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Oil-phase liquid crystal gel precursor preparation for hydrophilic drug and preparation method of oil-phase liquid crystal gel precursor preparation

A hydrophilic drug and oil phase technology, applied in liquid delivery, drug delivery, pharmaceutical formulations, etc., can solve the problems of poor sustained release effect, poor storage stability, poor stability, etc., to improve bioavailability and solubility. , to maintain the effect of effective concentration

Active Publication Date: 2018-12-28
武汉百纳礼康生物制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] However, for hydrophilic drugs, especially hydrophilic macromolecular drugs, such as protein IgG, PD-1, PD-L1, and insulin, the stability of the aqueous phase preparation is poor and easy to hydrolyze; while the hydrophilic drugs currently on the market Water-based drug oil phase preparations cannot form gels, and generally have the problem of poor sustained release effect; and poor storage stability
Hydrophilic drugs are difficult to dissolve in the oil phase and need to be dissolved in the water phase, so it is difficult to make liquid crystal gel precursor preparations with a uniform oil phase

Method used

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  • Oil-phase liquid crystal gel precursor preparation for hydrophilic drug and preparation method of oil-phase liquid crystal gel precursor preparation
  • Oil-phase liquid crystal gel precursor preparation for hydrophilic drug and preparation method of oil-phase liquid crystal gel precursor preparation
  • Oil-phase liquid crystal gel precursor preparation for hydrophilic drug and preparation method of oil-phase liquid crystal gel precursor preparation

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Experimental program
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Embodiment 1

[0032] The oil phase liquid crystal gel precursor preparation of the hydrophilic drug of this embodiment is prepared by the following steps of preparation method:

[0033] (S1) Preparation of phospholipid dispersion: Weigh 1 g of phosphatidylglycerol and 4 g of distilled water into the bottle, seal it, and disperse it on a shaker to form a coarse dispersion; ultrasonically disperse the coarse dispersion for 20 minutes in an ice bath, 50% ( 650W), 1s / 3s, forming a milky white phospholipid dispersion;

[0034] (S2) Preparation of hydrophilic drug solution: Weigh protein PD-15mg and add 1.5ml of water to completely dissolve it to make a 3.33mg / ml drug solution for later use;

[0035] (S3)) Preparation of the water phase: take 140uL of the phospholipid dispersion prepared in the step (S1) and mix with 300uL of the drug solution prepared in the step (S2) to obtain the water phase;

[0036] (S4) Preparation of the oil phase: add 0.3 mg of Tween 80 to 2.7 g of glyceryl dioleate, and...

Embodiment 2

[0045] The oil phase liquid crystal gel precursor preparation of the hydrophilic drug of this embodiment is prepared by the following steps of preparation method:

[0046] (S1) Preparation of phospholipid dispersion: Weigh 1 g of soybean lecithin and 4 g of distilled water into the bottle, seal it, and disperse it on a shaker to form a coarse dispersion; ultrasonically disperse the coarse dispersion for 20 minutes in an ice bath, 50% (650W ), 1s / 3s, forming a milky white phospholipid dispersion;

[0047] (S2) Preparation of hydrophilic drug solution: take 5 mg of protein IgG and add 1.5 ml of water to completely dissolve it to make a 3.33 mg / ml drug solution for subsequent use;

[0048] (S3)) Preparation of the water phase: take 200uL of the phospholipid dispersion prepared in the step (S1) and mix with 300uL of the drug solution prepared in the step (S2) to obtain the water phase;

[0049] (S4) Preparation of the oil phase: add 0.3 mg of Tween 80 to 2.7 g of glyceryl dioleat...

Embodiment 3

[0057] The oil phase liquid crystal gel precursor preparation of the hydrophilic drug of this embodiment is prepared by the following steps of preparation method:

[0058] (S1) Preparation of phospholipid dispersion: Weigh 1g of soybean lecithin, 0.3g of phosphatidylethanolamine and 4g of distilled water into the bottle, seal, and disperse on a shaker to form a coarse dispersion; ultrasonically disperse the coarse dispersion with a probe in an ice bath 20min, 50% (650W), 1s / 3s, forming a milky white phospholipid dispersion;

[0059] (S2) Preparation of hydrophilic drug solution: Weigh 20 mg of insulin and add 1 ml of water to completely dissolve it to make a 20 mg / ml drug solution for later use;

[0060] (S3)) Preparation of the water phase: take 210uL of the phospholipid dispersion prepared in the step (S1) and mix with 300uL of the drug solution prepared in the step (S2) to obtain the water phase;

[0061] (S4) Preparation of the oil phase: add 1 mg of Tween 80 to 2.7 g of ...

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Abstract

The invention belongs to the field of drug precursor preparations and discloses a preparation method of an oil-phase liquid crystal gel precursor preparation for a hydrophilic drug. The preparation method comprises following steps: a phospholipid dispersion and a hydrophilic drug solution are prepared firstly and mixed for preparation of an aqueous phase solution, then an oil phase solution is prepared, the oil phase solution and the aqueous phase solution are mixed and lyophilized, and a lyophilized sample is prepared; a mixed oil phase of phospholipid and glyceride is prepared, the mixed oilphase is added to the lyophilized sample and mixed uniformly, and the precursor preparation for the hydrophilic drug is prepared. The precursor preparation for the hydrophilic drug has good stability, can form gel in the presence of water, and has good slow-release effect. The system has the advantages of simple preparation process, small difference between batches, few influence factors and thelike, and new technology and new dosage form with great commercial transformation value are obtained.

Description

technical field [0001] The invention belongs to the field of drug precursor preparations, in particular to an oil phase liquid crystal gel precursor preparation of hydrophilic drugs and a preparation method thereof. Background technique [0002] Drugs can be divided into oral preparations, injection preparations, nasal preparations, transdermal preparations, etc. through different methods of administration. Different modes of administration require consideration of different factors. For example, for polypeptide and protein drugs with large molecular weight, short half-life, and poor fat solubility, oral preparations are prone to degradation and inactivation after gastric acid and pepsin; injections need to consider the biocompatibility of the carrier; transdermal preparations need to examine the individual and the site of action Differences in drug absorption and so on. In addition, how to improve the storage stability of drugs, reduce the frequency of administration, imp...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/06A61K38/17A61K38/28A61K39/395A61K47/14A61K47/24
CPCA61K9/0019A61K9/06A61K38/1774A61K38/28A61K39/395A61K47/14A61K47/24
Inventor 罗亮黄丽萍孟凡玲
Owner 武汉百纳礼康生物制药有限公司
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