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Lyophilized injection of lentinan and preparation process thereof

A technology of freeze-dried powder injection and lentinan, which is applied in the direction of freeze-drying transportation, powder transportation, antiviral agents, etc., can solve the problems of uneven suspension of aqueous solution, reduced use safety, loss of lentinan, etc., and achieve reduction of lentinan Loss, clinical use safety, effect of effective drug selection

Inactive Publication Date: 2007-05-30
成都普瑞法科技开发有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] At present, there are also reports of lentinan injection, which uses a single mannitol as a scaffold agent. The current production adopts the pH adjustment to neutrality and then filters, and dissolves with high-concentration sodium hydroxide, which is likely to cause the loss and decomposition of lentinan. Inhomogeneous suspension and other phenomena lead to reduced safety in use

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] Example 1 Screening Test of Lentinan Freeze-dried Powder and Injection Auxiliaries of the Present Invention

[0026] Take 5 200ml volumetric flasks, add 115mg of lentinan raw material, 3ml of 1 molar sodium hydroxide solution, let it swell naturally, stir to dissolve, add a small amount of water for injection to dilute, stir well, add glycine, alanine, Serine, proline, mannitol 14.0g, filter, and the filtrate is neutralized to pH7.2 with hydrochloric acid, adds water for injection to 200 milliliters, carries out solution homogeneity test, and the result is shown in Table 1.

[0027] Table 1 Solution uniformity test result

[0028] excipient

[0029] The experimental results show that compared with the amino acid that is simply used as a scaffolding agent using mannitol, the lentinan is more uniformly dispersed in the aqueous solution. Due to the uniform dispersion, it is safer to use clinically.

Embodiment 2

[0030] Example 2 Excipient ratio screening test of lentinan freeze-dried powder injection of the present invention

[0031] Take 7 200ml volumetric flasks, add 115mg of lentinan raw material, 3ml of 1 molar sodium hydroxide solution, let it swell naturally, stir to dissolve, add a small amount of water for injection to dilute, stir well, add glycine, 10.0g, in turn in Add mannitol 0g, 2g, 5g, 10g, 15, 30g, 40g to 7 volumetric flasks, mix well, filter, neutralize the filtrate with hydrochloric acid to pH7.2, add water for injection to 200ml, and test the uniformity of the solution , the results are shown in Table 2.

[0032] Table 2 solution homogeneity test results

[0033] Glycine: Mannitol

[0034] The experimental results show that amino acid can be used alone as a scaffold, but the dosage is slightly larger, but when combined with mannitol, it can not only improve the shape of the freeze-dried preparation, but also reduce the overall dosage of excipients.

Embodiment 3

[0035] Example 3 Compatibility Screening Test of Lentinan Freeze-dried Powder Injection Main Material and Excipients of the Present Invention

[0036] Take 115mg of this product, dissolve in 50ml of 0.25mol / L sodium hydroxide, add appropriate amount of excipients, add water for injection to 150ml, adjust pH to 7.0-7.5, dilute to 200ml with sterile water for injection, filter aseptically, and pack ( 2ml / bottle), freeze-dried, and the test results are shown in Table 3.

[0037] Table 3 Determination of the amount of auxiliary materials

[0038] Main drug: excipients

[0039] The test results show that it is the best when the amount of auxiliary material (glycine) for each injection is 150 mg, that is, the main ingredient: auxiliary material is 1.15:150, that is, 1:130.

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PUM

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Abstract

The invention discloses a freeze dried of mushroom polysaccharide, which comprises the following steps: adopting neutral amino acid as rack agent; blending evenly; reducing the density of sodium hydroxide; filtering; adjusting pH value.

Description

technical field [0001] The invention relates to a lentinan freeze-dried powder injection, which belongs to the field of medicines. Background technique [0002] Lentinan is an active substance isolated from shiitake mushrooms with obvious anti-cancer effects. It was first discovered in Japan in 1969. It was first produced in Japan in 1986 and prepared into powder injections for sale abroad. It is mainly used clinically for gastric cancer, For rectal cancer and other digestive system cancers, its main route of administration is intravenous drip or injection. In 1988, my country began to import Japanese Ajinomoto lentinan and apply it clinically. Since 1982, Sichuan Institute of Antibiotics and Henan Pharmaceutical Industry Research Institute have successively extracted lentinan from the liquid of shiitake mushrooms cultured by submerged fermentation, named "lentinan", to distinguish lentinan from fruiting bodies. In 1986, Henan Kaifeng Pharmaceutical Factory produced Lentinan...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/715A61K9/19A61P35/00A61P1/16A61P31/20
Inventor 吴四灵王小林
Owner 成都普瑞法科技开发有限公司
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