当归饮片的炮制工艺及质量控制研究
摘要
当归为常用中药,为伞形科植物当归Angelica sinensis(Oliv.)Diels的干燥根,味甘、辛、温。归肝、心、脾经。具有补血活血,调经止痛,润肠通便。用于血虚萎黄,眩晕心悸,月经不调,经闭痛经,虚寒腹痛,肠燥便秘,风湿痹痛,跌打损伤,痈疽疮疡。酒当归活血痛经,用于经闭经痛,风湿痹痛,跌打损伤。《本草通玄》中说“头止血而上行,梢破血而下行,身养血而中守,全活血而不定”,临床上对当归的使用也是分开入药。
本文对当归饮片的炮制工艺做了系统性的研究,分步骤地完成了当归炮制工艺的研究,确定了当归炮制工艺各个技术环节水处理工艺、切制和干燥工艺、酒炙工艺的技术参数,为制定出当归的最佳炮制方法及开展中药饮片炮制规范化研究提供有效的借鉴。在水处理工艺中,我们选择了加水量、洗涤时间、洗涤次数作为考察因素,以水溶性浸出物、醇溶性浸出物、灰分为考察指标,采用综合评分法,最终制定出水处理工艺,即10倍量水,洗2次,每次1min。在浸润切制工艺中,对浸润不同时间,测其含水量。其中最利切片的当归为:取50克当归平铺,上面盖一层浸湿的麻袋,每隔8h淋水一次,一共润48h,计算含水量为80%。在干燥工艺中,我们选择了温度、时间、翻动次数、厚度作为考察因素,以水溶性浸出物、醇溶性浸出物、水分为考察指标,采用综合评分法,最终制定出干燥工艺,即60℃,8h,中间不翻动,松散烘干。在酒当归炮制工艺中,我们选择了辅料用量、闷润时间、加入饮片时的温度、饮片受热时间作为考察因素,以有效成分阿魏酸为考察指标进行评价,最终制定出炮制工艺,即每100kg加辅料10kg,加入饮片时的温度为190℃,炒7分钟。为了考查炮制工艺的可行性,我们将上述实验室研究结果在中试基地单位进行了9批放大中试,各项指标测定结果表明9批成品质量均符合要求,经老中药师传统质量鉴别,认为9批炮制品均达到了《药典》要求的合格标准,说明制定的炮制工艺合理可行。本文坚持传统炮制经验与现代科学技术相结合,容易控制质量,便于标准化规范化操作。此炮制工艺炮制的饮片与传统制法炮制的饮片从外观到内在质量均一致,符合要求,为实现当归炮制工艺的现代化和产业化研究提供了重要的依据。
在质量标准研究中,我们尝试了光谱鉴别,光谱鉴别采用紫外谱线组法,通过运用四种不同极性的溶剂(蒸馏水,无水乙醇,氯仿,石油醚(60～90℃))对同一样品的当归和酒当归提取,在200nm-400nm进行紫外光区扫描,方法简便,重现性好,本紫外谱线组提供了GAP示范基地的当归和其它当归的鉴别指标。在含量测定下,当归主要有效成分之一为阿魏酸,因此对阿魏酸进行定量分析,可作为评价当归生药质量的重要依据,本文采用HPLC法对当归中所含的有效成分阿魏酸进行了含量测定方法的研究,以十八烷基硅烷键合硅胶为填充剂;以乙腈-0.085%磷酸溶液(17:83)为流动相;检测波长为316nm;柱温35℃;流速0.8ml/min,经反复试验,结果表明超声提取比回流提取和冷浸法的效果好。该提取方法简便、快速、易控;且超声提取时间短,当归中的阿魏酸基本能提取完全。测定结果线性关系良好,精密度、稳定性和重现性好,操作简单。通过对当归饮片质量标准的研究,将改变柴当归片质量无量化指标的现状,它将为管理部门对中药当归饮片生产的监督和管提供科学依据和有力的手段,更重要的是将为中药饮片生产的规范化研究和产业化开发起到一定的促进作用,为中药饮片生产厂家提供品牌产品。
Angelica commonly used for traditional Chinese medicine,umbrella plant Angelica Angelica sinensis(Oliv.)Diels of the dry root,Wei Gan, Xin Wen.In the liver,heart,spleen by.With the blood Huoxue,Tiaojing pain,Run will be smooth.For blood deficiency Wei Huang,dizziness palpitation,Irregular Menstruation,the closure dysmenorrhea, Deficiency-Cold Zheng abdominal pain,bowel dry constipation,rheumatism Bitong,injury or flutter,carbuncle Ju Chuang Yang.Liquor Angelica Huoxue dysmenorrhea.Amenorrhea for the pain,rheumatoid Bitong,injury or flutter.
