The Study On Preparative Process And Quality Standard Of Safflower (Carthamus Tinctorius L.) Formula Granule

Objective:Research the quality of safflowers in xinjiang by quality analysis and evaluation,and study the preparation process and quality standard of safflower formula granules.Methods:?1?The characters,microscopy,TLC identification,examination and content determination were carried out by the Pharmacopoeia of people's Republic of China.?2?The contents of four flavonoids components in safflower were determined by using high performance liquid chromatography?HPLC?.?3?To optimize the best extraction process for safflower formula granule by using L₉?3⁴?orthogonal experimental method and Box-beknken response surface method,at the same time,the study of concentration,drying,molding process.?4?Applied fourier transform infrared spectroscopy?FTIR?to analysis and compare infrared spectrum of safflower medicines,safflower extract,safflower formula particles.?5?Using TLC to identify safflower formula particles,check the moisture content,granularity,melting,determine the content of HSYA of formula particles and the quality standard was established.?6?Study on of the fingerprint chromatogram of safflower formula particles by HPLC.Results:?1?The 7batches of medicinal materials the content of impurity was 0.61±0.32%,moisture was7.14±1.10%,total ash was 8.64±2.28%,acid insoluble ash was 2.49±0.93%,and water-soluble extract was 38.0±4.73%,all meet the national standards;TLC methods of safflower was established,the stationary phase was polyamide thin layer plate,3.6%hydrochloric acid solution:methanol:acetic acid ethyl ester?7:3:1?as developing agent,the map spots were clear and has good separation effect,but the content is different,HSYA content in 11.24 mg/g²6.32 mg/g range.HSYA content was in the range of 23.72³4.43 mg/g by HPLC.?2?The use of HPLC to simultaneously determine the average content of HSYA was 5.57±0.91mg/g,rutin was 1.41±0.44mg/g and quercetin was 0.11±0.04mg/g,kaempferia galanga was 0.24±0.07mg/g in 7 batches of safflower medicines.?3?Comparison of two methods found that the Box-beknken response surface method was better.Preparation technology and technological parameters for safflower medicines was with 16 times the amount of water extracted 3 times,each time 43 min,combined solution,with gauze filtration,the filtrate centrifugal removing impurity?3000 r/min?,stress concentration?60??to the relative density of 1.18¹.25,60?vacuum drying,the extract powder add right amount dextrin,blending,obtained formula particles.?4?According to the information of IR peak shape and peak position,the characteristic of IR of safflower medicines,water extract and formula particles has not distinguished.The second derivative IR can amplify the differences samples.It may relate to content and composition changes of medicinal materials and preparation process.?5?To establish a quality standard safflower formula granules.?6?The determination of acquisition of 10batches of safflower formula particles,calibration of 12 common peaks,and the establishment of its fingerprint chromatogram.Conclusion:Through preliminary analysis of the safflower quality,safflower formula granule preparation technology was optimized and combined with infrared spectrum and second derivative of safflower medicines,water extract and formula particle consistency research,quality standard of safflower formula particles was made to provide certain scientific basis for safflower formula particles for instead of safflower yinpian,lay a foundation for developing the characteristic resources in xinjiang.Meanwhile,firstly conducted a fingerprinting research to safflower formula granule.It offered a new method for the quality control of safflower formula granule.