Study On Preparation And Quality Control Of Ibuprofen Lysine Capsules

Ibuprofen lysine (I-Lys), the compound of ibuprofen and lysine, is a water-solubility drug . I-Lys is widely used as antipyretic, anti-inflammatory, and analgesic agents.I-Lys can be more dissolved and efficient than ibuprofen due to its high water-solubility.There are some preparations of I-Lys including in oversea markets, such as Tablets, Caplets and Injection, but they are very expensive and unavailable in China now. In the present paper, we prepared I-Lys Capsules and studied its prescription, preparation technique, quality control, stability and pharmacodynamics.In this paper, to optimize prescription, the character, angle of repose, powder rate and disintegration time of different bonding agents on prescription were studied. The preparation process of I-Lys Capsules is simple, maturity and the quality of Capsules was controllable after the optimization of preparation.In this study, the quality control and stability of I-Lys Capsules were studied. A HPLC method was established for determination ibuprofen of I-Lys Capsules and its related substances. The standard curve of assay was linear in the range of 400～500μg·mL^-1 and the correlation coefficient was 0.9999.The standard curve of dissolution was linear in the range of 2.5～100μg·mL^-1and the correlation coefficient was 0.9999. The proposed method is simple, rapid, accurate and reliable. To study the stability of I-Lys Capsules, we designed influencing factor test and accelerated test. All the speci- fications examined including dissolution rate, assay and related substances were not distinguished changed in compare with those were pre-exposured. After the Capsules were exposed to RH92.5% the moisture absorption was severe and dissolution rate a little quicker, and after those were exposed to 60℃dissolution rate was a little slower. However, the stability of I-Lys Capsules was not affected by surroundings so the I-Lys Capsules were very stable and they should be preserved in well-closed containers, and stored at controlled room temperature.The antipyretic and anti-inflammatory of I-Lys Capsules and ibuprofen Tablets was compared. I-Lys Capsules effected faster than ibuprofen Tablets due to the analysis of variance.