CN100434085C - Process for removing toxic component from oleum fructus bruceae - Google Patents
Process for removing toxic component from oleum fructus bruceae Download PDFInfo
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- CN100434085C CN100434085C CNB2005100862095A CN200510086209A CN100434085C CN 100434085 C CN100434085 C CN 100434085C CN B2005100862095 A CNB2005100862095 A CN B2005100862095A CN 200510086209 A CN200510086209 A CN 200510086209A CN 100434085 C CN100434085 C CN 100434085C
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Abstract
The invention discloses a toxin removing method of extracted oleum fructus bruceae from traditional Chinese medicine, which is characterized by the following: the solvent is selected from 10-50% alcohol solution or 0.1-0.5% alkaline solution, which is 10% alcohol solution or 0.5% alkaline solution at best; the bulk rate of oleum fructus bruceae and solvent is 1:1-3 for oil and alcohol solution as well as oil and alkaline solution.
Description
Technical field
What the present invention relates to is a kind of method of removing toxic component from Chinese medicine extract Oleum Fructus Bruceae.
Background technology
Bruceolic oil emulsion is pure Chinese medicine anticancer preparation, now Shang Shi dosage form has two kinds of injection and oral liquids, it is the anticarcinogen of extensive use clinically, through national bruceolic oil emulsion anticancer research cooperative groups-Beijing Friendship Hospital, China attached institute of medical university, attached institute of Bethune medical university, Shanghai chest hospital, nearly 300 tame clinical hospitals such as Anhui attached institute of medical university are observed, the scientific research personnel has observed 16 sick kinds altogether, routine patient surplus in the of 30000, emphasis (comprises lung cancer metastasis to pulmonary carcinoma, bone shifts, lymph metastasis) esophageal carcinoma, gastric cancer, colorectal cancer and bladder cancer, hepatocarcinoma etc. have been carried out clinical practice widely.A large amount of clinical verifications finds that most of cancer patients are through after the treatment of Java brucea fruit oil emulsion injection, and clinical symptoms is improved greatly, pain relief, and appetite increases, and sleep also improves weight increase.In addition, radiotherapy, chemotherapy can alleviate the side effect of radiotherapy, chemotherapy with the Java brucea fruit oil emulsion injection therapeutic alliance, heighten the effect of a treatment.
The active ingredient of Chinese medicine Fructus Bruceae can be divided into water solublity and fat-soluble two parts, the main effective ingredient of its antineoplastic is fat-soluble unsaturated fatty acid, with tumor cell specific affinity is arranged, water-soluble portion is amaroid-tetracyclic triterpenoid, has certain toxicity.The Oleum Fructus Bruceae emulsion formulation is to be raw material with the Fructus Bruceae ligroin extraction, is the oil-in-water emulsion that emulsifying agent is made with refining soybean phospholipid.But owing to still have the small amounts of water soluble toxic substance in raw materials for production-Fructus Bruceae ligroin extraction, make producing, selling and uying of Oleum Fructus Bruceae emulsion formulation be subjected to its toxic puzzlement, obstruction always, restricted the expansion production of Oleum Fructus Bruceae emulsion formulation and clinical extensive use to a certain extent.Having only its toxic component of thorough removal just to can be tumor patient provides pure safely and effectively Chinese medicine anticancer Oleum Fructus Bruceae emulsion formulation.
Summary of the invention
The objective of the invention is on the basis that guarantees the effective ingredient quality, a kind of method of removing toxic component from Oleum Fructus Bruceae is provided, thereby reduce toxicity, minimizing drug side effect, for tumor patient provides pure Chinese medicinal preparation safely and effectively.
According to the physicochemical property of Oleum Fructus Bruceae toxic composition tetracyclic triterpenoid, adopt solvent-extracted method that it is separated with effective ingredient, thereby obtain refining Oleum Fructus Bruceae.Solvent for use is selected from 0.1～0.5% aqueous slkali or 10～50% alcoholic solution, preferred 0.5% aqueous slkali or 10% alcoholic solution, and used aqueous slkali can be selected from sodium hydroxide solution, sodium carbonate liquor or sodium bicarbonate solution, preferred sodium hydroxide solution.Oleum Fructus Bruceae and solvent are respectively by volume: oil: aqueous slkali is 1: 1～3; Oil: alcoholic solution is 1: 1～3;
At first prepare Oleum Fructus Bruceae with conventional method: after getting the ripe fruit of khosam pulverizing of fresh dried, use petroleum ether (60～90 ℃ of boiling ranges) to extract, after petroleum ether was reclaimed in the extracting solution distillation, filtration got the Oleum Fructus Bruceae crude product.
