Résumé
Objective To establish a quality control method for detecting impurities in chloral hydrate raw materials, improve the quality standards and control limits of raw materials. Methods The determination methods of chloroform and halogenated carboxylic acid in chloral hydrate were established to monitor the change of impurities in chloral hydrate through stability. Results The research and establishment of chloroform and halogenated carboxylic acid methods met the requirements of relevant regulations for analytical methodology verification, which could accurately detect four impurities in raw materials and preparations by one method. Conclusion The study provides technical support for the improvement and optimization of the quality standards of chloral hydrate and preparations. It is very necessary to implement the impurity monitoring in preparation research and production process by the chloral hydrate impurity detection and the stability comparison of this product at high temperature and light, which could largely promote the safety of medication.
Résumé
Objective In order to solve the obvious adverse reactions of ribavirin, to develop ribavirin liposome inhalation powder and to evaluate its quality characteristics. Methods The ribavirin liposomes were prepared by the thin film dispersion method, and then lyophilized to prepare ribavirin liposome powder. The appearance, fluidity, bulk density, encapsulation efficiency, particle size of the complex solution, PDI, potential and hydrophilicity were examined. Results Ribavirin liposome powder has good morphology, particle size, potential, fluidity and hydrophilicity, which can meet the basic requirements of powder medicine for drug administration. Conclusion The technique of preparing ribavirin liposome powder aerosol preparation by this method is feasible, and it provides the basic technology for future in vivo and in vitro studies.
Résumé
Objective To establish a HPLC method for determination of related substances of risedronate sodium tab‐lets .Methods The C18 column ,5 μm ,150 mm × 4 .6 mm ,the buffer solution (3 .22 g tetrabutyl ammonium bromide was added to a buffer solution of 1 000 ml 0 .05 mol/L ammonium chloride ,then adjusted pH to 7 .8 ± 0 .05 by ammonia)‐methanol‐aceto‐nitrile =250:50:25 as mobile phase ,column temperature:room temperature ,flow rate:1 .0 ml/min ,detection length:254 nm . Results Determined by HPLC at high temperature ,acid ,alkali degradation ,the main peak and the impurity peaks were separa‐ted well ,and the peaks had a linear relationship ,Y=1 .28 × 107 X-1 .62 × 105 (r=0 .999 9) .Conclusion The method was rap‐id ,simple ,accurate and sensitive ,and suitable for determination of risedronate sodium tablets related substances .
Résumé
Objective To establish a method for determination of imatinib mesylate liposome and related substances. Methods The liquid chromatography was carried out on a Kromasil C18 column. The mobile phase A consisted of methanol-octane sulfonate solution(42:58). The mobile phase B consisted of methanol-octane sulfonate solution(4:96). The flow rate of gradient elution was 1. 2 mL·min-1 . The detection wavelength was 268 nm. The column temperature was room temperature. Results The intermediates and degraded substances could be seperated under the selected chromatographic conditions. Imatinib mesylate showed a good linear relationship within 1-100μg·mL-1,r=0. 999 1(n=5). Conclusion The method is specific, accurate,sensitive,and simple,and can be used for quality control of imatinib mesylate liposome.