红色诺卡氏菌细胞壁骨架药膜的制备与含量测定  

Preparation and content determination of a Nocardia rubra cell wall skeleton film

作　　者：杨煌建[1] 王娟[1] 陈洲琴 程贤 严凌斌[1] 林仙菊 张祝兰[1] 连云阳[1] YANG Huang-jian;WANG Juan;CHEN Zhou-qin;CHENG Xian;YAN Ling-bin;LIN Xian-ju;ZHANG Zhu-lan;LIAN Yun-yang(Fujian Key Laboratory of Screening for Novel Microbial Products,Fujian Institute of Microbiology,Fuzhou 350007,China)

机构地区：[1]福建省微生物研究所福建省新药(微生物)筛选重点实验室,福州350007

出　　处：《药物分析杂志》2024年第1期51-57,共7页Chinese Journal of Pharmaceutical Analysis

基　　金：福建省属公益类研究所基本科研专项(2021R1005007、2022R1005007);福州市科技创新平台项目(2021-P-25)。

摘　　要：目的:制备红色诺卡氏菌细胞壁骨架(N-CWS)药膜并考察其含量测定方法。方法:以N-CWS为模型药物,壳聚糖、聚乙烯醇为成膜材料,通过溶液浇铸法制备N-CWS药膜;使用扫描电子显微镜(SEM)、红外光谱仪、万能试验机对药膜性能进行表征;采用柱前衍生化高效液相色谱法测定药膜中D-阿拉伯糖的含量,采用Kromasil C_(18)(150 mm×4.6 mm, 5μm)色谱柱,以50 mmol·L^(-1)(pH 7.0)磷酸盐缓冲液-乙腈(80∶20,v/v)为流动相,流速1.0 mL·min^(-1),检测波长254 nm,柱温40℃。结果:当壳聚糖与聚乙烯醇质量比为3∶2,膜材与甘油质量比为1∶2时,断裂拉伸应变为136.67%,拉伸应力为2.47 mPa。扫描电镜观察到N-CWS主要分布在膜的底面,呈不对称分布;制备的药膜中D-阿拉伯糖在1.1~220μg·mL^(-1)范围内线性关系良好,平均加样回收率为99.5%,测得3批次药膜中D-阿拉伯糖分别为(0.988±0.041)mg·g^(-1)、(1.035±0.049)mg·g^(-1)、(1.088±0.046) mg·g^(-1)。结论:N-CWS药膜制备工艺简单易行,含量测定方法准确快速,本研究可为N-CWS的新剂型开发提供参考依据。Objective:To prepare and investigate the content determination of Nocardia rubra cell wall skeleton(N-CWS) loading film. Methods: Taking chitosan and polyvinyl alcohol as film-forming materials, N-CWS film was prepared by solution casting method. The film was characterized by scanning electron microscopy(SEM), Fourier transform infrared spectroscopy(FTIR) and universal tensile testing machine. Determination of arabinose in N-CWS film was carried out by HPLC. The Kromasil C_(18 )column(150 mm×4.6 mm, 5 μm) was adopted, with the elution of 50 mmol·L^(-1) phosphate buffer(pH 7.0)-acetonitrile(80∶20,v/v). The flow rate was 1.0 mL·min^(-1), the detection wavelength was 254 nm, and the column temperature was 40 ℃. Results: When the mass ratio of chitosan to polyvinyl alcohol was 3∶2 and the mass ratio of membrane material to glycerol was 1∶2, the tensile modulus reached 2.47 mPa and the tensile strain at break was 136.67%. Scanning electron microscopy showed that N-CWS was distributed asymmetrically on the bottom of the film. The linear relationship of D-arabinose in the prepared film was good in the range of 1.1-220 μg·mL^(-1), and the average recovery rate was 99.5%. The determination results of three batchs N-CWS films showed that the contents of D-arabinose in the films were(0.988±0.041) mg·g^(-1),(1.035±0.049) mg·g^(-1),(1.088±0.046) mg·g^(-1), respectively. Conclusion: The preparation process of N-CWS loading film is simple and feasible, and the content determination method is accurate and fast. This study can provide reference for the development of new dosage forms of N-CWS.

关 键 词：红色诺卡氏菌细胞壁骨架 壳聚糖 聚乙烯醇 药膜 柱前衍生化 含量测定 D-阿拉伯糖 

分 类 号：R917[医药卫生—药物分析学]