Partial Pharmacy Study Of Gan Shi Qing Dai Paste And Its Clinical Observation On Treatment Of Neurodermatitis

1 ObjectiveTo formulate the quality standard draft of Ganshi Qingdai Ointment; test its stability;investigate the safety of Ganshi Qingdai Ointment through skin irritation test and skin allergy test; investigate the percutaneous permeability through the experiment of percutaneous absorption in vitro; observe the clinical curative effect on treatment of neurodermatitis.2 MethodsIn the part of experimental study, the quality standard was tested on the raw and supplementary material of Ganshi Qingdai Ointment under the provisions of Chinese Pharmacopoeia 2010 edition,including of the amount of drug loading,particle size and microbial limit;establish thin-layer identification method of herbs in compound preparation;establish the method for the simultaneous determination of indigo and indirubin in Ganshi Qingdai Ointment by HPLC; To investigate the stability of Ganshi Qingdai Ointment through long-term test and accelerated test. Investigate the safty of Ganshi Qingdai Ointment through skin irritation test on White rabbits and skin allergy test on Guinea pigs;the cumulative transmittance was calculated through the experiment of percutaneous absorption in vitro using the rat skin.In the part of clinical research,patients with neurodermatitis were divided into two groups randomly according to the method of positive drug randomized control,Ganshi Qingdai Ointment group(60 cases) and Binghuang Fule Ointment group(60 cases),both of them were used twice a day,the period of treatment was 4 weeks, photos were taken to the target lesions,and the lesion area,the degree of erythema, papules and pruritus were recorded in the course of treatment, finally the curative effect was evaluated.3 ResultsIn the part of experimental study,the raw and supplementary material of Ganshi Qingdai Ointment,the amount of drug loading,particle size and microbial limit were all in accordance with the Chinese Pharmacopoeia 2010 edition; thin-layer identification method of Qingdai, Kushen and Huangbai was established, the method to determining the content of indigo and indirubin by HPLC was established;The quality standard draft was formulated.Three batches of samples were tested under the normal and accelerated conditions, the results showed that there were no obvious changes after 6 months.In skin irritation test,there was no erythema and edema neither in intact skin nor in damaged skin of white rabbits, indicated that there was no stimulation of Ganshi Qingdai Ointment to the skin of white rabbits; in ACA and PCA test, the sensitization rate of Positive medicine group was 100%,while in the other three groups, there were no allergic reactions such as erythema and edema, indicated that there was no allergic reaction of Ganshi Qingdai Ointment to the skin of Guinea Pigs.The test condition in the experiment of percutaneous absorption in vitro was established,the transdermal effect was best when using polysorbas20 -carbinol as receiving liquid.In the part of clinical research, the treatment group(PPS) has 52 cases, its total effective rate was 76.92%. The control group has 51 cases,its total effective rate was 68.60%. The effective rate between the two groups has no Statistical difference (P=0.3441>0.05)In both of the two groups,the color,pimples,area and itching degree of the lesions were obviously improved after treatment; the lesion area of the two groups has obvious Statistical difference,and the treatment group was better than the control group;while there were no significant differences on skin color and pimples between the two groups; the treatment group was better than the control group in the aspect of relieve itching,and the Statistical difference was obvious.4 ConclusionsThe quality standard of Ganshi Qingdai Ointment was established,and the quality of the preparation could be controlled; the quality was stable in 6 months under the condition of Polyethylene plastic box packaging, Sealed storage and ordinary temperature; it has no skin irritation on white rabbits and no allergic reactions on Guinea pigs, its a safe topical preparation; Ganshi Qingdai Ointment Binghuang Fule Ointment showed similar efficacy in the treatment of neurdermatitis, Ganshi Qingdai Ointment was better than on Binghuang Fule Ointment improvement of the lesion area and relieving of skin itching.