Method for determining enzyme dissolution of bexarotene softgel
A technology of soft capsules and dissolution media, applied in the field of medicine, can solve the problems of unbreakable swelling of preparations, affecting the measurement of capsule preparations, cross-linking of soft capsules, etc., and achieve the effect of overcoming the reduction of in vitro release
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Embodiment 1
[0031] Embodiment 1: the method for measuring the dissolution of besarotene soft capsule plus enzyme
[0032] (1) Prepare phosphate buffer solution: prepare 2100ml of 0.05M potassium dihydrogen phosphate solution and 450ml of 0.2M sodium hydroxide solution, add water to 6 liters, adjust pH to 7.5±0.05 with phosphoric acid or sodium hydroxide;
[0033] Prepare dissolution medium A with the above-mentioned phosphate buffer solution: add 80.0 mg of trypsin to 4 liters of phosphate buffer solution and stir evenly;
[0034] Prepare dissolution medium B with the above-mentioned phosphate buffer solution: add 30g HDTMA to 2 liters of phosphate buffer solution and stir at 37°C for 1 hour;
[0035] (2) Run the dissolution apparatus: the setting conditions are the slurry method, the dissolution speed is 75rpm / min, the temperature is 37°C, and the dissolution time is 45 minutes;
[0036] (3) Preparation of the test solution: add 600ml of dissolution medium A to the dissolution cup, run ...
Embodiment 2
[0046] Embodiment 2: Dissolution methodological research
[0047] 1. Dissolution speed and dissolution medium are added step by step: when the amount of trypsin in dissolution medium A is 20mg / L, the dissolution time is 45min, the dissolution volume is 900ml, and the speed is 50rpm / min, 75rpm / min, and 100rpm / min, the dissolution The dissolution rate of medium A and dissolution medium B mixed and added and added step by step, the results are shown in Table 1, wherein 900ml (A+B) refers to the addition of dissolution medium in one step, which includes the phosphate buffer solution of the present invention , trypsin and HDTMA, the preparation method is: add 80mg of trypsin and 30g of HDTMA to 6L of phosphate buffer, stir at 37°C for 1h.
[0048] Table 1 The results of dissolution speed and dissolution medium added step by step
[0049]
[0050] The result shows that directly adding 900ml dissolution medium, the soft capsule does not dissolve. Add in steps, and when the disso...
Embodiment 3
[0059] Embodiment 3: HPLC methodology verification
[0060] 1. Linear
[0061] 1.1 Preparation of reference substance stock solution
[0062] Weigh 80mg of besarotene compound standard into a 100ml volumetric flask (concentration is 800ug / mL), first dissolve it with 30ml of methanol, and then use the dissolution medium (the volume ratio of dissolution medium A to dissolution medium B is 2:1) Volume.
[0063] 1.2 Precisely pipette the reference substance stock solution according to Table 4
[0064] The pipetting of table 4 reference substance stock solution
[0065] sample Volume of control stock solution constant volume Concentration (ug / mL) 1 2mL 100mL 16 2 4mL 100mL 32 3 4mL 50mL 64 4 5mL 50mL 80 5 15mL 100mL 120
[0066] 1.3 The linearity measured by HPLC is y=26835.929x+6749.964, R 2 = 1.000.
[0067] 2. Precision
[0068] According to the dissolution method of the present invention, 6 besarotene soft ...
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