Study On The Pharmacy Of Toutongning Nasal Spray

The toutongning nasal spray are modern compound Chinese medicine that studied bychanging form of prepared drugs that used in clinic, which is used to cure hemicrania、megrim、and migraine. According to the standard of the Chinese new drugs, we studied itspreparation process, quality standard and preliminary stability systematically with modernscience and technology. The study details are as the following:1.Study on Literature: With the guidance of Traditional Chinese Medicine, the sourceof the prescription, the survey of the studies and the significance of developing the issue areelaborated widely. At the same time, we sum up the present research about cavum nasiadministration.2.Study on preparation process: With carrying on the volatile oil of the prescriptionmedicine material, the water decoction craft and ethanol to sink craft, by orthogonaldesign, we get a volatile oil to withdraw the best craft, The decoction of water withdrawsthe best craft and ethanol to sink the best craft. With the index of the clear degree ofpreparation, the pH worth, the even of volatile oil dispersion and the productivemaneuverability, and so on. the preparation forming technology was studied withparallel-contrast and orthogonal experiment. We select quality, mixture ratio, use level ofaccessories. We choose the preparation progress, the the end the make sure the of model thecraft is:The medicine of liquid joins the the distilled water to 1:2. joining the volatile oil,various of accessories, load separately, then get.3.study on quality control method: Establish the examination items of the preparationgeneral rules of toutongning nasal spray with recommend pH、weight differential andother indications. Set up the composition identified method of Ligusticum chuanxiongHort.. Radix angelicae dahuricae. Radix saposhnikoviae and Herba menthae by TLC.Establish a method for contend of Aconitine-type Alkaloid and ferulic acid determination intoutongning nasal spray by Acid-dye Colorimetry and HPLC. Stipulate the minimumlimit quantity of Aconitine-type Alkaloid and ferulic acid.On the basis of the above studies, we draw up the quality standard draft of toutongning nasal spray and it’s specification.4. Stability investigation: Because toutongning preparation belong to preparation ofcavum nasi administration, the stability test is carried out on the basis of the drug physicsand chemistry character and its applied purpose, referring to preparation of cavum nasiadministration items requirements of Pharmacopoeia of the People’s Republic of China(2005 Ed, Part 1, Appendix IX), nasal spray items requirements of Pharmacopoeia of thePeople’s Republic of China (2005 Ed, Part 2, Appendix IR)and the relative items in "Thetechnical requirement on new Chinese traditional medicine quality stability research".According to the quality standard draft of toutongning nasal spray, the preliminary stabilityinvestigation were carried on within three months, which showed that the indications werein the qualified range, and the tablets were stable in the condition of it’s packaging.