CN1709442A - Anti-cancer Chinese medicine lyophilized injection agent - Google Patents
Anti-cancer Chinese medicine lyophilized injection agent Download PDFInfo
- Publication number
- CN1709442A CN1709442A CN 200510080685 CN200510080685A CN1709442A CN 1709442 A CN1709442 A CN 1709442A CN 200510080685 CN200510080685 CN 200510080685 CN 200510080685 A CN200510080685 A CN 200510080685A CN 1709442 A CN1709442 A CN 1709442A
- Authority
- CN
- China
- Prior art keywords
- injectable powder
- lyophilized injectable
- preparation
- hours
- radix
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
Landscapes
- Medicinal Preparation (AREA)
- Medicines Containing Plant Substances (AREA)
Abstract
The present invention relates to an anticancer Chinese medicine freeze-dried injection preparation and its preparation method. It is characterized by that said injection preparation is made up by using (by weight portion) 15 portions of mylabris, 500 portions of ginseng, 1000 portions of astragalus root and 1500 portions of acanthopanax root as raw material and adopting the processes of extraction and adding 0.5-15 portions of excipient. Besides, said injection preparation contains mannitol and pH regulating agent.
Description
Technical field:
The present invention relates to a kind of Chinese medicine medicine for preventing freezing-dried powder injection and preparation method thereof, it is characterized in that, be by following Chinese medicine raw materials by weight proportion: 15 parts of Mylabris, 500 parts of Radix Ginsengs, 1000 parts of the Radixs Astragali, 1500 parts of Radix Et Caulis Acanthopanacis Senticosis add 0.5～15 part of excipient again after extracting, learn a skill with conventional formulation and make.
Background technology:
By Mylabris, Radix Ginseng, (trade name is the anti-cancer injection that the Radix Astragali, Radix Et Caulis Acanthopanacis Senticosi are made: ad pro injection) used for many years clinically, be applicable to primary hepatocarcinoma, pulmonary carcinoma, intestinal cancer, nasopharyngeal carcinoma, urological cancer, malignant lymphoma, gynecologic malignant tumor etc.Clinically can be used for the tumor post-operation after treatment, use with chemotherapy combined and can improve curative effect, reduce toxic and side effects.
Discover, this injection formulation is owing to the reason of extraction process and preparation process, poor stability is arranged, the defective that untoward reaction is many, the present invention is through technological transformation, injection is made lyophilized injectable powder, add avirulent substantially mannitol as the lyophilizing caffolding agent,, find that its untoward reaction obviously reduces through clinical verification, and the lyophilized injectable powder volume of this medicine is little, and transportation, storage are conveniently.Because medicine is a solid state, thus stability improve greatly, and significant prolongation the effect duration of medicine.
Summary of the invention:
Lyophilized injectable powder of the present invention, be achieved through the following technical solutions: with Mylabris, Radix Ginseng, the Radix Astragali, Radix Et Caulis Acanthopanacis Senticosi is primary raw material, through extracting processing, makes suitable extract, this extract is added excipient mannitol or lactose, make lyophilized injectable powder of the present invention.
Lyophilized injectable powder of the present invention, the weight proportion of forming medicine is: 15 parts of Mylabris, 500 parts of Radix Ginsengs, 100. parts of the Radixs Astragali, 1500 parts of Radix Et Caulis Acanthopanacis Senticosis.After extracting, add 5～150 parts of excipient, utilize the conventional formulation technology to be prepared from.
Described excipient is mannitol, sorbitol or lactose, preferred mannitol.
More than form to be by weight as proportioning, to can be made into 1000 doses of lyophilized injectable powders.Calculate with 1g as if 1 part, can make 1000 of freeze-dried powders according to the prescription that above weight proportion is formed.
When producing, can increase or reduce according to corresponding proportion, as large-scale production can be unit with the kilogram, or is unit with the ton, and small-scale production can be unit with the milligram also, weight can increase or reduce, but the constant rate of the raw medicinal herbs weight proportion between each composition.
