目的 探讨超净配药器在静脉用药调配中心（pharmacy intravenous admixture services,PIVAS）中药注射剂调配中的应用效果。方法 选取2025年5月22日—6月10日广州中医药大学深圳医院PIVAS调配的康艾、复方苦参和肾康3种中药注射剂,根据配药方式分为人工组及超净配药器组。其中康艾和复方苦参各200份（人工组、超净配药器组各100份）,肾康80份（人工组、超净配药器组各40份）。比较人工和超净配药器的配药效率、药液残留量、调配的稳定性及引入超净配药器对配药注射器内表面、残留药液微生物检出率和空气洁净度产生的影响。结果 调配3种中药注射剂,复方苦参注射液、肾康注射液超净配药器组每袋平均调配时间显著短于人工组[（42.40±3.364）s vs（46.65±4.722）s,（55.18±4.299）s vs （63.90±5.891）s],康艾注射液超净配药器组与人工组相比,调配时间无明显差异[（60.05±3.866）vs （60.96±4.829）s]。这3种中药注射剂的药液残留量两组间差异没有统计学意义。在当前研究的大多数情况下调配时间和残留量变异系数小,使用超净配药器更稳定,引入超净配药器对配药注射器内表面、残留药液微生物检出和空气洁净度,在当前研究条件下未发现显著影响。结论 以康艾注射液、复方苦参注射液和肾康注射液为例,超净配药器组能缩短调配时间,稳定性更好,未发现其对药液残留量和微生物检测结果产生显著不利影响,为PIVAS探索标准化流程和智能化配药方案提供了一个具有潜力的选择。

Objective To investigate the application effect of an automatic dispenser in the compounding of commonly used Traditional Chinese Medicine (TCM) injections in PIVAS. Methods From May 22 to June 10, 2025, Compound Kushen Injection, Shenkang Injection, and Kangai Injection compounded at the PIVAS of Shenzhen Hospital of Guangzhou University of Chinese Medicine were enrolled. Samples were categorized into a manual group and an ultra-clean dispensing device group according to the preparation technique. The sample sizes comprised 200 prescriptions each for Kangai and Compound Kushen Injections (split evenly into 100 per group) and 80 prescriptions for Shenkang Injection (40 per group). The efficiency of manual versus automatic dispenser, residual drug volume, compounding stability, microbial detection rates in residual solution/syringes and air cleanliness were compared. Results When compounding three types of Traditional Chinese Medicine injections, the average preparation time per bag in the ultra-clean dispensing device group was significantly shorter than that in the manual group for both compound Kushen Injection and Shenkang Injection [(42.40±3.364) s vs (46.65±4.722) s and (55.18±4.299) s vs (63.90±5.891) s, respectively]. However, no significant difference in preparation time was observed between the two groups for Kangai Injection [(60.05±3.886) s vs (60.96±4.829)]. In the present study most coefficients of variation for compounding time and residual volume were small when using the automatic dispenser. No statistically significant differences were observed in residual drug volume. Under the current research conditions, the introduction of the automatic dispenser has no significant impact on the microbial detection of the inner surface of dispensing syringes, residual medication or air cleanliness. Conclusion Taking Kang'ai Injection, Compound Kushen Injection, and Shenkang Injection as examples, the automatic dispenser significantly reduces the compounding time per bag of finished infusion solution and makes it more stable time. No significant adverse effects were observed on the residual drug volume or microbial test results. This provides a promising option for PIVAS to explore standardized procedures and intelligent compounding.