Add the extraction solvent of proper volume in by conventional method gained Oleum Fructus Bruceae, fully mixing leaves standstill, treat to discard the solvent layer that contains the toxicity material after its layering, oil reservoir with purified water wash to the eluate pH value be 6.0, discard water layer, oil reservoir boils off moisture, filters, and must make with extra care Oleum Fructus Bruceae.
The specific embodiment
Embodiment 1
Get Oleum Fructus Bruceae crude product 1.2kg, adding concentration is the sodium hydroxide solution 2.4L of 0.1% (w/v, together following), and fully mixing left standstill 24 hours, and layering discards the aqueous alkali layer.It is 6.0 that oil reservoir is washed till the eluate pH value with purified water, discards water layer, after oil reservoir boils off moisture, filters, and gets Oleum Fructus Bruceae elaboration 1.0L, by refining Oleum Fructus Bruceae quality standard (Ministry of Public Health ministry standard WS
3-B-2739-97) the acid number item is stipulated down to detect the Oleum Fructus Bruceae acid number, be 1.1, and above-mentioned quality standard regulation acid number should be not more than 6.
Embodiment 2
Get Oleum Fructus Bruceae crude product 1.2kg, adding concentration is 0.3% sodium hydroxide solution 2.4L, and operating process gets Oleum Fructus Bruceae elaboration 1.OL with embodiment 1, detects acid number, is 0.9.
Embodiment 3
Get Oleum Fructus Bruceae crude product 1.2kg, adding concentration is 0.5% sodium hydroxide solution 2.4L, and operating process gets Oleum Fructus Bruceae elaboration 1.0L with embodiment 1, detects acid number, is 0.3.
Embodiment 4
Get totally 5 parts of Oleum Fructus Bruceae crude products, every part of 1.2kg adds concentration respectively and is each 2.4L of sodium bicarbonate solution of 0.1%, 0.2%, 0.3%, 0.4% and 0.5%.Operating process gets each about 1.0L of Oleum Fructus Bruceae elaboration respectively with embodiment 1, detects the Oleum Fructus Bruceae acid number, and all conformance with standard is respectively 1.5,1.2,0.9,0.9 and 0.6.
Embodiment 5
Get totally 5 parts of Oleum Fructus Bruceae crude products, every part of 1.2kg adds concentration respectively and is 0.1%, 0.2%, 0.3%, 0.4% and 0.5% sodium carbonate liquor 2.4L.Operating process gets each about 1.0L of Oleum Fructus Bruceae elaboration respectively with embodiment 1, detects the Oleum Fructus Bruceae acid number, and all conformance with standard is respectively 1.6,1.4,0.9,0.9 and 0.7.
Embodiment 6
Get totally 5 parts of Oleum Fructus Bruceae crude products, every part of 1.2kg, add concentration respectively and be 10% (v/v, down with), each 2.4L of alcoholic solution of 20%, 30%, 40% and 50%.Operating process gets each about 1.0L of Oleum Fructus Bruceae elaboration respectively with embodiment 1.Detect the Oleum Fructus Bruceae acid number, all conformance with standard is respectively 1.0,1.8,2.1,2.5 and 2.7.Wherein, when the alcoholic solution with 10% washed, the standing demix time was the shortest.
Embodiment 7 toxicity tests
Take the Oleum Fructus Bruceae that conventional method is extracted, and each 100ml of purified Oleum Fructus Bruceae among the embodiment 1～6, being divided into is 19 groups, presses WS
3The standard recipe of-B-2739-97 is made Java brucea fruit oil emulsion injection respectively, check item pertinent regulations down with reference to Guangdong QWS-1829-86 Java brucea fruit oil emulsion injection quality standard " undue toxicity ", get by normal raising condition and raise 110 of the healthy mices that body weight is 17～20g, be divided into 20 groups at random, every group 5, every group of corresponding a kind of above-mentioned injection, tail vein injection 0.5ml.Wherein whole mices of conventional method extraction group are all dead in 48 hours after administration, and other respectively organize mice still survival in 48 hours after administration, do not see death.The result shows: method used herein can be removed the toxic component in the Oleum Fructus Bruceae effectively.
