A kind of soft capsule filling quantity difference detection device and detection method for analysis

Abstract

The invention relates to the technical field of soft capsule quality inspection, in particular to a device for detecting the difference in the content of soft capsules for analysis and a detection method thereof. The detection device includes a box body, a controller and an operation screen that are electrically connected to each other. The box body is provided with a capsule fixing grille and a capsule shell cleaning tray. The capsule fixing grille is provided with a capsule placement hole, and a capsule placement hole is provided next to the capsule placement hole. There is a support device and an integrated operation table. The support device includes an inner cavity that can enter and exit the soft capsule and an umbrella-shaped support frame that can be retracted or opened. The integrated operation table includes a cutting knife, a cleaning pipe and a purging pipe. The detection method is as follows: the soft capsule is placed in the hole where the capsule is placed; then the upper end of the soft capsule is cut with a cutting knife, the soft capsule shell is stretched by the umbrella-shaped support frame, and the lower end of the soft capsule is cut by the cutting knife and returned to its original position; The capsule fixing grid descends to the capsule shell cleaning plate and shakes, and then rises to the in-situ shaking; the cleaning pipe cooperates with the spray cleaning device to spray the soft capsule shell, and then the purging pipe cooperates with the purging device to purge the soft capsule shell .

Description

technical field [0001] The invention relates to the technical field of soft capsule quality inspection, in particular to a device for detecting the difference in the content of soft capsules for analysis and a detection method thereof. Background technique [0002] Loading volume difference: one of the uniformity detection indicators of pharmaceutical preparations, commonly found in dosage forms such as capsules and powder injections, and is mainly a parameter reflecting the stability of the pharmaceutical production process. "Chinese Pharmacopoeia" 2020 Edition Four Section 0103 stipulates the inspection method for the difference in capsule filling volume: Unless otherwise specified, take 20 capsules (10 capsules from traditional Chinese medicine) for testing, and accurately weigh them, respectively. Soft capsules or contents are half The solid or liquid hard capsule shell is washed with a volatile solvent such as ether, placed in a ventilated place to evaporate the solvent...

AI Technical Summary

Problems solved by technology

[0005] 1) Data uniformity is poor

Each soft capsule sample is manually operated by the experimenter. During the operation, the soft capsule shell may fall off or the contents may not be cleaned, which makes the uniformity of the experimental results poor.

[0006] 2) The experimental process takes a long time and is easily affected by the environment

The experimenters need to inspect 20 soft capsules (10 for traditional Chinese medicine) in turn. The cutting and cleaning process should be done carefully. Due to the slow cutting and cleaning process, the time for each soft capsule shell to stand and dry is different. Therefore, the experimental results are easily affected by various factors

[0007] 3) Poor security and low detection efficiency

For small pills and soft capsules, the volume is small, and it is easy to cut fingers when cutting with a knife. When operating with scissors, it is easy to cause the contents to spray, pollute the operation table, and the contents are easy to stick to gloves. It is complicated to handle and will produce more medical waste

[0008] 4) Poor environmental protection, harmful to the health of experimenters

When cleaning the soft capsule shell, organic reagents are often used, which are highly volatile and toxic, and are likely to affect the health of experimenters

In addition, for spherical soft capsules, it is not easy to cut during manual operation, and fingers are often scratched

[0009] 5) There are many measurement samples in the determination of the difference in loading capacity, which is easy to cause confusion

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