On May 23, Qidu Pharmaceutical compound sodium acetate Ringer injection (brand name: Qi Heng, specifications: 250ml and 500ml, packaging: non-PVC soft bag) generic drug quality and efficacy consistency evaluation study was approved by the State Drug Administration, the company became the third company in the country to pass the consistency evaluation of the product.

Compound Sodium acetate Ringer injection is mainly used in clinic to supplement extracellular fluid when circulating blood volume and interstitial fluid decrease, and to correct metabolic acidosis. It belongs to body fluid, electrolyte and acid-base balance regulation drugs, and is a new generation of Ringer injection after compound sodium chloride injection, sodium lactate Ringer injection and sodium acetate Ringer injection. Compound sodium chloride injection is the first generation of Ringer's solution, containing sodium ions, potassium ions and calcium ions, but does not have the ability to buffer acid-base balance. Sodium lactate Ringer injection is the second generation of Ringer's fluid, which can increase the burden of liver and kidney after metabolism and easily cause hyperlactacemia. Sodium acetate Ringer injection, which does not contain glucose, can cause an increase in endogenous fat metabolism, resulting in low liver glycogen content and abnormal rise in blood sugar. The electrolyte composition of compound sodium acetate Ringer injection is more similar to that of extracellular solution, adding 1% glucose and using sodium acetate as buffer, which has obvious advantages in safety and medication compliance. The annual sales of the product in the past 5 years are more than 1 billion yuan, stable clinical application, and broad market prospects.

Qiheng ®- Compound Sodium acetate Ringer Injection, developed and produced by Qidu Pharmaceutical, was approved for listing in 2018, and the company initiated a project to evaluate the consistency of quality and efficacy immediately after the product was approved. The project team scientific division of labor, clear responsibilities, overall coordination, systematic in-depth research and analysis of prescription technology, raw materials and preparations quality standards, adverse reactions, domestic and foreign research progress of similar products, etc., optimized the production process and improved the quality standards. In the content determination, it was found that the impurity peak after the gluconate peak affected the baseline separation, the project team looked up the relevant information, while exploring optimization, lasted for 3 months and hundreds of tests, and finally separated the impurity peak and gluconate peak, quality control is safe and reliable, the method has applied for a national patent. During the product review, the CDE supplementary answer involves a lot of content and technical difficulty, and the most difficult question is to establish the basis for finding the fructose limit. The project team set up a commando team, consulted the major databases day and night, extracted from the massive Chinese and English literature of millions of words, and finally found the basis for formulating the fructose limit, successfully completed the supplementary answer and realized the corner overtaking.

Through consistency evaluation, this product is of great significance for improving product quality, consolidating the advantages of injection sector, especially body fluid balance products, and enhancing market competitiveness and brand influence. The product is expected to enter the tenth batch of national collection, which can better meet the needs of customers and medical units for safe, effective and accessible clinical drugs, and make new contributions to promoting the national drug collection work and the reform of the medical and health system.