The Development And Quality Research On Halometasone Triclosan Cream

Chronic dermatitis and eczema is the most common dermatological disease,often characterized by inflammation and itching of the epidermis.The etiology of dermatitis and eczema is complex and may be caused by multiple factors.The two most common eczemas are seborrheic dermatitis and atopic dermatitis.Studies abroad have shown that the occurrence of dermatitis has a close relationship with bacterial infections,especially S.aureus infections.The exotoxins secreted by them have superantigen characteristics and can induce or even aggravate dermatitis and eczema.Therefore,in the treatment of dermatitis and eczema,antibacterial treatment of damaged parts of the skin is also necessary.In this study,we combine halomethasone which has powerful anti-inflammatory effect of significant glucocorticoid and triclosan which has broad-spectrum antibacterial agent these two main drugs,ascorbyl palmitate,cetyl alcohol,2-phenoxyethanol,sodium lauryl sulfate,EDTA-2Na,glycerin,propylene glycol,stearic acid,stearyl alcohol,and white petrolatum were used to be a a compound preparation-halometasone triclosan cream.And we carried out the following research:First of all,we conducted a study on the formulation process:selecting the appropriate emulsifiers,stabilizers,preservatives,and antioxidants;screening the amounts of cetyl alcohol,stearyl alcohol,and stearic acid;By examining the Indicators we determine the optimal prescription.Secondly,during the terms of quality research,we made reference to homemade cream Sicorten plus' s import registration standard JX20080304 in China and requirements for creams in the 2015 Pharmacopoeia.We used HPLC to determine the related substances and contents of halometasone and triclosan and conducted detailed methodological studies to provide experimental basis for the quality control of halomethasone triclosan cream.At the same time,stability inspections also play a crucial role in the quality management of pharmaceuticals.In order to determine the storage conditions of halometasone triclosan cream,we investigated the influence of temperature,humidity,and light on self-made creams from three aspects: influential factors,accelerated tests,and long-term tests.The test results show that the self-made cream has good stability and is suitable for storage in a cool place,avoiding high temperatures.Finally,we conducted in vitro transdermal absorption tests on self-made creams and commercially available creams.The results showed that the permeation capacity of self-made creams and commercially available creams is similar,and it can be considered that both have consistency in transdermal absorption in vitro.