CN106420773A - Chinese and western medicinal composition for treating radioactive enteritis, and preparation method and application thereof - Google Patents
Chinese and western medicinal composition for treating radioactive enteritis, and preparation method and application thereof Download PDFInfo
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- CN106420773A CN106420773A CN201611186953.7A CN201611186953A CN106420773A CN 106420773 A CN106420773 A CN 106420773A CN 201611186953 A CN201611186953 A CN 201611186953A CN 106420773 A CN106420773 A CN 106420773A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/66—Phosphorus compounds
- A61K31/662—Phosphorus acids or esters thereof having P—C bonds, e.g. foscarnet, trichlorfon
- A61K31/663—Compounds having two or more phosphorus acid groups or esters thereof, e.g. clodronic acid, pamidronic acid
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/13—Amines
- A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
- A61K31/137—Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
- A61K31/191—Carboxylic acids, e.g. valproic acid having two or more hydroxy groups, e.g. gluconic acid
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Abstract
The invention discloses a Chinese and western medicinal composition for treating radioactive enteritis, and a preparation method and application thereof. The Chinese and western medicinal composition comprises, by weight, 3-7 parts of alendronate sodium, 11-19 parts of bromhexine, 5-13 parts of taurine and 1-5 parts of calcium lactate. The preparation method includes mixing the alendronate sodium with the bromhexine and the calcium lactate, adding deionized water, increasing the temperature to 75-77 DEG C, and stirring the raw materials for 38-40 minutes to obtain a mixture A; mixing the mixture A with the taurine, performing ultrasonic treatment at the temperature of 58 DEG C for 25 minutes, and performing stirring at the temperature of 63 DEG C until drying to obtain the Chinese and western medicinal composition, wherein the ultrasonic power is 900W. The Chinese and western medicinal composition has a unique formula and low price, is safe and convenient, has better effect than regularly-used western medicine, can effectively treat colon and rectum injuries caused by radiotherapy, has high cure rate and quick action and is free from toxic and side effect; recurrence of the radioactive enteritis is avoided after curing; the preparation process is simple, raw materials are simple and easy to get, production cycle is short, cost is low, and the Chinese and western medicinal composition is suitable for industrial production and large-scale popularization.
Description
Technical field
The present invention relates to pharmaceutical technology field, specifically a kind of Chinese and western medicinal composition of therapeutic radiation enteritis and its preparation
Methods and applications.
Background technology
Radiation enteritiss are the intestinal tract complications that pelvic cavity, abdominal cavity, retroperitoneal malignant tumor cause through radiotherapy.Can distinguish
Involve small intestinal, colon and rectum, therefore be also called radioactivity rectum, colon, enteritis.The big of radiation dose is subjected to according to intestinal
Radiation sickness is typically divided into acute and chronic two kinds by the length of little, time, the emergency of morbidity.Placed according to ray source again
The difference of internal external position is classified as external exposure radiation sickness and interior irradiation radiation sickness.Update in early stage protection of intestinal mucosal barrier cells and pressed down
System, with metarteriole wall swelling, obturation, causes intestinal wall ischemia, mucosal erosion.Late period intestinal wall causes fibrosiss, stenosis of bowel or
Perforation, intraperitoneal forms abscess, fistula road and intestinal adhesion etc..
Radiation colitises not only affect the quality of life of patient, but also can have influence on controlling for tumor because postponing treatment
Therapeutic effect.The main clinical manifestation of radiation colitises is stomachache, diarrhoea, and severe patient occurs has blood in stool and Electrolyte imbalance.
Effective treatment Chinese and western medicinal composition or method there is no at present, and each medical institutions' majority adopts symptomatic treatment, Chinese medicine and western medicine group used
Compound is also different, and more multiplex is using Western medicine symptomatic treatment, such as gives anti-inflammatory analgetic, the method such as fluid infusion antidiarrheal.
Content of the invention
It is an object of the invention to provide a kind of Chinese and western medicinal composition of therapeutic radiation enteritis and preparation method thereof and should
With to solve the problems, such as to propose in above-mentioned background technology.
For achieving the above object, the present invention provides following technical scheme：
A kind of Chinese and western medicinal composition of therapeutic radiation enteritis, is made up of the following raw material according to weight portion：Alendronic Acid
Sodium 3-7 part, bromhexine 11-19 part, taurine 5-13 part, calcium lactate 1-5 part.
As the further scheme of the present invention：The Chinese and western medicinal composition of the therapeutic radiation enteritis, by following according to weight
The raw material composition of amount part：Alendronate sodium 4-6 part, bromhexine 13-17 part, taurine 7-11 part, calcium lactate 2-4 part.
