CN106727619A - A kind of Chinese and western medicinal composition of therapeutic radiation enteritis - Google Patents

A kind of Chinese and western medicinal composition of therapeutic radiation enteritis Download PDF

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Publication number
CN106727619A
CN106727619A CN201611236004.5A CN201611236004A CN106727619A CN 106727619 A CN106727619 A CN 106727619A CN 201611236004 A CN201611236004 A CN 201611236004A CN 106727619 A CN106727619 A CN 106727619A
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parts
chinese
medicinal composition
western medicinal
therapeutic radiation
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不公告发明人
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Henan Eight Ling Electronic Technology Co Ltd
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Henan Eight Ling Electronic Technology Co Ltd
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/13Amines
    • A61K31/135Amines having aromatic rings, e.g. ketamine, nortriptyline
    • A61K31/137Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/185Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19Carboxylic acids, e.g. valproic acid
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/185Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19Carboxylic acids, e.g. valproic acid
    • A61K31/195Carboxylic acids, e.g. valproic acid having an amino group
    • A61K31/197Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid
    • A61K31/198Alpha-amino acids, e.g. alanine or edetic acid [EDTA]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/66Phosphorus compounds
    • A61K31/662Phosphorus acids or esters thereof having P—C bonds, e.g. foscarnet, trichlorfon
    • A61K31/663Compounds having two or more phosphorus acid groups or esters thereof, e.g. clodronic acid, pamidronic acid

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Emergency Medicine (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

The invention discloses a kind of Chinese and western medicinal composition of therapeutic radiation enteritis, the Chinese and western medicinal composition is made up of the following raw material according to weight portion:37 parts of Alendronate sodium, 11 19 parts of ambroxol, 5 13 parts of lysine, 15 parts of calcium lactate.Alendronate sodium, ambroxol, calcium lactate are mixed, deionized water is added, 75 77 DEG C, and the 40min of stir process 38 is warming up to, mixture A is obtained;Mixture A is mixed with lysine, the ultrasonically treated 25min at a temperature of 58 DEG C, ultrasonic power is 900W, then stirred to dry at a temperature of 63 DEG C and obtain final product Chinese and western medicinal composition.The present invention has prescription unique, cheap, safe ready, its effect is better than conventional use of Western medicine, Colorectal injury caused during radiotherapy can effectively be cured, cure rate is high, instant effect, have 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 and large-scale promotion.

