CN102871960A - Lentinan injection and preparation method thereof - Google Patents
Lentinan injection and preparation method thereof Download PDFInfo
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- CN102871960A CN102871960A CN2012104192016A CN201210419201A CN102871960A CN 102871960 A CN102871960 A CN 102871960A CN 2012104192016 A CN2012104192016 A CN 2012104192016A CN 201210419201 A CN201210419201 A CN 201210419201A CN 102871960 A CN102871960 A CN 102871960A
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- lentinus edodes
- lentinan
- edodes polysaccharide
- injecta
- preparation
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Abstract
The invention relates to a lentinan injection and a preparation method thereof. The lentinan injection comprises lentinan, sodium hydroxide, sodium dihydrogen phosphate and water for injection. The lentinan injection prepared according to the invention has the advantages of high storage stability and high compatible stability.
Description
Technical field
The present invention relates to pharmaceutical field, be specifically related to a kind of immunomodulator and preparation method thereof.
Background technology
Lentinan (Lentinan) claim again lentinan, and chemical name is β-(1 → 3) (1 → 6)-D-glucosan.As a kind of immunomodulator, lentinan is widely used in the auxiliary treatment of malignant tumor clinically.Lentinan is water-soluble hardly, non-lipophilic substance again, and this becomes the significant obstacle in the drug discovery process.Therefore, the selection of excipient substance seems especially crucial for the exploitation of lentinan agent.And all there are problems in various lentinan agent of the prior art.
The lentinan injection of Japan aginomoto company exploitation contains dextran, can cause the serious adverse reactions such as anaphylactic shock.
CN00112407.2 discloses a kind of freeze dried lentinan holoside powder injecta, and it does not contain dextran, and adopts mannitol as freeze-dried excipient.But the chemical nature of lentinan is glucosan, and its assay adopts classical sulphuric acid anthrone method and reducing sugar test method, and mannitol has obvious interference to its assay.
CN96116294.5 discloses a kind of lentinus edodes polysaccharide injecta, and it is dissolved in lentinan in the sodium hydroxide solution, uses the Fructus Citri Limoniae acid for adjusting pH value to 7.0-7.5 again, filter, and packing, sterilization, and get final product.
Improving quality and the stability of existing lentinan injection, is the target that those skilled in the art constantly pursue.
Summary of the invention
In the research process for lentinan, the inventor is surprised to find, and different pH adjusting agents also has material impact to quality and the stability of this injection except the pH value that can regulate lentinus edodes polysaccharide injecta.Based on this, the applicant has finished the present invention.
One of purpose of the present invention provides high and stable lentinus edodes polysaccharide injecta of a kind of quality and preparation method thereof.
Based on above-mentioned purpose, the present invention realizes according to following technical scheme:
1, a kind of lentinus edodes polysaccharide injecta is comprised of lentinan, sodium hydroxide, sodium dihydrogen phosphate and water for injection.
2, according to the lentinus edodes polysaccharide injecta of item 1, formed by following component:
3, according to the lentinus edodes polysaccharide injecta of item 2, the concentration of wherein said sodium hydroxide solution is 0.4-0.6mol/L.
4, according to the lentinus edodes polysaccharide injecta of item 2, the concentration of wherein said sodium hydroxide solution is 0.5mol/L.
5, according to the lentinus edodes polysaccharide injecta of item 2, the concentration of wherein said sodium dihydrogen phosphate is 0.7-0.8mol/L.
6, according to the lentinus edodes polysaccharide injecta of item 2, the concentration of wherein said sodium dihydrogen phosphate is 0.75mol/L.
7, the preparation method of 1 or 2 a described lentinus edodes polysaccharide injecta comprises:
1) lentinan is added in the sodium hydroxide solution, be stirred to entirely molten;
2) regulate pH to 6.5～7.5 with sodium dihydrogen phosphate;
3) adsorb 20-40min with activated carbon adsorption;
4) extremely clear and bright with the nylon filtering with microporous membrane;
5) water for injection adds to full dose;
6) embedding, sterilization.
8, according to the preparation method of item 7 described lentinus edodes polysaccharide injectas, wherein said active carbon is needle-use activated carbon, and consumption is 0.01% (w/v).
9, according to the preparation method of item 7 described lentinus edodes polysaccharide injectas, the aperture of wherein said nylon microporous filter membrane is 0.22 μ m.
The present invention has obtained unforeseeable technique effect: with utilize other pH adjusting agent, compare such as citric acid solution or hydrochloric acid solution, regulate the quality of the lentinus edodes polysaccharide injecta of pH value with sodium dihydrogen phosphate, storage stability, and all obviously improve with the compatibility stability of sodium chloride injection.
The specific embodiment
The specific embodiment of the present invention only is used for explanation the present invention, must not be interpreted as any limitation of the invention.
The preparation of embodiment 1 lentinus edodes polysaccharide injecta
Prescription:
Preparation technology:
1) lentinan with recipe quantity adds in the sodium hydroxide solution, is stirred to entirely molten;
2) regulate pH to 6.5～7.5 with sodium dihydrogen phosphate;
3) in solution, add 0.01% (w/v) needle-use activated carbon (that is, in 100ml solution, adding the 0.01g needle-use activated carbon), room temperature absorption 30min;
4) extremely clear and bright with 0.22 μ m nylon filtering with microporous membrane;
5) water for injection adds to full dose;
6) fill is in ampoule bottle, and 2ml/ props up, sealing by fusing;
7) 121 ℃ of high temperature hot pressings were sterilized 20 minutes;
8) lamp inspection, the packing warehouse-in.
