CN103610636A - Medicinal composition containing epigallocatechin gallate and application of medicinal composition - Google Patents
Medicinal composition containing epigallocatechin gallate and application of medicinal composition Download PDFInfo
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- CN103610636A CN103610636A CN201310619428.XA CN201310619428A CN103610636A CN 103610636 A CN103610636 A CN 103610636A CN 201310619428 A CN201310619428 A CN 201310619428A CN 103610636 A CN103610636 A CN 103610636A
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Abstract
The invention provides a medicinal composition containing epigallocatechin gallate and an application of the medicinal composition. The composition is prepared by mixing the following raw materials in parts by weight: 0.002-0.2 part of epigallocatechin gallate, 0.09-3 parts of sodium chloride, 0.05-5 parts of citric acid and 90-99.9 parts of ultrapure water or distilled water. The medicinal composition is used for preventing and treating acute radioactivity esophageal injury.
Description
Technical field
The present invention relates to the acute radiation esophageal injury that radiotherapy to the chest is relevant, relate in particular to a kind of containing epigallocatechin-3-gallate pharmaceutical composition and the application in the prevention of acute radiation esophageal injury and treatment thereof.
Background technology
Acute radiation esophageal injury is that patients with thoracic tumor carries out particularly dose-limiting toxicity during Synchronous Radio chemotherapy of radiotherapy, especially sees nonsmall-cell lung cancer or Patients With Small Cell Carcinoma of The Lung.The last generally betiding radiotherapy and starting 2nd～3 weeks, and may persist to radiotherapy and finish about rear January.Accept in the patient of radiotherapy to the chest nearly 2/3rds patient acute radiation esophageal injury occurs, the person of being in a bad way can not take food so that body constitution worsens rapidly.Along with the increase of radiotherapy dosage, after Esophageal Mucosa exposure, death comes off, and normal structure has little time maybe can not repair filling, so that form deeply in ulcer, and then can cause the complication such as esophago-tracheal fistula, Postural drainage.Acute radiation esophageal injury generally adopts radiotherapy tumor cooperative groups (RTOG) acute radiation injury grade scale to grade, 0 grade: asymptomatic; 1 grade: slight dysphagia or swallow pain, need or enter semifluid diet with topical anesthetic, the analgesia of non-narcotic medicine; 2 grades: moderate dysphagia or swallow pain, needs anesthetics analgesia or enter liquid diet; 3 grades: severe dysphagia or swallow pain, companion's dehydration or weight loss are greater than 15%, need nose stomach to raise or venous transfusion supplements the nutrients; 4 grades: block completely, ulcer, perforation Huo Lou road form.
Acute radiation esophageal injury there is no the Therapeutic Method of standard at present, and the Therapeutic Method existing at present has: 1 through medicines such as combined with intravenous application antibiotic, glucocorticoid hormone, vitamin; The 2 oral compound preparations that contain antibiotic, hormone, local anesthetic; 3 traditional Chinese medical science, Chinese medicine etc.The shortcoming that above method exists has: 1 antibiotic application may cause the side effect such as bacterial resistance, dysbacteriosis; 2 glucocorticoids can cause the hyperfunction syndrome of cortex hormone function, bring out or increase the weight of to infect, bring out or increase the weight of Peptic Ulcers, bring out the multiple side effect such as hypertension and arteriosclerosis; 3 Chinese medicines have the shortcoming slow, that uncertain therapeutic efficacy is cut that takes effect more.
Consider that it is the generation that ray has caused free radical in cell that lonizing radiation cause the dominant mechanism of the damage of normal structure, free radical causes DNA damage by the indirect action of radiation.Therefore the medicine that can remove in theory free radical can prevent and treat acute radiation damage.Representational medicine is amifostine in this respect, shows that this medicine is to hemopoietic organ in clinical practice, and gastrointestinal tract has good protective action, but has following shortcoming: 1) for cerebral tissue, the protective action of lung is not good; 2) effective dose and the toxic dose due to this medicine of intravenous applications approaches, and while applying this medicine, may occur the untoward reaction such as hypotension, gastrointestinal reaction, hypocalcemia, erythra; 3) this medicine can only intravenous applications; 4) half-life is short; 5) expensive.
