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Total organic carbon detection method during compound salvia miltiorrhiza dripping pill production process

A detection method and production process technology, applied in the direction of measuring devices, instruments, scientific instruments, etc., can solve the problems of difficult to meet the requirements of cleaning verification, unsatisfactory sensitivity, etc.

Active Publication Date: 2013-05-08
TIANJIN TASLY PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] At present, the cleaning verification of compound Danshen dripping pills uses UV detection method to scan the full wavelength. Due to the limitation of ultraviolet method, it can only detect substances with conjugated double bonds, and the sensitivity is not ideal (10 -4 -10 -6 )
It is difficult to meet the requirements of some units for cleaning validation

Method used

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  • Total organic carbon detection method during compound salvia miltiorrhiza dripping pill production process
  • Total organic carbon detection method during compound salvia miltiorrhiza dripping pill production process
  • Total organic carbon detection method during compound salvia miltiorrhiza dripping pill production process

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0164] Example 1 Measure the TOC value of the cleaning verification sampling point, the stirring blade of the No. 3 chemical material tank on the No. 2 line of the compound Danshen dripping pill production line.

[0165] Randomly select an area of ​​10cm*10cm on the stirring blade of No. 3 chemical material tank on Line 2, take a wiping cotton swab, moisten it with ultrapure water, and control it to dry at the mouth of the sampling bottle until no water drips, and then wipe it horizontally with the cotton swab Sampling point, turn the cotton swab over, wipe the sampling point vertically, turn the cotton swab over, wipe the sampling point from the bottom left to the top right, turn the cotton swab over, and wipe the sampling point from the top left to the bottom right. After sampling, break off the sampling cotton swab in the sampling bottle (do not touch the cotton swab head with your hands during the process). As attached in the manual figure 1 shown. Add 40ml of ultrapure ...

Embodiment 2

[0166] Example 2 Measuring the TOC value of the cleaning verification sampling point of the final rinse water of the No. 4 chemical material tank of the No. 1 line of the compound Danshen dripping pill production line

[0167] After cleaning the No. 4 chemical material tank of Line 1 according to the cleaning procedures, add a certain amount of purified water to it, rinse the entire chemical material tank, use a sampling bottle to collect about 40ml of final rinse water, and observe whether there are large particles in the sample And the color of the sample (if there are larger particles, you need to wait for the particles to settle, then take 30ml of the supernatant to another sampling bottle for testing to prevent the particles from clogging the sampling tube. If the color of the sample is darker, you need to dilute After that, the sample can be tested, in case the amount of organic carbon is too high and exceeds the detection range of the instrument.), insert the mouth of th...

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Abstract

The present invention relates to a total organic carbon detection method during a compound salvia miltiorrhiza dripping pill production process. The method comprises the following steps: 1, sampling, 2, sample treating, and 3, sample detecting. The sampling in the step 1 is wiping sampling or water leaching sampling. The sample treating in the step 2 comprises the following steps: wiping a sample: adopting a pipette gun to precisely take and transfer 40 ml of ultrapure water to a TOC vial filled with the wiping sample, and shaking for 1 min to completely dissolving substances on a cotton bud, wherein the solution is colorless after the sample is dissolved, and the obtained solution is spare to be detected; and leaching water: shaking a TOC sample vial filled with leaching water for 1 min, wherein the sample is colorless to be spare to be detected. The sample detecting in the step 3 comprises: shaking again before detecting to uniformly mix the solution, placing the sample vial in a TOC determinator to detect, and calculating a TOC value.

Description

Technical field: [0001] The invention relates to a method for detecting total organic carbon in a production environment in a pharmaceutical process, in particular to a method for detecting total organic carbon in the production process of compound salvia miltiorrhiza dripping pills. The method can be used to determine the cleanliness in the production environment and perform cleaning verification in pharmaceutical factories. Background technique: [0002] Total organic carbon refers to the total amount of carbon contained in dissolved and suspended organic matter in water. There are many types of organic matter in water, and it is not possible to separate and identify all of them at present. Often referred to as "TOC". TOC is a comprehensive indicator for rapid testing, which expresses the total amount of organic matter in water by the amount of carbon. The unit is ppm or ppb. [0003] Cleaning validation is the process of demonstrating that the cleaning of production eq...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/00G01N1/10
Inventor 王建平周庆凯孙巍孙玉侠曹凤兰
Owner TIANJIN TASLY PHARMA CO LTD
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