1.目的
为使仪器正常运转，保证结果之可靠性，特制定此操作规程。
2.适用范围
化验室
3.责任者
化验员应严格遵照该操作规程,QC主管负责监督本规程的实施。
4.定义
无
5.安全注意事项
无
6.操作规程
6.1.准备
6.1.1.控制水槽水位，使之高于溶出杯中介质的高度。
6.1.2.开启溶出仪，自动取样器及打印机电源。
6.1.3.排除对试验有影响振动干扰。
6.1.4.调节高度：将桨或蓝的底部轻轻置于杯的底部，抬起显示面板，垫上标准垫块P或B(P为转桨法，B为转蓝法)，放下显示面板，测桨或蓝的底部距杯底距离应为2.5+0.2cm。
6.1.5.溶出介质使用前需脱气。
6.1.6.设定试验所需参数：按JKL键进入PROTOCOL画面，依次设定转速、水浴温度、试验时长、自动打印间隔、设定药品名称、药品剂量及测定方法。
6.1.7.按Esc键退回主菜单后，光标移至Header项下，输入操作员姓名，药品批号及注意事项，按ENTER键。
6.2.试验操作过程
6.2.1.在采用逐个取样时，转蓝法要在转蓝到位后才能按下RUN键启动计时，桨板法要在药片到达底部时才能启动转轴计时。
6.2.2.采用自动样器要注意交叉污染。
6.2.3.取样位置在转蓝上部或转桨叶上部到介质表面中间位置，距离溶出杯壁约1cm处取样，并尽量在30秒内完成。
6.2.4.按各药品项下规定取出适量溶液，弃去初滤液，续滤液备用。
6.2.5.样品取出待冷却到室温后，按规定方法测定。
6.3.结束工作
6.3.1.先清洗转蓝或转轴，再取出杯子进行清洗。
6.3.2.试验结束后按STOP键，待画面消失后，切断电源。
6.3.3.试验中如有不正常情况，应做记录并报上级主管。
6.4.在使用此设备后应填写使用记录(参见附录1)。
7.仪器的维护
7.1每次实验完毕，要将溅洒在系统上的溶出介质，用湿布擦拭干净.
7.2每周检查两个水浴循环器，检查空气滤头是否堵塞，气泡的流动形
状是否正常，至少每月更换一次水浴锅中的水，每六个月更换一
次水浴循环器的空气滤头。
7.3 Check the accuracy of the temperature every six months. If the temperature displayed by the temperature probe is the same as that of a
Compared with the calibrated glass thermometer, if the temperature difference exceeds 0.1oC, it must be calibrated sequentially
The temperature of the temperature probe and Water Bath.
7.4 Check the drive head and guide rod every six months. If the up and down movement of the guide rod is not smooth enough, you need to
On the guide rod, apply a proper amount of lubricating oil.
7.5 Check whether the rotation of the bearing is flexible every six months. If there is any problem, you need to contact the maintenance engineer.
7.6 Check whether the idler wheel rotates flexibly once a year, and check the wear of the drive belt, the tightness and vibration of the drive belt during movement. If the drive belt is found to be excessively worn, it must be replaced with a new one.
7.7 Verticality Correction of Dissolution Apparatus Paddle
The person in charge of laboratory instruments uses a calibrated triangular ruler to measure the verticality of each paddle every week. Each paddle should be 90 degrees from the bottom platform of the dissolution apparatus. If there is any abnormality, notify the supplier in time Adjust it.
7.8 Calibration of the Center Position of Dissolution Apparatus Paddle
Every week, the person in charge of the laboratory instrument uses the calibration tool provided by the supplier to measure the center position of each blade, and measure the center position of each blade under the operating conditions of 50rpm and 100rpm respectively.
Acceptance limit: the deviation should not be greater than 2mm.
7.8 The height between the paddle of the dissolution apparatus and the bottom of the dissolution vessel
The person in charge of laboratory instruments uses the calibration tool provided by the supplier every week (the diameter of the tool should be calibrated with a calibrated travel caliper every year, and the diameter should be within the range of 25±2mm) to adjust the dissolution apparatus paddles and dissolution vessels. Measure the spacing of the bottom, place the paddle of the dissolution apparatus in the normal operating state, use this tool to measure the spacing of the 6 dissolution cups, the ball should just pass through the spacing.
8. Calibration of the instrument
8.1 Calibration frequency: every 6 months
8.2 Main console level detection:
Use a spirit level to check the level, and calibrate the main control platform at the operating position to ensure that the main control platform and the base are level.
8.3 Rotation speed:
Use the calibrated tachometer to calibrate the speed of the instrument, paste a special reflective tape on the shaft of the dissolution apparatus, set the speed of the instrument to 50rpm and 100rpm, and use the tachometer to measure. Each axis needs to be measured for 1 minute, and the 3 readings displayed are randomly recorded, and the average value is taken as the measurement result.
Acceptance limit: The measurement result needs to be within ±4% of the set value.
8.4 Water bath temperature:
将溶出仪的温度设定在37℃，待仪器温度达到稳定后使用经过校正的温度计对每个溶出杯的温度进行测定，从1号杯至6号杯逐个进行测定并记录，随后重新对6个溶出杯的温度进行测定，取平均值为测定结果。
接受限度：测定结果需要在37±0.5℃的范围内。
8.5去氢可的松10mg片溶出度测试
标准溶液：取约16mg去氢可的松对照品于100ml容量瓶内，加入5ml无水乙醇，用水稀释至刻度。取该溶液5ml于100ml容量瓶内，加水稀释至刻度。
向每个溶出杯内加入500ml经过脱气的纯化水。设定仪器的参数为37℃，50rpm。在每个溶出杯内加入一片10mgUSP去氢可的松校正片待30分钟后(±36sec).取15ml溶液，弃去1~2ml初滤液。取续滤液在242nm测定标准溶液及样品溶液的吸收度。
按下式计算去氢可的松的Q值
8.6水杨酸片溶出度测试：
0.05M磷酸缓冲液的配制：称取61.24g磷酸二氢钾于2250ml无二氧化碳水中，加入1760ml的0.2M的氢氧化钠溶液(取16g氢氧化钠于2000ml无二氧化碳水中)。然后用无二氧化碳水稀释到9L。确保在室温条件下该溶液的pH值在7.35~7.45之间。
标准溶液：取约45mg去水杨酸对照品于250ml容量瓶内，用0.05M的磷酸钾缓冲液稀释到250ml。取20ml该溶液于100ml容量瓶内，用0.05M的磷酸钾缓冲液稀释至刻度。
向每个溶出杯内加入900ml的0.05M的磷酸钾缓冲液，设定仪器的参数为37℃，50rpm。在每个溶出杯内加入一片300mgUSP水杨酸校正片待30分钟后(±36sec)。取15ml溶液，弃去1~2ml初滤液。取续滤液10ml,用磷酸盐缓冲液稀释到20ml。在296nm测定标准溶液及样品溶液的吸收度。
按下式计算水杨酸的Q值
9.化验员的培训
化验员需要经过操作及日常维护的培训后，方能使用该仪器。
10.参照
《SR8plus溶出仪使用手册》
《DISSOETTEII自动取样器操作手册》
CAP002溶出度的测定(Version02)
11.分发部门
Quality Assurance Department
12. Revision history:
In the daily inspection of the dissolution apparatus, the requirements for the verticality and centrality of the paddles of the dissolution apparatus and the calibration of the bottom of the paddle and the bottom of the dissolution vessel are added.