Lyophilized injectable powder of the present invention, its preparation can be passed through following steps:
A. the preparation of extract:
Get the four Chinese medicine material of recipe quantity, the Radix Ginseng section is extracted secondary with 50% alcohol heating reflux, and 3 hours for the first time, 1.5 hours for the second time, merge extractive liquid, filtered, and reclaims ethanol, and medicinal liquid is standby; Three flavors such as medicinal residues and all the other Mylabris decoct with water three times, 3 hours for the first time, 1.5 hours for the second time, 1 hour for the third time, collecting decoction filtered, filtrate and Radix Ginseng extractive solution merge, with stone sulfur method precipitation process secondary, the gained supernatant concentration is to an amount of, adds ethanol and makes and contain the alcohol amount and reach 80%, standing over night, get the supernatant decompression recycling ethanol to there not being the alcohol flavor, add injection 100ml and embedding in corresponding container, hot pressing (115 ℃) sterilization secondary, each 30 minutes, after the cooling, the paper pulp sucking filtration, filtrate is standby as active constituents of medicine.
B. the preparation of lyophilized injectable powder:
Filtrate is added injection be diluted with water to 200ml, stir, in filtrate, add the mannitol of recipe quantity, stir, the needle-use activated carbon (W/V) of adding 0.1%, being heated to 100 ℃ and boiled 15 minutes, filtering carbon removal, is 6.5-7.5 with acid or alkali adjusting PH, microporous filter membrane fine straining with 0.45 μ m, and carry out aseptic filtration with the microporous filter membrane of 0.22 μ m, the filtrate fill in the cillin bottle of 7ml, every bottled 2～3ml.And be placed in the freeze drying box pre-freeze evacuation after 3～5 hours.Condensation temperature remains unchanged, and after 24 hours, unpacks, and makes dried frozen aquatic products, and gland is sealed with wax, labeling, promptly.
It is wherein said that to regulate PH with acid or alkali is 6.5-7.5, sodium bicarbonate preferably, and pH value is 6.8-7.2 preferably, and most preferably 7, can make preparation more stable by regulating pH value.
It is less that lyophilized injectable powder of the present invention has untoward reaction, and its character is a solid state, compares with the ad pro injection of present listing that to have a volume little, and transportation, storage are convenient, and stability is high, the characteristics that effect duration is long, and advantage is very obvious.
The experimental data of concrete superiority is as follows:
The sample of embodiment of the invention method preparation is placed 12 months every detection indexs and is compared with " 0 month ", does not see significant change, and this product steady quality is described.Concrete data are as follows:
| Outward appearance | The light brown block that loosens | The light brown block that loosens | The light brown block that loosens | The light brown block that loosens | The light brown block that loosens | |
| PH value | ??4.7 | ??4.6 | ??4.5 | ??4.6 | ??4.5 | |
| Clarity and color | Up to specification | Up to specification | Up to specification | Up to specification | Up to specification | |
| Moisture % | ??2.41 | ??2.43 | ??2.43 | ??2.44 | ??2.42 | |
| Content (mg/ bottle) | Total saponins | ??57.5 | ??59.2 | ??58.4 | ??58.7 | ??57.9 |
| Astragaloside | ??1.1 | ??1.2 | ??1.2 | ??1.0 | ??1.1 | |
| Total sugar | ??175.4 | ??180.4 | ??178.9 | ??171.8 | ??177.2 | |
The specific embodiment:
Following examples further specify the present invention, include but not limited to the following example.
Embodiment 1
A. the preparation of extract
Get the four Chinese medicine material Mylabris 15g of recipe quantity, Radix Ginseng 500g, Radix Astragali 1000g, Radix Et Caulis Acanthopanacis Senticosi 1500g, the Radix Ginseng section is extracted secondary with 50% alcohol heating reflux, 3 hours for the first time, 1.5 hours for the second time, the ethanol consumption is respectively 7 times of amounts, 5 times of amounts, and merge extractive liquid, filters, reclaim ethanol, medicinal liquid is standby; Three flavors such as medicinal residues and all the other Mylabris decoct with water three times, and 3 hours for the first time, 1.5 hours for the second time, 1 hour for the third time, water consumption was respectively 8 times of amounts, 6 times of amounts, 6 times of amounts.Collecting decoction filters, and filtrate and Radix Ginseng extractive solution merge, with stone sulfur method precipitation process three times, the gained supernatant adds ethanol to be made and contains alcohol amount and reach 80%, and standing over night is got the supernatant decompression recycling ethanol to there not being the alcohol flavor, add injection 100ml and embedding in corresponding container, heat five (115 ℃) sterilization secondary, each 30 minutes, after the cooling, the paper pulp sucking filtration, filtrate for later use.
