The Study Of Development Of Purring Injection

The major component of purring injection purring is willing legumes kudzu Pereira or rose in a falconoid glycoside. Purring mainly used in the clinical treatment of coronary heart disease, angina and myocardial infarction, retinal artery and vein obstruction, sudden deafness, and so on.In this paper, according to the "Drug Registration management practices" requirements, according to the nature of prescription drugs in the pharmacological effects and determined Purring injection production processes and quality standards and their initial stability test was studied.Purring based medicine, propylene glycol for the co solvent, hydrochloric acid or sodium hydroxide solution for PH regulator, the Canadian injecting water into Purring injection. The solubility of observation, that for every 100 mg of purring be completely dissolved in 1 ml of propylene glycol, so every 250 mg of purring can be completely dissolved in 5 ml of solvent, that is the prescription of purring prescription can be completely dissolved in the solvent volume; Through Preparation 10 different pH values Purring Injection and at 10 days at room temperature, the test results showed that in the Pharmacopoeia purring injection of PH value of good physical and chemical stability; we finally decided sterilization conditions 100℃flow of steam sterilization 30 minutes.Quality standards in the study, purring in color identification, the three batches of samples, and a number of commercial goods in response to test results were positive. In preparation by HPLC determination of purring in content, and other components can be better separated.In accelerated stability test, in accordance with the Guiding Principles of Drug stability test, the appearance of characters purring injection, the solution of color, PH, we can see that foreign body, the material and content inspection, the results no obvious change in the indicators, show that the goods under the conditions in the accelerated nature of a test stability; After the goods inspected 12 months long, sample the indicators compared with 0, no obvious change in the long-term that the goods inspected conditions, the nature of relatively stable.