The preparation of embodiment 2 lentinus edodes polysaccharide injectas
Prescription:
Preparation technology:
1) lentinan with recipe quantity adds in the sodium hydroxide solution, is stirred to entirely molten;
2) regulate pH to 6.5 with sodium dihydrogen phosphate;
3) in solution, add 0.01% (w/v) needle-use activated carbon, room temperature absorption 20min;
4) extremely clear and bright with 0.22 μ m nylon filtering with microporous membrane;
5) water for injection adds to full dose;
6) fill is in ampoule bottle, and 2ml/ props up, sealing by fusing;
7) 121 ℃ of high temperature hot pressings were sterilized 20 minutes;
8) lamp inspection, the packing warehouse-in.
The preparation of embodiment 3 lentinus edodes polysaccharide injectas
Prescription:
Preparation technology:
1) lentinan with recipe quantity adds in the sodium hydroxide solution, is stirred to entirely molten;
2) regulate pH to 7.5 with sodium dihydrogen phosphate;
3) in solution, add 0.01% (w/v) needle-use activated carbon, room temperature absorption 40min;
4) extremely clear and bright with 0.22 μ m nylon filtering with microporous membrane;
5) water for injection adds to full dose;
6) fill is in ampoule bottle, and 2ml/ props up, sealing by fusing;
7) 121 ℃ of high temperature hot pressings were sterilized 20 minutes;
8) lamp inspection, the packing warehouse-in.
The preparation of reference examples 1 lentinus edodes polysaccharide injecta
Prescription:
Identical with embodiment 1, difference is to replace the 0.75mol/L sodium dihydrogen phosphate with the 0.05mol/L citric acid solution.
The preparation of reference examples 2 lentinus edodes polysaccharide injectas
Prescription:
Preparation technology:
Identical with embodiment 1, difference is to replace the 0.75mol/L sodium dihydrogen phosphate with the 0.05mol/L hydrochloric acid solution.
Experimental example 1 exposure experiments to light
Get lentinus edodes polysaccharide injecta (low borosilicate flint glass ampoule packing), remove outer package, (4500Lux) placed 10 days under illumination condition, and testing result is as follows.
Experimental example 2 hot tests
Get lentinus edodes polysaccharide injecta sample (low borosilicate flint glass ampoule packing), remove outer package, (60 ℃) were placed 10 days under hot conditions, and testing result is as follows.
The test of experimental example 3 compatibilities
1 lentinus edodes polysaccharide injecta sample (low borosilicate flint glass ampoule packing) decant(-ation) is observed its outward appearance, visible foreign matters in 0h, 1h, 2h, 4h, 6h, 8h, and measured pH value in 250ml 0.9% sodium chloride injection, and the result is as follows.
Claims (9)
1. a lentinus edodes polysaccharide injecta is comprised of lentinan, sodium hydroxide, sodium dihydrogen phosphate and water for injection.
2. according to claim 1 lentinus edodes polysaccharide injecta is comprised of following component:
3. according to claim 2 lentinus edodes polysaccharide injecta, the concentration of wherein said sodium hydroxide solution is 0.4-0.6mol/L.
4. according to claim 2 lentinus edodes polysaccharide injecta, the concentration of wherein said sodium hydroxide solution is 0.5mol/L.
5. according to claim 2 lentinus edodes polysaccharide injecta, the concentration of wherein said sodium dihydrogen phosphate is 0.7-0.8mol/L.
6. according to claim 2 lentinus edodes polysaccharide injecta, the concentration of wherein said sodium dihydrogen phosphate is 0.75mol/L.
7. the preparation method of claim 1 or 2 described lentinus edodes polysaccharide injectas comprises:
1) lentinan is added in the sodium hydroxide solution, be stirred to entirely molten;
2) regulate pH to 6.5～7.5 with sodium dihydrogen phosphate;
3) adsorb 20-40min with activated carbon adsorption;
4) extremely clear and bright with the nylon filtering with microporous membrane;
5) water for injection adds to full dose;
6) embedding, sterilization.
8. the preparation method of lentinus edodes polysaccharide injecta according to claim 7, wherein said active carbon is needle-use activated carbon, consumption is 0.01% (w/v).
9. the preparation method of lentinus edodes polysaccharide injecta according to claim 7, the aperture of wherein said nylon microporous filter membrane is 0.22 μ m.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2012104192016A CN102871960A (en) | 2012-10-29 | 2012-10-29 | Lentinan injection and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2012104192016A CN102871960A (en) | 2012-10-29 | 2012-10-29 | Lentinan injection and preparation method thereof |
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| CN102871960A true CN102871960A (en) | 2013-01-16 |
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| CN2012104192016A Pending CN102871960A (en) | 2012-10-29 | 2012-10-29 | Lentinan injection and preparation method thereof |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| 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 |
| CN115120618A (en) * | 2021-03-23 | 2022-09-30 | 北京盛美诺生物技术有限公司 | Cartilage extract with function of improving immune response, preparation method and application thereof |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1160538A (en) * | 1996-03-28 | 1997-10-01 | 中国科学院上海药物研究所 | Lentinus edodes polysaccharide injecta and its preparation |
-
2012
- 2012-10-29 CN CN2012104192016A patent/CN102871960A/en active Pending
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1160538A (en) * | 1996-03-28 | 1997-10-01 | 中国科学院上海药物研究所 | Lentinus edodes polysaccharide injecta and its preparation |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| 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 |
| CN115120618A (en) * | 2021-03-23 | 2022-09-30 | 北京盛美诺生物技术有限公司 | Cartilage extract with function of improving immune response, preparation method and application thereof |
| CN115120618B (en) * | 2021-03-23 | 2024-01-26 | 安徽盛美诺生物技术有限公司 | Cartilage extract with immune response improving effect, preparation method and application thereof |
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Application publication date: 20130116 |