注射用氨酪酸的制备与质量控制

目的研究注射用氨酪酸的处方与制备工艺，并建立其含量测定方法。方法对注射用氨酪酸灭菌粉末的赋形剂进行筛选，并研究其制备工艺，以柱前衍生化高效液相色谱法测定其含量，用薄层色谱法检测其他氨基酸。并考察注射用灭菌粉末的稳定性。结果注射用氨酪酸的最佳赋形剂为甘氨酸。柱前衍生化高效液相色谱法测定氨酪酸含量灵敏、准确，薄层色谱法检测其他氨基酸可行，注射用氨酪酸制剂稳定性良好。结论该处方和工艺简单可行。制剂质量稳定．

Preparation and Quality Control of Aminobutyric Acid for Injection

Objective To study the formula and preparation technology of aminobutyric acid for injection and to set up a method for its content determination. Methods The excipients of the sterilized powder of the aminobutyric acid for injection were screened and its preparation technology was studied.The content of aminobutyric acid was determined with the pre-column derivation HPLC by reacting with 6-aminoquinoly-N-hydroxysuccinimdyl carbamate(AQC).The other amino acids were assayed with thin layer chromatography(TLC).The stability of the sterilized powder of the aminobutyric acid for injection was inspected. Results The best excipient for the aminobutyric acid for injection as glycine.The RP-HPLC method was sensitive and accurate in the content determination of aminobutyric acid and the TLC method was feasible in the assay of other amino acids.The preparation of aminobutyric acid also showed good stability. Conclusion The preparation technology of the aminobutyric acid for injection was shown to be simple and convenient,and the preparation was also stable.