【作者】 李博萍；

【导师】 张军；

【作者基本信息】 广州中医药大学 ， 中药学， 2008， 硕士

【摘要】 目的急性咽炎含片组方来源于多年喉科临床经验专家的经验方,具有清热解毒,化痰利咽,滋阴润燥,生津散结之功,在临床上证明对急性咽炎具良好的疗效。本研究拟用现代提取工艺和先进的制剂工艺将其制成口含片,使药物在局部发挥最大限度的作用,以便有效地缓解病痛。本论文重点开展复方提取工艺、稳定性及质量标准方面的研究,为后期的新药申报奠定基础。方法急性咽炎含片处方由金银花、桔梗、射干、山豆根、金果榄、锦灯笼、冰片、薄荷脑等药味组成,本论文在文献研究和预实验的基础上,确定采用乙醇回流提取工艺,实验中以金果榄中的盐酸巴马汀、射干中的鸢尾苷平均提取率为指标,采用正交试验方法,综合考察醇提工艺的醇浓度、提取时间、溶媒用量等因素对复方提取的影响。以盐酸巴马汀、鸢尾苷含量为指标,考察醇提药液在65℃水浴中温孵5小时,药液中盐酸巴马汀、鸢尾苷成分的稳定性,籍此模拟药液在减压浓缩条件下的稳定性。制剂质量标准研究方面,以制剂中君药金银花所含的绿原酸为指标,建立含量测定项,结合方中其它药材的薄层色谱鉴别共同作为制剂质量控制的方法。结果依据正交试验结果并结合生产实际,优选确定复方提取工艺如下:金银花药材以金银花提取物代替;桔梗、金果榄、射干、山豆根、锦灯笼等五味以8倍量60%乙醇回流提取三次,每次1小时,滤过,合并提取液,即得。结果显示,在此工艺条件下,药液中盐酸巴马汀、鸢尾苷的保留率均可达90%左右。稳定性研究结果显示,在上述实验条件下,指标成分基本稳定。提取液可减压(70℃～80℃,-0.08MPa)回收乙醇、浓缩至相对密度1.08～1.10(80℃),进而干燥、制粒、压片。质量标准研究方面,建立了制剂中金银花提取物、桔梗、射干、金果榄、山豆根、冰片、薄荷脑等药味的TLC鉴别方法;采用高效液相色谱法,建立了制剂中绿原酸的HPLC含量测定方法:以十八烷基硅烷键合硅胶为固定相;乙腈-0.4%磷酸(13∶87)为流动相,流速为1.0ml/min,柱温30℃。结论剂型改进的关键是能否最大限度地提取出原方中药材的有效成分及制定行之有效的质量标准。本研究采用正交试验来优化提取工艺,并用TLC和高效液相色谱法鉴别和检测药材成分,方法切实可行。更多还原

【Abstract】 With the function of heat-clearing and detoxicating,dissipating phlegm and relieving sore-throat,promoting the production of body fluid and eliminating stagnation,the prescription of Jixing Yanyan buccal tablet comes from a laryngology clinical expert’s experiment.Its effect is reliable and clear.We will apply modern extracting method and advanced compound preparation artwork to make it into buccal tablet for using efficiently.The prescription of Jixing Yanyan buccal tablet was composed by Flos Lonicerae Japonicae,Radix Platycodonis,Rhizoma Belamcandae,Radix et Rhizoma Sophorae Tonkinensis,etc.Based on the investigation of literature and the pre-experiment,we adopt ethanol recirculation to extract the medicines.We made component palmatine and tectoridin as the index,applied orthogonal experiment in the best artwork research of complex prescription extracting.According to the results of orthogonal experiment and industrial actuality, the best extrace artwork was as follows:Flos Lonicerae Japonicae replaced by extractive which could bought in market,Radix Platycodonis etc extracted by 60%EtOH 3 times,each time 1 hour.Under this condition,the reservation rate of component palmatine and tectoridin contained in extract solution can be 90%.Then,we studied the stability of extract solution by put them into 65℃waterbath 5 hours,and then investigated the quantity of component palmatine and tectoridin.The results of stability study shows that,the index components were steady.On quality standard study,we founded HPLC quantity determination method of caffeotannic acid contained in Flos Lonicerae Japonicae,and TLC identified methods for others.We founded TLC identified methods of Radix Platycodonis, Rhizoma Belamcandae,Radix et Rhizoma Sophorae Tonkinensis,etc,and HPLC quantity assay method of caffeotannic acid:used Octadecylsilane chemically bonded silica as fixed phase,acetonitrile-0.4%H₃PO₄ solution（13:87）as mobile phase,the flow rate is 1.0ml/min,column temperature is 30℃.The key to success in dosage improvement is based on technological processes and quality standard.The atricle proves the Ji-xing-yan-yan buccal tablet is well done.更多还原