氧化锌洗剂处方及配制工艺改进后的稳定性考察

Study on the Stability of Zinc Oxide Lotion Prescription and the Improved Preparation Process

目的通过改进氧化锌洗剂的处方及配制工艺,提高氧化锌洗剂的稳定性。方法通过比较2009年1月1日-2018年12月31日(以下简称改进前)及2019年1月1日—3月31日(以下简称改进后)三个批次的氧化锌洗剂试样的性状、微粒大小、沉降容积比、重新分散能力、氧化锌含量等,考察氧化锌洗剂的稳定性,判断改进后的氧化锌洗剂的处方及配制工艺是否合理、科学。结果三个批次的氧化锌洗剂试样改进后的微粒粒径分别为(5.51±0.52)μm、(5.82±0.87)μm、(5.57±0.59)μm,小于改进前的(9.69±1.08)μm、(9.53±1.12)μm、(9.18±0.85)μm,差异显著(P<0.05);三个批次的氧化锌洗剂试样改进后的F平均值(静置24h)分别为0.650±0.048、0.645±0.043、0.657±0.041,高于改进前的0.541±0.049、0.537±0.043、0.539±0.032,差异显著(P<0.05);三个批次的氧化锌洗剂试样改进后的含量测定分别为(101.00±1.10)%、(100.70±1.38)%、(101.05±1.45)%,高于改进前的(98.63±1.40)%、(99.24±0.87)%、(99.62±0.96)%,差异显著(P<0.05)。结论氧化锌洗剂的处方及配制工艺改进后,不仅提高了氧化锌洗剂的稳定性,而且提高了制剂效率以及患者的用药依从性;质量稳定,值得推广。

Objective To improve the stability of the zinc oxide lotion by improving the prescription and preparation technology of the zinc oxide lotion. Methods This study investigated the stability of zinc oxide lotion and determined whether the prescription and preparation process of the modified zinc oxide detergent were reasonable and scientific or not by comparing the properties, particle size, sedimentation volume ratio, redispersion ability, zinc oxide content, etc of three batches of zinc oxide lotion samples from the periods that from January 1^st, 2009 to December 31^st, 2018 ( hereinafter referred to as before improvement ) and January 1^st, 2019 to March 31^st, 2019 ( hereinafter referred to as improvement ). Results The particle sizes of three batches of zinc oxide lotion samples were (5.51±0.52)μm,(5.82±0.87)μm and (5.57±0.59)μm which were less than (9.69 ±1.08)μm,(9.53 ±1.12)μm and (9.18 ±0.85)μm before improvement. The difference was significant (P < 0.05);the average F value of three batches of the zinc oxide lotion samples ( standing for 24 hours) were respectively 0.650±0.048, 0.645±0.043 and 0.657±0.041 which were significantly higher than 0.541 ±0.049, 0.537±0.043 and 0.539 ±0.032 before improvement, the difference was significant (P < 0.05);the content of three batches of zinc oxide lotion samples were respectively (101.00 ±1.10)%,(100.70 ±1.38)% and (101.05 ±1.45)% were higher than (98.63 ±1.40)%,(99.24 ±0.87)% and (99.62 ±0.96)% before improvement, the difference was significant (P < 0.05). Conclusion After the improvement of the prescription and preparation process of the zinc oxide lotion, it not only improves the stability of the zinc oxide lotion, but also improves the efficiency of the preparation and the drug compliance of the patients;the quality is stable and will be worth popularizing.