| The pharmacological effects of rehmannia glutinosa are very extensive.Different origins and processing methods have a great influence on the pharmacological effects of rehmannia glutinosa.The effect of fresh rehmannia radix is different from that of dry products.The active ingredient of fresh rehmannia radix cool blood is catalpol.At present,the preservation technology of fresh medicinal materials is relatively backward.Therefore,this project aims to establish the quality control indicators related to fresh rehmannia radix and develop suitable freeze-drying production techniques based on them,so as to promote the development of the basic theory and clinical rational application of common fresh rehmannia radix progress.Based on various aspects,this paper proposes two methods of vacuum freeze-drying and ultra-fine pulverization of traditional Chinese medicine,which provides a new idea for the production and use of fresh Chinese medicine.The main contents are as follows:1.Production process of fresh rehmannia radix ultrafine powderOn the basis of the determination of the fresh rehmannia radix point,the water and catalpol content of the intermediate product after freeze-drying were used as indicators to investigate the pre-freezing method and temperature-drying process parameters of fresh rehmannia radix.The ultra-fine pulverization time of rehmannia glutinosa has determined the key production process of this product: the non-medicinal parts are removed by net selection,washed with water to remove the soil,cut into thin slices,and placed in a vacuum freeze dryer to dry the water to less than 8%;The lyophilized fresh rehmannia tablets are placed in a traditional Chinese medicine sterilizer for ozone sterilization to ensure that the microbial limit meets the relevant regulations.The freshly sterilized fresh rehmannia radix tablets are pulverized in a vibrating mill at a low temperature of 45-50 minutes.2.Quality control of fresh rehmannia radix ultrafine powder(1)According to the relevant methods of the Chinese Pharmacopoeia 2015 edition,the traits,identification(microscopic identification,thin layer identification),inspection and leachate of fresh radix decoction pieces were determined,and the results were in compliance with the regulations.(2)A HPLC method for the determination of catalpol content was established,and the methodological verification was carried out.The results showed that the precision,specificity and durability were good;the recovery rate was between 96.3% and 102.0%,which met the requirements;linear relationship [ Y(area)=-226.1 + 6516.9 × X(?g / ml)(r = 0.99997,n = 7)is good.According to the method,the dry weight content of the ten batches of samples is between 5.1% and 7.2%,respectively.The dry content is 6.1%,which is in compliance with the regulations.(3)A HPLC method for the determination of acteoside content was established,and the method was verified.The results showed that the precision,specificity and durability of the method were good;the recovery rate was 95.9%~106.0%,which met the requirements;The linear relationship [Y(area)=-31250.0 + 53380.0 × X(?g / ml)(r = 0.99961,n = 5)] is consistent.The dry content of the ten batches of samples determined according to the method was 0.054%~0.154%,and the average dry content was 0.102%,which was in compliance with the regulations.3.The usage of fresh rehmannia radix ultrafine powder(1)The in catalpol dissolution curves of fresh rehmannia radix ultrafine powder in different water temperatures were determined by using catalpol and acteoside as indicators.And Simulated conditions before and after eating,the dissolution curve of fresh rehmannia radix ultrafine powder in pH 1.2 hydrochloric acid solution,pH 4.5 phosphate buffer solution and pH 6.8 phosphate buffer medium was measured.Through comprehensive analysis,it is determined that the use of this product is “soak,take it togetheror in combination with formula granules”,and the boiling water is brewed and taken after the meal.(2)According to the multiple freeze lyophilization yield and catalpol retention rate of the fresh radix rehmannia,combined with the usage and dosage of fresh radix rehmannia(12~30g)in the 2015 edition of the Chinese Pharmacopoeia,the dosage of fresh rehmannia radix ultrafine powder is 2~5g.This topic mainly researches the the fresh rehmannia radix ultrafine powder freeze-drying and pulverization process,determines the production process of fresh ground fresh rehmannia radix ultrafine powder,and has established the quality control standard suitable for fresh rehmannia radix ultrafine powder,and the usage and dosage of fresh rehmannia radix ultrafine powder.Exploratory research was carried out to provide a theoretical basis for the clinical application of this product,and provided a feasible idea for the research and development of fresh medicine.Freeze-drying and pulverization process,determines the production process of fresh ground fresh rehmannia radix ultrafine powder,and has established the quality control standard suitable for fresh rehmannia radix ultrafine powder,and the usage and dosage of fresh rehmannia radix ultrafine powder.Exploratory research was carried out to provide a theoretical basis for the clinical application of this product,and provided a feasible idea for the research and development of fresh medicine. |
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