Hubei Fritillaria Processing Technology And Quality Standards Study

Hubei Fritillaria is a traditional Chinese medicine,attached to the lily family plant. Its dry bulbs can be used for medicinal and it has been recorded in the Chinese Pharmacopoeia 2005 edition. With a heat lungs, the effect Sanjie Huatanzhike and detoxification, Hubei Fritillaria bulbs contains the main active ingredient alkaloids, such as Zhejiang Tony A prime, peiminine, lake shell A prime, A prime glycosides Tony Lake, Tony Lake B Su, Tony Lake triazine, a new shell lake, lake shell piperidine, Lake shell glycosides, a new E-bay and so on, and bulb type and content of alkaloids are higher than Fritillaria cirrhosa D.Don and Fritillaria thunbergii Miq.In short, the traditional Chinese medicine Hubei Fritillaria has showed high clinical value and good prospects for research and development.At present, there is no coverage of net washing precess about Hu bei Fritillaria, and no large-scale production quantitative criteria used. This paper preliminary developed the best Fritillaria net washing precess and quality standards.This provided with the quality control standards for the mechanization of mass production, and with reference slices for grading management for the state.In this paper, we screen Hubei Fritillaria washing processing and drying processing and establish preliminarily the best concocted technology, and make the validated test and the pilot test. By studying character, identification, inspection, extract, Fritillaria a prime target of content, we develop preliminarily Hubei Fritillaria quality standards. In this test,with three batches Fritillaria of the same package as listed products, By studying character, identification, inspection, extract, Fritillaria a prime target of content, we take a long-term stability test and a accelerated stability test, and the results of all the indexes were normal. Pieces of the 10 batches of Hubei Fritillaria conducted fingerprint study through the use of HPLC. The fingerprint study provide a scientific foundation for the GAP cultivation of Hubei Fritillaria herbs and quality control of concocted Hubei Fritillaria.At the same time, we supply also a quantitative reference with the fingerprint study for further study of Fritillaria concocted mechanism.一,Hubei Fritillaria Determination of optimum processing technologyCombining with reality and considering the comprehensive characteristics of Hubei Fritillaria, we make use of orthogonal design test method to screen Hubei Fritillaria washing and drying processes.In the end, the best processing technology is determined, and then provide quantitative data in Fritillaria Hubei concocting processing.In the washing process test, adding water, washing time and washing frequency of three factors should be screened for four visits indicators which consist of the content of Fritillaria Su A, water-soluble extract, alcohol-soluble extract and total ash. Using L9 (34) orthogonal test method and compositing scores on the determination results,we reach the optimized washing process conclusion. The result is that one amount of washing water, washing twice, each time for two minutes. For the purpose of getting a perfect conclusion,the best washing process is verified.In the drying process test,taking the drying temperature,drying time and flipping frequency of three factors into account, through the measurement of the water content, water-soluble extract, alcohol-soluble extract three study indicators will be measured. Using L9 (34) orthogonal test method and compositing scores on the determination results,we reach the optimized drying process conclusion:65℃, dried for four hours, during which the two flip better, and the best drying process to validate tests.二,Hubei Fritillaria Pieces formulation of quality standardsAccording to the nature of the chemical constituents of HubeiFritillaria,fromthecharacters, identification, inspection,e xtract and content etc,we establish preliminarily quality standards of Hubei Fritillaria Pieces.Using microscope, TLC Physical and chemical methods,we identified Fritillaria slices. The thin layer chromatography condition is used to analysis the original character and quality,and the TLC method is accurate and reproducible.By TLC method using Chinese Pharmacopoeia 2005 edition Hubei Fritillaria is inspected qualitatively. Making use of physical and chemical properties of the main components of Fritillaria alkaloids,we carried out color reactions and fluorescence absorption. The method is simple, specific and well.We examined four indicators,such as the impurities, moisture, ash and microorganism,and developed a range of indicators.By determining the water-soluble and alcohol-soluble extracts, we developed a range of indicators.Employing silica gel G thin-layer plate, with benzene ethyl acetate diethylamine (30:20:3.8) as the expand agent, Hubei Fritillaria pieces are distinguished by being sprayed with dilute bismuth potassium iodide test solution. The method is simple, rapid, specific and well.Using HPLC-ELSD method, Fritillaria prime A in Hubei Fritillaria were determined to measure the content. In all batches of Fritillaria samples, the minimum content of prime A is 0.090 percent. Taking into account storage and place of origin, we developed initially the content of Fritillaria prime A not less than 0.05%.三,Test the stability of FritillariaIn the long-term stability test, according to their storage requirements, three batches Fritillaria of the same package as listed products were ventilated in a dry place. At0,3,6,9,12,18 months respectively, we investigated the character, identification, inspection, extract and Fritillaria A content, and the results were normal.In the accelerated stability test, we kept three batches Fritillaria of the same package as listed products in a environment where the temperature was 40±2℃and relative humidity was 75±5%. At 0,1,2,3,6 months respectively, we investigated the character, identification, inspection, extract and Fritillaria A content,and the results were normal. Based on the above results, we formulate initially the expiration of eighteen months.四,HPLC fingerprint of Fritillaria Hubei Qualitative Identification We have established fingerprints of the ten batches of Hubei Fritillaria Pieces samples, and have stardardized ten shared peaks, furthermore have contrasted the relative total peak retention time and peak area ratio in the ten shared peaks. Comparing the concocted Fritillaria with the not-concocted Fritillaria, the results showed that:concocted before and after, there were no significant changes in the relative retention time of the peaks, but significant changes have taken place in peaks area ratio. The phenomenon indicates that the main components content has changed concocted before and after. This research result lays the foundation for further Hubei Fritillaria Pieces quality and comprehensive assessment of strengths and weaknesses.