镇咳宁软胶囊的研制
|
摘要
中成药是中华民族宝贵的文化遗产,其疗效历经几千年的验证毋庸置疑。目前,随着社会的发展,科学的进步及生活水平的提高,人们对药品的关心度和需求量不断增加,中医药在治疗、康复、养生等方面的特色和优势也不断得到发挥,中药及天然药物的应用已经受到国内外的普遍重视,并以其特有的疗效和安全性正在逐渐为国际社会所接受。
镇咳宁软胶囊是镇咳宁糖浆改变剂型而研制的新药。本研究确立了镇咳宁软胶囊有效成分的提取方法,选择恰当的赋形剂和适当的胶皮配比,确立压丸的成型工艺。确立采用甘草流浸膏、桔梗、盐酸麻黄碱3味药进行定性薄层鉴别,采用高效液相色谱法测定镇咳宁软胶囊中盐酸麻黄碱的含量,制定含量限度,研究镇咳宁软胶囊稳定性,以确认镇咳宁软胶囊是否符合要求。
鉴于此,本研究在这方面进行了有益的尝试,以镇咳宁软胶囊为研究对象,运用新方法、新技术对其进行工艺改革,剂型优化,并采用现代分析手段进行质量控制,力求探寻中药现代化的可行性思路。
本研究以中医药理论为指导,采用现代技术试验手段,对镇咳宁软胶囊进行二次开发,为中药现代化提供可靠的实验数据,从而为开发出剂型先进、质量可控、科技含量高,有国际竞争力的产品打下坚实的基础。
Proprietary Chinese medicine is a valuable cultural heritage of Chinese. It's no doubt about its efficacy after thousands of years of certification. Currently, with the development of society, scientific progress and improvement of the living standard, the people's concern and demand for drugs are increasing. Chinese medicine has been playing a more and more important role of the characteristics and advantages in the treatment, rehabilitation, health and other aspects. The application of Chinese medicine and natural medicine has been taking the widespread attention by whole world. its unique efficacy and safety are being gradually accepted by the international community.
Zhenkening soft capsules was changed and developed from Zhenkening Syrup as new drugs. This study established the town to cough rather the craft of Zhenkening soft capsules. The fabrication process used to Gancaoliujingao, Jiegeng, Ephedrini Hydrochloridtlm, three ingredients ephedrine hydrochloride the qualitative TLC. Zhenkening soft capsules using HPLC determination of the content of ephedrine hydrochloride capsules, The Zhenkening soft capsules limits of content was to confirm whether it meets the requirement of Zhenkening soft capsules.
The present study, under the guidance of the Traditional Chinese Medicinal (TCM) theory and practice, using modern experiment technology and method, to redevelopment the Zhenkening soft capsules, which provides the reliable experiment datum for the traditional Chinese medicinal modernization, and set up the strong foundation for developing new product with advanced dosage form, quality controllable, the high technology content and owning the international competitive power.
镇咳宁软胶囊是镇咳宁糖浆改变剂型而研制的新药。本研究确立了镇咳宁软胶囊有效成分的提取方法,选择恰当的赋形剂和适当的胶皮配比,确立压丸的成型工艺。确立采用甘草流浸膏、桔梗、盐酸麻黄碱3味药进行定性薄层鉴别,采用高效液相色谱法测定镇咳宁软胶囊中盐酸麻黄碱的含量,制定含量限度,研究镇咳宁软胶囊稳定性,以确认镇咳宁软胶囊是否符合要求。
鉴于此,本研究在这方面进行了有益的尝试,以镇咳宁软胶囊为研究对象,运用新方法、新技术对其进行工艺改革,剂型优化,并采用现代分析手段进行质量控制,力求探寻中药现代化的可行性思路。
本研究以中医药理论为指导,采用现代技术试验手段,对镇咳宁软胶囊进行二次开发,为中药现代化提供可靠的实验数据,从而为开发出剂型先进、质量可控、科技含量高,有国际竞争力的产品打下坚实的基础。
Proprietary Chinese medicine is a valuable cultural heritage of Chinese. It's no doubt about its efficacy after thousands of years of certification. Currently, with the development of society, scientific progress and improvement of the living standard, the people's concern and demand for drugs are increasing. Chinese medicine has been playing a more and more important role of the characteristics and advantages in the treatment, rehabilitation, health and other aspects. The application of Chinese medicine and natural medicine has been taking the widespread attention by whole world. its unique efficacy and safety are being gradually accepted by the international community.
Zhenkening soft capsules was changed and developed from Zhenkening Syrup as new drugs. This study established the town to cough rather the craft of Zhenkening soft capsules. The fabrication process used to Gancaoliujingao, Jiegeng, Ephedrini Hydrochloridtlm, three ingredients ephedrine hydrochloride the qualitative TLC. Zhenkening soft capsules using HPLC determination of the content of ephedrine hydrochloride capsules, The Zhenkening soft capsules limits of content was to confirm whether it meets the requirement of Zhenkening soft capsules.
