医美填充类产品主要成分与盐酸利多卡因相容性研究

Compatibility of main ingredients of commonly used filling products in medical and aesthetic fields with lidocaine hydrochloride

目的研究医美领域常用填充类产品主要成分与盐酸利多卡因的相容性。方法根据《中华人民共和国药典》(2020年版)四部通则9001原料药与制剂稳定性试验指导原则和《化学药物制剂研究基本技术指导原则》中相容性试验项下相关试验要求,对医美领域常用填充类产品主要成分与盐酸利多卡因进行相容性考察。结果该研究的9种医美领域常用填充材料中,聚己内酯(PCL)与盐酸利多卡因配伍,高温条件下可促进盐酸利多卡因氧化生产杂质C;胶原蛋白(CO)与盐酸利多卡因配伍,高温和光照条件下均不产生降解杂质;透明质酸钠(HA)、聚乳酸(PLLA)、羟基磷灰石(HAP)、羧甲基纤维素钠(CMC)、羟丙基甲基纤维素(HPMC)、聚乙烯醇(PVA)和左旋乳酸-乙二醇共聚物(PEG-PLLA)7种材料与盐酸利多卡因配伍,高温条件下不产生降解杂质,光照条件下一些未知降解杂质有不同程度的增长趋势,用带有规格≥250 GSM(g/m^(2))的白卡纸作为外包装,可有效避免因光照引起的变化。结论本研究的9种医美领域常用填充材料中,聚己内酯与盐酸利多卡因配伍时不稳定;胶原蛋白与盐酸利多卡因配伍十分稳定;透明质酸钠、聚乳酸、羟基磷灰石、羧甲基纤维素钠、羟丙基甲基纤维素、聚乙烯醇和左旋乳酸-乙二醇共聚物7种材料与盐酸利多卡因配伍时增加适宜的外包装(≥250 GSM的白卡纸制成的纸盒)后稳定。

Objective To study the compatibility of main ingredients of commonly used filling products in medical and aesthetic fields with lidocaine hydrochloride.Methods According to the General Principles 9001 of the Pharmacopoeia of the People's Republic of China(2020 edition)for Stability Testing of Raw Materials and Preparations and the relevant test requirements under the compatibility test item in the"Basic Technical Guidelines for the Study of Chemical Drug Formulations",the compatibility of the main ingredients of commonly used filling products in the field of medical aesthetics with lidocaine hydrochloride was investigated.Results Among the 9 commonly used filling materials in the field of medical aesthetics in this study,the combination of Ploycarprolactone(PCL)and lidocaine hydrochloride could promote the oxidation of lidocaine hydrochloride to produce impurity C under high temperature conditions;Collagen(CO)was compatible with lidocaine hydrochloride and did not produce degradation impurities under high temperature and light conditions;7 materials,Sodium Hyaluronate(HA),Polylactic acid(PLLA),Hydroxyapatite(HAP),CM Cellulose(CMC),Hydroxypropyl Methyl Cellulose(HPMC),Polyvinyl Alcohol(PVA)and L-Lactide-Polyethylene Glycol Copolymer(PEGPLLA)compatible with lidocaine hydrochloride did not produce degradation impurities under high temperature conditions,and some unknown degradation impurities have different degrees of growth trends under light conditions.Using white cardboard with a specification of no less than 250 GSM(g/m^(2))as the outer packaging could effectively avoid changes caused by light.Conclusion Among the 9 commonly used filling materials in the field of medical aesthetics in this study,loycarprolactone is unstable when mixed with lidocaine hydrochloride;Collagen is highly stable in combination with lidocaine hydrochloride;Sodium hyaluronate,polylactic acid,Hydroxyapatite,CM Cellulose,Hydroxypropyl Methyl Cellulose,Polyvinyl Alcohol and L-Lactide-Polyethylene Glycol Copolymer,when used in combination with lidocaine hydrochloride,are stabilized after adding appropriate external packaging(paper boxes made of white cardboard of not less than 250GSM).