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目的:分析复方磺胺甲唑片批内、批间及厂间均匀性的主要相关因素,为该片均匀性生产过程控制方案的制订提供依据。方法:采用高效液相色谱仪、分析天平、片剂硬度仪和游标卡尺分别测定复方磺胺甲唑片4个厂家13批共258片样品的磺胺甲唑(SMZ)含量、甲氧苄啶(TMP)含量、片重(TW)和片抗张强度(TRTS),结合近红外光谱、采用方差分析法分析以上相关因素对复方磺胺甲唑片批内、批间及厂间均匀性的影响。结果:复方磺胺甲唑片批内均匀性的主要相关因素各厂不同,厂A为TW(变异为0.772×10-5~3.22×10-5g2),厂B为SMZ含量[变异为19.3×10-5~34.4×10-5(g·g-1)2]及TMP含量[变异为0.623×10-5~1.27×10-5(g·g-1)2],厂C为TW(变异为6.48×10-5~24.3×10-5g2);批间均匀性的主要相关因素为TW(变异为0.121×10-5~10.3×10-5g2);厂间均匀性的主要相关因素为TW(变异为13.9×10-5g2)及SMZ含量[变异为13.2×10-5(g·g-1)2]。结论:本研究证明SMZ含量、TMP含量、TW和TRTS均是复方磺胺甲唑片均匀性的相关因素。在制订该片均匀性生产过程控制方案时,应控制各厂的主要相关因素以提高批内均匀性:主要控制TW变异以提高批间均匀性,控制TW及SMZ含量的变异以提高厂间均匀性。本研究也为其他片剂的均匀性研究与控制提供了参考。
OBJECTIVE: To analyze the main factors related to the uniformity of sulfamethoxazole tablets in batches, batches and plants, and provide the basis for the formulation of the control scheme for the uniformity of the tablets. Methods: The contents of sulfamethoxazole (SMZ), trimethoprim (TMP) and trimethoprim (SM) in 258 samples from 13 batches of four groups of compound sulfamethoxazole tablets were determined by HPLC, (TW) and sheet tensile strength (TRTS). The ANOVA was used to analyze the influence of the above factors on the intra, inter and inter plant uniformity of sulfamethoxazole tablets. Results: The main factors related to the uniformity of sulfamethoxazole tablets in batches were different from factory to factory, with plant A being TW (variation 0.772 × 10-5 ~ 3.22 × 10-5g2) and factory B being SMZ content [variation was 19.3 × 10 -5 ~ 34.4 × 10-5 (g · g -1) 2] and TMP content [variation was 0.623 × 10-5 ~ 1.27 × 10-5 (g · g -1) 2] (6.48 × 10-5 ~ 24.3 × 10-5g2). The main correlation coefficient of inter-batch uniformity was TW (the variation was 0.121 × 10-5 ~ 10.3 × 10-5g2). The main inter-plant uniformity correlation was TW (Variation of 13.9 × 10-5g2) and SMZ content [variation of 13.2 × 10-5 (g · g-1) 2]. Conclusion: This study demonstrated that SMZ content, TMP content, TW and TRTS are all related factors for the uniformity of compound sulfamethoxazole tablets. In formulating the control plan for the uniformity of production process, the main relevant factors of each plant should be controlled to improve intra-batch uniformity: the main control TW variation to improve uniformity between batches, the variation of TW and SMZ content in order to improve the uniformity of the plant Sex. This study also provides reference for the research and control of the uniformity of other tablets.