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 C18(150 mm×4.6 mm, 5 μm)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1.1~220 μg·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 C18 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.
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