复方柴胡解郁片的制备工艺及质量标准研究
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摘要
抑郁症是一种以极度绝望和无助为主要特征的精神疾病。抑郁症发病机理复杂,临床症候多样。现有西药由于抗抑郁谱窄,疗效有限且毒副作用大、价格较高,在临床应用上有诸多局限性,而中医药治疗抑郁立足于整体调节,是通过多途径、多靶点、多层次来实现的。因而,在中医药理论的指导下,运用现代科学研究方法,开发研制高效低毒的抗抑郁中药新制剂,是中医药工作者需不断探索的课题。
复方柴胡解郁片是在传统方剂基础上结合临床研究和现代科学研究成果而开发的新型中药复方,初步的药效学研究显示该复方具有抗抑郁作用,本文研究了其制备工艺和质量标准。
根据药材中与本适应症相关的有效成分的理化性质,采用正交设计法确定了各味药的提取工艺,如红花水浸提、柴胡等药材醇提、当归、白术挥发油水蒸气蒸馏提取工艺等;采用TLC、GC、DSC几种不同的分析方法对当归、白术挥发油的包合物进行了表征,证明包合前后挥发油性质未发生改变,且具有良好的稳定性,并利用GC-MS对挥发油进行了初步的成分分析;设计和筛选适宜的处方完成了复方柴胡解郁片的成型工艺。
为提高药材质量标准,加强药材的质量控制,建立了柴胡药材中柴胡皂苷a含量测定的HPLC方法。
建立了复方柴胡解郁片的质量标准。以柴胡皂苷a为指标建立了制剂含量测定的HPLC方法,并对制剂中的柴胡、白术、红花等药材进行TLC鉴别。
Depression,a mental illness marked by a feeling of extreme sadness and hopelessness,has complicated pathogenesis and diverse clinical symptoms .The existing western medicines are limited in applications due to their narrow spectrum of antidepressant,lower clinical efficacy and higher price together with serious side effects .However, depression treated by traditional Chinese medicine is based on the overall adjustment and through a lot of channels, targeted spots and levels.On the basis of the traditional theories, traditional Chinese medicine (TCM) has played more and more important role in treating depression. Guided by TCM’s theories, combining with contemporary theories, developing new Chinese herbal preparations with higher effects and lower side effects is a new project for chinese medical workers.
According to traditional Chinese Prescription and combined with clinical research and modern scientific research results Compound Chaihujieyu Tablet was created to treat depression. Preliminary studies show the antidepressant efficacy of the compound . In this paper ,preparation process and quality standard for Compound Chaihujieyu Tablet was studied.
A suitable preparation process line according to the physical and chemical properties of the effective ingredients in the herbs was selected. We made an orthogonal design of extraction technology for each herb in the compound,such as water extraction process of Carthamus tinctorius L.; the alcohol extraction process of Bupleurum chinese DC.(and other herbs). distillation extraction technology of the volatile oil from Angelica and Baizhu; the process of volatile oil-β-CD inclusion preparation, and so on; characterization of the volatile oil inclusion complex was researched through several methods, such as TLC, GC, DSC .which proved that the nature of volatile oil had not changed after being included,and GC results indicated the favorable stability of the inclusion complex;In addition,chemical composition was preliminarily analyzed by GC-MS;appropriate prescription was designed and chosen.
To strengthen the quality control of herbs, we drafted the standard of Bupleurum chinense DC. The HPLC method was established to make quantitative analysis of saikosaponina a.
Quality standard of“Compound Chaihujieyu Tablet”was studied. We chose saikosaponina a. as the index and established HPLC methodology to control the quality of preparation. The Bupleurum chinense DC., Carthamus tinctorius L. and Atractylodes macrocephala Koidz were identified with TLC.
复方柴胡解郁片是在传统方剂基础上结合临床研究和现代科学研究成果而开发的新型中药复方,初步的药效学研究显示该复方具有抗抑郁作用,本文研究了其制备工艺和质量标准。
根据药材中与本适应症相关的有效成分的理化性质,采用正交设计法确定了各味药的提取工艺,如红花水浸提、柴胡等药材醇提、当归、白术挥发油水蒸气蒸馏提取工艺等;采用TLC、GC、DSC几种不同的分析方法对当归、白术挥发油的包合物进行了表征,证明包合前后挥发油性质未发生改变,且具有良好的稳定性,并利用GC-MS对挥发油进行了初步的成分分析;设计和筛选适宜的处方完成了复方柴胡解郁片的成型工艺。
为提高药材质量标准,加强药材的质量控制,建立了柴胡药材中柴胡皂苷a含量测定的HPLC方法。
建立了复方柴胡解郁片的质量标准。以柴胡皂苷a为指标建立了制剂含量测定的HPLC方法,并对制剂中的柴胡、白术、红花等药材进行TLC鉴别。
Depression,a mental illness marked by a feeling of extreme sadness and hopelessness,has complicated pathogenesis and diverse clinical symptoms .The existing western medicines are limited in applications due to their narrow spectrum of antidepressant,lower clinical efficacy and higher price together with serious side effects .However, depression treated by traditional Chinese medicine is based on the overall adjustment and through a lot of channels, targeted spots and levels.On the basis of the traditional theories, traditional Chinese medicine (TCM) has played more and more important role in treating depression. Guided by TCM’s theories, combining with contemporary theories, developing new Chinese herbal preparations with higher effects and lower side effects is a new project for chinese medical workers.
According to traditional Chinese Prescription and combined with clinical research and modern scientific research results Compound Chaihujieyu Tablet was created to treat depression. Preliminary studies show the antidepressant efficacy of the compound . In this paper ,preparation process and quality standard for Compound Chaihujieyu Tablet was studied.
A suitable preparation process line according to the physical and chemical properties of the effective ingredients in the herbs was selected. We made an orthogonal design of extraction technology for each herb in the compound,such as water extraction process of Carthamus tinctorius L.; the alcohol extraction process of Bupleurum chinese DC.(and other herbs). distillation extraction technology of the volatile oil from Angelica and Baizhu; the process of volatile oil-β-CD inclusion preparation, and so on; characterization of the volatile oil inclusion complex was researched through several methods, such as TLC, GC, DSC .which proved that the nature of volatile oil had not changed after being included,and GC results indicated the favorable stability of the inclusion complex;In addition,chemical composition was preliminarily analyzed by GC-MS;appropriate prescription was designed and chosen.
To strengthen the quality control of herbs, we drafted the standard of Bupleurum chinense DC. The HPLC method was established to make quantitative analysis of saikosaponina a.
Quality standard of“Compound Chaihujieyu Tablet”was studied. We chose saikosaponina a. as the index and established HPLC methodology to control the quality of preparation. The Bupleurum chinense DC., Carthamus tinctorius L. and Atractylodes macrocephala Koidz were identified with TLC.
引文
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