The present study, under the guidance of the Traditional Chinese Medicinal (TCM) theory and practice, using modern experiment technology and method, to redevelopment the Zhenkening soft capsules, which provides the reliable experiment datum for the traditional Chinese medicinal modernization, and set up the strong foundation for developing new product with advanced dosage form, quality controllable, the high technology content and owning the international competitive power.
引文
1.国家药典委员会.中华人民共和国药典2005版(一部)[s].北京:化学工业版社,2000:654.
2.王北婴,李仪奎主编.中药新药研制开发技术与方法.上海科学技术出版社,2001.
3.钟海利,郑志燕.咳嗽与镇咳药的合理选用.中华今日医学杂志,2003,3(24):35-36.
4.陈海娇.北药甘草的药理学研究进展.吉林农业科技学院学报,2006,15(2).
5.刘振华,梁波,田景奎.桔梗属植物的化学和药理学研究进展.科研,2006,7:59-63.
6.冯冰虹,赵宇红,黄建华.桑白皮的有效成分筛选及其药理学研究.
7.郑萍,戴贵东,李汉青.麻黄碱及伪麻黄碱药理作用研究进展.宁夏医学杂志,2002,24(2):126-127.
8.赵金明,李中平,张艳玲,张丽君.镇咳宁糖浆的药理研究.中医药研究,1999,15(1):32-41.
9.高鸿霞,邵世和,王国庆.中药甘草研究进展.井冈山医专学报,2004,11(5):8-11.
10.慕桂娟.甘草化学成分的研究进展.包头医学,2005,29(2):25-27.
11.陈红.甘草药理作用概述.海峡药学,2005,17(4):37-41.
12.张小荣,王彩艳,何亚农.甘草的药理作用及临床应用近况.社区中医药,2004,20(270).
13.许海琴,等主编.常用天然提取物质量标准参考手册.北京:化学工业出版社,2003.4:19.
14.国家医药管理局中草药情报中心站编.植物药有效成分手册.北京:人民卫生出版社,1986.3:390.
15.汤光,李大奎主编.现代临床药物学.北京:化学工业出版社,2003.1:346-347.
16.Dipalma JR.Basic Pharmacology in Medicine.Mcgraw Hill Book Company,1976:175.
17.Garrett,ER.et al.Drug Fate and Metabolism.Methods and Techniques (Vol3)New York:Marcel Dekker,INC.1979:230-233.
18.刘贺之,龙卿,宋殿坤主编.北京:军事医学科学院出版社,2002:568.
19.宋杨,齐云.桔梗的药理研究进展.中药房,2006,17(2):140-141.
20.毛一亮.桔梗的临床应用.中药天地,2001,10(10):65.
21.吴志平,谈建中,顾振纶.中药桑白皮化学成分及药理活性研究进展.中国野 生植物资源,2004,23(5):10-16.
22.崔颖,屠锡德.国外口服软胶囊的研究.药学进展,2003,27(6):340-345.
23.戴仪.软胶囊剂的概况和工艺.制药技术,1995,9:34-35.
24.彭红英,周晓源,孔红.中药软胶囊制剂研究技术探讨与展望.首都医药,2006,30-31.
25.张亚中,张彤,陶建生.中药软胶囊的研究进展.中成药,2006,28(6):871-874.
26.范碧亭主编.中药药剂学.上海:上海科学技术出版社,2002:502.
27.彭智聪,李芳艳.软胶囊有待解决问题的探讨.中药园地,2004,26(4):50-51.
28.马旭,刘建平等.软胶囊崩解迟缓现象影响因素研究.中国药科大学学报,2003,34(5):414-418.
29.马旭,刘建平等.软胶囊崩解迟缓现象影响因素研究.中国药科大学学报,2003,34(5):414-418.
30.赵远.姜黄渗漉提取工艺研究.云南中医中药杂志,2005,26(6):39-40.
31.生产现场.软胶囊中PEG配方的基本技术.
32.时军,程怡.辅料在软胶囊剂型中的应用.中医药学刊,2003,21(9):1429-1464.
33.齐惠敏,赵晓东,李静.软胶囊剂的工艺研究现状.天津药学,1997,9(4):32-33.
34.贺志宇,张冬平.浅谈中药软胶囊的研制.时珍国药研究,1995,7(1):50-52.
35.柯雪红.HPLC法测定舒金克喘胶囊中盐酸麻黄碱的含量.中国药师,2006,9(8):774-775.
36.Garrett,ER.et al.Drug Fate and Metabolism.Methods and Techniques (Vol3) New York:Marcel Dekker,INC.1979:230-233
37.李向阳,屠万倩.HPLC法测定哮喘宁胶囊中盐酸麻黄碱的含量.中药新药与临床药理,2005,16(5):359-361.
