose injection,5%GS)调配后成品输液的渗透压范围在278~311 mOsmol·kg^(-1),接近人体血浆渗透压(280~310 mOsmol·kg^(-1)),且随着时间的推移变化不大。(3)不溶性微粒数:在0~2 h内,参麦注射液与0.9%NS和5%GS调配后成品输液,血必净注射液与0.9%NS、5%GS和10%葡萄糖注射液(10%glucose injection,10%GS)调配后成品输液;在0~4 h内,参附注射液与5%GS和10%GS调配后成品输液中的≥10μm不溶性微粒数<25,≥25μm不溶性微粒数<3,均符合药典要求;随着时间的推移,不溶性微粒数均有所增加,不符合药典要求。结论:参麦注射液宜选用0.9%NS、5%GS作为溶媒;血必净注射液宜选用0.9%NS、5%GS作为溶媒;参附注射液宜选用5%GS作为溶媒。上述3种药品的成品输液使用时限方面,参麦和血必净注射液尽量在2 h内使用;参附注射液尽量在4 h内使用。
OBJECTIVE To investigate the stability of finished infusion after the compatibility of commonly used Shenmai,Xuebijing and Shenfu injection with commonly used clinical solvents,in order to provide technical guidance for safe and rational drug use in clinical practice.METHODS According to the general technical requirements of Chinese Pharmacopoeia 2020 edition,Shenmai,Xuebijing and Shenfu injection were mixed with different solvents to prepare the infusion solution of clinical common concentration.The samples were taken at 0,2,4,6,8,12,24 hours to investigate the pH value,Osmotic pressure and the number of insoluble particles.RESULTS(1)pH value:Within 0~24 hours,the pH values of Shenmai,Xuebijing and Shenfu injections mixed with different solvents ranged from 4.03 to 8.98,which were close to the human pH value(5~8).The pH values of each diluted solution did not change much with time.Compared with the pH value at 0 hour,the changes were all less than 1.(2)Osmolarity:Within 0~24 hours,the osmotic pressure of Shenmai,Xuebijing and Shenfu injection combined with 0.9% sodium chloride injection and 5% glucose injection ranged from 278~311 mOsmol·kg^(-1),which were close to the human plasma osmotic pressure(280~310 mOsmol·kg^(-1)).The Osmolarity of each diluted solution did not change much over time.(3)Insoluble particles:Within 0~2 hours the number of insoluble particles≥10μm were less than 25 and the number of insoluble particles≥25μm were less than 3 in the diluted drug solution of Shenmai injection after compatibility with 0.9% NS and 5% glucose,Xuebijing injection after compatibility with 0.9% NS,5% glucose and 10% glucose injection.Within 0~4 hours the number of insoluble particles≥10μm were less than 25 and the number of insoluble particles≥25μm were less than 3 in the diluted drug solution of Shenfu injection after compatibility with 5% glucose and 10% glucose.With the passage of time,the number of two kinds of insoluble particles in the infusion of the above finished products increased,and one of them did not meet the requirements of pharmacopoeia.With the passage of time,the number of insoluble particles increased,which did not meet the requirements of pharmacopoeia.CONCLUSIONS Shenmai injection should be diluted in 0.9% NS or 5% glucose injection for intravenous drip fluid,Xuebijing injection appropriate chooses 0.9% NS or 5% glucose as a solvent;Shenfu injection diluted to 5% glucose.In terms of the time limit for infusion of finished products of the above 3 drugs,Shenmai and Xuebijing injection should be used within 2 hours as far as possible;Shenfu injection should be used within 4 hours.
作者
黄莺
童彤
李培芳
方明
刘圣
肖明
HUANG Ying;TONG Tong;LI Pei-fang;FANG Ming;LIU Sheng;XIAO Ming(Department of Pharmacy,Anhui Provincial Hospital,The First Affiliated Hospital of University of Science and Technology of China,Anhui Hefei 230001,China)
出处
《中国医院药学杂志》
CAS
北大核心
2023年第8期892-896,共5页
Chinese Journal of Hospital Pharmacy
基金
安徽省教育厅高等学校省级质量工程项目(编号:2020jyxm2319)。
