姜半夏炮制工艺及其质量规范化研究
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摘要
半夏为天南星科植物半夏Pinellia temata(Thunb.)Breit的干燥块茎,因有毒,临床使用多需炮制。姜半夏是半夏炮制品的主流品种,具有温中化痰,降逆止呕的功效。但姜半夏的质量标准至今未见有系统的研究报告,2005版《中国药典》姜半夏置于半夏项下,仅有简单的性状描述,无客观的检测指标,无法有效地控制饮片质量。本文在大量文献研究的基础上,对姜半夏的炮制工艺和质量标准进行了系统研究。
姜半夏采用生姜和白矾进行炮制,白矾制半夏已有深入的研究报告,故本文主要对姜半夏中的辅料生姜的质量、姜制工艺优化以及姜半夏的炮制品的质量标准进行系统研究。其主要研究内容和工作如下:
1辅料生姜的质量研究
从生姜水分、灰分、浸出物、挥发油和6-姜醇含量测定等方面对不同主产地的生姜进行了比较。研究表明优选出山东莱芜产生姜的质量较佳,并用作本文中姜半夏的炮制辅料。
2姜半夏炮制工艺研究
建立了姜半夏炮制品的总有机酸、6-姜醇、白矾残留量的检测方法。采用正交设计,以辅料生姜用量、白矾用量,煮制时间为因素,以总游离有机酸、6-姜醇、白矾残留量为指标,以家兔眼结膜刺激性的强度分值、小鼠血管通透性为刺激性毒性指标,以鼠胃排空抑制率为药效学指标,多指标综合评分优选姜半夏的炮制工艺参数。
最终确定药典法姜半夏的优化炮制工艺为:即每100g生半夏经用水浸泡至内无干心时,取出;另取生姜25g切片煎汤,加白矾12.5g与半夏共煮4小时,取出,晾干,切片干燥。
3姜半夏药典法与改进工艺的比较研究
比较了改进法和优选出的药典法两种不同工艺炮制品中成分含量差异及药效学差异。结果表明改进法姜半夏中的6-姜醇含量高于药典法姜半夏、白矾残留量明显低于药典法姜半夏。药典法姜半夏的总有机酸含量高于改进法姜半夏。而两者之间的刺激性毒性及对胃肠运动没有显著差异。而改进法姜半夏工艺生产操作更加简便。
4姜半夏质量标准考察
收集了全国不同来源的10批次姜半夏,从饮片性状、鉴别、检查、浸出物及白矾残留限量检查等方面对姜半夏的质量进行了研究,建立了姜半夏的质量标准。
Pinellia Tuber is the dry tuber of Pinellia ternata (Thunb) Breit. Because of its toxicity, it is mostly processed before it is ready for clinical use. Pinellia Rhizoma prepared by ginger is the chief variety of the processed products of Pinellia Rhizoma, and has the effects of warming the spleen and stomache, diluting the sputum, putting down the inverse air of people and stopping the vomit. But there are no systematic research reports on the quality standard of Pinellia Rhizoma prepared by ginger as yet. Pinellia Rhizoma prepared by ginger is classified under the category of Pinellia Rhizoma in Chinese Pharmacopoeia (2005), and it has no objective detection index except for simple character description in this Pharmacopoeia, so its quality couldn' t be controlled effectively .On the basis of massive literature research, we have made systermatic studies on the processing technology and quality standards of Pinellia Rhizoma prepared by ginger in this paper.
Pinellia Rhizoma prepared by ginger is processed by ginger and alumen, and there has been deep research on Pinellia Rhizoma processed by alumen, so in this paper,we mainly make systermatic studies on the quality of adjuvantes--crude ginger, optimizing the processing technology and the quality standards of Pinellia Rhizoma prepared by ginger. The main research contents and work are as follows:
1 Quality research on crude ginger
To compare the moisture, ash, extract, volatile oil and 6-gingerol content of crude ginger from different main producing areas. Research shows that the quality of ginger produced in Laiwu, Shandong is better , which is chosen as the processing adjuvantes for the paper.
2 Processing technology research on Pinellia Rhizoma prepared by ginger
Establish the detection methods of total organic acid, 6-gingerol, alumen residual amount of Pinellia Rhizoma prepared by ginger. Apply orthogonal design , taking the amount of processing adjuvantes -crude Ginger, alumen ,and boiling time as factors, total organic acid, 6-gingerol, and alumen residual amount as index, intention propotin of rabbit's eye-conjunctiva pungent and rat's bloodvessel's quality of penetration as toxic index, and inhibition rate of gastric emptying in rates as pharmacodynamic index, and using comprehensive score on multiple indexes to optimize the processing technology parameters of Pinellia Rhizoma prepared by ginger.
The final processing technology of Pinellia Rhizoma prepared by ginger of pharmacopeia method is : take 100 g raw pinellia ternate, soak it in water until it is wet to core , then take it out ;take 25 g rude ginger, slice , add water 600 ml, decoct, add 12.5g alumen and pinellia ternate ,boil them together for 4 hours, take the pinellia ternate out , air dry ,slice and dry it.
3 Comparative study between Pinellia Rhizoma prepared by ginger of pharmacopeia method and improved process
Compare the content differences and pharmacodynamics differences of processed products by improved process and pharmacopeia method . Results show that, compared with pharmacopeia method, there is more 6-gingerol in processed products by improved process. While the alumen residual amount is much lower, so is the total organic acid amount. But there are no dramatic differences in stimulation toxic and gastrointestinal motility between them . However, the operation of improved process is more simple and convenient.