38.Niu CQ,et al.Determination of isoquinoline alkaloids in Chetudomun mayus L.byion-pair high performance liquid chromatography.J Chromatogr 1991:542:198-203.
39.王瑞冬,陈新善,田军,聂渝琼.分光光度法测定复方喷鼻剂中盐酸麻黄碱的含量.解放军药学学报,2002,18(5):310-312.
40.何树芸,陈桂歌.差示分光光度法测定复方呋喃西林滴鼻液中盐酸麻黄碱的含量.陕西中医学院学报,2003,26(5):57-58.
41.茹建华.双波长等吸收分光光度法测定氯麻灌洗液中盐酸麻黄碱的含量.海峡药学,2004,16(1):54-55.
42.程德才,王慧琛.旋光法快速测定盐酸麻黄碱滴鼻液的含量.天津药学,2002, 14(2):67.
43.刘利,胡洪章,曾道元.旋光法测定呋麻液中盐酸麻黄碱的含量.药品检测,2002,11(6):55.
44.郑荣庆,李光秀,贾德武,吴华,曹美云.PH指示剂吸收度比值法测定盐酸麻黄碱含量.山东医药工业,1990,9(3):20-21
45.崔艳萍,刘姗姗,潭新保.导数光谱测定小儿化痰止咳冲剂中吐根碱和盐酸麻黄碱的含量.中成药,1994,16(5):17-18.
46.杨快儿,洪俊荣.酸性染料萃取法测定麦得灵滴眼液中盐酸麻黄碱的含量.汕头大学医学院学报,1995,1:97-98.
47.徐艺立,白鸥.系数倍率法测定麻杏止咳片中盐酸麻黄碱的含量.中成药,1991,13(12):13-14.
48.胡妹英,黄诺嘉.正交函数光谱法测定氟麻嘭鼻液液中盐酸麻黄碱的含量.汕头科技,1998,2:60-62.
49.邵淑梅,于盛茂,李金泉.比色法测定止咳平喘口服液中盐酸麻黄碱的含量.药物分析杂志,2001,21(6):445-446.
50.蒋学华,杨华元,徐维平.毛西管气相色谱法测定制剂中盐酸麻黄碱的含量.华西药学杂志,1990,5(3):158-160.
51.陈恒武,等.流动注射在线固相萃取预富集毛细管区带电泳测定血浆中的伪麻黄碱.高等学校化学学报,1999,11(20):1688-1691.
52.杨汉煜,等。液相色谱-串联质谱法测定人血浆中的伪麻黄碱浓度.沈阳药科大学学报,2001,18(2):116-118.
2.王北婴,李仪奎主编.中药新药研制开发技术与方法.上海科学技术出版社,2001.
3.钟海利,郑志燕.咳嗽与镇咳药的合理选用.中华今日医学杂志,2003,3(24):35-36.
4.陈海娇.北药甘草的药理学研究进展.吉林农业科技学院学报,2006,15(2).
5.刘振华,梁波,田景奎.桔梗属植物的化学和药理学研究进展.科研,2006,7:59-63.
6.冯冰虹,赵宇红,黄建华.桑白皮的有效成分筛选及其药理学研究.
7.郑萍,戴贵东,李汉青.麻黄碱及伪麻黄碱药理作用研究进展.宁夏医学杂志,2002,24(2):126-127.
8.赵金明,李中平,张艳玲,张丽君.镇咳宁糖浆的药理研究.中医药研究,1999,15(1):32-41.
9.高鸿霞,邵世和,王国庆.中药甘草研究进展.井冈山医专学报,2004,11(5):8-11.
10.慕桂娟.甘草化学成分的研究进展.包头医学,2005,29(2):25-27.
11.陈红.甘草药理作用概述.海峡药学,2005,17(4):37-41.
12.张小荣,王彩艳,何亚农.甘草的药理作用及临床应用近况.社区中医药,2004,20(270).
13.许海琴,等主编.常用天然提取物质量标准参考手册.北京:化学工业出版社,2003.4:19.
14.国家医药管理局中草药情报中心站编.植物药有效成分手册.北京:人民卫生出版社,1986.3:390.
15.汤光,李大奎主编.现代临床药物学.北京:化学工业出版社,2003.1:346-347.
16.Dipalma JR.Basic Pharmacology in Medicine.Mcgraw Hill Book Company,1976:175.
17.Garrett,ER.et al.Drug Fate and Metabolism.Methods and Techniques (Vol3)New York:Marcel Dekker,INC.1979:230-233.
18.刘贺之,龙卿,宋殿坤主编.北京:军事医学科学院出版社,2002:568.