As the further scheme of the present invention：The Chinese and western medicinal composition of the therapeutic radiation enteritis, by following according to weight
The raw material composition of amount part：5 parts of Alendronate sodium, 15 parts of bromhexine, 9 parts of taurine, 3 parts of calcium lactate.
A kind of preparation method of the Chinese and western medicinal composition of therapeutic radiation enteritis, comprises the steps of：
1) by Alendronate sodium, bromhexine, calcium lactate mixing, the deionized water of 3.1 times of three's mass is added, is warming up to
75-77 DEG C, and stir process 38-40min at such a temperature, prepared mixture A；
2) mixture A is mixed with taurine, supersound process 25min at a temperature of 58 DEG C, ultrasonic power be 900W, then
Stir to dry at a temperature of 63 DEG C and obtain final product Chinese and western medicinal composition.
As the further scheme of the present invention：It is warming up to 76 DEG C, and stir process 39min at such a temperature.
Application of the Chinese and western medicinal composition in therapeutic radiation enteritis Chinese and western medicinal composition is prepared.
Compared with prior art, the invention has the beneficial effects as follows：
The present invention have prescription uniqueness, low price, safe ready, its effect be better than conventional use of Western medicine, Ke Yiyou
Effect cures caused Colorectal injury during radiotherapy, and cure rate is high, and instant effect has no toxic side effect, non-relapse after healing,
Preparation process is simple, raw material is simple and easy to get, with short production cycle and low cost, is suitable to industrialized production with large-scale promotion.
Specific embodiment
Below in conjunction with the embodiment of the present invention, the technical scheme in the embodiment of the present invention is clearly and completely described,
Obviously, described embodiment is only a part of embodiment of the present invention, rather than whole embodiments.Based in the present invention
Embodiment, the every other embodiment obtained under the premise of creative work is not made by those of ordinary skill in the art, all
Belong to the scope of protection of the invention.
Embodiment 1
In the embodiment of the present invention, a kind of Chinese and western medicinal composition of therapeutic radiation enteritis, by the following original according to weight portion
Material composition：3 parts of Alendronate sodium, 11 parts of bromhexine, 5 parts of taurine, 1 part of calcium lactate.
By Alendronate sodium, bromhexine, calcium lactate mixing, the deionized water of 3.1 times of three's mass is added, is warming up to 75
DEG C, and stir process 38min at such a temperature, prepared mixture A.Mixture A is mixed with taurine, at a temperature of 58 DEG C
Supersound process 25min, ultrasonic power is 900W, then stirs to dry at a temperature of 63 DEG C and obtain final product Chinese and western medicinal composition.
Embodiment 2
In the embodiment of the present invention, a kind of Chinese and western medicinal composition of therapeutic radiation enteritis, by the following original according to weight portion
Material composition：7 parts of Alendronate sodium, 19 parts of bromhexine, 13 parts of taurine, 5 parts of calcium lactate.
By Alendronate sodium, bromhexine, calcium lactate mixing, the deionized water of 3.1 times of three's mass is added, is warming up to 77
DEG C, and stir process 40min at such a temperature, prepared mixture A.Mixture A is mixed with taurine, at a temperature of 58 DEG C
Supersound process 25min, ultrasonic power is 900W, then stirs to dry at a temperature of 63 DEG C and obtain final product Chinese and western medicinal composition.
Embodiment 3
In the embodiment of the present invention, a kind of Chinese and western medicinal composition of therapeutic radiation enteritis, by the following original according to weight portion
Material composition：4 parts of Alendronate sodium, 13 parts of bromhexine, 7 parts of taurine, 2 parts of calcium lactate.
By Alendronate sodium, bromhexine, calcium lactate mixing, the deionized water of 3.1 times of three's mass is added, is warming up to 76
DEG C, and stir process 39min at such a temperature, prepared mixture A.Mixture A is mixed with taurine, at a temperature of 58 DEG C
Supersound process 25min, ultrasonic power is 900W, then stirs to dry at a temperature of 63 DEG C and obtain final product Chinese and western medicinal composition.
Embodiment 4
In the embodiment of the present invention, a kind of Chinese and western medicinal composition of therapeutic radiation enteritis, by the following original according to weight portion
Material composition：6 parts of Alendronate sodium, 17 parts of bromhexine, 11 parts of taurine, 4 parts of calcium lactate.
By Alendronate sodium, bromhexine, calcium lactate mixing, the deionized water of 3.1 times of three's mass is added, is warming up to 76
DEG C, and stir process 39min at such a temperature, prepared mixture A.Mixture A is mixed with taurine, at a temperature of 58 DEG C
Supersound process 25min, ultrasonic power is 900W, then stirs to dry at a temperature of 63 DEG C and obtain final product Chinese and western medicinal composition.
