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Method for analyzing content of hydroxypropyl-beta-cyclodextrin in butylphthalide sodium chloride injection

A technology of beta-cyclodextrin and analysis method, which is applied in the field of analysis of hydroxypropyl beta-cyclodextrin content in butylphthalide injection, and can solve the complicated operation process and the peak shape of hydroxypropyl beta-cyclodextrin. problems such as poor analysis methods and long time consumption of analysis methods, to achieve the effect of accurate measurement results and reliable quality control methods

Pending Publication Date: 2021-11-19
JIANGSU ALICORN PHARMATECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Butylphthalide can be used clinically for acute ischemic stroke, but the chemical has the disadvantages of poor water solubility and low bioavailability. Butylphthalide injection can improve the bioavailability of butylphthalide. In order to ensure the safety, effectiveness and quality control of butylphthalide injection, it is necessary to analyze the content of hydroxypropyl beta cyclodextrin in the injection
[0005] In the current quality standard, gas phase method or volumetric method is used to determine the content of hydroxypropyl beta cyclodextrin. The operation process is cumbersome and the analysis method consumes a long time.
Consult the relevant literature, the peak shape of hydroxypropyl beta cyclodextrin in the method for the determination of hydroxypropyl beta cyclodextrin reported in the literature is not good, resulting in inaccurate integration of the results of the determination of hydroxypropyl beta cyclodextrin. The determination method of hydroxypropyl beta-cyclodextrin uses the unconventional gel chromatographic column in the analysis laboratory as the analytical column, which increases the detection cost

Method used

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  • Method for analyzing content of hydroxypropyl-beta-cyclodextrin in butylphthalide sodium chloride injection
  • Method for analyzing content of hydroxypropyl-beta-cyclodextrin in butylphthalide sodium chloride injection
  • Method for analyzing content of hydroxypropyl-beta-cyclodextrin in butylphthalide sodium chloride injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] High performance liquid chromatography conditions:

[0032] The chromatographic column is a cyanosilane bonded silica gel column thermo hypersil GOLD CN (250 × 4.67 mm, 5 μm), and the flow phase A of 5 mmol / L acetate is a flow phase A, with acetonitrile to flow phase B, flow rate of 1.0 mL / min, column Temperate 20 ° C, the injection volume is 10 μL, evaporated light scatter detector (parameter: carrier gas pressure: 0.5MPa; drift tube temperature: 70 ° C; carrier gas flow rate: 2.0ml / min; diversion mode), press the table wash Take off.

[0033] Table 1 elution program

[0034]

[0035] Sample formulation:

[0036] Blank excipient solution: Precision quantity taking 1ml of sodium phthalonate injection without hydroxypropylene cyclodextrin, placed in a 25 mL volumetric flask, diluted with water to the scale, shake well, to a blank excipient solution.

[0037] Systematic Solution: Take hydroxypropyloid cyclodextrin control and sodium chloride control, add water to diss...

Embodiment 2

[0043] High performance liquid chromatography conditions: in Example 1.

[0044] Sample formulation:

[0045] Systematic Solution: That Example 1.

[0046] Take the solution: Take the amount of hydroxypropyloid cyclodextrin, precisely, add water to dissolve and quantitatively dilute the solution of about 0.28 mg of hydroxypropylene rhythmic cyclodextrin per 1 ml, as a solution solution .

[0047] For test solution: in Example 1.

[0048] Determination: Applicable solution, refollective solution, and test solution solution, 10 μl of injection liquid chromatography in each precision amount after formulation of 0, 1, 2, 4, 6, 8, 12, 16, 20, 24 hours, respectively Record the chromatogram, calculate the results of 24h stability, and the results are shown in Table 2, Table 3, Table 4.

[0049] Table 2 Systematic Solution Stability Test Results

[0050]

[0051] Table 3 Test results for the stability test

[0052]

[0053] Table 4 Test results of solution solution solution

[0054]

...

Embodiment 3

[0057] High performance liquid chromatography conditions: in Example 1.

[0058] Sample formulation:

[0059] Hydroxypropyliphyde radioplasm Take the preparation reserve: It is called the hydroxypropyl propyride, and it is precisely known, and the 50mL volumetric flask is added, and the appropriate amount of water is ultrasonically dissolved and diluted to the scale, shake well , As a hydroxypropyl propyride cyclodextrin to the illumination stock solution.

[0060] Hydroxypropylphamphetama cyclodextrin series control solution: precisely precise amounts of hydroxypropyl dipyethylene cyclodextrin to 1ml, 1.5 mL, 2 mL, 2.5ml, 3ml in 10mL volume bottle, plus water To obtain a series of linear solutions for hydroxypropyliphyde radioptride.

[0061] Determination: Precision quantity takes the systematic solution, for the test solution, and 10 μl of the series of injectable solutions, and record chromatograms.

[0062] Table 5 Hydroxypropylbahtha Cyclodextrin Linearity and Range Test Res...

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Abstract

The invention discloses a method for analyzing the content of hydroxypropyl-beta-cyclodextrin in a butylphthalide sodium chloride injection, which adopts a high performance liquid chromatography, and the chromatographic conditions are as follows, a cyano bonded silica gel chromatographic column is used as a chromatographic column, 5mmol / L ammonium acetate is used as a mobile phase A, acetonitrile is used as a mobile phase B, the ratio of the mobile phase A to the mobile phase B is (50: 50), isocratic elution is performed, the flow velocity is 1.0 ml per minute, the column temperature is 20 DEG C, a detector is an evaporative light scattering detector, and parameters of the detector are as follows, carrier gas pressure is 0.5 Mpa, drift tube temperature is 70 DEG C, carrier gas flow velocity is 2.0 ml / min, and a shunting mode is adopted. The method can be used for accurately, simply, conveniently and efficiently measuring the content of the hydroxypropyl-beta-cyclodextrin in the butylphthalide sodium chloride injection.

Description

Technical field [0001] The present invention relates to a chemical analysis method according to in the art, and more particularly to analytical methods of hydroxypropylene cyclodextride in a biphenylphthalide. Background technique [0002] HydroxyPyl-β-cyclodextrin, is a chloride cyclodextrin and 1,2-oxide ether etherification, its molecular formula C 63 Hide 112 O 42 The molecular weight is 1541.538, and the structural formula is as follows: [0003] [0004] Hydroxypropylbahtha cyclodextrin is a white powder, and is an etherification of a cyclodextrin and 1,2-propylene oxide. The introduction of hydroxypropyl group breaks the molecular intramolecular hydrogen bond of β-cyclodextrin, and overcomes the main disadvantage of β-cyclo paste water dissolution while maintaining the cyclodextrin cavity. In the pharmaceutical industry, it is an ideal injection solubility and drug excipient due to relative surface activity and hemolytic activity and no irritation to muscles. The water s...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/06G01N30/86
Inventor 李娟高超宋敏
Owner JIANGSU ALICORN PHARMATECH CO LTD
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