B. the preparation of lyophilized injectable powder:
Filtrate is added injection be diluted with water to 200ml, stir, in filtrate, add mannitol 600g, stir, the needle-use activated carbon (W/V) of adding 0.1%, be heated to 100 ℃ and boiled 15 minutes, filter carbon removal, adjusting PH is 6.5-7.5, microporous filter membrane fine straining with 0.45 μ m, and carry out aseptic filtration with the microporous filter membrane of 0.22 μ m, the filtrate fill in the cillin bottle of 7ml, every bottled 2～3ml.And be placed in the freeze drying box pre-freeze evacuation after 3～5 hours.Condensation temperature remains unchanged, and after 24 hours, unpacks, and makes dried frozen aquatic products, and gland is sealed with wax, labeling, promptly.Promptly get 1000 bottles (1g/ bottles).
Claims (10)
1. a Chinese medicine medicine for preventing lyophilized injectable powder is by the raw material of Chinese medicine Mylabris, Radix Ginseng, and the Radix Astragali, Radix Et Caulis Acanthopanacis Senticosi is processed into through extraction, it is characterized in that, and each composition weight proportioning is: 15 parts of Mylabris, 500 parts of Radix Ginsengs, 1000 parts of the Radixs Astragali, 1500 parts of Radix Et Caulis Acanthopanacis Senticosis.
2. the lyophilized injectable powder of claim 1 also comprises 5～150 parts of medicinal acceptable excipient.
3. the lyophilized injectable powder of claim 2, excipient wherein is selected from mannitol, sorbitol, lactose.
4. the lyophilized injectable powder of claim 3, excipient wherein is a mannitol.
5. the lyophilized injectable powder of claim 1 also comprises the PH regulator.
6. the lyophilized injectable powder of claim 5, the PH regulator is a sodium bicarbonate.
7. the preparation method of the lyophilized injectable powder of claim 1 is characterized in that, the process following steps:
A. the preparation of extract:
Get the four Chinese medicine material of recipe quantity, the Radix Ginseng section is extracted secondary with 50% alcohol heating reflux, and 3 hours for the first time, 15 hours for the second time, merge extractive liquid, filtered, and reclaims ethanol, and medicinal liquid is standby; Three flavors such as medicinal residues and all the other Mylabris decoct with water three times, 3 hours for the first time, 15 hours for the second time, 1 hour for the third time, collecting decoction filtered, filtrate and Radix Ginseng extractive solution merge, with stone sulfur method precipitation process secondary, the gained supernatant concentration is to an amount of, adds ethanol and makes and contain the alcohol amount and reach 80%, standing over night, get the supernatant decompression recycling ethanol to there not being the alcohol flavor, add injection 100ml and embedding in corresponding container, the pressure sterilizing secondary, each 30 minutes, after the cooling, the paper pulp sucking filtration, filtrate is standby as active constituents of medicine;
B. the preparation of lyophilized injectable powder:
The filtrate that makes is added injection be diluted with water to 200ml, stir, add the mannitol of recipe quantity, stir, the needle-use activated carbon of adding 0.1%, be heated to 100 ℃ and boiled 15 minutes, filter carbon removal, adjusting PH is 6.5-7.5, microporous filter membrane fine straining with 0.45 μ m, and carry out aseptic filtration with the microporous filter membrane of 0.22 μ m, the filtrate fill in the cillin bottle of 7ml, every bottled 2～3ml; And be placed in the freeze drying box pre-freeze evacuation after 3～5 hours; Condensation temperature remains unchanged, and after 24 hours, unpacks, and makes dried frozen aquatic products, and gland is sealed with wax, labeling, promptly.
8, the preparation method of claim 7, wherein regulating PH among the step b is 6.8-7.2.
9, the preparation method of claim 8, wherein regulating PH among the step b is 7.0.
