Study On Preparation And Antibacterial Activity Of Biyuan Dropping Pills

Objective:Rhinitis is a commonly and frequently encountered disease in clinic. Biyuan dropping pills developed by our laboratory consists of Rhizoma Coptidis,Radix Angelicae Dahuricae, fructus xanthii, flos magnoliae , Asarum Heterotropoides and Cucumis Melo. Under the guidance of the theories of Traditional Chinese Medicine and Pharmacy, the six category of new Chinese herb has been studied on pre-clinical pharmacy by adopting modern pharmaceutical techniques. Methods:Through analysing the related literature ,on the basis of the function and treatment as well as the properties of the effective components of the herbs,the extraction process was determined by using orthogonal method. With the hardness, the tailed degree, the spherical degree, the coefficient of heavy variation of the dropping pills , and others as the index to decide the proportion of extract and matrix, temperature of extract and refrigerant, size of internal diameter of the dropper, dropping speed, etc. orthogonal design was applied to optimize the proportion of extract and matrix, temperature of extract and refrigerant, dropping distance on the basis of the preliminary experiments. The TLC methods was used to indentify fructus xanthii, radix angelicae dahuricae , flos magnoliae and others in Biyuan dropping pills. The content of berberine was determined in the prescription by HPLC. Using 4 bactiral such as Staphylococcus aureus,etc. employing micro-dilution, observe the lowest inhibition concentration of Biyuan dropping pills. Results:The optimal process of the volatile oil for Biyuan dropping Pills is that: coarse powder was choosed , macerating 1 hour with 9 times water and distilling 4 hours . The optimal conditions for the water extraction of Biyuan dropping pills is as follows: macerating 1 hour with 15 times water,decocting 3 times, 1 hour for each time, the optimal shaping process were :semi-synthesized fatty acid grease and the extract atthe proportion of 4 ?' 1 were heated in a water bath and were completely stired for melting . the pills were dropping into the 65% alcohol (10°C) at temperature 40°C at the constant rate of 60 drops perminute. The diameter(internal)of the dropping tip is 2.0mm . The TLC spots developed were fairly clear, and the blank showed no interference. The result of HPLC analysis for berberine showed a good linearty between 0.1 ~ 1.0 u g with an average recover of 97.70%, RSD was 1.99%. Antibacterial experiment suggested that Biyuan dropping pills had some antibacterial effect. Conclusion:A systematic study on the procedure,quality standards and the preliminary pharmacodynamics on Biyuan dropping pills has been carried out. It is a good basis for register of new medicine .