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Method for determining content of chloroethanol in gelatin hollow capsule

A hollow capsule and measurement method technology, which can be applied to measurement devices, instruments, scientific instruments, etc., can solve the problems of cumbersome detection and low sensitivity, and achieve the effects of short analysis time, strong specificity, and small amount of use.

Pending Publication Date: 2021-10-26
JIANGSU TASLY DIYI PHARMA CO LTD
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  • Abstract
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Problems solved by technology

[0004] In the preparation process of gelatin hollow capsules, the toxic organic solvent chloroethanol is used, so its content must be monitored, but the existing detection methods are low in sensitivity and cumbersome.

Method used

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  • Method for determining content of chloroethanol in gelatin hollow capsule
  • Method for determining content of chloroethanol in gelatin hollow capsule
  • Method for determining content of chloroethanol in gelatin hollow capsule

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Experimental program
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Embodiment 1-4

[0035] Chromatographic conditions and system suitability test according to gas chromatography (Chinese Pharmacopoeia 2015 edition four general rules 0521) test, adopting the capillary that stationary phase is 6% cyanopropylphenyl-94% dimethyl polysiloxane is analytical column (DB -624, 30m×0.32mm×1.8μm), the initial column temperature is 80°C, keep for 2 minutes, raise the temperature to 230°C at a rate of 15°C per minute, keep for 3 minutes, the temperature of the inlet is 230°C, the detector The temperature is 250°C, the FID detector uses nitrogen as the carrier gas, the flow rate is 1.0ml per minute, the split ratio is 10:1, and the injection volume is 1.0μl.

[0036] Determination method Take an appropriate amount of gelatin hollow capsule, cut it into pieces, take 1.0g, accurately weigh it, put it in a 20ml headspace bottle, add 3ml of n-hexane accurately, seal it, soak it overnight, take the subsequent filtrate as the test solution, and do a blank test at the same time T...

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Abstract

The invention discloses a method for determining the content of chloroethanol in a gelatin hollow capsule, which comprises the following steps: step 1, preparing a test solution, taking a proper amount of gelatin hollow capsule, cutting into pieces, weighing, placing in a headspace bottle, precisely adding n-hexane, sealing, dipping overnight, taking the subsequent filtrate as the test solution, and preparing a blank sample by using the n-hexane to perform a blank test; step 2, preparing a reference substance solution, taking a proper amount of a chloroethanol reference substance, precisely weighing, dissolving with n-hexane, and quantitatively diluting chloroethanol to prepare a solution; and step 3, determination: taking the test solution, the blank sample and the reference solution prepared in the step 1 and the step 2, and carrying out gas chromatograph detection on the test solution, the blank sample and the reference solution. The detection method provided by the invention is verified by a test, and a result shows that the method is strong in specificity, good in precision and high in accuracy, and the content of chloroethanol can be rapidly measured.

Description

technical field [0001] The invention relates to a method for determining, in particular to a method for determining the content of chloroethanol in gelatin hollow capsules. Background technique [0002] Hollow capsules can also be called capsule shells, which are mainly used in the pharmaceutical industry to contain solid medicines such as self-made powders, solid powders, granules, health products, medicines, etc. Hollow capsules solve the problems of difficult entrance and poor taste for users. place. Empty capsules are generally made of food-grade pharmaceutical gelatin after refined treatment and auxiliary materials, which have good bioavailability and can be dissolved quickly, reliably and safely. [0003] Gelatin, as the main material currently used in the capsule industry, is partially degraded by collagen in connective tissues such as animal skin, bone, sarcolemma, and musculoskeletal tissue to become white or light yellow, translucent, slightly shiny flakes or powd...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/06G01N30/68
CPCG01N30/02G01N30/06G01N30/68G01N2030/047
Inventor 成芳丁爱忠孔凯丽洪林云黄巧燕
Owner JIANGSU TASLY DIYI PHARMA CO LTD
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