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A kind of method for measuring nimodipine soft capsule plus enzyme dissolution

A technology of nimodipine and nimodipine, which is applied in the field of medicine, can solve the problems that the preparation does not swell, affect the dissolution outside the capsule, and the dissolution measurement method needs to be optimized, and achieves the effect of overcoming the reduction of the release in vitro.

Active Publication Date: 2022-03-15
HUMANWELL PURACAP PHARM WUHAN CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Its rubber is water-soluble, but under accelerated conditions (40°C±2°C, 75%±5%RH) the rubber is sensitive, affected by temperature, humidity, oxidation, thermal sensitivity, UV light and other environmental influences, which can easily lead to gelatin in the capsule shell and The content undergoes a chemical reaction. At this time, a thin film is formed on the inner and outer surfaces of the capsule. In the dissolution test, it is observed that the thin film becomes a jelly-like substance, which is difficult to release or does not rupture, that is, the phenomenon of cross-linking and bonding of the soft capsule occurs, which makes the preparation swell and does not break, which limits the drug. The release of the capsule affects the determination of the in vitro dissolution of the capsule preparation and affects the real in vitro dissolution of the capsule.
However, changes in in vitro dissolution characteristics can objectively reflect the in vivo dissolution behavior. The cross-linking phenomenon of soft capsules makes the traditional dissolution determination method need to be optimized. It is necessary to find a dissolution medium to dissolve soft capsules.

Method used

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  • A kind of method for measuring nimodipine soft capsule plus enzyme dissolution
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  • A kind of method for measuring nimodipine soft capsule plus enzyme dissolution

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0037] Embodiment 1: Screening of dissolution medium

[0038] The results are shown in Table 1, wherein the pH of the laboratory water is in the range of 4.5-6.8.

[0039] The dissolution effect of different dissolution media on the sample of table 1

[0040]

[0041]

[0042] By above-mentioned dissolving test, find that the sample of nimodipine soft capsule only has 450ml papaya enzyme solution added in front 15 minutes, then adds 10g / L sodium lauryl sulfate solution 450ml, and the dissolution time is 45 minutes under the condition that has very good effect altogether. The dissolution effect, the sample solution can be very clear and uniformly dispersed, other conditions or capsule swelling does not rupture, or the solution is turbid.

[0043] In order to solve the dissolution problem of the sample, the present invention adopts 450ml papain solution (the amount of papain is no more than 550,000Units / L) that is easy to dissolve the rubber, and then adds 10g / L sodium la...

Embodiment 2

[0046] Embodiment 2: measure the method for nimodipine soft capsule adding enzyme dissolution

[0047] (1) Preparation of dissolution medium: prepare papain solution and 10g / L sodium lauryl sulfate solution respectively, wherein the amount of papain in the papain solution is no more than 550,000Units / L;

[0048] (2) Run the dissolution apparatus: under the condition of room temperature and dark, set the conditions as the slurry method, the dissolution speed is 50rpm / min, the temperature is 37±0.5°C, and the dissolution time is 45 minutes;

[0049] (3) Preparation of the test solution: add 450ml of the papain solution in step (1) to the dissolution vessel, run the instrument to 37°C, add nimodipine soft capsules, and add the step of preheating to 37±0.5°C after 15 minutes (1) 450ml of sodium lauryl sulfate solution, absorb the stripping solution after the dissolution is completed, filter through a 0.45 μm filter membrane, discard 4mL of the initial filtrate, and collect the sub...

Embodiment 3

[0068] Embodiment 3: HPLC methodology validation

[0069] 1. Good system adaptability

[0070] Main peak theoretical plate number: 9900;

[0071] Main peak tailing factor: 1.0;

[0072] The recovery rate of the reference substance: 99.3%;

[0073] RSD of the top 5 main peak areas against the standard solution: 0.1%.

[0074] 2. Good specificity

[0075] Such as figure 2 As shown, the diluent does not interfere with the main peak, and the unknown peak in the sample solution does not interfere with the main peak.

[0076] 3. Linear

[0077] The linear regression equation of nimodipine is y=23242.36x+1058.11, and the correlation coefficient is 1.000. In the concentration range of 6.62 μg / ml~66.16 μg / mL, the peak area has a good linear relationship with the concentration.

[0078] 4. Method precision

[0079] Six dissolution sample solutions were prepared for injection, RSD=0.7%, and the average dissolution rate in 45 minutes was 99.4%. The results showed that the precisi...

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Abstract

The invention discloses a method for measuring the dissolution of nimodipine soft capsules plus enzymes. The method mainly includes the preparation of a dissolution medium, the preparation of a test solution, the preparation of a reference solution and the measurement. This method more truly reflects the in vivo dissolution and release behavior of Nimodipine Soft Capsules, overcomes the problem of reduced release in vitro due to the cross-linking of gelatin in the capsule material, and objectively reflects the actual dissolution behavior and preparation quality of Nimodipine Soft Capsules .

Description

technical field [0001] The invention relates to the field of medicine, in particular to a method for measuring dissolution of nimodipine soft capsule plus enzyme. Background technique [0002] Nimodipine is suitable for improving blood circulation in cerebral vasospasm after subarachnoid hemorrhage of various causes and in the recovery period of acute cerebrovascular disease. In view of the characteristics of high stability, anti-oxidation, convenient administration, and high bioavailability of soft capsules, nimodipine and soft capsules are combined to develop nimodipine soft capsules that can improve drug stability and reduce patient dosage. The main ingredient of Nimodipine Soft Capsules is light yellow powder, insoluble in water, soluble in ethanol and chloroform, sensitive to light, when the prepared solution is exposed to light, it will quickly undergo photooxidation to form inactive Pyridine compounds. Therefore, in the process of dissolution determination, it is ne...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/02
CPCG01N30/02
Inventor 黄芸刘波胡帅楠徐欣蔡波涛叶翔
Owner HUMANWELL PURACAP PHARM WUHAN CO LTD
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