CN1087610C - Lentinus edodes polysaccharide injecta and its preparation - Google Patents
Lentinus edodes polysaccharide injecta and its preparation Download PDFInfo
- Publication number
- CN1087610C CN1087610C CN96116294A CN96116294A CN1087610C CN 1087610 C CN1087610 C CN 1087610C CN 96116294 A CN96116294 A CN 96116294A CN 96116294 A CN96116294 A CN 96116294A CN 1087610 C CN1087610 C CN 1087610C
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- CN
- China
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- lentinan
- lentinus edodes
- injection
- preparation
- injecta
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- Expired - Lifetime
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Abstract
In the present invention, purified lentinan is dissolved in sodium hydroxide solution with proper concentration, the pH value is regulated to 7.0 to 7.5 with citric acid, insoluble matters are filtered, and filtrate is packed and is disinfected at high temperature to obtain lentinan injection.
Description
The present invention relates to polysaccharide, be specifically related to polysaccharide formulation.
The component that lentinan system extracts from mushroom fruiting body, separation and purification obtains.The various countries scientist just carries out broad research to all kinds of polysaccharide as far back as early seventies, the discovery polysaccharide not only can be treated the cancer that body immune system is subjected to major injury, can treat the damaged disease of panimmunity again, as chronic viral hepatitis and some drug-resistant bacteria or the viral chronic disease that causes, can also treat the autoimmune disease such as rheumatism, Japan in 1986 at first produces and that lentinan is prepared into the injectable powder export trade is external, the clinical alimentary tract cancers such as gastric cancer, rectal cancer that are mainly used in, its main route of administration is intravenous drip or injects.
It is little that lentinan has dosage, and curative effect height, poison are paid advantages such as effect is little, but because its dissolubility in water is less, must make injectable powder to use, and the equipment requirements for preparing injectable powder as everyone knows is very high, and the specification requirement height makes it the cost height.The intramuscular injection that China supplies in the market is placed with precipitation for a long time with the multicomponent lentinan and occurs, and influences product quality, can not continue to use.
The object of the invention is being developed on the basis of single lentinan, according to the characteristics of the stabilized aqueous solution of lentinan and in water the less character of dissolubility seek out a kind of lentinan dissolubility in water that can make and increase, the long-term placement of product can not produce sedimentary method, is prepared into the aqueous injection dosage form of lentinan.
The present invention adopts the following step to implement:
Lentinan (raw material) → be dissolved in NaOH solution → Fructus Citri Limoniae acid for adjusting pH to 7.0-7.5 → filtration → filtrate → packing → high-temperature sterilization → lentinus edodes polysaccharide injecta.
Getting qualified raw material prescription lentinan or multicomponent lentinan is dissolved in the dilute NaOH solution, stir and slowly add citric acid down, at any time measure pH value, when treating that pH is 7.0-7.5, neutralization finishes and continues stirred for several minute, remove by filter insoluble matter, filtrate is sub-packed in the ampoule, promptly gets the lentinan for injection injection after 120 ℃ of high-temperature sterilizations in 0.5 hour.
The following example further specifies the present invention, does not impose any restrictions.
Embodiment 1
But get crude drug lentinan 0.5 gram (lentinan content is 99%) that injection for intravenous is used, under agitation add 610 milliliters of 0.1 mol NaOH solution, make its whole dissolvings, stir 390 milliliters of citric acids that slowly add 0.05 mol down, making pH is 7.0-7.5, can't reach above-mentioned scope as pH, it is 7.0-7.5 that then available several 0.1 mol NaOH solution are adjusted to pH, filter some insoluble matters of elimination, filtrate clarification, concentration is 0.5 mg/ml, press 2 milliliters of per ampoule packing, sterilized 30 minutes, but promptly get the lentinus edodes polysaccharide injecta that injection for intravenous is used for 120 ℃.With this injection in 5 ℃ of refrigerators or room temperature placed six months, there is no solid and separate out, the clarity test of injection meets 90 editions pharmacopeia of China.
Embodiment 2
But get raw material prescription lentinan 1.05 grams (lentinan content is 98%) that injection for intravenous is used, under agitation slowly splash into 1220 milliliters of 0.1 mol NaOH solution, make its dissolving, after treating all dissolvings, under agitation slowly add concentration and be 790 milliliters of the citric acids of 0.05 mol, making pH value is 7.0-7.5, filtering the gained filter liquor concentration is 0.5 mg/ml, 2 milliliters of the above-mentioned filtrates of per ampoule packing, 120 ℃ of high-temperature sterilizations 30 minutes promptly get the used for intravenous injection lentinus edodes polysaccharide injecta, and this injection was placed six months in room temperature or in 5 ℃ of refrigerators, do not find that any solid separates out, clarity test meets 90 editions Chinese Pharmacopoeias.
Embodiment 3
Get and to make raw material (wherein lentinan content is 21.5%) for the multicomponent lentinan that intramuscular injection is used, 900 milligrams, under agitation slowly add 0.2 mol NaOH140 milliliter, make its dissolving, after treating all dissolvings, continue to stir, slowly splash into 46 milliliters of the citric acids of 0.2 mol, making pH value is 7.0-7.5, and then adds injection water to 300 milliliter, filters, filter liquor concentration is 3 mg/ml, press 2 milliliters of packing of per ampoule, 120 ℃ of high-temperature sterilizations 30 minutes promptly get the muscle lentinus edodes polysaccharide injecta.This injection was deposited six months for 5 ℃ at room temperature, refrigerator respectively, did not see that any solid separates out, and clarity test meets 90 editions Chinese Pharmacopoeias.
