Objective: To improve formulation and preparation technology of ligustrazine hydrochloide and sodium chloride injection. Method: With sodium citrate to adjust samples solution to pH 4.0

and try to make ligustrazine to form salt in injection

then long-term stability test

accelerated stability test and influencing factors test of three batches of pilot products was adopted

which were prepared by improving prescription. Result: Improved prescription was as following:ligustrazine hydrochloide 0.8 g

sodium chloride 9.0 g

added water for injection into 1 L

added a amount of 10% citric acid and 10% sodium citrate to adjust pH of samples solution.Under conditions of long-term stability test[24 months

room temperature of (25±2)℃]

accelerated stability test[6 months

(40±2)℃] and influencing factors test

quality of three batches of test products was stable without tiny spots and white block. Conclusion: Improved formulation and preparation process were feasible and stable.Change of pH regulator was not change substance basis of drug and controllability

safety

efficacy of drug quality

and stability of samples got better.