Panax Active Cream Preparation Process And Quality Standards

Objective:To establish the preparation and quality standard of the Sanqihuoluo Ointment (SQHL Ointment).To set up the pharmaceutical foundation for the study on new drug exploitation of SQHL Ointment.Method:◆Quality control of the medical materials According to the requirement of China Pharmacopoeia 2005,all the medical materials in prescription will be identified and determined.◆Study on preparation The dosage form is selected to be O/W ointment owing to the characteristics of treatment on orthopedics and grammatology.The medical materials are divided into two groups according to their properties..Two kinds of extraction are applied to the different groups.According to common property of pubescent angelica,angelica saneness and dried ginger,they will be extracted by percolation simultaneously,The residual medical materials will be extracted by alcohol extraction.HPLC will be used to measure the content of osthole and polydatin in the two different kinds of extaction respectively,and orthogonal design will be used to optimize both of extracting processes. To research the forming process of SQHL ointment preparation,and the stability of it will be investigated after that.The process parameters will be investigated in 10 batches of SQHL ointment.◆Study on quality standard of SQHL ointment Angelica sinensis,pubescent angelica, panax notoginseng are planned to be identified by TLC.α-Pinene,β-Pinene,Cineole, Camphor,isobomeol,bomeol,eugenol and laurocapram are planned to be identified by GC. The content of aconitine in SQHL ointment are planned to be moritored by UV-spectrophotometry.General examination items of ointment will be completed.The content of polydatin and osthole in the SQHL ointment are planned to be determined by HPLC.The content of Cineole,Camphor,bomeol and eugenol are planned to be determined by GC simutaneously.Result◆The result of quality on the medical materials All the medical materials and essential oils are collected in China Pharmacopoeia 2005,and they all are accordance with the requirement of China Pharmacopoeia 2005 respectively.◆The result of the preparation It was found that the diacolation procedure could achieve a good result when the medical materials were percolating at the speed of 3ml/min, with 6-time 80%ethanolwater solution after infused for 24h,and the result of the methol extraction as follow:adding 6-time 70%ethanol extracting within 1h for 3 times.◆The result of forming process Mix the extraction with glycerol,sodium benzoate, and aqueous solution of carbomer,and heated at 60℃to form the water phase.,Adjust the value of pH of the water-phase to 6.7-7.0.Then mixed the laurocapram and emulsifier together and heat them at 60℃to become excipient oil phase,and put turpentine,menthol, borneol,camphor and basil oil into the excipient oil phase to become oil phase.Lastly,mix the oil phase with water phase before adding water and grinding.◆The result of pilot test The dose of pilot test was 10 times as that of prescription. The pilot test was completed according to the best scheme of preparation.As a result,the transferring rate of the polydatin and osthole is 73.85%and 80.32%respectively.◆The result of quality standard TLC and GC identification for 10 kind of metarial in the prescription were established.It was proved that the method is simple and accuracy and all the result are positive.The method of monitor the content of the aconitine in the product was established.It was proved that the method is feasible and accuracy.As the result,the content of the aconitine must be not more than 0.17mg/g in the product,,HPLC was used to determination the polydatin.Its coefficient of linear correlation(R)is 0.9999,recovery rate range from 100.57%to 101.53%.It was confirmed that the least content of polydatin in product must more than 0.03mg/g after the 10 batches of the pilot test had been determined. It was established that the contents of Cineole,Camphor,borneol and eugenol were determined by GC simutaneously and the mothed is simple and accuracy.All the values of R is more than 0.996,recovery rates of them were more than 98.39%..It was confirmed that the contents of Cineole,Camphor,bomeol and eugenol must be more than 10.4mg/g,20.8mg/g,5.8mg/g,and 7.2mg/g after 10 batches of the pilot test had been determined.Conclusion The methods of preparation are reasonable and the quality standard is established successfully to monitor the SQHL ointment.