| Panax notoginseng(Burk.)F.H.Chen is dried roots and rhizomes of Panax notoginseng plants of genus Panax of the Araliaceae family.It has the effect of lowering blood fat,lowering blood pressure and promoting blood circulation and removing stasis.With the increase of Panax notoginseng awareness,in addition to the in-depth study of its pharmacological effects,the researchers'concerns shifted from the research of Chinese medicinal materials to the study of compound preparations,including the composition of the drug in the compound preparation,the pharmacological action and the optimization of preparation technology and so on,but there are few studies on the formula granules.This research focused on the development of Panax notoginseng formula particles,which not only improved the quality of the Panax notoginseng formula granules,but also provided new ideas and methods for the production and processing of other traditional Chinese medicine dispensing granules and granules.In this article,the effect of the preparation process of Panax notoginseng extracts on its anticoagulant activity was investigated by using biological titer as an indicator.The formula particles of Panax notoginseng was optimized by the uniformity experiment.The quality of the Panax notoginseng formula particles was characterized by modern analytical methods,and the rationality and feasibility of the new technology were investigated.At last,the quality of the prepared granules was evaluated by TLC,HPLC and activity evaluation.The research contents of this paper include:1?In this paper,different extraction and different drying methods were used to extract and dry Panax notoginseng which made extract of Panax notoginseng.We measured the comprehensive coagulation evaluation value of Panax notoginseng extracts which prepared by different processes,according to the comprehensive coagulation evaluation value,we calculate the biological value of extracts by the parallel method of quantitative reaction,HPLC was used to analyze the content of active ingredients in the extract,using SPSS 19.0 software to linearly correlate the content of extracts with biological potency,in order to examine the preparation process of extraction.The experimental results showed that the highest biological value of extract is material ratio of 1:8,ethanol concentration of 80%,ultrasonic extraction combined with vacuum freeze-drying process,which was 448.81,and there was a significant positive correlation between the biological titer and the active ingredient,and R~2 was 0.784.Under this process,the extract has the best anticoagulant biological activity.2?A new preparation process was designed.Taking the molding rate,fluidity,color and hygroscopicity of the dispensing granules as indictors,comparison and analysis between new preparation process and traditional preparation process.The experimental results showed that the formulation,flowability,color,and hygroscopicity of granules prepared by new process are superior than traditional process.The formulation rate of formula granules increased about 3.20%~8.25%,the angle of repose decreased about 13.37°~26.65°,the equilibrium moisture absorption decreased about 17%~31%,and the equilibrium time extended about 9%~22%.In the examination of color,the value of a increased about 6%~104%,the value of L about 6%~25%,and the value of b about 13%~68%.It shows that compared with the traditional preparation process,the new preparation process can improve the yield of Panax notoginseng formula particles,improve the powder properties of Panax notoginseng formula particles,and delay the preservation time of Panax notoginseng formula particles at the same time.3?The experiment compares the formulation rate,fluidity,color and hygroscopicity of Panax notoginseng formulation particles prepared from five kinds of commonly used excipients,and screened the best excipients of Panax notoginseng formulation particles,and based on this,designed the homogeneity experiment to examine the hygroscopicity of each prescription,in order to optimize the prescription of Panax notoginseng formulation particles.The experimental results show that the highest molding excipients are mannitol and microcrystalline cellulose,the best flowable excipient is dextrin,and the best color excipient is microcrystalline cellulose,with the longest hygroscopic equilibrium time and the most balanced excipients.Dextrin.Comprehensive analysis of the above results,the final selection of mannitol and microcrystalline cellulose as a mixed auxiliary materials,design uniformity test.The experimental results show that when the ratio of mannitol to microcrystalline cellulose is 2:1 and the ratio of extract to excipient is 1:2,the moisture absorption of Panax notoginseng formula particles is the best.It is considered that this formula can be used as the best preparation of Panax notoginseng formula particles.4?The experiments use modern analytical techniques such as IR,DSC,XRD,and SEM to characterize Panax notooginseng granules,in order to further examine the rationality of the new preparation process.The experimental results showed that there was no physical or chemical change between extracts and excipients from Panax notoginseng granules prepared by two processes.The Panax notoginseng extract from Panax notoginseng formula granules prepared by new process can better inhibit the degree of crystallization of excipients.The surface structure of the granules which prepared by new process has changed significantly,the surface of the granules is smoother.It shows that the new preparation process is more reasonable in the production process of Panax notoginseng formula granules.5?The experiment used fingerprint and activity evaluation experiments to evaluate the quality of Panax notoginseng formulation granules.The experimental results show that in the TLC chromatograms,the Panax notoginseng formula granules have the same color spots in the same position as the reference drug and reference substance.HPLC chromatograms showed that the contents of the five major saponins in Panax notoginseng formula granules were higher.The results of XRD,IR and DSC show that the spectral lines of Panax notoginseng formula granules have the effect of spectral line superposition of extracts and excipients of Panax notoginseng and no new peaks appear,indicating that the extracts and excipients do not produce new crystal forms and no physical or chemical reaction occurred either.The activity evaluation experiment showed that Panax notoginseng formula granules and Panax notoginseng powder both can reduce blood fat,and Panax notoginseng formula granules have more therapeutic effect. |
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