Theoretical And Experimental Study On Investigation On The Stability Of Shengmai Concentrated Ointment

Objection: Estimate the stability of shengmai concentrated ointment after variety of stability tests by determine chemical composition of the concentrated ointment ingredient give base for predict the concentrated ointment shelf life and condition of storage.Methods: The chemical composition were determined by Think Layer Chromatography(TLC) method. The contents of Panaxsaponin Re and lignan were determined Spectrophotometry method.The dosage form was carried of①long﹣term test: put the concentrated ointment 7 months under the condition of (25±2)℃and RH(60±10)%, take sample at the time according to the Pharmacopoeia to confirm its shelf life.②Classical constant temperature test: put concentrated ointment at different temperature of 60℃,70℃,80℃,90℃, take sample at different time, the change of different indexes content at different time was determined to estimate the shelf life of the concentrated ointment.③Stress test: under the condition in the pharmacopoeia stress test, exposed the concentrated ointment to high moisture(90±5) % ,high temperature (60℃)and tungsten lamp(4500±500lx)for 10days,determine the infuse of these condition to concentrated ointment by the result of different indexes.④Moisture stability test: put concentrated ointment under relative humidity (RH)30%,45%,60%,75%,90%condition for 7 days,estimate this concentrated ointment critical relative humidity (CRH).⑤Accelerated test of the Pharmacopoeia: put sample under temperature (40士5)℃and RH(60士5)% condition 3 months, the change of different indexes content at different time was determined to estimate the shelf life of the concentrated ointment.Results: 1,Result of TLC: the concentrated ointment compositions stability by TLC is stable and there is not any difference between the experiment result and stability control standard.2,Result of quantity control:①Stress test make it certain that this concentrated ointment ingredients have certain moisure stability, photo stability and temperature stability.②The activate energies of different indexes was calculated based on Arrhinius formula and the shelf–life was predicted 1.72(a)for Panaxsaponin,2.4(a)for lignan.③The result of accelerated test in the pharmacopoeia indicate the concentrated ointment has the quality to apply for the clinical test.④Long–term experiment:quantity test give different shelf–life according to different indexes. The shelf–life was predicted 2.0(a)for Panaxsaponin, 3.6 (a)for lignan.⑤The CRH is 54.1% .Conclusion: After variety of stability test to the shengmai concentrated ointment,determined its stability in different condition.So there are kinds of factor influence its stability. There for by variety of indexes to estimate the stability of Chinese medicine may be the best way to measure shelf life.