溶出度对照中，盐酸舍曲林的拖尾因子应不大于2.0。 根据外标法，以溶出

Dissolution controls, sertraline hydrochloride tailing factor should not exceed 2.0. <br>The external standard method, in order to control the dissolution of the average peak area of the front pin. 5 S1 calculated dissolution control S2 and the control content of the dissolution reinspection S1 at the end of the sample should be 98.0% -102.0%. <br>d. report print out and fill in the results in the appendix. <br>5.1.5 dissolution parameters <br>75rpm. <br>Dissolution volume: <br>sample volume: <br>0.45 m filter the PES. <br>Sampling point: <br>slurry method. <br>Preparation of mobile phase: <br>Preparation of dissolution medium: <br>pH 4.5 acetate buffer (Weigh 6.8g of sodium acetate trihydrate to 1000ml water, the pH adjusted with 2N acetic acid solution to 4.5 ± 0.05, mixing, filtration) <br>take eluted media that was. <br>The hybrid materials blank 0.01096g set 200ml volumetric flask, adding an appropriate amount of the dissolution medium, ultrasonic 10min, add dissolution medium diluted to the mark, the 0.45μm PES membrane filtration, filtrate was discarded early 5ml, taking The formulation ratio filtrate as accessories blank solution. <br>Weigh accurately sertraline hydrochloride reference 0.03011g, 0.03033g were placed in a 50ml volumetric flask, dissolution medium is added 35ml of ultrasound to dissolve, add dissolution medium diluted to volume, shake. <br>Two parallel formulated as the reference stock solution S1 ', S2'. <br>Reference solution (25mg specifications): <br>precision drawing reference stock solution 5.0ml 100ml flask, add diluted with dissolution medium to volume, shake, two parallel preparation.

In the solute control, the trailing factor of hydrochloric acid sherquin should not be greater than 2.0.<br> According to the external marking method, the content of the correlation control control s2 and the end of the sample with the average peak area of the first 5 needles of the solubility control should be 98.0% to 102.0%.<br>d. Print out the report and fill in the results in the appendix.<br>5.1.5 Dissolve parameters<br>75rpm.<br>Dissolve volume:<br>Sample volume:<br>0.45 m PES membrane.<br>Sample point:<br>Pulp method.<br>Preparation of flow phases:<br>Preparation of dissolved media:<br>pH4.5 acetate buffer (called 6.8g trihydrated sodium acetate to 1000ml water, adjusted pH to 4.5 x 0.05 with 2N acetate solution, mixed, filtered)<br>The dissolved medium is obtained.<br>According to the prescription ratio to take the mixing auxiliary blank 0.01096g set 200ml capacity bottle, add the appropriate amount of dissolved media, ultrasonic 10min, add dissolved medium diluted to the scale, shake well, filtered by 0.45 m PES filter film, discarded the primary filter 5 ml, take the filter as a waste solution.<br>Accurately weighed hydrochloric acid shequlin control product0.03011g, 0.03033g were placed in a 50 ml measuring bottle, added 35 ml of dissolved media ultrasound to dissolve, add the dissolved medium diluted to scale, shake well.<br>Two servings are formulated in parallel as a control stock of liquid S1', S2'.<br>Control solution (25mg specification):<br>Precision absorption control liquid 5.0 ml placed 100 ml measuring bottle, added media diluted to scale, shake well, parallel preparation of two copies.

In the dissolution control, the tailing factor of sertraline hydrochloride should not be more than 2.0.<br>According to the external standard method, the average peak area of the first five needles of the dissolution control S1 was used to calculate the content of the dissolution control S2 and the retest dissolution control S1 at the end of injection, which should be 98.0% ~ 102.0%.<br>D. print out the report and fill in the results in the appendix.<br>5.1.5 dissolution parameters<br>75rpm.<br>Dissolution volume:<br>Sampling volume:<br>0.45 μ m PES membrane.<br>Sampling point:<br>Pulp method.<br>Preparation of mobile phase:<br>Preparation of dissolution medium:<br>PH4.5 acetate buffer solution (weigh 6.8g of sodium acetate trihydrate into 1000ml of water, adjust the pH to 4.5 ± 0.05 with 2n acetic acid solution, mix and filter)<br>Take out the dissolving medium.<br>Take 0.01096g of the blank of mixed auxiliary materials according to the prescription proportion and put it into a 200ml volumetric flask, add a proper amount of dissolution medium, ultrasonic for 10min, add the dissolution medium to dilute to the scale, shake well, filter through a 0.45 μ m PES filter membrane, discard 5ml of the initial filtrate, and take the continuous filtrate as the blank solution of auxiliary materials.<br>Accurately weigh 0.03011g and 0.03033g of sertraline hydrochloride reference into 50ml measuring bottles respectively, add 35ml of dissolution medium for ultrasonic dissolution, add the dissolution medium for dilution and constant volume to the scale, and shake well.<br>Prepare two copies in parallel as reference stock solution S1 ', S2'.<br>Control solution (25mg specification):<br>Accurately suck 5.0ml of the reference stock solution into a 100ml volumetric flask, add the dissolution medium to dilute to volume, shake well, and prepare two copies in parallel.<br>