Embodiment 4
But get crude drug lentinan work 0.5 gram (lentinan content is 99%) that injection for intravenous is used, under agitation slowly splash into 610 milliliters of 0.3 mol NaOH solution, make its dissolving, after treating all dissolvings, under agitation slowly adding concentration is 390 milliliters of 0.16 mol citric acids, making pH value of solution is 7.0-7.5, filter then, the concentration of gained filtrate is 0.5 mg/ml, 2 milliliters of the above-mentioned filtrates of per ampoule packing were sterilized 30 minutes, and were promptly got the used for intravenous injection lentinus edodes polysaccharide injecta for 120 ℃, this injection is placed at room temperature or 5 ℃ of low temperature and was not found that any solid separated out in six months, and clarity test meets 90 editions Chinese Pharmacopoeias regulations.
Embodiment 5
But get crude drug lentinan 0.5 gram (lentinan content is 99%) that injection for intravenous is used, under agitation slowly splash into 610 milliliters of 0.6 mol NaOH solution, make its dissolving, after treating all dissolvings, under agitation slowly add concentration and be 390 milliliters of the citric acids of 0.32 mol, make pH value of solution be 7.0-7.5, filter then, the concentration of gained filtrate is 0.5 mg/litre, 2 milliliters of the above-mentioned filtrates of per ampoule packing were sterilized 30 minutes, and were promptly got the used for intravenous injection lentinus edodes polysaccharide injecta for 120 ℃, this injection is placed at room temperature or 5 ℃ of low temperature and was not found that any solid separated out in six months, and clarity test meets 90 editions Chinese Pharmacopoeias regulations.
Claims (3)
1, lentinus edodes polysaccharide injecta is characterized in that single lentinan or multicomponent lentinan are dissolved in the NaOH solution of suitable concn, stirs to add citric acid solution adjusting pH to 7.0-7.5 down, filter, filtrate packing aequum is to ampoule, and high-temperature sterilization makes lentinus edodes polysaccharide injecta.
2, according to the preparation method of the described injection of claim 1, it is characterized in that lentinan is dissolved in the NaOH solution of suitable concn, stir and slowly add citric acid solution down, regulate pH to 7.0-7.5, filter, the elimination insoluble matter, filtrate packing aequum is to ampoule, high-temperature sterilization makes lentinus edodes polysaccharide injecta.
3, preparation method according to claim 2, the NaOH solution that it is characterized in that suitable concn are 0.1 mole-0.6 mol.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN96116294A CN1087610C (en) | 1996-03-28 | 1996-03-28 | Lentinus edodes polysaccharide injecta and its preparation |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN96116294A CN1087610C (en) | 1996-03-28 | 1996-03-28 | Lentinus edodes polysaccharide injecta and its preparation |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1160538A CN1160538A (en) | 1997-10-01 |
| CN1087610C true CN1087610C (en) | 2002-07-17 |
Family
ID=5123411
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN96116294A Expired - Lifetime CN1087610C (en) | 1996-03-28 | 1996-03-28 | Lentinus edodes polysaccharide injecta and its preparation |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN1087610C (en) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US7091336B2 (en) | 2000-07-19 | 2006-08-15 | Nanjing Zhenzhong Bioengineering Co., Ltd. | Lyophilized powder of lentinan and the process of preparation thereof |
Families Citing this family (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN100349922C (en) * | 2004-10-27 | 2007-11-21 | 山西亚宝药业集团股份有限公司 | Nanometer mushroom amylose and preparation method of its injection |
| CN101695475B (en) * | 2009-10-17 | 2011-06-22 | 海南利能康泰制药有限公司 | Ozagrel sodium injection and preparation method thereof |
| CN103040731B (en) * | 2011-11-30 | 2014-07-02 | 成都盛尔嘉科技有限公司 | Preparation method of injection capable of improving body immunity |
| CN102871960A (en) * | 2012-10-29 | 2013-01-16 | 江苏盈科生物制药有限公司 | Lentinan injection and preparation method thereof |
| CN103110576A (en) * | 2013-03-11 | 2013-05-22 | 河北凯盛医药科技有限公司 | Lentinan injection preparation and preparation method thereof |
| CN103932995B (en) * | 2014-04-24 | 2016-08-24 | 上海慈瑞医药科技有限公司 | A kind of lentinan agent and preparation method thereof |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1076112A (en) * | 1992-03-08 | 1993-09-15 | 郭如明 | Change quiet notes lentinan powder pin into liquid drugs injection |
-
1996
- 1996-03-28 CN CN96116294A patent/CN1087610C/en not_active Expired - Lifetime
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1076112A (en) * | 1992-03-08 | 1993-09-15 | 郭如明 | Change quiet notes lentinan powder pin into liquid drugs injection |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US7091336B2 (en) | 2000-07-19 | 2006-08-15 | Nanjing Zhenzhong Bioengineering Co., Ltd. | Lyophilized powder of lentinan and the process of preparation thereof |
Also Published As
| Publication number | Publication date |
|---|---|
| CN1160538A (en) | 1997-10-01 |
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| C14 | Grant of patent or utility model | ||
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Owner name: JINDING UNITED FIBER TECHNOLOGY CO., LTD. Free format text: FORMER OWNER: SHANGHAI PHARMACEUTICAL INST., CHINESE ACADEMY OF SCIENCES Effective date: 20030425 |
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| C41 | Transfer of patent application or patent right or utility model | ||
| TR01 | Transfer of patent right |
Effective date of registration: 20030425 Address after: 210009 No. 238 Central Road, Nanjing Patentee after: Technology Centre of Jinling Pharmaceutical Co., Ltd. Address before: 200031 No. 294, Taiyuan Road, Shanghai Patentee before: Shanghai Institute of Materia Medica, Chinese Academy of Sciences |
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| CX01 | Expiry of patent term |
Granted publication date: 20020717 |
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| EXPY | Termination of patent right or utility model |