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A detection method for vaginal expansion suppository

A vaginal expansion plug and a detection method technology, applied in the detection field of vaginal expansion plug, can solve the problems of lack of tensile strength and elasticity, fracture and breakage, large expansion value, etc., to increase operability, improve accuracy, and ease The effect of judgment

Active Publication Date: 2016-03-30
哈尔滨田美药业股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The expansion materials disclosed in the prior art have poor water absorption expansion rate and low mechanical strength, and do not have good tensile strength and elasticity. After expanding to a certain range, they will break and break; The expansion rate cannot be controlled in the medium, resulting in an excessive expansion value

Method used

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  • A detection method for vaginal expansion suppository
  • A detection method for vaginal expansion suppository
  • A detection method for vaginal expansion suppository

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0102] The detection method of embodiment 1 clotrimazole expansion plug

[0103] Drug-containing matrix: active ingredient: clotrimazole

[0104] Base: Macrogol 400 and Macrogol 6000

[0105] Expansion carrier: cotton sliver;

[0106] 1) Determination of expansion value: Take 3 capsules of the clotrimazole expansion plug, measure the diameter of the sliver at the tail with a vernier caliper, roll it about 90° and measure it again, measure twice for each capsule, and obtain the average of the 2 measurements for each capsule Take out the remaining sliver immediately after the above-mentioned 3 plugs are used for the determination of the melting time limit. After the water stops dripping, place them lightly on a glass plate, and measure the two ends and the middle three parts of each sliver with a vernier caliper. , roll about 90° and then measure three parts, obtain six data for each sliver, and calculate the average value r of the six measurements i , calculate the expansion...

Embodiment 2

[0113] The expansion value determination method of embodiment 2 clotrimazole expansion plug

[0114] Drug-containing matrix: active ingredient: clotrimazole

[0115] Base: Semi-synthetic fatty acid esters and lanolin

[0116] Expansion carrier: cotton sliver, where the bulk density from the front end to the tail end of the sliver is 0.2g / cm 3 Gradually increase to 1.0g / cm 3 The expansion material is compressed;

[0117] Method for measuring expansion value: take 3 capsules of the clotrimazole expansion plug, measure the diameter of the sliver at the tail with a vernier caliper, roll about 90° and measure again, measure twice for each capsule, and obtain the average value Ri of the 2 measurements for each capsule Take out the remaining sliver immediately after the above-mentioned 3 plugs are used for the measurement of the melting change time limit. After the water stops dripping, place them lightly on a glass plate, measure the two ends and the middle three parts of each sl...

Embodiment 3

[0120] The determination method of the swelling value of embodiment 3 compound metronidazole swelling suppositories

[0121] Drug-containing base: active ingredients: metronidazole, ginsenosides and vitamin E

[0122] Base: mixed fatty acid glycerides, propylene glycol stearate

[0123] Swelling carrier: cotton sliver

[0124] The front end of the sliver is pressed from flax;

[0125] The tail end of the sliver is pressed from the following components by weight and ratio:

[0126] rubber 3

[0127] Agarose 6.5

[0128] Dicumyl peroxide 1.5

[0129] Method for measuring expansion value: take 3 capsules of the compound metronidazole expansion plug, measure the diameter of the sliver at the tail with a vernier caliper, roll about 90° and measure again, measure twice for each capsule, and obtain the average value of the 2 measurements for each capsule Ri: Use the above 3 plugs to take out the remaining sliver immediately after the measurement of the melting time limit, and p...

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Abstract

The present invention relates to a detection method for vaginal expansion suppositories. The detection method includes a method for measuring swelling value and a method for measuring weight difference. The detection method is more scientific and has high reproducibility; another aspect of the present invention also provides The vaginal expansion plug detected by the detection method, the expansion plug includes a drug-containing matrix and an expandable expansion carrier, the expansion carrier is divided into a front end and a tail end, and the front end and the tail end have different expansion values ​​and expansion speeds, which can be Prevent the outflow of medicinal liquid and maintain the drug concentration in the vagina.

Description

technical field [0001] The invention relates to a detection method for suppositories, in particular to a detection method for vaginal expansion suppositories. Background technique [0002] The second appendix of the Pharmacopoeia of the People's Republic of China 2010 stipulates that suppositories should be tested for content determination, weight difference, and melting time limit; Time-limit determination method, take 3 expansion carriers, after standing at room temperature for 1 hour, measure the diameter D1 of the sliver at the tail respectively; place the 3 expansion carriers on the lower discs of the 3 metal frames respectively, and put them into their respective Put the above-mentioned devices vertically into containers filled with not less than 4L of 37.0°C±0.5°C water, the upper end of which should be 90mm below the water surface, and install a rotator in the container, Turn the device over in the solution once every 10 minutes; after 60 minutes, when it is taken o...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01B5/08G01G17/00A61K9/02A61K31/4174A61K31/4164A61K47/38
Inventor 邱学良邱明世
Owner 哈尔滨田美药业股份有限公司
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