复方液化颗粒的药学研究
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摘要
慢性前列腺炎(chronic prostatitis,CP)是男性泌尿生殖系统的常见疾病。目前认为,前列腺炎不是一个独立的疾病,是具有多种临床症状表现的综合征,其症状包括尿道刺激症、盆底神经丛刺激症、精神症状等。同时,由于前列腺是男性特有的生殖腺体,发生炎症时,必将对男性生殖健康产生影响,如性功能减退或障碍、其他附属性腺的感染,生育能力下降甚至导致男性不育。近年来C P日益受到医学界的重视,临床治疗研究取得了一定的成绩。中医药治疗慢性前列腺炎有明显的特色和优势,其疗效已得到国内男科学界的认同,尤其是慢性或反复发作的前列腺炎,显示出中医药自身的优势和潜力。
液化汤是同济医院临床应用达二十多年的协定处方。临床疗效显著,先后在妇产科生殖中心、泌尿科外和中医科应用多年。本研究将复方液化汤制成复方液化颗粒,研究复方液化颗粒最佳制备工艺,拟订复方液化颗粒的质量标准,并且对该颗粒进行初步药效学考察,为今后的新药研究提供实验依据。具体研究如下:
(一)提取及精制工艺研究
分别以黄柏中的盐酸小檗碱含量、丹参中的丹参酮ⅡA含量以及水提液浸膏得率为考察指标,采用正交设计,对复方液化颗粒的醇提工艺和水提工艺进行了考察,并且对水提液进行了精制,确定了复方液化颗粒的提取以及精制的最佳工艺。
(二)制备工艺研究
采用星点设计,对颗粒剂辅料用量和润湿剂的浓度进行考察,确定制剂的最优成型工艺。
(三)质量标准研究
采用TLC法对制剂中黄柏、丹参、枸杞子进行了鉴别;结果表明薄层色谱斑点清晰,阴性无干扰,适用于复方液化颗粒的定性鉴别。
采用HPLC法测定复方液化颗粒中盐酸小檗碱的含量,结果表明,HPLC的精密度、重复性、线性以及加样回收率良好,可用于盐酸小檗碱的含量测定。并且制定了含量限度,规定每袋复方液化颗粒含盐酸小檗碱不得少于9.43mg。
(四)药效学初步研究
本实验研究通过用二甲苯所致小鼠耳廓肿胀和大鼠棉球肉芽肿形成实验,观察复方液化颗粒对急、慢性炎症的抗炎作用。结果表明,复方液化颗粒对小鼠二甲苯的致炎作用有显著性减轻作用,对小鼠棉球肉芽肿形成有明显的抑制作用。复方液化颗粒具有明显抗炎作用,提示该药对慢性前列腺炎有较好的治疗效果。
研究结果表明:复方液化颗粒的工艺及质量控制方法切实可行,稳定可靠,药效学实验为临床提供了理论基础。
Chronic prostatitis is a common diseases of urogenital system. Prostatitis is a syndrome with a variety of clinical symptoms. The symptoms including Stimulate urethral syndrome, Plexus to stimulate the pelvic floor disorders and Psychiatric symptoms. It is a male gonad-specific body which is bound to have an impact on male reproductive health, such as sexual dysfunction or obstacles, other subsidiary gland infection, decreased fertility and even cause male infertility. CP have been concerned to the medical profession, clinical research of CP has made some achievements in recent years. Chinese herbs medicine treatment of chronic prostatitis has the following features and advantages. Chinese herbs medicine treatment to CP has been earned domestic agreement with the scientific community. Besides, the treatment shows the advantages and the potential, especially in the treatment to chronic prostatitis and recurrent prostatitis.
YeHua decoction is the agreement prescription of Tongji Hospital which have been used for more than twenty yearss. It have a significant clinical efficacy, which have used in reproductive center obstetrics and gynecology, urology for many years. In this study, YeHua decoction is made into Granula. The best preparation and the quality of preparation of YeHua Granula were studied. The quality standards and preliminary study in pharmacodynamics of YeHua Granula were developed,which for future research to provide experimental datas for new drugs development. Specific studies are as follows:
(A) Extraction and Refining Technology
Berberine in Phellodendron, content of Tanshinone SalviaeⅡA and water extract content are chosed to be extract yield indicators, and the YeHua Granula ethanolic liquefaction processes and refined water extract are studied by the use of orthogonal design. Finally the best extraction process of YeHua Granula was identified.
(B) Formulation of Yehua Granules Technology
The amount of accessories and the concentration of wetting agent are studied by the use of Central Composite Design/Response Surface Methodology to optimal formulations Process.
(C) Quality Control
Phellodendron, Salvia, Lycium was identified by Thin-Lay Chromatography(TLC) method. The results show that the TLC spots are clear and negative non-interference, applicable to the characterization of Yehua Granules.
The concentration of Berberine in Yehua Granules is determined by High Performance Liquid Chromatography(HPLC) method. The results show that the precision, repeatability, linearity, and good recovery rate, can be used for the determination of concentration of berberine.