Embodiment 5
In the embodiment of the present invention, a kind of Chinese and western medicinal composition of therapeutic radiation enteritis, by the following original according to weight portion
Material composition：5 parts of Alendronate sodium, 15 parts of bromhexine, 9 parts of taurine, 3 parts of calcium lactate.
By Alendronate sodium, bromhexine, calcium lactate mixing, the deionized water of 3.1 times of three's mass is added, is warming up to 76
DEG C, and stir process 39min at such a temperature, prepared mixture A.Mixture A is mixed with taurine, at a temperature of 58 DEG C
Supersound process 25min, ultrasonic power is 900W, then stirs to dry at a temperature of 63 DEG C and obtain final product Chinese and western medicinal composition.
Comparative example 1
In addition to calcium lactate is not contained, its formula and preparation process are consistent with embodiment 5.
Comparative example 2
Only contain calcium lactate, its preparation process is consistent with embodiment 5.
Comparative example 3
In addition to no ultrasonic step, remaining constituent content and preparation process are consistent with embodiment 5.
6 toxicity test of embodiment
1) acute toxicity testing：
Application NIH mice 60, SPF level, male and female half and half, 18～22g of body weight, carry out acute toxicity test.Mice is random
It is divided into two groups, per 30, i.e. matched group of group and administration group, fasting 12 hours before experiment；In prepared by embodiments of the invention 5
Western medicine compound is dissolved in water, (concentration is 6.58g crude drug/ml, maximum concentration) gavage, and gavage volume is that 5ml/kg is (i.e. single
Secondary dosage is 32.9 crude drugs/kg), matched group gives normal saline, is administered 2 times within one day, and delivery time 6 is little
When, Continuous Observation 14 days after administration, and record toxic reaction and the death toll of mice.Test result indicate that：With matched group ratio
Relatively, after administration, mice has no notable difference, tests Continuous Observation 14 days, and mouse systemic situation, diet, drinking-water, body weight increase are equal
Normally.Chinese and western medicinal composition LD50 32.9 crude drugs of the ＞/kg of the Mouse oral gavage present invention, daily maximum dosage-feeding is 65.8 lifes
Medicine/kg/ day.The Chinese medicine clinical application amount of the present invention be 1.5g crude drug/day/people, adult body weight in terms of 60kg, average dosage
For 0.025g crude drug/kg/ day.By weighing machine：The Chinese and western medicinal composition of mice (average weight is in terms of 20g) the oral administration gavage present invention
Dosis tolerata be 1316 times of quantity.Therefore the Chinese and western medicinal composition acute toxicity of the present invention is low, clinical application safety.
2) long term toxicity test：
The Chinese and western medicinal composition of the embodiment of the present invention 5 presses 10.78,20.35 and 33.48g crude drugs/kg continuous use to mice
After 15 weeks (1.0ml/100g body weight, daily 2 times) and drug withdrawal 3 weeks, as a result show：Hair of the Chinese and western medicinal composition of the present invention to rat
Send out, behavior, defecation, body weight, organ weights, hemogram, hepatic and renal function, blood glucose, the index such as blood fat all have no significant effect, internal organs meat
Eye does not find that difference change and histological indications show, medication 15 weeks and after being discontinued 3 weeks, and each internal organs of rat are all no substantially
Change.Chinese and western medicinal composition of the present invention is described to small toxicity after rat long-term prescription, also without abnormal reaction, application peace after drug withdrawal
Entirely.
7 clinical trial of embodiment
1. case selection
Select pelvic cavity radiation therapy patient 450, be randomly divided into 9 groups, per group 50, respectively 1 group of embodiment, enforcement
2 groups of example, 3 groups of embodiment, 4 groups of embodiment, 5 groups of embodiment, 1 group of comparative example, 2 groups of comparative example, 3 groups of comparative example, 4 groups of comparative example.
Each group rectal cancer 25, colon cancer 10, cervical cancer 15, ordinary circumstance compares that there was no significant difference.
2. Therapeutic Method
All patients take embodiment 1-5 or comparative example by group while conventional radiotherapy is received daily respectively
1-3 Chinese and western medicinal composition or commercially available treatment Chinese and western medicinal composition once, 10 days are a course for the treatment of.The course for the treatment of carries out curative effect after terminating and comments
Fixed.
3. efficacy evaluation
It is that clinical symptoms and sign disappear to fully recover, and times of defecation is normal, lab testing also normal person；Take a turn for the better aobvious for symptom
Write and mitigate, times of defecation and outward appearance are normal；Head increases for no significant change or have before and after treatment.
4. each group Clinical efficacy comparison：
Each group compares, and the effect of embodiment group is good compared with comparative example group, and each group relatively has significant difference (the results are shown in Table 1).
The present invention is under the interaction of each raw material, and the curative effect of therapeutic radiation enteritis is extremely notable.