In this paper,Angelica Pieces of the processing done a systematic study,completed a step-by-processing technology of Angelica,identified Angelica concocted various technical aspects of water treatment process, cut-and drying process,liquor Sunburn of the technical parameters, Angelica to develop the best methods and processing for standardization of traditional Chinese medicine Pieces prepared to provide an effective draw.In the water treatment process,we chose to increase water,washing, washing as the number of inspection,to water-soluble extract,the extract of Alcohol,ash inspection indicators,a comprehensive balance, eventually develop water treatment process,that is,10 Times the volume of water,washed twice,each 1 min.Cutting in infiltration in the process of infiltration at different times,measured the water content.One of the most Liqie tablets Angelica:from 50 grams Angelica tile,covered a layer above the sacks Jinshi,Lin Shui once every 8 h,a total of Run-48 h,calculating the water content of 80 per cent.
In the drying process,we selected the temperature,time,number of Fandong,as the thickness of Investigation,to water-soluble extract, Alcohol-extract,water indicators for the study,a comprehensive balance method,developed the final drying process,that is 60℃,8h,not Fandong the middle,loose drying.Angelica wine produced in the process, we selected the amount of materials,nausea Run-time,when the temperature by adding Pieces,Pieces heating time as the inspection,ferulic acid components in an effective inspection indicators for the evaluation and ultimately develop processing technology,which is 100kg plus accessories 10kg,adding Pieces when the temperature was 190℃,speculation seven minutes.In order to examine the feasibility of processing technology, we will study the laboratory test results in the base unit was enlarged in September approved test,the results showed that the nine indicators of the quality of approved products are in line with requirements of the old traditional pharmacists in the quality of identification,9 approved processed products that meet the "Pharmacopoeia" requirements of the eligibility criteria that the development of processing technology as reasonably practicable.Adhere to the traditional paper processing experience and modern science and technology,easier to control quality, and facilitate the operation of Standardization.Concocted this concocted by Pieces of the traditional method of processing the Pieces from the appearance of an inherent quality to the unanimous,to meet the requirements for the realization of Bupleurum concocted The process of modernization and industrialization of research provides an important basis.
Quality standards in the study,we try to identify the spectral, differential use of spectrum ultraviolet spectrum group,through the use of four different polar solvents(distilledwater,ethanol,chloroform, petroleum ether(60-90℃))On the same samples from Angelica Angelica and wine in a 200nm-400nm UV area scanning method was simple,reproducible, the ultraviolet spectrum to provide the GAP group of demonstration bases Angelica Angelica and other indicators of identification.In the determination,Angelica one of the main active ingredients for the ferulic acid,ferulic acid on a quantitative analysis,evaluation of Angelica as a health-an important basis for quality,the paper by HPLC on Angelica the active ingredients contained in the ferulic acid A determination of the study to 18 alkyl silane bonded silica as filler;acetonitrile-0.085% phosphoric acid(eighty-three past five p.m.)for the mobile phase detection at 316 nm;column temperature of 35℃.Flow rate of 0.8 ml /min.After repeated tests,the results showed that the ultrasonic extraction than the return of the extraction and Lengjin good effect.The extraction method is simple,quick and easy control;Ultrasonography and extracting a short time,Angelica in the basic ferulic acid can be extracted completely.The results of the linear relationship was good, precision,stability and reproducible,easy to operate.By Angelica Pieces of quality standards,will change the quality of Chai-Angelica no quantitative indicators of the status quo,it will of Chinese medicine for the management of Angelica Pieces of production supervision and to provide a scientific basis and powerful means,is more important for Chinese medicine Pieces of the production of standardized research and development of the industry plays a certain role in promoting,for Pieces of Chinese medicine manufacturers to provide brand name products.
