CAJ | 학술논문

磷酸肌酸作为一种的新能量供给剂，能够给心肌细胞提供外源性能量，维持细胞高能磷酸水平，同时它还能通过稳定心肌细胞的纤维膜，抑制膜磷脂的降解，从而保护心肌。自国内仿制品上市十余年来，临床应用的适应症不断扩大，具有使用安全，疗效确切，质量可控等特性，因此国家药典委员会拟将载入2015版中国药典二部，在药学研究方面做出了更高的要求，本文针对磷酸肌酸钠的药学研究中，结晶水与晶型，质量标准提高的具体方面，如稳定性及贮藏条件，杂质限量及钡盐的控制，合成工艺与含量等进行了详细的解析。国家药典委员会制订的磷酸肌酸钠原料及制剂的质量标准，全面提升了产品的安全性，有效性和质量可控水平，最大程度地保证了患者的使用利益，维护了公众健康。
린산기산작위일충적신능량공급제，능구급심기세포제공외원성능량，유지세포고능린산수평，동시타환능통과은정심기세포적섬유막，억제막린지적강해，종이보호심기。자국내방제품상시십여년래，림상응용적괄응증불단확대，구유사용안전，료효학절，질량가공등특성，인차국가약전위원회의장재입2015판중국약전이부，재약학연구방면주출료경고적요구，본문침대린산기산납적약학연구중，결정수여정형，질량표준제고적구체방면，여은정성급저장조건，잡질한량급패염적공제，합성공예여함량등진행료상세적해석。국가약전위원회제정적린산기산납원료급제제적질량표준，전면제승료산품적안전성，유효성화질량가공수평，최대정도지보증료환자적사용이익，유호료공음건강。
Creatine phosphate as a new energy supply agent was capable of providing exogenous energy to the heart muscle cells and maintaining high energy phosphate levels of cells, but it also through stabilizing fiber membrane of myocardium cells, get inhibition of degradation of membrane phospholipids, so as to myocardial protection. Since domestic imitation listed more than ten years, indications of clinical applications continued to expand, with the use of safe, effective, controllable and other characteristics, and therefore the State Pharmacopoeia Commission intends loaded version of 2015 Chinese Pharmacopoeia, made a higher demand in pharmaceutical research, this paper pharmaceutical research of phosphate sodium in crystalline and crystalline water, improving specific aspects of quality standards, such as stability and storage conditions, control of impurity limits and barium salts, conducted a detailed analysis of synthetic process and content. Creatine phosphate sodium quality standards of raw materials and preparations formulated by State Pharmacopoeia Commission enhanced the safety, effectiveness and control level of quality, to ensure that the interests of maximizing the use of patients, maintaining public health.