19.宋杨,齐云.桔梗的药理研究进展.中药房,2006,17(2):140-141.
20.毛一亮.桔梗的临床应用.中药天地,2001,10(10):65.
21.吴志平,谈建中,顾振纶.中药桑白皮化学成分及药理活性研究进展.中国野 生植物资源,2004,23(5):10-16.
22.崔颖,屠锡德.国外口服软胶囊的研究.药学进展,2003,27(6):340-345.
23.戴仪.软胶囊剂的概况和工艺.制药技术,1995,9:34-35.
24.彭红英,周晓源,孔红.中药软胶囊制剂研究技术探讨与展望.首都医药,2006,30-31.
25.张亚中,张彤,陶建生.中药软胶囊的研究进展.中成药,2006,28(6):871-874.
26.范碧亭主编.中药药剂学.上海:上海科学技术出版社,2002:502.
27.彭智聪,李芳艳.软胶囊有待解决问题的探讨.中药园地,2004,26(4):50-51.
28.马旭,刘建平等.软胶囊崩解迟缓现象影响因素研究.中国药科大学学报,2003,34(5):414-418.
29.马旭,刘建平等.软胶囊崩解迟缓现象影响因素研究.中国药科大学学报,2003,34(5):414-418.
30.赵远.姜黄渗漉提取工艺研究.云南中医中药杂志,2005,26(6):39-40.
31.生产现场.软胶囊中PEG配方的基本技术.
32.时军,程怡.辅料在软胶囊剂型中的应用.中医药学刊,2003,21(9):1429-1464.
33.齐惠敏,赵晓东,李静.软胶囊剂的工艺研究现状.天津药学,1997,9(4):32-33.
34.贺志宇,张冬平.浅谈中药软胶囊的研制.时珍国药研究,1995,7(1):50-52.
35.柯雪红.HPLC法测定舒金克喘胶囊中盐酸麻黄碱的含量.中国药师,2006,9(8):774-775.
36.Garrett,ER.et al.Drug Fate and Metabolism.Methods and Techniques (Vol3) New York:Marcel Dekker,INC.1979:230-233
37.李向阳,屠万倩.HPLC法测定哮喘宁胶囊中盐酸麻黄碱的含量.中药新药与临床药理,2005,16(5):359-361.
38.Niu CQ,et al.Determination of isoquinoline alkaloids in Chetudomun mayus L.byion-pair high performance liquid chromatography.J Chromatogr 1991:542:198-203.
39.王瑞冬,陈新善,田军,聂渝琼.分光光度法测定复方喷鼻剂中盐酸麻黄碱的含量.解放军药学学报,2002,18(5):310-312.
40.何树芸,陈桂歌.差示分光光度法测定复方呋喃西林滴鼻液中盐酸麻黄碱的含量.陕西中医学院学报,2003,26(5):57-58.
41.茹建华.双波长等吸收分光光度法测定氯麻灌洗液中盐酸麻黄碱的含量.海峡药学,2004,16(1):54-55.
42.程德才,王慧琛.旋光法快速测定盐酸麻黄碱滴鼻液的含量.天津药学,2002, 14(2):67.
43.刘利,胡洪章,曾道元.旋光法测定呋麻液中盐酸麻黄碱的含量.药品检测,2002,11(6):55.
44.郑荣庆,李光秀,贾德武,吴华,曹美云.PH指示剂吸收度比值法测定盐酸麻黄碱含量.山东医药工业,1990,9(3):20-21
45.崔艳萍,刘姗姗,潭新保.导数光谱测定小儿化痰止咳冲剂中吐根碱和盐酸麻黄碱的含量.中成药,1994,16(5):17-18.
46.杨快儿,洪俊荣.酸性染料萃取法测定麦得灵滴眼液中盐酸麻黄碱的含量.汕头大学医学院学报,1995,1:97-98.
47.徐艺立,白鸥.系数倍率法测定麻杏止咳片中盐酸麻黄碱的含量.中成药,1991,13(12):13-14.
48.胡妹英,黄诺嘉.正交函数光谱法测定氟麻嘭鼻液液中盐酸麻黄碱的含量.汕头科技,1998,2:60-62.
49.邵淑梅,于盛茂,李金泉.比色法测定止咳平喘口服液中盐酸麻黄碱的含量.药物分析杂志,2001,21(6):445-446.
50.蒋学华,杨华元,徐维平.毛西管气相色谱法测定制剂中盐酸麻黄碱的含量.华西药学杂志,1990,5(3):158-160.
51.陈恒武,等.流动注射在线固相萃取预富集毛细管区带电泳测定血浆中的伪麻黄碱.高等学校化学学报,1999,11(20):1688-1691.
52.杨汉煜,等。液相色谱-串联质谱法测定人血浆中的伪麻黄碱浓度.沈阳药科大学学报,2001,18(2):116-118.