本文对当归饮片的炮制工艺做了系统性的研究,分步骤地完成了当归炮制工艺的研究,确定了当归炮制工艺各个技术环节水处理工艺、切制和干燥工艺、酒炙工艺的技术参数,为制定出当归的最佳炮制方法及开展中药饮片炮制规范化研究提供有效的借鉴。在水处理工艺中,我们选择了加水量、洗涤时间、洗涤次数作为考察因素,以水溶性浸出物、醇溶性浸出物、灰分为考察指标,采用综合评分法,最终制定出水处理工艺,即10倍量水,洗2次,每次1min。在浸润切制工艺中,对浸润不同时间,测其含水量。其中最利切片的当归为:取50克当归平铺,上面盖一层浸湿的麻袋,每隔8h淋水一次,一共润48h,计算含水量为80%。在干燥工艺中,我们选择了温度、时间、翻动次数、厚度作为考察因素,以水溶性浸出物、醇溶性浸出物、水分为考察指标,采用综合评分法,最终制定出干燥工艺,即60℃,8h,中间不翻动,松散烘干。在酒当归炮制工艺中,我们选择了辅料用量、闷润时间、加入饮片时的温度、饮片受热时间作为考察因素,以有效成分阿魏酸为考察指标进行评价,最终制定出炮制工艺,即每100kg加辅料10kg,加入饮片时的温度为190℃,炒7分钟。为了考查炮制工艺的可行性,我们将上述实验室研究结果在中试基地单位进行了9批放大中试,各项指标测定结果表明9批成品质量均符合要求,经老中药师传统质量鉴别,认为9批炮制品均达到了《药典》要求的合格标准,说明制定的炮制工艺合理可行。本文坚持传统炮制经验与现代科学技术相结合,容易控制质量,便于标准化规范化操作。此炮制工艺炮制的饮片与传统制法炮制的饮片从外观到内在质量均一致,符合要求,为实现当归炮制工艺的现代化和产业化研究提供了重要的依据。
在质量标准研究中,我们尝试了光谱鉴别,光谱鉴别采用紫外谱线组法,通过运用四种不同极性的溶剂(蒸馏水,无水乙醇,氯仿,石油醚(60～90℃))对同一样品的当归和酒当归提取,在200nm-400nm进行紫外光区扫描,方法简便,重现性好,本紫外谱线组提供了GAP示范基地的当归和其它当归的鉴别指标。在含量测定下,当归主要有效成分之一为阿魏酸,因此对阿魏酸进行定量分析,可作为评价当归生药质量的重要依据,本文采用HPLC法对当归中所含的有效成分阿魏酸进行了含量测定方法的研究,以十八烷基硅烷键合硅胶为填充剂;以乙腈-0.085%磷酸溶液(17:83)为流动相;检测波长为316nm;柱温35℃;流速0.8ml/min,经反复试验,结果表明超声提取比回流提取和冷浸法的效果好。该提取方法简便、快速、易控;且超声提取时间短,当归中的阿魏酸基本能提取完全。测定结果线性关系良好,精密度、稳定性和重现性好,操作简单。通过对当归饮片质量标准的研究,将改变柴当归片质量无量化指标的现状,它将为管理部门对中药当归饮片生产的监督和管提供科学依据和有力的手段,更重要的是将为中药饮片生产的规范化研究和产业化开发起到一定的促进作用,为中药饮片生产厂家提供品牌产品。
Angelica commonly used for traditional Chinese medicine,umbrella plant Angelica Angelica sinensis(Oliv.)Diels of the dry root,Wei Gan, Xin Wen.In the liver,heart,spleen by.With the blood Huoxue,Tiaojing pain,Run will be smooth.For blood deficiency Wei Huang,dizziness palpitation,Irregular Menstruation,the closure dysmenorrhea, Deficiency-Cold Zheng abdominal pain,bowel dry constipation,rheumatism Bitong,injury or flutter,carbuncle Ju Chuang Yang.Liquor Angelica Huoxue dysmenorrhea.Amenorrhea for the pain,rheumatoid Bitong,injury or flutter.
