Asarin composite freeze-dried powder for injection

A technology of freeze-dried powder injection and asarum, applied in freeze-drying delivery, drug combination, powder delivery and other directions, can solve the problems of many types of excipients, unsatisfactory reconstitution effect, and large proportion of excipients added, so as to improve the Dissolving properties, reducing the amount of excipients, and ensuring the effect of stability

Active Publication Date: 2010-10-13
SHANDONG LUOXIN PARMACEUTICAL GROUP STOCK CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The defect of this patent is that there are many types of auxiliary materials added, and the proportion of auxiliary materials added is large, and the reconstitution effect is still not ideal

Method used

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  • Asarin composite freeze-dried powder for injection
  • Asarin composite freeze-dried powder for injection
  • Asarin composite freeze-dried powder for injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0045] Composed of:

[0046] Asarum 8.0g

[0047] 95% ethanol 40ml

[0048] Mannitol 80.0g

[0049] Add water for injection to 1000ml

[0050]

[0051] Make 500 vials after freeze-drying.

[0052] (1) preparing polysorbate-80 mass percent is 0.1% deionized aqueous solution as anti-solvent;

[0053] (2) preparation mass percentage is the diethyl ether solution of 0.1g / ml Asarone as solvent;

[0054] (3) Under the conditions of 2~6°C and a stirring speed of 600 rpm, quickly add solvent to the anti-solvent, wherein the volume ratio of solvent to anti-solvent is 1:15; after white crystals are produced, put the crystals and the solution at 42°C Conditioned under aging 2 hours, through filtering, washing, filter cake dispersion and spray drying; Gained ultrafine particle asarone obtains CSD curve and figure 1 same;

[0055] (4) dissolving the ultrafine particle Asarum solution in 95% ethanol in proportion to obtain liquid A;

[0056] (5) D...

Embodiment 2

[0059] The prescription is:

[0060] Asarum 8.0g

[0061] 100% ethanol 80ml

[0062] Mannitol 80.0g

[0063] Add water for injection to 1000ml

[0064]

[0065] Make 500 vials after freeze-drying.

[0066] (1) prepare polysorbate-80 mass percentage as the deionized aqueous solution of 0.5% as anti-solvent;

[0067] (2) preparation mass percentage is the diethyl ether solution of 1g / ml Asarone as solvent;

[0068] (3) Under the conditions of 6°C and a stirring speed of 1200 rpm, quickly add solvent to the anti-solvent, wherein the volume ratio of solvent to anti-solvent is 1:21; after white crystals are produced, put the crystals and the solution at 55°C Aging for 5 hours, through filtration, washing, filter cake dispersion and spray-drying, the ultrafine particle asarone of gained obtains CSD curve and figure 1 same;

[0069] (4) dissolving the ultrafine particle Asarum solution in 100% ethanol in proportion to obtain liquid A;

[0070] ...

Embodiment 3

[0073] The prescription is:

[0074] Asarum 6.0g

[0075] 98% ethanol 40ml

[0076] Mannitol 24.0g

[0077] Add water for injection to 1000ml

[0078]

[0079] Make 500 vials after freeze-drying.

[0080] (1) preparing polysorbate-80 mass percentage is the deionized aqueous solution of 0.25% as anti-solvent;

[0081] (2) preparation mass percentage is the diethyl ether solution of 0.5g / ml Asarone as solvent;

[0082] (3) At 4°C and a stirring speed of 1000 rpm, quickly add solvent to the anti-solvent, wherein the volume ratio of solvent to anti-solvent is 1:20; after white crystals are produced, put the crystals and the solution at 45°C Aged for 3 hours, filtered, washed, filter cake dispersed and spray-dried; the resulting ultrafine particle asarone was obtained by a laser particle size measuring instrument with a CSD curve and figure 1 same;

[0083] (4) dissolving the ultrafine particle Asarum solution in 98% ethanol in proportion to...

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Abstract

The invention relates to an asarin injection preparation and in particular relates to an asarin composite aseptic freeze-dried powder preparation for injection. The asarin composite freeze-dried powder for injection comprises 4 to 8 grams of asarin, 40 to 80ml of ethanol of which the volume ratio is between 95 and 100 percent and 24 to 80 grams of mannitol. The raw materials is added with water for injection to a volume of 1,000 to 2,000ml and the obtained product is freeze-dried to prepare 500 to 1,000 bottles of the freeze-dried powder, wherein the asarin is ultrafine particles prepared by an anti-solvent crystallization method. The asarin composite preparation for injection also comprises 0.01 to 10 grams of polysorbate-80, preferably 1 to 8 grams of polysorbate-80. Due to adoption of the ultrafine particles of the asarin, which is prepared by the anti-solvent crystallization method, the asarin composite aseptic freeze-dried powder preparation for injection greatly improves solubility property of the asarin so as to obtain the freeze-dried powder preparation with excellent stability and redissolution property by adding a small quantity of cosolvent or without adding the cosolvent when preparing the asarin preparation.

Description

technical field [0001] The invention relates to an injection preparation of asarone, in particular to a sterile freeze-dried powder preparation of asarone composition for injection. Background technique [0002] Asarone (2,4,5-trimethoxy-1-propenylbenzene), mainly exists in the volatile oil of plants such as Araceae plant Shichangpu, the test shows that this product can obviously prevent asthma attacks, and it is close to Because of the same antitussive effect, it also has certain choleretic and sedative effects. Clinically, it is mainly used for the treatment of bronchial asthma, chronic bronchitis, pneumonia and chronic obstructive pulmonary disease with acute inflammation of the lungs. [0003] In recent years, due to factors such as the aggravation of air pollution and the development of the chemical industry, the incidence of asthma has gradually increased. In the 1940s, the incidence of asthma in developed countries was about 0.5%. According to reports from the Unit...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K31/09A61P11/06A61P11/00
Inventor 李明华宋显荣郭中明
Owner SHANDONG LUOXIN PARMACEUTICAL GROUP STOCK CO LTD
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