Embodiment 8
The oil emulsion injection of the purified Oleum Fructus Bruceae preparation of the inventive method of learning from else's experience is used for clinical, and select the treatment of 400 routine clinical cancer patients at random in the 303 hospital of the Chinese People's Liberation Army, No.181 Hospital, PLA, Guangxi Yulin Red Cross Hospital with Java brucea fruit oil emulsion injection year June in July, 2004 to 2005, be designated as test group, select 400 examples to accept the cancer patient of conventional chemotherapy, radiotherapy in addition, be designated as matched group.Performance and calibration standard according to the acute toxicity of WHO chemotherapy, test group and matched group have significant difference at the calibration of acute toxicities such as bone marrow depression, nausea and vomiting, alopecia and chest pain, routine number takes place the acute toxicity of test group and light and heavy degree all will be less than matched group, and concrete outcome sees Table 1.Test group hepatic and renal function, routine blood test all find no the variation of statistical significance, do not find phenomenons such as digestive tract reaction and alopecia.
Table 1 Java brucea fruit oil emulsion injection randomized controlled trial toxic and side effects relatively
Claims (5)
1, a kind of method of removing toxic component from Chinese medicine extract Oleum Fructus Bruceae may further comprise the steps:
(1) extracts Oleum Fructus Bruceae according to a conventional method;
(2) add the extraction solvent in step (1) gained Oleum Fructus Bruceae, fully mixing leaves standstill, and treats to discard solvent layer after its layering, and oil reservoir washs with purified water, treats to discard water layer after the layering;
(3) oil reservoir boils off moisture, filters, and must make with extra care Oleum Fructus Bruceae;
Wherein solvent for use is selected from 0.1～0.5% aqueous slkali or 10～50% alcoholic solution in the step (2).
2, the method for claim 1, wherein solvent for use is 0.5% aqueous slkali or 10% alcoholic solution in the step (2).
3, method as claimed in claim 1 or 2, wherein Oleum Fructus Bruceae and solvent are respectively oil by volume in the step (2): aqueous slkali is 1: 1～3; Oil: alcoholic solution is 1: 1～3.
4, method as claimed in claim 1 or 2, wherein used aqueous slkali is selected from sodium hydroxide solution, sodium carbonate liquor or sodium bicarbonate solution in the step (2).
5, method as claimed in claim 1 or 2, wherein used aqueous slkali is a sodium hydroxide solution in the step (2).
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2005100862095A CN100434085C (en) | 2005-08-05 | 2005-08-05 | Process for removing toxic component from oleum fructus bruceae |
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| CNB2005100862095A CN100434085C (en) | 2005-08-05 | 2005-08-05 | Process for removing toxic component from oleum fructus bruceae |
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| CN1907304A CN1907304A (en) | 2007-02-07 |
| CN100434085C true CN100434085C (en) | 2008-11-19 |
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Families Citing this family (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101804085B (en) * | 2010-05-06 | 2011-04-20 | 沈阳药大药业有限责任公司 | Brucea javanica oil and pharmaceutical composition containing the same and preparation method thereof |
| CN112494525B (en) * | 2017-05-08 | 2022-06-03 | 沈阳药大雷允上药业有限责任公司 | Oleum fructus Bruceae, pharmaceutical composition containing oleum fructus Bruceae, and its preparation method |
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2005
- 2005-08-05 CN CNB2005100862095A patent/CN100434085C/en active Active
Non-Patent Citations (2)
| Title |
|---|
| 鸦胆子油乳诱导HL260细胞凋亡的研究. 王，芳，曹，玉，刘红岩，付招娣，韩，锐.中国中药杂志，第28卷第8期. 2003 |
| 鸦胆子油乳诱导HL260细胞凋亡的研究. 王，芳，曹，玉，刘红岩，付招娣，韩，锐.中国中药杂志，第28卷第8期. 2003 * |
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