鼻窦净还原颗粒的研制
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摘要
目的:研究治疗慢性鼻窦炎的中药制剂鼻窦净还原颗粒的研制方案。方法:采用正交实验设计,以挥发油提取率为指标,对川芎、细辛、辛夷、白芷、野菊花、当归、苍耳子七味药的水蒸汽蒸馏的最佳提取条件进行了筛选,同时确定了挥发油的β-环糊精包结的最适条件;以丹参酮ⅡA和正丁醇部位干浸膏为指标,优选败酱草、桔梗、丹参、皂角刺、薏苡仁药材的醇提工艺;以黄芩苷为指标,优选了黄芩、黄芪的水提取工艺;以其成型性、溶化性、颗粒口感为考察指标,筛选出制粒的最佳辅料及配比。本制剂质量标准的研究中,采用高效液相色谱法对黄芩苷进行了定量控制,并对黄芩、丹参、黄芪作了定性鉴别。同时进行了6个月的加速试验考察。结果:挥发油提取工艺为加8倍量水,浸泡2h,蒸馏提取6h,所提取的挥发油加入10倍量β-环糊精,40℃搅拌1h进行包合;醇提工艺采用8倍量90%乙醇回流提取1h,再用8倍量70%乙醇回流1h;水提取工艺为加水10倍,煎煮3次,每次1h。优选出糊精和微晶纤维素为最佳辅料,干浸膏:糊精:微晶纤维素=1:1:0.2,80%乙醇为润湿剂制粒。黄芩苷含量测定平均回收率为96.4%,RSB=1.66%。结论:工艺及质量控制方法简便可行,稳定可靠。
Objective: A scientific researching proposal to develop a new traditional Chinese Medicine dosage form—Bi Doujing Reduced Granule, which is used to cure chronic nasoinusitis. Methods: Orthogonal Design is adopted to optimize the best conditions of the weater extraction from such materials as Ligusticum Chuanxiong Hort、Asarum sieboldii Miq、Magnolia biondii Pamp、Angelica dahurica Benth et Hook f、Chrysanthemum indicum L、Angelica sinensis(oliv)Diels、Xanthium sibiricum Patr in terms of the volatile oil extraction ratio, and at the same time the optimal parameter of including volatile oil with ?-cyclodextrin (?-CD) is determined.The technological process of the ethanol extraction from the materials such as P.villosa (Thunb.) Juss, Platycodongrandiflorum, Radix Puerariae, Salvia rniltiorrhiza Bge, Gleditsiasinensis Lam according to the content of Platycodon grandiflorum(Jacq )A.DC, Salvia miltiorrhiza BgeKetone-IIA and Dry extract.of n-BuOH content and the optimized weater extraction from Scutellaria baicalensis Georgi A.membranaceus(Fisch) Bge according to the content of baicalin are also obtained through the orthogonal design. The proper excipient and its ratio in the whole Granule are optimized in terms of its formation, solution and taste.The quality control of Baicalin and Salvia rnilti-orrhiza Bgeketone IIA in the Granule is carried out according to high efficiency liquid chromatography, and the ingredients of Scutellaria baicalensis Georgi Platycodongrandiflorum Ligusticum Chuanxiong Hort Salvia rnilti-orrhiza Bge are all TLC-appraised.Result: Tthe extract process parameters of volatile oil is with 8 times water, soaked for 2 hours and extracted for 6 hours in the steam, the optimal parameter of including volatile oil is with ?-cyclodextrin at the ratio of 10:1, mixed for one hour at 40℃; the ethanol extract technological process is carried out with eight times of 90% ethonol for one hour and with eight times of 70% ethanol for one hour; the weater extract process is boiled three times with 8 times of water and each time for one hour. The excipient is common cyclodextrin and minor fibrin at the ratio of 1:1:0.2, and 80% ethanol is taken as moisture. The average content retrieving ratio of Baicalin is 96.4 % , RSB=1.66%.Conclusion: The technological process and quality control are easy and practical. This granule is of highly reliable quality.
Objective: A scientific researching proposal to develop a new traditional Chinese Medicine dosage form—Bi Doujing Reduced Granule, which is used to cure chronic nasoinusitis. Methods: Orthogonal Design is adopted to optimize the best conditions of the weater extraction from such materials as Ligusticum Chuanxiong Hort、Asarum sieboldii Miq、Magnolia biondii Pamp、Angelica dahurica Benth et Hook f、Chrysanthemum indicum L、Angelica sinensis(oliv)Diels、Xanthium sibiricum Patr in terms of the volatile oil extraction ratio, and at the same time the optimal parameter of including volatile oil with ?-cyclodextrin (?-CD) is determined.The technological process of the ethanol extraction from the materials such as P.villosa (Thunb.) Juss, Platycodongrandiflorum, Radix Puerariae, Salvia rniltiorrhiza Bge, Gleditsiasinensis Lam according to the content of Platycodon grandiflorum(Jacq )A.DC, Salvia miltiorrhiza BgeKetone-IIA and Dry extract.of n-BuOH content and the optimized weater extraction from Scutellaria baicalensis Georgi A.membranaceus(Fisch) Bge according to the content of baicalin are also obtained through the orthogonal design. The proper excipient and its ratio in the whole Granule are optimized in terms of its formation, solution and taste.The quality control of Baicalin and Salvia rnilti-orrhiza Bgeketone IIA in the Granule is carried out according to high efficiency liquid chromatography, and the ingredients of Scutellaria baicalensis Georgi Platycodongrandiflorum Ligusticum Chuanxiong Hort Salvia rnilti-orrhiza Bge are all TLC-appraised.Result: Tthe extract process parameters of volatile oil is with 8 times water, soaked for 2 hours and extracted for 6 hours in the steam, the optimal parameter of including volatile oil is with ?-cyclodextrin at the ratio of 10:1, mixed for one hour at 40℃; the ethanol extract technological process is carried out with eight times of 90% ethonol for one hour and with eight times of 70% ethanol for one hour; the weater extract process is boiled three times with 8 times of water and each time for one hour. The excipient is common cyclodextrin and minor fibrin at the ratio of 1:1:0.2, and 80% ethanol is taken as moisture. The average content retrieving ratio of Baicalin is 96.4 % , RSB=1.66%.Conclusion: The technological process and quality control are easy and practical. This granule is of highly reliable quality.
