Study On Production Process Of Fufang Xuelian Dropping Pill

Objection:The production process and the elementary pharmacodynamics research(anti-inflammatory,analgesic)of Fufang Xuelian dropping pills were studied in this article. The processes were evaluated to be reasonable and feasible so that they can provide the technology parameters for production. Method: In the extraction process, Herba saussureae involucratae,Radix Angelicae Pubescentis,Rhizoma et radix notopterygii, Fructus chaenomelis and Cortex periplocae extracted in the same extracting technical conditions. Orthogonal design was used for studying the effect of four extracting factors (alcohol density, alcohol volume, time and times),with the chologenic acid,rutin,osthole,isomperatorin content and the solid content as markers to optimize the extraction condition and to study on purification technology by Macroporous adsorbing resins;The optimal extraction process of Rhizoma corydalis,Radix aconiti praeparata and Radix aconiti kusnezoffii praeparata are selected with single factor test and orthogonal design. The content of total alkaloid,corydalis B and the solid content are used to evaluate the optimum preparative process. In the shaping process, orthogonal test was used for the choice of matrix and refrigerant, proportion of drug and matrix, temperature of drug with the hardness, spherical degree,tailing degree, dropping process, weight's varient; and orthogonal test was used for the choice of temperature of refrigerant, size of internal and external diameter of burette, dropping speed and space with the weight's varient and dissolution's time as the evaluation quota to decide the optimum dropping condition. Pharmacodynamic model was applied to compare with the dropping pill extracts of the former purified,the later purified parts and the capsule, which to evaluate the reasonable of the process of Fufang Xuelian dropping pill. Result: In the optimum extraction process,its were as follows: Rhizoma corydalis,Radix aconiti praeparata and Radix aconiti kusnezoffii praeparata was adding 50% alcohol for 2 times, soaked 1.0h, first 8 times amount, refluxed 2.0h,then 6 times amount,refluxed 1.5h.Others was adding 12 times 65% alcohol,refluxing and extracting for 3 times,1 hour each time.Resin HPD400 gave good separation performance and was selected to purify the effective part.The optimum parameters were established as the following:4 BV sample extract whichadjusted to pH 2-3 by HCl was passed through the column with a flow rate of 1 BV/h, 12 hours later, the column was washed with 4 BV acid water, 30% ethanol,50% ethanol and 95% ethanol 4 BV,respectively. The combined 30%,50% and 95% ethanolic elutes were concentrated to yield the purified effective part.The best moulding technical conditions: make the scale of medicine and radicle was 1:2 ,the scale of PEG4000 and PEG6000 was l:l ,the refrigerant was dimethylsilicon oil,the temperature of drugs was 75℃, the internal and external diameter of burette was 3.8mm and 4.9mm, respectively, the burette was 6cm above the surface of refrigerant,drug was dropped into refrigerant of 15℃at 30 drops per minute. The results of the elementary pharmacodynamics research showed that the dropping pill extracts of the purified parts could remarkably prolong the time of mice lick its backfoot, reduce the twisting times, relieve mouse ear-swelling induced by dimethylbenzene and the increase of rat capillary permeability induced by glacial acetic acid, which were superior to the capsule(P<0.05), but there was not distinctive difference between the dropping pill samples before and after purification (P>0.05). Conclusion: The optimum processes were reasonable and feasible, pharmacodynamics were remarkable.