4 Study on quality standards of Pinellia Rhizoma prepared by ginger
Collect 10 batches of Rhizoma Pinelliae prepared by ginger from different places in our country ,study on their quality standards from features of pieces, identification, examinations, extract and alumen residual amount, and build up the quality standards of Pinellia Rhizoma prepared by ginger.
姜半夏采用生姜和白矾进行炮制,白矾制半夏已有深入的研究报告,故本文主要对姜半夏中的辅料生姜的质量、姜制工艺优化以及姜半夏的炮制品的质量标准进行系统研究。其主要研究内容和工作如下:
1辅料生姜的质量研究
从生姜水分、灰分、浸出物、挥发油和6-姜醇含量测定等方面对不同主产地的生姜进行了比较。研究表明优选出山东莱芜产生姜的质量较佳,并用作本文中姜半夏的炮制辅料。
2姜半夏炮制工艺研究
建立了姜半夏炮制品的总有机酸、6-姜醇、白矾残留量的检测方法。采用正交设计,以辅料生姜用量、白矾用量,煮制时间为因素,以总游离有机酸、6-姜醇、白矾残留量为指标,以家兔眼结膜刺激性的强度分值、小鼠血管通透性为刺激性毒性指标,以鼠胃排空抑制率为药效学指标,多指标综合评分优选姜半夏的炮制工艺参数。
最终确定药典法姜半夏的优化炮制工艺为:即每100g生半夏经用水浸泡至内无干心时,取出;另取生姜25g切片煎汤,加白矾12.5g与半夏共煮4小时,取出,晾干,切片干燥。
3姜半夏药典法与改进工艺的比较研究
比较了改进法和优选出的药典法两种不同工艺炮制品中成分含量差异及药效学差异。结果表明改进法姜半夏中的6-姜醇含量高于药典法姜半夏、白矾残留量明显低于药典法姜半夏。药典法姜半夏的总有机酸含量高于改进法姜半夏。而两者之间的刺激性毒性及对胃肠运动没有显著差异。而改进法姜半夏工艺生产操作更加简便。
4姜半夏质量标准考察
收集了全国不同来源的10批次姜半夏,从饮片性状、鉴别、检查、浸出物及白矾残留限量检查等方面对姜半夏的质量进行了研究,建立了姜半夏的质量标准。
Pinellia Tuber is the dry tuber of Pinellia ternata (Thunb) Breit. Because of its toxicity, it is mostly processed before it is ready for clinical use. Pinellia Rhizoma prepared by ginger is the chief variety of the processed products of Pinellia Rhizoma, and has the effects of warming the spleen and stomache, diluting the sputum, putting down the inverse air of people and stopping the vomit. But there are no systematic research reports on the quality standard of Pinellia Rhizoma prepared by ginger as yet. Pinellia Rhizoma prepared by ginger is classified under the category of Pinellia Rhizoma in Chinese Pharmacopoeia (2005), and it has no objective detection index except for simple character description in this Pharmacopoeia, so its quality couldn' t be controlled effectively .On the basis of massive literature research, we have made systermatic studies on the processing technology and quality standards of Pinellia Rhizoma prepared by ginger in this paper.
Pinellia Rhizoma prepared by ginger is processed by ginger and alumen, and there has been deep research on Pinellia Rhizoma processed by alumen, so in this paper,we mainly make systermatic studies on the quality of adjuvantes--crude ginger, optimizing the processing technology and the quality standards of Pinellia Rhizoma prepared by ginger. The main research contents and work are as follows:
1 Quality research on crude ginger
To compare the moisture, ash, extract, volatile oil and 6-gingerol content of crude ginger from different main producing areas. Research shows that the quality of ginger produced in Laiwu, Shandong is better , which is chosen as the processing adjuvantes for the paper.
2 Processing technology research on Pinellia Rhizoma prepared by ginger
Establish the detection methods of total organic acid, 6-gingerol, alumen residual amount of Pinellia Rhizoma prepared by ginger. Apply orthogonal design , taking the amount of processing adjuvantes -crude Ginger, alumen ,and boiling time as factors, total organic acid, 6-gingerol, and alumen residual amount as index, intention propotin of rabbit's eye-conjunctiva pungent and rat's bloodvessel's quality of penetration as toxic index, and inhibition rate of gastric emptying in rates as pharmacodynamic index, and using comprehensive score on multiple indexes to optimize the processing technology parameters of Pinellia Rhizoma prepared by ginger.
The final processing technology of Pinellia Rhizoma prepared by ginger of pharmacopeia method is : take 100 g raw pinellia ternate, soak it in water until it is wet to core , then take it out ;take 25 g rude ginger, slice , add water 600 ml, decoct, add 12.5g alumen and pinellia ternate ,boil them together for 4 hours, take the pinellia ternate out , air dry ,slice and dry it.
3 Comparative study between Pinellia Rhizoma prepared by ginger of pharmacopeia method and improved process
Compare the content differences and pharmacodynamics differences of processed products by improved process and pharmacopeia method . Results show that, compared with pharmacopeia method, there is more 6-gingerol in processed products by improved process. While the alumen residual amount is much lower, so is the total organic acid amount. But there are no dramatic differences in stimulation toxic and gastrointestinal motility between them . However, the operation of improved process is more simple and convenient.
4 Study on quality standards of Pinellia Rhizoma prepared by ginger
Collect 10 batches of Rhizoma Pinelliae prepared by ginger from different places in our country ,study on their quality standards from features of pieces, identification, examinations, extract and alumen residual amount, and build up the quality standards of Pinellia Rhizoma prepared by ginger.
引文
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