痹痛消巴布膏的质量标准研究

Quality Standard Research of Bitongxiao Cataplasm

关键词:  痹痛消巴布膏  质量标准  桑寄生  红花  丹参  高效液相色谱法

Key words:  Bitongxiao cataplasm  quality standard  Taxillus chinensis  Carthamus tinctorius  Salvia miltiorrhiza  HPLC

摘要:

目的 建立痹痛消巴布膏的质量标准。方法 按照中国药典一部规定，进行薄层色谱鉴别和含量测定研究。以槲皮素为指标，建立桑寄生的鉴别方法；以红花药材为对照，建立红花的鉴别方法；以丹酚酸B为指标，建立丹参的HPLC含量测定方法。结果 采用甲醇-水提取，酸水解，以甲苯（水饱和）-乙酸乙酯-甲酸（5∶4∶1）为展开剂，可鉴别巴布膏中的桑寄生；采用80%丙酮溶液提取，以乙酸乙酯-甲酸-水-甲醇（7∶2∶3∶0.4）为展开剂，可鉴别巴布膏中的红花。在Diamonsil C₁₈色谱柱（250 mm×4.6 mm，5 mm），以甲醇-乙腈（3∶1）为有机相（A），1.7%甲酸水溶液为水相（B），A∶B=30%∶70%等度洗脱，流速1.0 mL·min^-1，柱温30℃，进样量10 μL，检测波长286 nm条件下，巴布膏中丹酚酸B能有效分离，方法学考察符合含量测定要求。结论 建立的质量标准能够用于痹痛消巴布膏的质量控制。

Abstract:

OBJECTIVE To establish the quality standard of Bitongxiao cataplasm. METHODS With the guide of Chinese Pharmacopoeia, research work for TLC identification and quantitative analysis was carried out. The TLC identification for Taxillus chinensis and Carthamus tinctorius was improved based on reference methods, quercetin and safflower medicinab materials were used as indexes and controls, respectively. The content of Salvia miltiorrhiza was determined by HPLC with salvianolic acid B as an indictor. RESULTS Taxillus chinensis could be identified with toluene(water saturation)-ethyl acetate-formic acid(5︰4︰1) as developing agent. Carthamus tinctorius could be identified by TLC method with ethyl acetate-formic acid-water-methanol(7︰2︰3︰0.4) as developing agent. The separation of salvianolic acid B had effective separation on the HPLC condition as followes:the Diamonsil C₁₈ column(250 mm×4.6 mm, 5 μm)with the mobile phase containing methanol and acetonitrile(3:1) as the organic phase(A), 1.7% formic acid aqueous solution as the water phase(B), A:B=30%:70% of elution, the flow rate was 1.0 mL·min^-1, the temperature of column was 30℃, injection volume was 10 μL, and the detection wavelength was 286 nm. Methodological investigation accorded with the requirement of content determination. CONCLUSION The established quality standard of Bitongxiao cataplasm is suitable for the quality control.