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Bicyclol-containing water-soluble pharmaceutical composition and preparation, and preparation method thereof

A technology for water-soluble drugs and bicyclic alcohols, applied in the directions of drug combinations, active ingredients of heterocyclic compounds, drug delivery, etc., can solve the problem of large amount of emulsifier, and achieve strong solubilization ability, convenient clinical medication, and low toxicity and side effects. Effect

Active Publication Date: 2015-05-27
BEIJING UNION PHARMA FACTORY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, in the above-mentioned patent scheme, due to the large amount of emulsifier, it is only applicable to the oral administration product of bicyclol

Method used

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  • Bicyclol-containing water-soluble pharmaceutical composition and preparation, and preparation method thereof
  • Bicyclol-containing water-soluble pharmaceutical composition and preparation, and preparation method thereof
  • Bicyclol-containing water-soluble pharmaceutical composition and preparation, and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0047] The composition and dosage ratio are shown in Table 1.

[0048] Table 1

[0049] components

1000 consumption (g)

bicyclol

0.5

Solutol HS15

100

Mannitol

375

Add water for injection to

1500

[0050] The preparation method is as follows:

[0051] (1) The preparation process of the liquid medicine before freezing:

[0052] According to the dosage ratio shown in Table 1, add the solubilizer Solutol HS15 and bicyclic alcohol into the preparation container, and stir to dissolve under the heating condition of 50°C; add 80% water for injection, then add the proppant mannitol, and stir until completely dissolve, add water for injection to the full amount, and mix uniformly to obtain a water-soluble pharmaceutical composition containing bicyclic alcohol.

[0053] (2) Sterilize and filter the above-mentioned water-soluble pharmaceutical composition containing bicycloalcohol, and pack it into injection bottles, 1.5g / ...

Embodiment 2

[0060] The composition and dosage ratio are shown in Table 2.

[0061] Table 2

[0062] components

1000 consumption (g)

bicyclol

5

Cremophor RH40

40

PEG400

5

lactose

80

ethanol

300

Propylene Glycol

100

Add water for injection to

2000

[0063] The preparation method is as follows:

[0064] (1) The preparation process of the liquid medicine before freezing:

[0065] According to the dosage ratio shown in Table 2, add solubilizer Cremophor RH40, PEG400 and cosolvent ethanol, propylene glycol into the preparation container, stir and heat, and mix evenly; % of water for injection, then add proppant lactose, stir until fully dissolved, add water for injection to the full amount, and mix uniformly to obtain a water-soluble pharmaceutical composition containing bicyclic alcohol.

[0066] (2) Sterilize and filter the above-mentioned water-soluble pharmaceutical composition containing bic...

Embodiment 3

[0073] The composition and dosage ratio are shown in Table 3. For the preparation method, refer to the preparation method in Embodiment 1.

[0074] table 3

[0075] components

1000 consumption (g)

bicyclol

7.5

Solutol HS15

80

Poloxamer 188

30

Sorbitol

150

ethanol

600

Glycerol

100

Add water for injection to

1500

[0076] The preparation method is as follows:

[0077] (1) The preparation process of the liquid medicine before freezing:

[0078] According to the dosage ratio shown in Table 3, add solubilizer Solutol HS15, poloxamer 188 and cosolvent ethanol, glycerol into the preparation container, stir and heat, and mix well; Stir to dissolve; add 70% water for injection, then add proppant sorbitol, stir until fully dissolved, add water for injection to the full amount, and mix uniformly to obtain a water-soluble pharmaceutical composition containing bicyclol.

[0079] (2) Steril...

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Abstract

The invention relates to a bicyclol-containing water-soluble pharmaceutical composition which is prepared by dissolving an active component bicyclol into a medicinal adjuvant and water for injection, wherein the medicinal adjuvant comprises a solubilizer; the solubilizer contains poly-ethoxylated fatty acid ester; the weight ratio of the poly-ethoxylated fatty acid ester to the bicyclol is (5-200):1; and the weight ratio of the water for injection to the bicyclol is not lower than 200:1. The invention also relates to a bicyclol-containing freeze-dried preparation for injection prepared from the pharmaceutical composition and a preparation method thereof. The bicyclol freeze-dried preparation for injection has the advantages of excellent dissolvability and stability, and high safety and reliability, and is easy for injection; and the preparation method is simple and low in production cost, and can easily implement industrialization.

Description

technical field [0001] The invention belongs to the technical field of medicine preparation, and in particular relates to a water-soluble medicine composition containing bicycloalcohol, a preparation prepared by using the medicine composition and a preparation method. Background technique [0002] Bicyclol is an innovative anti-hepatitis drug with independent intellectual property rights developed by the Institute of Materia Medica, Chinese Academy of Medical Sciences. It has obtained patent protection in 16 countries and regions, and the currently marketed dosage form is oral tablets. The bicyclol raw material and its tablets obtained the new drug certificate and production approval in 2001, and are exclusively produced by Peking Union Medical College Pharmaceutical Factory. Bicyclol is used for the treatment of chronic hepatitis, can significantly improve liver function, reduce transaminase, and has a certain antiviral effect at the same time, it is not easy to rebound aft...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K47/34A61K31/36A61K9/08A61K9/19A61P1/16
Inventor 吕昭云牛得蓂
Owner BEIJING UNION PHARMA FACTORY
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