引文
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[2]许凤山,刘忠钰,张玉亮.荔花鼻窦炎片治疗鼻窦炎30例临床观察[J].湖南中医学院学报,2002;22(4):56.
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[4]徐轩.补中益气汤加减在耳鼻喉科的应用[J].南京中医药大学学报,1998; (4):238.
[5]杜凤礼.从血瘀辨治鼻窦炎86例临床观察[J].中国中西医结合耳鼻咽喉科杂志,2001;9(6):299.
[6]魏能润.耳鼻咽喉科学[M],北京:人民卫生出版社,1988,66～68.
[7]张箭,王红燕.黄芩CO2超临界萃取物的化学成分进行研究.中国药学杂质,2003;38(6):471.
[8]夏元初.50种中药的微量元素含量测定.现代应用药学,1987;4(2):17.
[9]郑虎占,董泽宏等.中药现代研究与应用,北京:学苑出版社,1998,3943～3970.
[10]徐光,张礼萍.野黄芩甙元及其类似物对蛋白激酶C的抑制作用.上海医科大学学报,1993;20(3):187～191.
[11]潘菊芬,符磊.甘草对黄芩免疫调节作用的观察.天津医药,1991;19(8): 468～470.
[12]郑虎占,董泽宏.中药现代研究与应用.北京:学苑出版社,1998,3943～3970.
[13]杨奎,张德波.黄芩血清及黄芩苷影响内生致热源产生的研究.中药药理与研究,1994;10(11):13～14.
[14]杨得明.败酱草善治神经衰弱.中医杂质,2002;43(12):892.
[15]胡家石,吴咸中,鲁换章.内镜鼻胆管引流-清解灵治疗急性重型胆管炎的临床观察.中西医结合杂质,1989;9(3):144.
[16]国家药典委员会.中国药典(一部)2000年版,北京:化学工业出版社,2005:196.
[17]陈锋.活血化瘀法治疗心病用药探析[J].辽宁中医杂志,1994;21(2):59～60.
[18]康天瑞.复方皂刺煎剂加压喷雾治疗重症痤疮51例临床观察[J].甘肃中医,2001;14(4):79～80.
[19]张唐颂,郭卫.天丁颗粒治疗急性阑尾炎83例临床观察[J].中药材,2004;27(6): 465～465.
[20]蔡柏,张唐颂,陈倩,等.皂针颗粒治疗阑尾炎108例[J].中国医学理论与实践,2004;14(4):501～502.
[21]玉英,郭卫,张唐颂,等.天丁颗粒治疗慢性结肠炎98例[J].现代医药卫生,2005;21(16):2190～2190.
[22]王占彬,郭鲜敏,杨兰香,等.皂角刺提取物对肉仔鸡免疫功能的影响[J].养禽与禽病防治,2005;10(12):16～18.
[23] KenYasukawa;TomohiroKaminana;SusumuKiLanaka;etal.3?～Phydroxyhenzo yldehydrolumulosicacidfromPoriacornsanditsantiinflammatorvyeflect.Phytochemistry.1998;48(8):1357～1360.
[24]兆金,刘浚.茯苓有效成分三帖的研究进展.中成药.2001;23(1):58～62.
[25] Cuellar.M.Jesus; Giner.Roses,M;Carmen,etal.Two fungal lanostane derivatives as Phospholipase A2 in-Journalor. Journal of Natural Products,1996,59(10):977～979.
[26]王浴生主编.中医药理与应用,北京:人民卫生出版社,1983,508.
[27]陈炳铜.330种中药对常见化脓菌和肠道致病菌的抗菌作用.中华医药杂质,1964;50(8):524.
[28]孙远.中药对某些致病性皮肤癣菌抗菌作用的研究.中华皮肤科杂质,1985; 6(3):210.
[29]宋振玉.苍耳子的有毒成分及其药理作用.药学学报,1962;9(11):678.
[30]洪翠英,钱立群.细辛挥发油抑制大鼠棉球肉芽肿形成与血清锌、铜含量的关系.中国中药杂质,1992;17(4):236.
[31]韩双红.两种辛夷药理作用的比较.中药材,1990;13(9):33.
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