生产工艺对博落回口服液质量稳定性影响研究

Study on the influence of production Process on the qualitystability of Veterinary Oral Liquid made from Macleaya cordata

关键词:  博落回  口服液  生产工艺  质量稳定性  影响  博落回生物碱

Key words:  Macleaya cordata  Production process  oral liquid  stability  Influence  

摘要:

博落回口服液生产工艺简单,生产成本低,给药方便,节约大量人力物力,特别适合规模化养殖防控用药,是值得研究开发的一种兽药新制剂。生物碱类化合物是博落回口服液中含量最多、最主要的有效液的质量稳定性。 研究表成份,直接影响口服明,不同提取生产工艺对博落回生物碱质量稳定性影响较大,提取率从高到低依次为酸性乙醇浸提法﹥乙醇浸提法﹥酸水浸提法﹥沸水煮沸浸提法。在七种不同浓度乙醇的浸提中,以80%-90%的乙醇对博落回生物碱提取率高,均在90%以上,效果好,质量稳定。三批口服液样品在灭菌后生物碱含量平均下降0.15 mg/mL,占总量的2.8%。pH值对博落回口服液生产过程中质量稳定性影响较大,研究表明,口服液的pH值在4-6时生物碱含量高较稳定。在八种常用口服液的附加剂中以硫代硫酸钠、亚硫酸钠、偏重亚硫酸钠对博落回生物碱的稳定性影响较大,可使生物碱含量降低0.67-0.37mg/100mL。

Abstract:

Macleaya cordata oral liquid has the advantages of simple production process, low production cost, convenient administration, and large amount of human and material resources saving. It is especially suitable for large-scale breeding, prevention and control of drugs. It is a new veterinary drug preparation worthy of research and development.alkaloids are the most abundant and main active components in boluohui oral liquid, which directly affect the quality and stability of the oral liquid. The results showed that different extraction technology had great influence on the quality and stability of the total alkaloids from Macleaya. The order of extraction rate was acid ethanol extraction > ethanol extraction > acid water extraction > boiling water extraction.Among the seven extractions with different ethanol concentrations, the extraction rate of alkaloids from Macleamia cordata was high with 80%-90% ethanol, all above 90%.good effect and stable quality.