Table 1
| Number of cases | Recovery from illness | Take a turn for the better | Invalid | Total effective rate (%) | |
| 1 group of embodiment | 50 | 30 | 19 | 1 | 98 |
| 2 groups of embodiment | 50 | 32 | 18 | 0 | 100 |
| 3 groups of embodiment | 50 | 40 | 10 | 0 | 100 |
| 4 groups of embodiment | 50 | 41 | 9 | 0 | 100 |
| 5 groups of embodiment | 50 | 45 | 5 | 0 | 100 |
| 1 group of comparative example | 50 | 1 | 21 | 28 | 44 |
| 2 groups of comparative example | 50 | 0 | 2 | 48 | 4 |
| 3 groups of comparative example | 50 | 3 | 20 | 27 | 46 |
| 4 groups of comparative example | 50 | 25 | 20 | 5 | 90 |
It is obvious to a person skilled in the art that the invention is not restricted to the details of above-mentioned one exemplary embodiment, Er Qie
In the case of spirit or essential attributes without departing substantially from the present invention, the present invention can be realized in other specific forms.Therefore, no matter
From the point of view of which point, embodiment all should be regarded as exemplary, and be nonrestrictive, the scope of the present invention is by appended power
Profit is required rather than described above is limited, it is intended that all in the implication and scope of the equivalency of claim by falling
Change is included in the present invention.
Moreover, it will be appreciated that although this specification is been described by according to embodiment, not each embodiment is only wrapped
Containing an independent technical scheme, this narrating mode of description is only that those skilled in the art should for clarity
Using description as an entirety, the technical scheme in each embodiment can also form those skilled in the art through appropriately combined
Understandable other embodiment.
Claims (6)
1. a kind of Chinese and western medicinal composition of therapeutic radiation enteritis, it is characterised in that be made up of the following raw material according to weight portion：
Alendronate sodium 3-7 part, bromhexine 11-19 part, taurine 5-13 part, calcium lactate 1-5 part.
2. the Chinese and western medicinal composition of therapeutic radiation enteritis according to claim 1, it is characterised in that by following according to weight
The raw material composition of amount part：Alendronate sodium 4-6 part, bromhexine 13-17 part, taurine 7-11 part, calcium lactate 2-4 part.
3. the Chinese and western medicinal composition of therapeutic radiation enteritis according to claim 1, it is characterised in that by following according to weight
The raw material composition of amount part：5 parts of Alendronate sodium, 15 parts of bromhexine, 9 parts of taurine, 3 parts of calcium lactate.
4. a kind of preparation method of the Chinese and western medicinal composition of the therapeutic radiation enteritis as described in claim 1-3 is arbitrary, which is special
Levy and be, comprise the steps of：
1) by Alendronate sodium, bromhexine, calcium lactate mixing, the deionized water of 3.1 times of three's mass is added, is warming up to 75-77
DEG C, and stir process 38-40min at such a temperature, prepared mixture A；
2) mixture A is mixed with taurine, supersound process 25min at a temperature of 58 DEG C, ultrasonic power is 900W, then 63
Stir at a temperature of DEG C to dry and obtain final product Chinese and western medicinal composition.
5. the preparation method of the Chinese and western medicinal composition of therapeutic radiation enteritis according to claim 4, it is characterised in that rise
Temperature is to 76 DEG C, and stir process 39min at such a temperature.
6. the Chinese and western medicinal composition as described in claim 1-3 is arbitrary is in therapeutic radiation enteritis Chinese and western medicinal composition is prepared
Application.
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| Application Number | Priority Date | Filing Date | Title |
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| CN201611186953.7A CN106420773A (en) | 2016-12-21 | 2016-12-21 | Chinese and western medicinal composition for treating radioactive enteritis, and preparation method and application thereof |
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| Application Number | Priority Date | Filing Date | Title |
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| CN201611186953.7A CN106420773A (en) | 2016-12-21 | 2016-12-21 | Chinese and western medicinal composition for treating radioactive enteritis, and preparation method and application thereof |
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| CN106420773A true CN106420773A (en) | 2017-02-22 |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106511342A (en) * | 2016-12-21 | 2017-03-22 | 郑州莉迪亚医药科技有限公司 | Medicine for treating radiation enteritis and preparation method and application of medicine |
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| CN103251950A (en) * | 2012-02-16 | 2013-08-21 | 中国人民解放军军事医学科学院放射与辐射医学研究所 | Use of S1P receptor conditioning agent on preventing and curing intestinal radiation sickness and radiation enteritis |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106511342A (en) * | 2016-12-21 | 2017-03-22 | 郑州莉迪亚医药科技有限公司 | Medicine for treating radiation enteritis and preparation method and application of medicine |
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