A kind of natural drug of epigallocatechin gallate (EGCG) (EGCG) for extracting in green tea is the chief component composition of tea polyphenols.Epigallocatechin gallate (EGCG) (EGCG) is to remove free radical, a kind of catechin that oxidation resistance is the strongest, has and reports when the concentration of epigallocatechin gallate (EGCG) (EGCG) is 0.006mg/ml to oxygen-derived free radicals elimination factor 98%; When concentration is 0.1mg/ml, to hydroxy radical elimination factor, be 99.9%.
As a kind of antioxidant, at high temperature, ingress of air and while being subject to solar radiation, can there is autoxidation and cause curative effect to reduce in epigallocatechin gallate (EGCG), compositions of the present invention increases the stability of epigallocatechin gallate (EGCG), and has strengthened curative effect.
Summary of the invention
The present invention is intended to overcome the deficiencies in the prior art, one of object be to provide a kind of character stable containing epigallocatechin-3-gallate pharmaceutical composition, two of object is to provide the application of said composition in prevention and treatment acute radiation esophageal injury.
One of object of the present invention can be achieved by the following technical measures:
Of the present invention is that raw material by following weight portion proportioning mixes containing epigallocatechin-3-gallate pharmaceutical composition:
Epigallocatechin gallate (EGCG) 0.002～0.2 sodium chloride 0.09～3
Citric acid 0.05～5 ultra-pure water or distilled water 90～99.9.
Two of object of the present invention can be achieved by the following technical measures:
The epigallocatechin-3-gallate pharmaceutical composition that contains of the present invention is for the prevention of acute radiation esophageal injury and treatment.
At patients with thoracic tumor, carry out radiotherapy or Synchronous Radio chemotherapeutic period, slow oral this pharmaceutical composition of patient 10-50ml/ time, every day 3-5 time.
One stability test:
By in equivalent environment (unified temperature, humidity, illumination, airtight condition) place sodium chloride-containing, citric acid and variable concentrations epigallocatechin gallate (EGCG) composition solution with containing the contrast test of the simple epigallocatechin gallate (EGCG) solution of above-mentioned substance, do not find that the about 10-20 of time lengthening that solution character changes doubly.The character temperature of simple epigallocatechin gallate (EGCG) solution is fixed time and is about 3-5 days, and the character of compositions is about 30-100 days stabilization time
Two clinical practices: carry out carrying out in the small cell lung cancer of Synchronous Radio chemotherapy or Sequential chemotherapy and radiotherapy or Patients with Non-small-cell Lung in 24 examples, all obtained the oral or written informed consent of patient in advance.
Table 1, patient's physical data
| Patient's physical data | Patient's number (n=24 people) | % |
| Age | ? | ? |
| Median | 57 | ? |
| Scope | 37-72 | ? |
| Sex | ? | ? |
| Male | 20 | 83.3 |
| Women | 4 | 16.7 |
| Tumor classification | ? | ? |
| Nonsmall-cell lung cancer | 17 | 71 |
| Small cell lung cancer | 7 | 29 |
| Therapeutic scheme | ? | ? |
| Synchronous Radio chemotherapy | 12 | 50 |
| Sequential chemotherapy and radiotherapy | 12 | 50 |
| Radiotherapy dosimetry (Gy) | ? | ? |
| Median | 59.4 | ? |
| Scope | 50-64 | ? |
| The oral said composition time (my god) | ? | ? |
| Median | 32.5 | ? |
| Scope | 3-58 | ? |
Table 2, use RTOG scoring and patient before and after this pharmaceutical composition to swallow the change of pain
By table 2, can find out and use only patient's the RTOG classification and swallow Pain Grading and all have significance to reduce (p=0.000) after 3 days of this pharmaceutical composition, and continuous and effective is to using latter 21 days.Follow up a case by regular visits to and show owing to having used this pharmaceutical composition, after radiotherapy, 2 weeks patients acuity radioactivity esophageal injury RTOG classification is reduced to 0 grade.
Side effect incidence rate that may be relevant with this pharmaceutical composition is very low, may associated side effect be extremely slight feeling sick, abdominal distention, and incidence rate is all lower than 5%.
The specific embodiment:
Embodiment 1:
Get 0.002 gram of epigallocatechin gallate (EGCG), 3 grams of sodium chloride, 0.05 gram of citric acid and add in beaker, add 99.9 grams of ultra-pure waters or distilled water, stirring and evenly mixing, obtains product.
Embodiment 2:
Get 0.2 gram of epigallocatechin gallate (EGCG), 0.09 gram of sodium chloride, 5 grams of citric acids and add in beaker, add 90 grams of ultra-pure waters or distilled water, stirring and evenly mixing, obtains product.
