黄连解毒颗粒制备工艺的改进及质量控制研究
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摘要
黄连解毒颗粒是由黄连、黄柏、黄芩、栀子四味药味药组成的一种中草药制剂的新剂型,具有清热,解毒,消炎之功效。用于上呼吸道感染,急慢性扁桃体炎,急慢性咽喉炎等症。本研究以传统中医药理论为指导原则,运用现代制药技术,对该复方制剂中主要原药材的提取工艺、制剂的质量控制进行了系统的实验研究。
根据临床用药的需要,结合处方用药的性质,确定剂型为颗粒剂。根据处方的功能主治及药物所含成分的理化性质,采用正交实验方法,以多指标综合评分筛选最佳制备工艺。醇提的最佳工艺为：用14倍量40%的乙醇溶液在80℃下煎煮3次,每次2h。
对复方黄连颗粒的质量控制进行了研究。以HPLC法测定该方君药黄连所含主要有效成分小檗碱的含量,并建立了相应的测定方法和含量限度。同时在质量标准可控的基础上对该制剂进行了稳定性研究。试验结果表明,定性定量方法简便,灵敏,准确、精密,可作为该剂质量控制标准。
Huanglian-jiedu granules is a new kind of Chinese herbal medicine formulation, which consists of coptis(huanglian), cork(huangbo), Scutellaria(huangqin) and gardenia(zhizi). It has the function of clearing heat, relieving toxicity and diminishing inflammations. Therefore It can be used to cure a series of diseases such as upper respiratory tract infection, acute and chronic tonsillitis, throat swelling and ache. Under the guidance of theories of traditional chinese herbal medicines, it was studied systematically on the extraction process and quality control of Huanglian-jiedu granules with modern pharmaceutical technology.
Meeting the demands of clinic, taking the nature of its compositent medicines in the formula into account, the form of formula was decided as granules. According to the indicational functions and the physical and chemical properties of the compouds in the compositent medicines of the formila, orthogonal design test method was adopted to select the best preparation process by multi-index comprehensive evaluation. The best alcohol-extraction process is, decocting thrice under 80℃with 15 times of 40% ethanol solution,2 hours per time.
The methods of quality control were studied and the quality standards of the material medicine and the product were estamblished. By determining the content of berberine which is the main effective ingredient of coptis with HPLC, the corresponding methods of determining content was built and the limits of content were determined. Meanwhile studies on stability were undertook. The results showed that the foregoing method was a simple, sensitive, accurate and precise method which can be used as the quality control standard of the product.
根据临床用药的需要,结合处方用药的性质,确定剂型为颗粒剂。根据处方的功能主治及药物所含成分的理化性质,采用正交实验方法,以多指标综合评分筛选最佳制备工艺。醇提的最佳工艺为：用14倍量40%的乙醇溶液在80℃下煎煮3次,每次2h。
对复方黄连颗粒的质量控制进行了研究。以HPLC法测定该方君药黄连所含主要有效成分小檗碱的含量,并建立了相应的测定方法和含量限度。同时在质量标准可控的基础上对该制剂进行了稳定性研究。试验结果表明,定性定量方法简便,灵敏,准确、精密,可作为该剂质量控制标准。
Huanglian-jiedu granules is a new kind of Chinese herbal medicine formulation, which consists of coptis(huanglian), cork(huangbo), Scutellaria(huangqin) and gardenia(zhizi). It has the function of clearing heat, relieving toxicity and diminishing inflammations. Therefore It can be used to cure a series of diseases such as upper respiratory tract infection, acute and chronic tonsillitis, throat swelling and ache. Under the guidance of theories of traditional chinese herbal medicines, it was studied systematically on the extraction process and quality control of Huanglian-jiedu granules with modern pharmaceutical technology.
Meeting the demands of clinic, taking the nature of its compositent medicines in the formula into account, the form of formula was decided as granules. According to the indicational functions and the physical and chemical properties of the compouds in the compositent medicines of the formila, orthogonal design test method was adopted to select the best preparation process by multi-index comprehensive evaluation. The best alcohol-extraction process is, decocting thrice under 80℃with 15 times of 40% ethanol solution,2 hours per time.
The methods of quality control were studied and the quality standards of the material medicine and the product were estamblished. By determining the content of berberine which is the main effective ingredient of coptis with HPLC, the corresponding methods of determining content was built and the limits of content were determined. Meanwhile studies on stability were undertook. The results showed that the foregoing method was a simple, sensitive, accurate and precise method which can be used as the quality control standard of the product.
引文
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[6]张月星.观赏鱼真菌性疾病和寄生虫病的中草药治疗[J].水产科技情报,2002,29(4)：187-188.
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[8]孙克年.中草药在水产养殖业中的应用[J].饲料博览,2002(2)：37-38.