(D) The initial efficacy study
Xylene and cotton ball were employed to investigate the anti-inflammatory effect of the granules on inflammation of the auricles of mice and chronic inflammation of mice.yehua granules could inhibit the swelling of the mice auricle induced by xylene and suppress the granuloma formation of mice caused by cotton bal1.There was a marked difference between the therapeutic group and the control group.The results show that, the drug has a good therapeutic effect and possesses significant anti—inflammatory effects,thus has potentialfor treatment of chronic prostatitis in humans.
The results showed that: technology and quality control method of yehua granules is feasible, stable and reliable. The test for clinical pharmacodynamics provides a theoretical basis.
液化汤是同济医院临床应用达二十多年的协定处方。临床疗效显著,先后在妇产科生殖中心、泌尿科外和中医科应用多年。本研究将复方液化汤制成复方液化颗粒,研究复方液化颗粒最佳制备工艺,拟订复方液化颗粒的质量标准,并且对该颗粒进行初步药效学考察,为今后的新药研究提供实验依据。具体研究如下:
(一)提取及精制工艺研究
分别以黄柏中的盐酸小檗碱含量、丹参中的丹参酮ⅡA含量以及水提液浸膏得率为考察指标,采用正交设计,对复方液化颗粒的醇提工艺和水提工艺进行了考察,并且对水提液进行了精制,确定了复方液化颗粒的提取以及精制的最佳工艺。
(二)制备工艺研究
采用星点设计,对颗粒剂辅料用量和润湿剂的浓度进行考察,确定制剂的最优成型工艺。
(三)质量标准研究
采用TLC法对制剂中黄柏、丹参、枸杞子进行了鉴别;结果表明薄层色谱斑点清晰,阴性无干扰,适用于复方液化颗粒的定性鉴别。
采用HPLC法测定复方液化颗粒中盐酸小檗碱的含量,结果表明,HPLC的精密度、重复性、线性以及加样回收率良好,可用于盐酸小檗碱的含量测定。并且制定了含量限度,规定每袋复方液化颗粒含盐酸小檗碱不得少于9.43mg。
(四)药效学初步研究
本实验研究通过用二甲苯所致小鼠耳廓肿胀和大鼠棉球肉芽肿形成实验,观察复方液化颗粒对急、慢性炎症的抗炎作用。结果表明,复方液化颗粒对小鼠二甲苯的致炎作用有显著性减轻作用,对小鼠棉球肉芽肿形成有明显的抑制作用。复方液化颗粒具有明显抗炎作用,提示该药对慢性前列腺炎有较好的治疗效果。
研究结果表明:复方液化颗粒的工艺及质量控制方法切实可行,稳定可靠,药效学实验为临床提供了理论基础。
Chronic prostatitis is a common diseases of urogenital system. Prostatitis is a syndrome with a variety of clinical symptoms. The symptoms including Stimulate urethral syndrome, Plexus to stimulate the pelvic floor disorders and Psychiatric symptoms. It is a male gonad-specific body which is bound to have an impact on male reproductive health, such as sexual dysfunction or obstacles, other subsidiary gland infection, decreased fertility and even cause male infertility. CP have been concerned to the medical profession, clinical research of CP has made some achievements in recent years. Chinese herbs medicine treatment of chronic prostatitis has the following features and advantages. Chinese herbs medicine treatment to CP has been earned domestic agreement with the scientific community. Besides, the treatment shows the advantages and the potential, especially in the treatment to chronic prostatitis and recurrent prostatitis.
YeHua decoction is the agreement prescription of Tongji Hospital which have been used for more than twenty yearss. It have a significant clinical efficacy, which have used in reproductive center obstetrics and gynecology, urology for many years. In this study, YeHua decoction is made into Granula. The best preparation and the quality of preparation of YeHua Granula were studied. The quality standards and preliminary study in pharmacodynamics of YeHua Granula were developed,which for future research to provide experimental datas for new drugs development. Specific studies are as follows:
(A) Extraction and Refining Technology
Berberine in Phellodendron, content of Tanshinone SalviaeⅡA and water extract content are chosed to be extract yield indicators, and the YeHua Granula ethanolic liquefaction processes and refined water extract are studied by the use of orthogonal design. Finally the best extraction process of YeHua Granula was identified.
(B) Formulation of Yehua Granules Technology
The amount of accessories and the concentration of wetting agent are studied by the use of Central Composite Design/Response Surface Methodology to optimal formulations Process.
(C) Quality Control
Phellodendron, Salvia, Lycium was identified by Thin-Lay Chromatography(TLC) method. The results show that the TLC spots are clear and negative non-interference, applicable to the characterization of Yehua Granules.
The concentration of Berberine in Yehua Granules is determined by High Performance Liquid Chromatography(HPLC) method. The results show that the precision, repeatability, linearity, and good recovery rate, can be used for the determination of concentration of berberine.
(D) The initial efficacy study
Xylene and cotton ball were employed to investigate the anti-inflammatory effect of the granules on inflammation of the auricles of mice and chronic inflammation of mice.yehua granules could inhibit the swelling of the mice auricle induced by xylene and suppress the granuloma formation of mice caused by cotton bal1.There was a marked difference between the therapeutic group and the control group.The results show that, the drug has a good therapeutic effect and possesses significant anti—inflammatory effects,thus has potentialfor treatment of chronic prostatitis in humans.
The results showed that: technology and quality control method of yehua granules is feasible, stable and reliable. The test for clinical pharmacodynamics provides a theoretical basis.
引文
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