Embodiment 3:
Get 0.1 gram of epigallocatechin gallate (EGCG), 1 gram of sodium chloride, 2 grams of citric acids and add in beaker, add 95 grams of ultra-pure waters or distilled water, stirring and evenly mixing, obtains product.
Claims (2)
1. containing an epigallocatechin-3-gallate pharmaceutical composition, it is characterized in that said composition is that raw material by following weight portion proportioning mixes:
Epigallocatechin gallate (EGCG) 0.002～0.2 sodium chloride 0.09～3
Citric acid 0.05～5 ultra-pure water or distilled water 90～99.9.
2. the application in the prevention of acute radiation esophageal injury and treatment containing epigallocatechin-3-gallate pharmaceutical composition claimed in claim 1.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201310619428.XA CN103610636A (en) | 2013-11-29 | 2013-11-29 | Medicinal composition containing epigallocatechin gallate and application of medicinal composition |
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| CN201310619428.XA CN103610636A (en) | 2013-11-29 | 2013-11-29 | Medicinal composition containing epigallocatechin gallate and application of medicinal composition |
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| CN103610636A true CN103610636A (en) | 2014-03-05 |
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| CN201310619428.XA Pending CN103610636A (en) | 2013-11-29 | 2013-11-29 | Medicinal composition containing epigallocatechin gallate and application of medicinal composition |
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Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106922670A (en) * | 2017-02-13 | 2017-07-07 | 武汉中博绿亚生物科技有限公司 | A kind of sterilizing spray and preparation method for table-ware disinfection sterilizing after cleaning |
| CN109908131A (en) * | 2019-04-28 | 2019-06-21 | 四川清舒乐科技有限公司 | Pharmaceutical composition of nasal irrigation and its preparation method and application |
| CN113350333A (en) * | 2021-06-24 | 2021-09-07 | 山东第一医科大学附属肿瘤医院(山东省肿瘤防治研究院、山东省肿瘤医院) | EGCG (epigallocatechin gallate) combined medicine and medical application thereof |
| CN116139126A (en) * | 2023-04-07 | 2023-05-23 | 岳阳渔美康生物科技有限公司 | Application of epigallocatechin-3-gallate in preparing quorum sensing inhibitor of aeromonas hydrophila |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101744807A (en) * | 2009-12-22 | 2010-06-23 | 江苏天晟药业有限公司 | Epigallocatechin-3-gallate pharmaceutical composition and freeze-dried powder injection thereof |
| CN102524882A (en) * | 2010-12-22 | 2012-07-04 | 内蒙古伊利实业集团股份有限公司 | EGCG (Epigallocatechin Gallate)-added compound protein acidic beverage and preparation method thereof |
-
2013
- 2013-11-29 CN CN201310619428.XA patent/CN103610636A/en active Pending
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101744807A (en) * | 2009-12-22 | 2010-06-23 | 江苏天晟药业有限公司 | Epigallocatechin-3-gallate pharmaceutical composition and freeze-dried powder injection thereof |
| CN102524882A (en) * | 2010-12-22 | 2012-07-04 | 内蒙古伊利实业集团股份有限公司 | EGCG (Epigallocatechin Gallate)-added compound protein acidic beverage and preparation method thereof |
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106922670A (en) * | 2017-02-13 | 2017-07-07 | 武汉中博绿亚生物科技有限公司 | A kind of sterilizing spray and preparation method for table-ware disinfection sterilizing after cleaning |
| CN109908131A (en) * | 2019-04-28 | 2019-06-21 | 四川清舒乐科技有限公司 | Pharmaceutical composition of nasal irrigation and its preparation method and application |
| CN113350333A (en) * | 2021-06-24 | 2021-09-07 | 山东第一医科大学附属肿瘤医院(山东省肿瘤防治研究院、山东省肿瘤医院) | EGCG (epigallocatechin gallate) combined medicine and medical application thereof |
| CN113350333B (en) * | 2021-06-24 | 2022-03-22 | 山东第一医科大学附属肿瘤医院(山东省肿瘤防治研究院、山东省肿瘤医院) | EGCG (epigallocatechin gallate) combined medicine and medical application thereof |
| CN116139126A (en) * | 2023-04-07 | 2023-05-23 | 岳阳渔美康生物科技有限公司 | Application of epigallocatechin-3-gallate in preparing quorum sensing inhibitor of aeromonas hydrophila |
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Application publication date: 20140305 |