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Mass control method of ketelin lozenge

A quality control method, Trane's technology, applied in the field of quality control of Ketrane buccal tablets, can solve problems such as difficult to reproduce results, unguaranteed drug quality, unsatisfactory chromatographic separation effect and repeatability, etc., to achieve Good effect and good repeatability

Inactive Publication Date: 2008-05-21
广西药用植物园制药厂
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although the provisional standard for Keteling Granules contains the relevant content of thin-layer chromatography for chlorpheniramine maleate, but according to the conditions of the standard, the chromatographic separation effect and repeatability are not ideal, which is not good for the judgment of the sample. As a result, the quality of medicines cannot be guaranteed
Although there are also some reports in the literature on the determination of chlorpheniramine maleate content in Keteling tablets (capsules) by high performance liquid chromatography, it is difficult to reproduce the results in actual measurement. One of the main reasons why there is no accurate quantitative legal standard for the content determination of chlorpheniramine maleate in products

Method used

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  • Mass control method of ketelin lozenge
  • Mass control method of ketelin lozenge
  • Mass control method of ketelin lozenge

Examples

Experimental program
Comparison scheme
Effect test

specific Embodiment

[0043] 1 Instruments and materials:

[0044] Instrument: ZF-1 three-purpose ultraviolet analyzer produced by Shanghai Gucun Electro-optical Instrument Factory, Japan Shimadzu LC-10VP high-efficiency chromatography (LC-10ATvP pump, SPD-10AvP ultraviolet detector, Wemaron chromatography workstation), 1 / 100,000 electronic balance (GR-202, A&D Japan), KQ2200B ultrasonic cleaner (Kunshan Ultrasonic Instrument Co., Ltd.)

[0045] Reagents: Reagents for thin-layer chromatography are analytically pure; reagents for high-performance liquid chromatography are chromatographically pure.

[0046] Chlorpheniramine maleate reference substance: provided by China National Institute for the Control of Pharmaceutical and Biological Products, batch number: 100047-200305

[0047]Sample 1: Ketraling buccal tablet compressed granules, produced by Guangxi Medicinal Botanical Garden Pharmaceutical Factory, batch number: 070101, 070102, 070103:

[0048] Sample 2: The finished product of Ketraling bu...

Embodiment 1

[0050] Example 1. The thin-layer chromatography results of chlorpheniramine maleate of 070101, 070102, and 071003 Piketrex buccal tablets and compressed granules are shown in FIG. 1 .

Embodiment 2

[0051] Example 2. The results of HPLC content determination of chlorpheniramine maleate in Piketelin buccal tablet compressed granules of 070101, 070102 and 071003 are shown in Figures 2, 3, 4, 5, 6 and 7. Table 1 corresponds to Figure 2, Table 2 corresponds to Figure 3, Table 3 corresponds to Figure 4, Table 4 corresponds to Figure 5, Table 5 corresponds to Figure 6, and Table 6 corresponds to Figure 7.

[0052] Chlorpheniramine maleate reference substance high performance liquid phase (HPLC) assay result in Table 1 (07-1-8)

[0053] serial number

component name

keep time

Peak height

Peak area

Number of theoretical plates

Separation

peak asymmetry

1

2

3

3.24

5.69

15.32

1445

318

7859

16897

4275

159222

3355

3821

12834

0.00

7.03

18.00

0.00

0.00

1.05

[0054] Table 2 070101 batches of chlorpheniramine maleate b...

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Abstract

The invention relates to a quality control method of chlorpheniramine maleate of Keteling troche, which is characterized in that the method includes a chlorpheniramine maleate thin layer chromatographic method examination of the Keteling troche pressing grain, a content measurement of the chlorpheniramine maleate with high-efficiency liquid phase chromatography, a chlorpheniramine maleate thin layer chromatographic method examination of Keteling troche finished product and a content measurement of the chlorpheniramine maleate with high-efficiency liquid phase chromatography. The quality control method of the Keteling troche provided by the invention adopts the chromatography and the color developing conditions to lead the chlorpheniramine maleate to effectively separate from other ingredients, the test result has good repeatability; the content of the chlorpheniramine maleate can be precisely measured in the Keteling troche, and the quality of the Keteling troche finished product is effectively controlled.

Description

technical field [0001] The invention belongs to a quality control method for Ketraling buccal tablets. Background technique [0002] Keteling Buccal Tablets is a new type of Chinese and Western medicine compound preparation developed according to the existing national standard drug - Keteling Tablets by changing the route of administration. The main ingredients are Ficus microphylla medicinal material (banyan leaf) and chlorpheniramine maleate, and the specifications are that each tablet contains 90 mg of Ficus microphylla dry extract and 0.35 mg of chlorpheniramine maleate. In the current statutory standards of Keteling Tablets and Keteling Capsules (Quality Standard Standard Number for Keteling Tablets: WS3-B-2742-97; Quality Standard Number for Keteling Capsules: WS3-B-2743-97) Among them, there is the content of thin-layer chromatography inspection of Ficus cuspidatum, and in the interim standard of Keteling Granules (the trial standard W...

Claims

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Application Information

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IPC IPC(8): A61K36/60A61P11/14G01N30/02G01N30/90A61K31/4402
Inventor 蓝鸣生陈路
Owner 广西药用植物园制药厂
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