Description

A kind of Chinese and western medicinal composition of therapeutic radiation enteritis
Technical field
The present invention relates to pharmaceutical technology field, specifically a kind of Chinese and western medicinal composition of therapeutic radiation enteritis.
Background technology
Radiation enteritis is the intestinal tract complication that pelvic cavity, abdominal cavity, retroperitoneal malignant tumor cause through radiotherapy.Can be respectively Involve small intestine, colon and rectum, therefore be also called radioactivity rectum, colon, enteritis.The big of dose of radiation is subjected to according to enteron aisle Small, the time length, the emergency of morbidity, are typically divided into acute and chronic two kinds by radiation sickness.Placed according to ray source again The difference of internal external position is classified as external exposure radiation sickness and interior irradiation radiation sickness.Updated in early stage protection of intestinal mucosal barrier cells and pressed down System, with the swelling of metarteriole wall, obturation, causes intestinal wall ischemic, mucosal erosion.Late period intestinal wall causes fibrosis, stenosis of bowel or Perforation, intraperitoneal formation abscess, fistula road and intestinal adhesion etc..
Radiation colitis not only influences the quality of life of patient, but also can have influence on controlling for tumour because postponing treatment Therapeutic effect.The main clinical manifestation of radiation colitis is stomachache, diarrhoea, and severe patient occurs has blood in stool and Electrolyte imbalance. Effective treatment Chinese and western medicinal composition or method are there is no at present, and each medical institutions' majority uses symptomatic treatment, Chinese and Western medicine group used Compound is also different, and more multiplex is, using Western medicine symptomatic treatment, such as to give the methods such as anti-inflammatory analgetic, fluid infusion antidiarrheal.
The 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, to solve above-mentioned background skill The problem proposed in art.
To achieve 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 parts, ambroxol 11-19 parts, lysine 5-13 parts, calcium lactate 1-5 parts.
As further scheme of the invention:The Chinese and western medicinal composition of the therapeutic radiation enteritis, by following according to weight Measure the raw material composition of part:Alendronate sodium 4-6 parts, ambroxol 13-17 parts, lysine 7-11 parts, calcium lactate 2-4 parts.
As further scheme of the invention:The Chinese and western medicinal composition of the therapeutic radiation enteritis, by following according to weight Measure the raw material composition of part:5 parts of Alendronate sodium, 15 parts of ambroxol, 9 parts of lysine, 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) Alendronate sodium, ambroxol, calcium lactate are mixed, adds the deionized water of 3.1 times of three's mass, be warming up to 75-77 DEG C, and stir process 38-40min at such a temperature, mixture A is obtained;
2) mixture A is mixed with lysine, the ultrasonically treated 25min at a temperature of 58 DEG C, ultrasonic power is 900W, then Stirred at a temperature of 63 DEG C to dry and obtain final product Chinese and western medicinal composition.
As further scheme of the 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 beneficial effects of the invention are as follows:
The present invention has prescription unique, cheap, safe ready, and its effect is better than conventional use of Western medicine, Ke Yiyou Effect cures Colorectal injury caused 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 and 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 invention, rather than whole embodiments.Based in the present invention Embodiment, the every other embodiment that those of ordinary skill in the art are obtained under the premise of creative work is not made, 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 ambroxol, 5 parts of lysine, 1 part of calcium lactate.
Alendronate sodium, ambroxol, calcium lactate are mixed, the deionized water of 3.1 times of three's mass is added, 75 are warming up to DEG C, and stir process 38min at such a temperature, mixture A is obtained.Mixture A is mixed with lysine, at a temperature of 58 DEG C Ultrasonically treated 25min, ultrasonic power is 900W, then is stirred 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 ambroxol, 13 parts of lysine, 5 parts of calcium lactate.
Alendronate sodium, ambroxol, calcium lactate are mixed, the deionized water of 3.1 times of three's mass is added, 77 are warming up to DEG C, and stir process 40min at such a temperature, mixture A is obtained.Mixture A is mixed with lysine, at a temperature of 58 DEG C Ultrasonically treated 25min, ultrasonic power is 900W, then is stirred 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 ambroxol, 7 parts of lysine, 2 parts of calcium lactate.
Alendronate sodium, ambroxol, calcium lactate are mixed, the deionized water of 3.1 times of three's mass is added, 76 are warming up to DEG C, and stir process 39min at such a temperature, mixture A is obtained.Mixture A is mixed with lysine, at a temperature of 58 DEG C Ultrasonically treated 25min, ultrasonic power is 900W, then is stirred 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 ambroxol, 11 parts of lysine, 4 parts of calcium lactate.
Alendronate sodium, ambroxol, calcium lactate are mixed, the deionized water of 3.1 times of three's mass is added, 76 are warming up to DEG C, and stir process 39min at such a temperature, mixture A is obtained.Mixture A is mixed with lysine, at a temperature of 58 DEG C Ultrasonically treated 25min, ultrasonic power is 900W, then is stirred 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 ambroxol, 9 parts of lysine, 3 parts of calcium lactate.
