Research On Lysine Hydrochloride And Zinc Gluconate Oral Solution

Lysine Hydrochloride and Zinc Gluconate Oral Solution was changed dosage form on Lysine Hydrochloride and Zinc Gluconate Tablets to make children feel better when they take it. The main components of Lysine Hydrochloride and Zinc Gluconate Oral Solution are zinc gluconate and lysine hydrochloride. As a lysine supplement, lysine hydrochloride is usually used on malnutrition, hypoimmunity caused by lysine deficiency. Zinc gluconate is usually used on anorexia, growth retardation and recurrent oral ulceration caused by zinc deficiency as a zinc supplement.Objective:We researched the Oral Solution according to the regulations of the Chinese Pharmacopoeia(Ch P)(2010 and 2015 edition) and Guidance for Pharmaceutical Development of Chemical Drug Products enacted by the State Food and Drug Administration(SFDA). This research was mainly focused on the following four aspects: formulation selection, preparation process, quality standards and stability.Methods:According to the physical and chemical properties of lysine hydrochloride and zinc gluconate and the constituents of Calcium and Zinc Gluconates Oral Solution we researched the type and dosage of the excipients evaluated by stress testing. Take the characters, taste, p H and determination of this oral solution as the standards during the study. We studied the method of identification, microbial limit tests, related substances and content determination of Lysine Hydrochloride and Zinc Gluconate Oral Solution. Take the characters, p H, packing volumes, microbial limit, and related substances and content as indicators, we studied the stability of the oral solution by long-term test and accelerated test.Results: The final formulation is taking lysine hydrochloride 4.0g, zinc gluconate3.5g, sucralose 1.0g, potassium sorbate 2.0g and purified water to 1000 ml.The preparation process is adding lysine hydrochloride and zinc gluconate to 900 ml boiled purified water while stirring it, adding sucralose and potassium sorbate after the API dissolved, and adding boiled purified water to 1000 ml, mixing well. Filter and pour the solution into PET polyester bottle, foil seal and cover the lid at last. We finally choose chemical method and chromatography to identify lysine hydrochloride and zinc gluconate. Microbial limit test should perform as the regulations in general notices 1105 of Ch P2015. We set up the thin layer chromatography to exam the related substance inZinc Gluconate at first time. And the palmitamidopropyl group's column was used to determine the related substances and the content of lysine hydrochloride and zinc gluconate at first time. After contrasted the AAS and HPLC methods, we decided to determine the content by HPLC for its timesaving. This method was accurate, precise, reproducibility and stability. The results of stability tests showed that Lysine Hydrochloride and Zinc Gluconate Oral Solution were stable in 6 months.Conclusions:The results of the study indicated that the formulation and preparation process of Lysine Hydrochloride and Zinc Gluconate Oral Solution are reasonable and feasible, the quality can be controlled, and the solution is stable. All in all, the research above provides an experimental basis for further study and new drug application.