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Substance related to doxycycline hyclate as well as analysis and detection method thereof

A technology for doxycycline hydrochloride and products, which is applied in the directions of analyzing materials, measuring devices, material separation, etc., can solve problems such as insufficient research on doxycycline hydrochloride, and achieve improved safety and controllability, accurate and reliable results, and preparation methods. Simple and easy effects

Active Publication Date: 2016-09-07
ZHENJIANG GAOHAI BIOLOGICAL PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] At present, the research on related substances of doxycycline hydrochloride is not enough, and further research is needed

Method used

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  • Substance related to doxycycline hyclate as well as analysis and detection method thereof
  • Substance related to doxycycline hyclate as well as analysis and detection method thereof
  • Substance related to doxycycline hyclate as well as analysis and detection method thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0036] Example 1: Preparation and structural confirmation of doxycycline hydrochloride photodegradation product

[0037] Take 50g of doxycycline hydrochloride raw material and spread it evenly in a petri dish, place it under a cool white fluorescent lamp for 20 hours, and the light intensity is 1,200,000 lux; The irradiation intensity is 200 Wh / m2, and it is taken out after the irradiation is finished. Then, the photodamaged sample was dissolved in an aqueous methanol solution with a methanol volume percentage concentration of 80%, stirred for 20 minutes, filtered through a suction filter funnel, collected the filtrate, and concentrated under reduced pressure to obtain a concentrate; then the concentrate was dissolved in methanol and used Mix the sample with normal-phase silica gel with a particle size of 100-200 mesh, evaporate the solvent, use normal-phase silica gel with a particle size of 200-300 mesh as the separation silica gel for column chromatography, and use a mixed ...

Embodiment 2

[0041] Example 2: Doxycycline Hydrochloride Stability Test for Long-Term 6-Month Darkened and Not Lightened Sample Detection Analysis

[0042] Preparation of reference solution: Accurately weigh 2mg of photodegradable impurities in a 200ml volumetric flask, dissolve in acetonitrile to a constant volume, and use it as a photodegradable impurity stock solution; accurately measure 1ml of photodegradable impurity stock solution in a 20ml volumetric flask, and use liquid phase analysis The mobile phase of the initial ratio in the method was diluted to volume (about 0.5 μg / mL).

[0043] Preparation of the test solution: take out the doxycycline hydrochloride raw materials that have been protected from light for 6 months and those that have not been protected from light from the stability test light box, and accurately weigh 20 mg respectively in a 20ml volumetric flask. The mobile phase was dissolved to a constant volume, and the test solution of the raw material that was protected ...

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Abstract

The invention discloses a substance related to doxycycline hyclate as well as an analysis and detection method thereof. The invention discovers a novel photodegradation product of doxycycline hyclate, and the structure of the photodegradation product is reported for the first time. The invention provides a preparation method of the photodegradation product, the method is simple and easy to operate, and a large number of the photodegradation products can be prepared. A liquid phase analysis method is provided for rapidly detecting the photodegradation products, and a maximum absorption wavelength of the photodegradation products is used as a detection wavelength, so that the detection rate of the photodegradation products is improved, and the result is accurate and reliable; the photodegradation products can be used for detecting substances related to doxycycline hyclate and preparations thereof, further improving quality standards of doxycycline hyclate and preparations thereof, and improving safety and controllability thereof.

Description

technical field [0001] The invention relates to the field of biopharmaceuticals, in particular to a photodegradation product of doxycycline hydrochloride, a preparation method and an analysis and detection method of the photodegradation product. Background technique [0002] Doxycycline hydrochloride is a broad-spectrum semi-synthetic tetracyclic antibiotic that has been used in domestic clinics since the 1970s. Its antibacterial spectrum is basically the same as that of tetracycline and oxytetracycline, but its antibacterial effect is 5-10 times stronger than that of tetracycline and oxytetracycline. times, especially effective against tetracycline-resistant Staphylococcus aureus. Doxycycline hydrochloride is well absorbed orally, excreted slowly, and maintains an effective level of blood drug concentration longer than tetracycline and oxytetracycline (half-life 15-20h). It can be taken orally once a day. It is used for upper respiratory tract infection, exudative and acute...

Claims

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Application Information

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IPC IPC(8): G01N30/02
CPCG01N30/02G01N2030/027
Inventor 潘立李义高李小彪赵阳
Owner ZHENJIANG GAOHAI BIOLOGICAL PHARMA CO LTD
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