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Pretreatment method for detecting content of main drug and related substances in sustained-release preparation

A technology for sustained-release preparations and related substances, applied in the field of analytical chemistry, can solve the problems of inability to detect active drug content, serious loss of chromatographic columns, and easy contamination of chromatographic systems, and achieve improved fluidity, reduced solution viscosity, and sensitive detection results. Effect

Active Publication Date: 2020-11-27
BEIJING TIDE PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, due to the swelling of the hydrophilic gel matrix material with water and the presence of high-viscosity excipients, compared with ordinary sustained-release tablets containing only a hydrophilic gel matrix, the viscosity of the matrix system is higher, resulting in poor fluidity. , it is difficult to disperse or centrifuge in the pretreatment process of drug detection, and it is impossible to detect the content and related substances of active drugs
[0004] Chinese patent application 201511033198.4 discloses a pre-testing method for a hydrophilic gel skeleton type sustained and controlled release solid preparation, which describes the use of organic phase / water as a dispersion medium , and then through the action of amylase or cellulase, the fluidity of the solution system is improved. However, this method takes a long time to treat with enzymes, and the macromolecular protein remaining in the sample is easy to contaminate the chromatographic system. The loss is relatively serious, and enzymes have certain catalytic properties, and it is easy to introduce foreign aid substances. Therefore, it is necessary to develop a fast and accurate method that has the same precipitation effect on this type of sustained-release solid preparation

Method used

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  • Pretreatment method for detecting content of main drug and related substances in sustained-release preparation
  • Pretreatment method for detecting content of main drug and related substances in sustained-release preparation
  • Pretreatment method for detecting content of main drug and related substances in sustained-release preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0033] Comparison of different diluents and dilution steps in sample pretreatment of pregabalin sustained-release tablets

[0034] 1. Dilution step

[0035] 1) Dilution step 1: first add methanol, shake for 10 minutes to disperse, sonicate, then add water (20:80)

[0036] 2) Dilution step 2: first add acetonitrile, shake for 10 minutes to disperse, sonicate, then add water (20:80)

[0037] 3) Dilution step 3: first add methanol, shake for 10 minutes to disperse, ultrasonic, then add calcium chloride solution (20:80)

[0038] 4) Dilution step 4: first add acetonitrile, shake for 10 minutes to disperse, ultrasonic, then add calcium chloride solution (20:80)

[0039] 2. Processing method

[0040] 1) Treatment method 1: Weigh an appropriate amount of fine powder after grinding (about 1000 mg of pregabalin), put it in a 500 mL volumetric bottle, and dilute it according to the dilution step 1. The sample becomes gel and has no fluidity, and the follow-up cannot be completed. proce...

Embodiment 2

[0049] Comparison of different precipitants in sample pretreatment of pregabalin sustained-release tablets

[0050] 1. Precipitating agent

[0051] 1) Precipitating agent 1: 10% potassium chloride

[0052] 2) Precipitating agent 2: 10% sodium sulfate

[0053] 3) Precipitating agent 3: 10% calcium chloride

[0054] 2. Processing method

[0055] 1) Treatment method 1: Weigh an appropriate amount of fine powder after grinding (about 1000 mg of pregabalin), put it in a 500 mL measuring bottle, first add methanol, shake for 15 minutes to disperse, ultrasonicate, then add precipitant 1, shake well, Sonicate for 15 min, let cool to room temperature, add precipitant 1 to dilute to the mark, shake well, centrifuge, take the supernatant and filter, and take the subsequent filtrate to obtain the final product.

[0056] 2) Treatment method 2: Weigh an appropriate amount of fine powder after grinding (about 1000 mg of pregabalin), put it in a 500 mL measuring bottle, first add methanol...

Embodiment 3

[0063] Comparison of different concentrations of precipitant in sample pretreatment of Pregabalin Sustained-release Tablets

[0064] 1. Precipitant concentration

[0065] 1) Precipitant concentration 1: 1% calcium chloride solution

[0066] 2) Precipitant concentration 2: 40% calcium chloride solution

[0067] 2. Processing method

[0068] 1) Treatment method 1: Weigh an appropriate amount of fine powder after grinding (about 1000 mg of pregabalin), put it in a 500 mL measuring bottle, first add methanol, shake for 15 minutes to disperse, ultrasonicate, then add precipitant concentration 1, shake well , sonicate for 15 min, let cool to room temperature, add precipitant concentration 1 to dilute to the scale, shake well, centrifuge, take the supernatant and filter, take the subsequent filtrate, that is.

[0069] 2) Treatment method 2: Weigh an appropriate amount of fine powder after grinding (about 1000 mg of pregabalin), put it in a 500 mL measuring bottle, first add methan...

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Abstract

The invention discloses a pretreatment method for detecting the content of a main drug and related substances in a sustained release preparation containing a hydrophilic gel skeleton and a high-viscosity auxiliary material. The method is characterized in that an organic solvent is used as a dispersing solvent, inorganic salt is used as a precipitator, and the main component content and related substances in the sustained-release preparation are separated and determined through repeated shaking in combination with auxiliary treatment steps such as grinding, centrifuging, filtering and the likeunder the ultrasonic action for a certain period of time. According to the invention, the viscosity of a sample solution can be effectively reduced and the flowability is increased; dispersion and subsequent centrifugal filtration operation become easy, no substantial interference on the detection of the content and the related substances in the detection process is caused, the method has the advantages of strong specificity, high sensitivity and good accuracy, and can be effectively used for the quality control of the content and the related substances in the sustained release preparation containing the hydrophilic gel skeleton and the high-viscosity auxiliary material.

Description

technical field [0001] The invention relates to the technical field of analytical chemistry, in particular to a pretreatment method for detecting the main drug content and related substances in a sustained-release preparation, and in particular to a main drug in a sustained-release preparation containing a hydrophilic gel skeleton and high-viscosity auxiliary materials content and pretreatment methods of related substances. Background technique [0002] Drugs are generally used in the form of preparations to prevent, treat and diagnose diseases, and their effectiveness, safety, rationality and precision reflect the level of medicine and determine the effect of drugs. The first-generation dosage form is simply processed into pills, tablets, injections, capsules and aerosols for oral and external use. The drug activity of the second-generation dosage form is greatly improved, and it is now widely used clinically. The third-generation dosage form uses new drug excipients to co...

Claims

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Application Information

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IPC IPC(8): G01N1/38
CPCG01N1/38
Inventor 王羽周大涛徐佳佳
Owner BEIJING TIDE PHARMA