Studies On The Preparation And Quality Control Of Compound Vitamin B6 Gel

As a water-soluble vitamin, Vitamin B6 is also increasingly used in the treatment for many diseases,such as frostbite, dry ruffling, seborrheic dermatitis, glossitis. Fluocinonide belongs to drug of adrenal corticosteroids, which has anti-inflammatory, anti-allergic, anti-rheumatic effects. Due to its strong retention of water and sodium, it is currently only for external use. Fluocinonide and Vitamin B6 are joined to treat contact dermatitis, seborrheic dermatitis, neurodermatitis, chronic eczema and other skin diseases. At present, dosage forms include Fluocinonide and Vitamin B6 emulsion creams, creams, lotions. Emulsion and creams could easily lead to coat uneven, pollute clothing and absorb slow. Lotion has disadvantage of volatile and dispersed, which is restricted in clinical application. Currently, among two main drug forms in the market, there is no gel based on carbomer. As a new topical formulation, gel is even delicate texture and easy to apply the expanded coating on the skin to form a transparent film, which has advantage of strong adhesion, quick release, long residence, wash easy and no pollute clothing.The gel has non-irritating to the skin and mucous membranes, which is suitable for skin application and could improve greatly the patient medication compliance. In the present study, carbomer was used as gel matrix. A new topical gel was prepared by combining vitamin B6 and fluocinonide as main drugs. The quality control study was carried out. The lofting stability was observed according to commercially available simulation package. The release and skin irritation test were also carried out in vitro.This study was divided into the following four parts: Part 1,The prescription selecting and preparation process of compound Vitamin B6 gelVitamin B6 and fluocinolone were used as the main drugs. The assistant materials were selected from the currently prepared gel agents by prescription selecting. The type and dosage of assistant materials were selected by orthogonal test in the pharmaceutical industry. According to the order of two main drugs and ethylparaben, three kinds of preparation process were designed. A more favorable process was selected based on the indicators of the gel, including characters, viscosity, particle size and uniformity. The process reproducibility was studied by observing content, character, related substances and particle size.The optimized ratio of assistant materials was obtained by prescription selecting. The compound vitamin B6 gel prepared by the second preparation process was viscosity, good uniformity, appropriate size and good quality. The results showed that the satisfactory vitamin B6 gel formulation and reasonable preparation process were obtained. The compound vitamin B6 gel prepared was stable. Part 2, Study on quality standard of compound Vitamin B6 gelAccording to the relevant items of the standard quality of gels(Chinese pharmacopoeia and chemicals technical research guidelines), the complete quality standard of compound vitamin B6 gel was formulated. To establish the content determination method, HPLC was used to detect the content of the two main drugs and ethylparaben. The mehod validation was carried out. The other examinations of compound vitamin B6 gels were also detected, including the character, identification, p H, related substances, viscosity and particle size.The method of content determination was confirmed with the validation, which could determine the content of three components. It could achieve a separation of three substances. The separation,repeatability and reproducibility were good. Meanwhile it was specific, high accuracy and good precision. The results indicated that the quality standards could be developed for quality control of compound Vitamin B6 gel. Part 3, Experimental study on stability of compound Vitamin B6 gelAccording to Chinese pharmacopoeia,stressed acceleration and long-term test were carried out. The stability of compound Vitamin B6 gel was explored by observing the character, p H, content of two main drug, related substances.The compound Vitamin B6 gels were able to maintain stable quality at high temperature, high humidity, bright light test,acceleration and long-term test. The results showed that the quality of compound Vitamin B6 gels were relatively stable. It was suitable for long-term storage and could provide a basis for the formulation of the validity. Part 4, Release and skin irritation test of compound Vitamin B6 gel in vitroUsing percutaneous absorption test in vitro, samples were collected and detected within 0-12 h. The contents of cumulative release of two main drugs were calculated. At the same time, skin irritation test was used to investigate the security of compound vitamin B6 gel.The rate of cumulative penetration of Vitamin B6 and fluocinonide at 12 h were 61.96% and 75.11%. The test area of both blank gel and compound vitamin B6 gel had no skin erythema and edema, non-irritating to the skin of rabbit. The results showed that the vitamin B6 compound gel had good transdermal absorption and security was better.