10, the preparation method of claim 7, the PH regulator of regulating PH among the step b is a sodium bicarbonate.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200510080685 CN1709442A (en) | 2005-07-06 | 2005-07-06 | Anti-cancer Chinese medicine lyophilized injection agent |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200510080685 CN1709442A (en) | 2005-07-06 | 2005-07-06 | Anti-cancer Chinese medicine lyophilized injection agent |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN1709442A true CN1709442A (en) | 2005-12-21 |
Family
ID=35705773
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 200510080685 Pending CN1709442A (en) | 2005-07-06 | 2005-07-06 | Anti-cancer Chinese medicine lyophilized injection agent |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN1709442A (en) |
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101084983B (en) * | 2006-06-08 | 2011-06-08 | 天津天士力之骄药业有限公司 | Traditional Chinese medicine powder injection for treating tumor and its preparation process |
| CN101306077B (en) * | 2008-06-04 | 2012-08-22 | 贵州益佰制药股份有限公司 | Chinese traditional injection preparation for treating cancer and its preparation method |
| CN103417607A (en) * | 2012-05-22 | 2013-12-04 | 贵州益佰制药股份有限公司 | Applications of traditional Aidi Chinese medicine composition and preparations thereof in preparing drugs for curing depression |
| CN102091114B (en) * | 2009-12-15 | 2014-11-26 | 河北以岭医药研究院有限公司 | Traditional Chinese medicament freeze-drying injection and preparation method thereof |
-
2005
- 2005-07-06 CN CN 200510080685 patent/CN1709442A/en active Pending
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101084983B (en) * | 2006-06-08 | 2011-06-08 | 天津天士力之骄药业有限公司 | Traditional Chinese medicine powder injection for treating tumor and its preparation process |
| CN101306077B (en) * | 2008-06-04 | 2012-08-22 | 贵州益佰制药股份有限公司 | Chinese traditional injection preparation for treating cancer and its preparation method |
| CN102091114B (en) * | 2009-12-15 | 2014-11-26 | 河北以岭医药研究院有限公司 | Traditional Chinese medicament freeze-drying injection and preparation method thereof |
| CN103417607A (en) * | 2012-05-22 | 2013-12-04 | 贵州益佰制药股份有限公司 | Applications of traditional Aidi Chinese medicine composition and preparations thereof in preparing drugs for curing depression |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| CN101085216B (en) | Composition containing biological polysaccharide and biological polysaccharide wine made from the same | |
| CN104152521A (en) | Paeonia suffruticosa pollen protein polypeptide and preparation method and application thereof | |
| CN102293997A (en) | Preparation method of dried ginger extract | |
| CN111494507B (en) | Preparation method of internal heat clearing tablets | |
| CN1709442A (en) | Anti-cancer Chinese medicine lyophilized injection agent | |
| CN1657060A (en) | Shenkang freeze-dried powder injection for injection and its preparation technology | |
| CN102755379B (en) | Novel preparation technology of rabdosia rubescens tablet | |
| CN109082357A (en) | The brewage process of health care soft-taste white spirit | |
| CN103566165A (en) | Process of exocarpium citri grandis tablets | |
| CN112870271B (en) | Preparation method of high molecular weight rehmannia root polysaccharide and method for obtaining prepared rehmannia root by high-pressure steaming of fresh rehmannia root | |
| CN104920726A (en) | Qi-tonifying fluid-generating healthcare tea and making method thereof | |
| CN108969580B (en) | Preparation method and application of blue cloth total tannin | |
| CN114869923A (en) | National medicine double ginseng water-soluble extract and preparation method and application thereof | |
| CN113633714A (en) | Preparation method of golden fruit beverage | |
| CN104586910B (en) | Coreopsis tinctoria extract and preparation method thereof | |
| CN107625925B (en) | Traditional Chinese medicine composition capable of dispelling wind, relieving exterior syndrome, invigorating stomach and promoting digestion and preparation process and application thereof | |
| CN1320920C (en) | Freeze-dried powder injection of glossy privet fruit and astragalus root for strengthening body resistance and its making method | |
| CN114522207B (en) | Industrial production method of children's yellow dragon particles | |
| CN116327869B (en) | Preparation method of Chinese patent medicine Qianqu | |
| CN111000881B (en) | Propolis soft capsule rich in flavone and belonging to genus Brazilian breynia and preparation method thereof | |
| NL2030414B1 (en) | Fermentation pretreatment method of auxiliary materials for alcoholic drink mixed with fruit juice | |
| CN113398232B (en) | Preparation method of pharmaceutical composition for treating gout and gouty arthritis | |
| CN1456229A (en) | Preparation of donkey hide gelatin effervescent granules for nourishing blood | |
| CN1709443A (en) | Ginseng and astragalis body-resistance-strenthening lyophilized powder injection and its preparing method | |
| CN108383919B (en) | American ginseng polysaccharide extraction method and American ginseng polysaccharide capsule preparation method |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| C06 | Publication | ||
| PB01 | Publication | ||
| C02 | Deemed withdrawal of patent application after publication (patent law 2001) | ||
| WD01 | Invention patent application deemed withdrawn after publication |