Alendronate sodium, ambroxol, calcium lactate are mixed, the deionized water of 3.1 times of three's mass is added, 76 are warming up to DEG C, and stir process 39min at such a temperature, mixture A is obtained.Mixture A is mixed with lysine, at a temperature of 58 DEG C Ultrasonically treated 25min, ultrasonic power is 900W, then is stirred 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 without ultrasonic step, remaining constituent content and preparation process are consistent with embodiment 5.
The toxicity test of embodiment 6
1) acute toxicity testing:
Using NIH mouse 60, SPF grades, male and female half and half, 18~22g of body weight carries out acute toxicity test.Mouse is random It is divided into two groups, every group 30, i.e. control 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 drugs/ml, maximum concentration) gavage, and gavage volume is that 5ml/kg is (i.e. single Secondary dosage is 32.9 crude drugs/kg), control group gives normal saline, is administered 2 times within one day, and delivery time 6 is small When, Continuous Observation 14 days after administration, and record the toxic reaction and death toll of mouse.Test result indicate that:With control group ratio Compared with mouse has no notable difference after administration, tests Continuous Observation 14 days, and mouse systemic situation, diet, drinking-water, body weight increase are equal Normally.32.9 crude drugs of Mouse oral gavage Chinese and western medicinal composition LD50 > of the invention/kg, daily maximum dosage-feeding is 65.8 lifes Medicine/kg/ days.Chinese medicine clinical application amount of the invention be 1.5g crude drugs/day/people, adult body weight in terms of 60kg, average dosage For 0.025g crude drugs/kg/ days.By batheroom scale:Mouse (average weight is in terms of 20g) oral administration gavage Chinese and western medicinal composition of the invention Dosis tolerata be 1316 times of quantity.Therefore Chinese and western medicinal composition acute toxicity of the 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 uses to mouse 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 The indexs such as hair, behavior, stool and urine, body weight, organ weights, blood picture, hepatic and renal function, blood sugar, blood fat have no significant effect, internal organs meat Eye shows without finding difference change and histological indications, medication 15 weeks and after being discontinued 3 weeks, and each internal organs of rat are without obvious Change.Chinese and western medicinal composition of the present invention is illustrated to small toxicity after rat long-term prescription, also without abnormal reaction after drug withdrawal, using peace Entirely.
The clinical test of embodiment 7
1. case selection
The patient 450 of pelvic cavity radiation therapy is selected, 9 groups, respectively every group 50,1 group of embodiment, implementation are randomly divided into 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. The each group carcinoma of the rectum 25, colon cancer 10, cervical carcinoma 15, ordinary circumstance compares that there was no significant difference.
2. treatment method
All patients take embodiment 1-5 or comparative example respectively by group daily while conventional radiotherapy is received 1-3 Chinese and western medicinal compositions or commercially available treatment Chinese and western medicinal composition once, 10 days as one therapeutic course.The course for the treatment of carries out curative effect and comments after terminating It is fixed.
3. efficacy evaluation
It is that clinical symptoms and sign disappear to fully recover, and times of defecation is normal, laboratory examination also normal person;Take a turn for the better as symptom is aobvious Write and mitigate, times of defecation and outward appearance are normal;Head before and after treatment without significant change or to have exacerbation.
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 It is 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 without departing substantially from spirit or essential attributes of the invention, the present invention can be in other specific forms realized.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 requires to be limited rather than described above, 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 the present specification is described in terms of embodiments, not each implementation method is only wrapped Containing an independent technical scheme, this narrating mode of specification is only that for clarity, those skilled in the art should Specification an as entirety, the technical scheme in each embodiment can also be formed into those skilled in the art through appropriately combined May be appreciated 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 parts, ambroxol 11-19 parts, lysine 5-13 parts, calcium lactate 1-5 parts.
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 Measure the raw material composition of part:Alendronate sodium 4-6 parts, ambroxol 13-17 parts, lysine 7-11 parts, calcium lactate 2-4 parts.
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 Measure the raw material composition of part:5 parts of Alendronate sodium, 15 parts of ambroxol, 9 parts of lysine, 3 parts of calcium lactate.
4. the preparation method of the Chinese and western medicinal composition of a kind of therapeutic radiation enteritis as described in claim 1-3 is any, it is special Levy and be, comprise the steps of:
1)Alendronate sodium, ambroxol, calcium lactate are mixed, the deionized water of 3.1 times of three's mass is added, 75-77 is warming up to DEG C, and stir process 38-40min at such a temperature, mixture A is obtained;
2)Mixture A is mixed with lysine, the ultrasonically treated 25min at a temperature of 58 DEG C, ultrasonic power is 900W, then 63 Stirred 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 any is in therapeutic radiation enteritis Chinese and western medicinal composition is prepared Using.
CN201611236004.5A 2016-12-28 2016-12-28 A kind of Chinese and western medicinal composition of therapeutic radiation enteritis Pending CN106727619A (en)

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Application publication date: 20170531