ABSTRACT
OBJECTIVE:To establish the method for simultaneous contents determination of 5 kinds of acid and alkaline componentsin anti-cold compound preparation. METHODS:HPLC method was adopted. The workstation was Auto·Blend Plus software of ACQUITY Arc system. The determination was performed on Discovery?HS F5-5 column with mobile phase consisted of acid mixture-base mixture-methanol-0.3% triethylamine (gradient elution) at the flow rate of 1.0 mL/min. The detection wavelengths were set at 270 nm (acetaminophen,salicylamide,chlorphenamine maleate,triprolidine hydrochloride) and 299 nm (aspirin). The column temperature was 35 ℃,the sample size was 20 μ L. RESULTS:The linear ranges of acetaminophen, salicylamide,acetylsalicylic acid,chlorphenamine maleate,triprolidine hydrochloride were 26-411 μ g/mL(r＝0.999 6),16-254 μg/mL(r＝0.999 8),16-748 μg/mL(r＝0.998 1),35-565 μg/mL(r＝0.999 8)and 25-404 μg/mL(r＝0.999 7),respectively. LOQ were 3.6,3.1,4.0,9.6,6.3 μ g/mL;LOD were 1.9,1.3,1.4,2.9,2.3 μ g/mL,respectively. RSDs of intermediate precision, stability and reproducibility tests were all lower than 2%. Average recoveries were 100.0%-102.0%(RSD＝0.59%,n＝9), 95.2%-101.0%(RSD＝1.55%,n＝9),96.2%-99.9%(RSD＝1.24%,n＝9),96.2%-101.5%(RSD＝1.57%,n＝9),96.3%-98.9%(RSD＝0.83%,n＝9),respectively. RSDs of durability tests were lower than 3%. CONCLUSIONS:The method is simple, accurate,precise,stable,reproducible and durable,and can be used for simultaneous contents determination of 5 kinds of acid and alkaline components in anti-cold compound preparation.
ABSTRACT
OBJECTIVE: To compare several METHODS: ameliorating the disintegration of calcium citrate tablet .METHODS: To prepare calcium citrate tablet by six different METHODS: and to determine and evaluate the prepared tablet in respect to the apperance,difference in weight of tablets,hardness,friability and stability .RESULTS:The disintegration was not significantly ameliorated by increasing disintegrant or decreasing lubricant .The hardness was decreased and the friability was increased by decreasing the amount of binder or adding more disintegrant or crushing calcium citrate to powder.The two latter METHODS: increased the difference in weight of tablets.CONCLUSION:The optimal method to ameliorate the disintegration is to diminish the grain diameter and the other parameters of quality is able to be up to the standard.
ABSTRACT
Objective: To investigate several factors influencing Tongmaihuashuan Capsule packing variation. Methods:To prepare Tongmaihuashuan granule with different granule size and distribution. To add the talcum for 0,2%,5% in order to increase its fluidity and to place the granule under the different humidity in order to maintain different water content. To fill the capsule with these granules by the capsule filling machine with the rotating velocity of 1100r/min and 1430r/min, respectively. To determine precisely the capsules average weight and compare their weight standard deviation. Results: When the granule size of “b” is more uniform than that of “a”, the weight standard deviation of “b” and “a” are 0.0525g and 0.0623g, respectively. When the talcum is added for 0,2%,5%, the weight standard deviation are 0.064g, 0.052 g and 0.047g, respectively. When the water content of granule are 2.4%, 4.1%, 9.8%, the weight standard deviation are 0.043g, 0.064g, 0.075g . When the velocity of capsule filling machine are 1100r/min and 1430r/min, the weight standard deviation are 0.053g and 0.062g. Conclusion: The granule size, fluidity, water content and the velocity of capsule filling machine influence Tongmaihuashuan capsule packing variation. In order to control the capsule quality, these factors should be considered and optimized.