In this paper,Angelica Pieces of the processing done a systematic study,completed a step-by-processing technology of Angelica,identified Angelica concocted various technical aspects of water treatment process, cut-and drying process,liquor Sunburn of the technical parameters, Angelica to develop the best methods and processing for standardization of traditional Chinese medicine Pieces prepared to provide an effective draw.In the water treatment process,we chose to increase water,washing, washing as the number of inspection,to water-soluble extract,the extract of Alcohol,ash inspection indicators,a comprehensive balance, eventually develop water treatment process,that is,10 Times the volume of water,washed twice,each 1 min.Cutting in infiltration in the process of infiltration at different times,measured the water content.One of the most Liqie tablets Angelica:from 50 grams Angelica tile,covered a layer above the sacks Jinshi,Lin Shui once every 8 h,a total of Run-48 h,calculating the water content of 80 per cent.
In the drying process,we selected the temperature,time,number of Fandong,as the thickness of Investigation,to water-soluble extract, Alcohol-extract,water indicators for the study,a comprehensive balance method,developed the final drying process,that is 60℃,8h,not Fandong the middle,loose drying.Angelica wine produced in the process, we selected the amount of materials,nausea Run-time,when the temperature by adding Pieces,Pieces heating time as the inspection,ferulic acid components in an effective inspection indicators for the evaluation and ultimately develop processing technology,which is 100kg plus accessories 10kg,adding Pieces when the temperature was 190℃,speculation seven minutes.In order to examine the feasibility of processing technology, we will study the laboratory test results in the base unit was enlarged in September approved test,the results showed that the nine indicators of the quality of approved products are in line with requirements of the old traditional pharmacists in the quality of identification,9 approved processed products that meet the "Pharmacopoeia" requirements of the eligibility criteria that the development of processing technology as reasonably practicable.Adhere to the traditional paper processing experience and modern science and technology,easier to control quality, and facilitate the operation of Standardization.Concocted this concocted by Pieces of the traditional method of processing the Pieces from the appearance of an inherent quality to the unanimous,to meet the requirements for the realization of Bupleurum concocted The process of modernization and industrialization of research provides an important basis.
Quality standards in the study,we try to identify the spectral, differential use of spectrum ultraviolet spectrum group,through the use of four different polar solvents(distilledwater,ethanol,chloroform, petroleum ether(60-90℃))On the same samples from Angelica Angelica and wine in a 200nm-400nm UV area scanning method was simple,reproducible, the ultraviolet spectrum to provide the GAP group of demonstration bases Angelica Angelica and other indicators of identification.In the determination,Angelica one of the main active ingredients for the ferulic acid,ferulic acid on a quantitative analysis,evaluation of Angelica as a health-an important basis for quality,the paper by HPLC on Angelica the active ingredients contained in the ferulic acid A determination of the study to 18 alkyl silane bonded silica as filler;acetonitrile-0.085% phosphoric acid(eighty-three past five p.m.)for the mobile phase detection at 316 nm;column temperature of 35℃.Flow rate of 0.8 ml /min.After repeated tests,the results showed that the ultrasonic extraction than the return of the extraction and Lengjin good effect.The extraction method is simple,quick and easy control;Ultrasonography and extracting a short time,Angelica in the basic ferulic acid can be extracted completely.The results of the linear relationship was good, precision,stability and reproducible,easy to operate.By Angelica Pieces of quality standards,will change the quality of Chai-Angelica no quantitative indicators of the status quo,it will of Chinese medicine for the management of Angelica Pieces of production supervision and to provide a scientific basis and powerful means,is more important for Chinese medicine Pieces of the production of standardized research and development of the industry plays a certain role in promoting,for Pieces of Chinese medicine manufacturers to provide brand name products.
引文
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