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Indissolvable drug inclusion compound, inclusion method and chlortetracycline hydrochloride soluble powder

An insoluble drug, aureomycin hydrochloride technology, applied in the field of biomedicine, can solve the problems of drug efficacy reduction, easy to be oxidized and deteriorated, etc., to achieve the effect of enhancing stability, improving bioavailability, and improving rapid dissolution ability

Pending Publication Date: 2021-06-15
FOSHAN NANHAI EASTERN ALONG PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, most of the methods that need to increase the temperature to help dissolve in the plan are for drugs that do not decompose at high temperatures, and some insoluble drugs are easily oxidized and deteriorated at high temperatures or are easily degraded in high-temperature aqueous solutions (such as aureomycin hydrochloride). , if the clathrate is prepared under high temperature conditions, the efficacy of the original drug may be greatly reduced

Method used

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  • Indissolvable drug inclusion compound, inclusion method and chlortetracycline hydrochloride soluble powder
  • Indissolvable drug inclusion compound, inclusion method and chlortetracycline hydrochloride soluble powder
  • Indissolvable drug inclusion compound, inclusion method and chlortetracycline hydrochloride soluble powder

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0057] A kind of aureomycin hydrochloride clathrate, is prepared by the following steps:

[0058] S1. Weigh 0.03mol of hydroxypropyl β-cyclodextrin and dissolve it in 100ml of deionized water, and stir magnetically at 30°C for 1 hour to prepare a β-cyclodextrin solution;

[0059] S2. Weigh 0.01 mol of aureomycin hydrochloride powder, add a small amount to the β-cyclodextrin solution several times, keep stirring at 30°C for 2 hours, add 10.31 g of malic acid, and stir for 1 hour at room temperature to obtain a package combined solution;

[0060] S3. At room temperature, add 150ml of chemically pure acetone to the inclusion solution, continue to stir for 1 hour to recrystallize the inclusion product, stop stirring and let stand at 1°C for 12 hours, filter under reduced pressure to obtain a solid powder, and Naturally evaporate and dry at 40°C for 20 minutes.

[0061] Add 10g of sodium chloride to the filtered filtrate, take 150ml of the upper layer liquid after stirring and ad...

Embodiment 2

[0064] A kind of aureomycin hydrochloride clathrate, is prepared by the following steps:

[0065] S1. Weigh 0.01mol of hydroxypropyl β-cyclodextrin and dissolve it in 100ml of deionized water, and magnetically stir at 70°C for 2 hours to prepare a β-cyclodextrin solution;

[0066] S2. Weigh 0.01 mol of aureomycin hydrochloride powder, add a small amount to the β-cyclodextrin solution several times, keep stirring at 60°C for 4 hours, add 51.53 g of malic acid, and stir at room temperature for 2 hours to obtain a package combined solution;

[0067] S3. At room temperature, add 300ml of chemically pure acetone to the clathrate solution, continue to stir for 2 hours to recrystallize the clathrate product, stop stirring and let stand at 8°C for 48 hours, filter under reduced pressure to obtain a solid powder, and Naturally evaporate and dry at 40°C for 60 minutes.

[0068] Add 35g of sodium chloride to the filtered filtrate, take 300ml of the upper liquid after stirring and add 1...

Embodiment 3

[0070] A kind of aureomycin hydrochloride clathrate, is prepared by the following steps:

[0071] S1. Weigh 0.02mol of hydroxypropyl β-cyclodextrin and dissolve it in 100ml of deionized water, and magnetically stir at 45°C for 1 hour to prepare a β-cyclodextrin solution;

[0072] S2. Weigh 0.01mol of aureomycin hydrochloride powder, add a small amount to the β-cyclodextrin solution several times, keep stirring at 40°C for 4 hours, add 41.23g of malic acid, and stir for 1 hour at room temperature to obtain a package combined solution;

[0073] S3. At room temperature, add 300ml of chemically pure acetone to the clathrate solution, continue stirring for 1 h to recrystallize the clathrate product, stop stirring and let stand at 4° C. for 24 h, filter under reduced pressure to obtain a solid powder, and Naturally evaporate and dry at 40°C for 30 minutes.

[0074]Add 20g of sodium chloride to the filtered filtrate, take 300ml of the upper layer liquid after stirring and add 3g of...

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Abstract

The invention provides an indissolvable drug inclusion method, and belongs to the technical field of biological medicines. The method comprises the following steps of stirring and dissolving beta-cyclodextrin in water, and preparing a beta-cyclodextrin solution; adding an indissolvable drug into the beta-cyclodextrin solution in batches, fully stirring, adding an organic acid, and stirring and mixing again to prepare an inclusion solution; and adding an organic solvent into the inclusion solution, stirring to separate out an inclusion product, standing at low temperature, and filtering out the product to obtain the inclusion product. The preparation method comprises the following steps of conducting inclusion of the water indissolvable drug raw material and beta-cyclodextrin with entrapment capacity by using an inclusion-hydrotropy-recrystallization process flow, assisting the hydrotropy effect of organic acid, and carrying out recrystallization precipitation to prepare the inclusion drug composition. The method is especially suitable for pharmaceutical preparations which are difficult in water solubility, not resistant to high temperature and unstable in aqueous solution.

Description

technical field [0001] The invention relates to the technical field of biomedicine, in particular to an insoluble drug inclusion compound, an inclusion method and aureomycin hydrochloride soluble powder. Background technique [0002] The solubility of drugs is of great significance to the research of preparations and is an important content of pre-prescription research. Due to the low solubility of drugs, even saturated solutions are lower than the concentration required for treatment. At the same time, the solubility of solid preparation drugs will affect the dissolution rate in vivo The bioavailability of the drug, the solubility of the liquid preparation drug is too small will lead to insufficient drug concentration in the solution and no therapeutic effect, often need to improve their water solubility, therefore, some drug inclusion technology and process for preparing soluble powder began to be able to Development, commonly used methods are: salt-forming method, solid c...

Claims

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Application Information

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IPC IPC(8): A61K47/69A61K47/40A61K47/12A61K31/65A61K9/14
CPCA61K47/6951A61K47/12A61K31/65A61K9/145
Inventor 焦晓军朱水容李成应周淑贞付良凯
Owner FOSHAN NANHAI EASTERN ALONG PHARMA CO LTD
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