[9]许星鸿.中草药在水产养殖业中的应用[J].饲料世界,2001(12)：31.
[10]白元良,王洪鹏,魏祥法等.中草药与绿色家禽业[J].山东家禽,2002(8)：39-42.
[11]应赘,何志红,周世文,汤建林,黄永平,杨雪.正交试验优化提取黄连中小聚碱型生物碱[J].中国药房,2007,18(9)：270-272.
[12]欧阳淑,正交试验法对提取小璧碱工艺条件的考察[J].卫生职业教育,2005,23(10)：91-92；
[13]Dai K, Miki K, Fukuoka T, et al. Suppression of neuropePtides'mRNA expression by herbal medicine in a rat model of peripheral inflammation[J]. Life Sci,2000, 66(1):19-29.
[14]Lin SC, Lin CC, Lu FJ, et al. Protective and therapeutic effects of huanglian-jie-du-tang on hepatotoxin-induced liver injuries[J]. Am J Chin Med, 1996,24(3):219-229.
[15]曹于平,皋聪,孙继红等.黄连解毒汤提取物的药理作用研究[J].中国药科大学学报,1996,27(10)：605-608.
[16]赵新秀,秦龙建.日本应用黄连解毒汤的特点[J].实用中医内科杂志,1993,7(1)：35-40.
[17]向海艳,周春山,雷启福,等.大孔吸附树脂法分离纯化虎杖白黎芦醇营的研究[J].中国药学杂志,2005,42(2)：96-99.
[18]张泉鑫,张克家.黄连解毒汤—清热解毒基础方[J].中兽医学志,1998(3)：36-37.
[19]丛凤英.黄连素注射液对大鼠血清溶菌酶含量的影响[J].第二军医大学学报,2002(23)：910.
[20]于震,王军,周红艳,等.黄连素注射液粉针剂抑菌、清热实验研究[J].中医研究,2000,13(2)：28
[21]刘建,彭东信,刘晓晴,等.黄连素注射液粉针剂对肺炎支原体感染大鼠肺组织中碱性成纤维细胞生长因子蛋白质水平表达的影响[J].成都中医药大学学报,2001,24(3)：22
[22]刘建,彭东信,刘晓晴,等.黄连素注射液对肺炎支原体感染大鼠肺组织中PDGF-BB影响的免疫组织学研究[J].浙江中医学院学报,2001,25(3)：55.
[23]吴迪,张霞,陈宁,等.黄连素注射液对体外腹腔巨噬细胞分泌细胞因子的影响[J].中国中西医结合急救杂志,2000,7(3)：178.
[24]朱社敏,李君安,施存元.黄连素注射液滴丸的主要药效学研究[J].中国现代应用药学杂志,2001,18(2)：120.
[25]张力群,袁万图,张剑,等.黄连素注射液粉针剂对小鼠免疫功能及血管通透性影响[J].中国中医药科技,1995,2(3)：33.
[26]苏荣辉,金武柞.黄皮树果实中的酞胺类化合物[J].植物学报,1994,36(10)：817-820.
[27]Mori H, Fuehigami M,Innue N, et al. Pnneiple of the bark of Phellodendron Amurense to suppress the celluLar immune response[J].plantamed,1994,60(5): 445-449.
[28]Mori H, Fuehigami M,Innue N, et al. Pnneiple of the bark of Phellodendron Amurense to suppress the celluLar immune response[J].plantamed.,1995,60(1): 45-49.
[29]李凡,易世红,赵春艳,等.黄连素注射液粉针剂抗病毒作用[J].中草药,2002,33(1)：52
[30]吕海涛,杨吉成,袁志昌,等.黄连素注射液对aZa-干扰素抗柯萨奇病毒的协 同作用[J].中国中药杂志,2000,25(11)：682
[31]吕海涛,袁志昌,严文华,等.黄连素注射液粉针剂抗柯萨奇病毒B3型效应的实验研究[J].江苏医药杂志,2000,26(8)：595
[32]刘培辉,杨整修,王明丽.黄连素注射液抗柯萨奇B3型病毒感染大鼠原代心肌细胞的效应[J].安徽医科大学学报,2002,37(2)：108
[33]易世红,王放,王丽萍,等.黄连素注射液粉针剂体外抗病毒药效学研究[J].白求恩医科大学学报,2001,27(5)：490
[34]姜庆城,王彦美,陈同刚,等.黄连素注射液注射液在生物体内抗细菌内毒素的效果观察[J].中国医院药学杂志,2002,22(5)：276
[35]Nokamura T, Vrabe H. IndoloPyndoquinazoline, Furoquinoline and Canihimone. Type alkaloids from Phelfodendron amurense[J]. Phytoehemistry.1998,48(2): 285-291.
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