Lentinan lyophilized power injection and preparation method thereof

A technology of freeze-dried powder injection and lentinan, applied in the field of lentinan freeze-dried powder injection and its preparation, can solve the problems of unhelpful treatment, adverse side effects, adverse reactions, etc., reduce adverse reactions, reduce toxic and side effects, and improve safety sexual effect

Inactive Publication Date: 2010-01-27
上海慈瑞医药科技股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Components above 2 million Daltons are difficult to dissolve in aqueous solution, but the solubility of lentinan with large molecular weight in alkaline aqueous solution can be greatly improved, which is the current freeze-dried lentinan for injection. The reason why the preparation uses alkaline aqueous solution to dissolve lentinan
[0004] The lyophilized preparation of lentinan for injection is dissolved in an alkaline solution and then neutralized in an acidic solution. The salt produced during this process has no effect on the curative effect, but will cause some adverse reactions on the contrary. Especially for patients with cardiovascular disease and renal insufficiency
In addition, the excipients in powder injections only serve as the skeleton for drug formation, which is not helpful for treatment, but will cause adverse side effects. Formulation

Method used

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  • Lentinan lyophilized power injection and preparation method thereof
  • Lentinan lyophilized power injection and preparation method thereof
  • Lentinan lyophilized power injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0020] Preparation prescription:

[0021]

[0022] The preparation method of lentinan freeze-dried powder injection is characterized in that the specific steps are:

[0023] Step 1: Dissolve the lentinan that has met the national standard with water into a 0.2g / L lentinan solution. At 5°C, put the solution into a dialysis bag with a molecular weight cut-off of 10,000 Daltons and dialyze against water. Change the water once every 4 hours, and perform dialysis for 36 hours; filter the solution obtained by dialysis twice with a microfiltration membrane with a pore size of 0.14 μm at room temperature, and then ultrafiltrate the obtained filtrate with an ultrafiltration membrane with a molecular weight cut-off of 500,000 Daltons. The pressure difference of the ultrafiltration feed is set to 0.18MPa, the filtrate obtained by the ultrafiltration is concentrated under reduced pressure to 1 / 8 of the original volume, and freeze-dried to obtain a compound with a weight average molecul...

Embodiment 2

[0028] Preparation prescription:

[0029]

[0030] The preparation method of lentinan freeze-dried powder injection is characterized in that the specific steps are:

[0031] The first step: Dissolve the lentinan that has met the national standard with water into a 0.3g / L lentinan solution. At 20°C, put the solution into a dialysis bag with a molecular weight cut-off of 10,000 Daltons and dialyze against water. Change the water once every 6 hours, and perform dialysis for 48 hours; filter the solution obtained by dialysis twice at room temperature with a microfiltration membrane with a pore size of 0.2 μm, and then ultrafiltrate the obtained filtrate with an ultrafiltration membrane with a molecular weight cut-off of 1 million Daltons. The pressure difference of the ultrafiltration feed is set to 0.15MPa, the filtrate obtained by the ultrafiltration is concentrated under reduced pressure to 1 / 6 of the original volume, and then freeze-dried to obtain a Lentinan with a compon...

Embodiment 3

[0036] Preparation prescription:

[0037]

[0038] The preparation method of lentinan freeze-dried powder injection is characterized in that the specific steps are:

[0039] The first step: Dissolve the lentinan that has met the national standard with water into a 0.3g / L lentinan solution. At 20°C, put the solution into a dialysis bag with a molecular weight cut-off of 10,000 Daltons and dialyze against water. Change the water once every 6 hours, and perform dialysis for 48 hours; filter the solution obtained by dialysis twice at room temperature with a microfiltration membrane with a pore size of 0.2 μm, and then ultrafiltrate the obtained filtrate with an ultrafiltration membrane with a molecular weight cut-off of 1 million Daltons. The pressure difference of the ultrafiltration feed is set to 0.16MPa, the filtrate obtained by the ultrafiltration is concentrated under reduced pressure to 1 / 6 of the original volume, and then freeze-dried to obtain the Lentinan with a comp...

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Abstract

The invention relates to a lentinan lyophilized power injection and a preparation method thereof, belonging to the technical field of biological response modifier antitumor drugs. The lentinan lyophilized power injection is characterized in that the injection comprises 0.95-1.10 parts of lentinan and 1-33.5 parts of excipient by weight, wherein the weight mean molecular weight of lentinan is 400-800 thousands, the content of the components with more than 20 thousands is not less than 98wt% and the content of the components with more than 2000 thousands is less than 2wt%, the invention has the advantage that salt-free technology is used in the preparation method of the lyophilized preparation and water for injection is used for direct dissolution in the preparation of the injection. The salt-free preparation can reduce the adverse reaction of patients and improve the safety of medication. The invention ensures the curative effect of lentinan, reduces the poison and side effect, increases the safety and reduces the production cost and the preparation method is simple and is applicable to scale industrialized production.

Description

technical field [0001] The invention relates to a lentinan freeze-dried powder injection and a preparation method thereof, belonging to the technical field of biological response regulator antitumor drugs. Background technique [0002] Lentinan is a biologically active glucan extracted from Lentinus edodes, which is composed of β-(1→3) glycosidic bonds in the main chain, and the glucose groups connected by β-(1→6) are randomly distributed along the main chain It is a comb branch structure. Lentinan was first obtained by Japanese scholar Chihara Goro in 1969 through the extraction and purification of the fruiting body of Lentinus edodes. In 1974, Ajinomoto Co., Ltd. of Japan was entering the research and development of lentinan, and completed a series of clinical research in ten years. In 1985, the freeze-dried sub-needle intravenous injection of lentinan was officially approved as a new drug for marketing. Lentinan is a kind of biological immunomodulator, which has inhibit...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/14A61K31/715A61K47/26A61K47/10A61P35/00
Inventor 金幸陈林祥朱益锋
Owner 上海慈瑞医药科技股份有限公司
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