CN106860463A - A kind of medicament for reducing dexamethasone acetate tablets clinical side effects - Google Patents
A kind of medicament for reducing dexamethasone acetate tablets clinical side effects Download PDFInfo
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- CN106860463A CN106860463A CN201710102338.1A CN201710102338A CN106860463A CN 106860463 A CN106860463 A CN 106860463A CN 201710102338 A CN201710102338 A CN 201710102338A CN 106860463 A CN106860463 A CN 106860463A
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- 239000003814 drug Substances 0.000 title claims abstract description 22
- FPVRUILUEYSIMD-RPRRAYFGSA-N [(8s,9r,10s,11s,13s,14s,16r,17r)-9-fluoro-11-hydroxy-17-(2-hydroxyacetyl)-10,13,16-trimethyl-3-oxo-6,7,8,11,12,14,15,16-octahydrocyclopenta[a]phenanthren-17-yl] acetate Chemical compound C1CC2=CC(=O)C=C[C@]2(C)[C@]2(F)[C@@H]1[C@@H]1C[C@@H](C)[C@@](C(=O)CO)(OC(C)=O)[C@@]1(C)C[C@@H]2O FPVRUILUEYSIMD-RPRRAYFGSA-N 0.000 title claims abstract description 18
- 229960003657 dexamethasone acetate Drugs 0.000 title claims abstract description 18
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- UREBDLICKHMUKA-CXSFZGCWSA-N dexamethasone Chemical compound C1CC2=CC(=O)C=C[C@]2(C)[C@]2(F)[C@@H]1[C@@H]1C[C@@H](C)[C@@](C(=O)CO)(O)[C@@]1(C)C[C@@H]2O UREBDLICKHMUKA-CXSFZGCWSA-N 0.000 description 1
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- HLUCICHZHWJHLL-UHFFFAOYSA-N hematein Chemical compound C12=CC=C(O)C(O)=C2OCC2(O)C1=C1C=C(O)C(=O)C=C1C2 HLUCICHZHWJHLL-UHFFFAOYSA-N 0.000 description 1
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Classifications
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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
- A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
- A61K31/57—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
- A61K31/573—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/36—Caryophyllaceae (Pink family), e.g. babysbreath or soapwort
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/70—Polygonaceae (Buckwheat family), e.g. spineflower or dock
- A61K36/704—Polygonum, e.g. knotweed
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/71—Ranunculaceae (Buttercup family), e.g. larkspur, hepatica, hydrastis, columbine or goldenseal
- A61K36/716—Clematis (leather flower)
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/88—Liliopsida (monocotyledons)
- A61K36/898—Orchidaceae (Orchid family)
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
- A61K2236/331—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using water, e.g. cold water, infusion, tea, steam distillation or decoction
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- Health & Medical Sciences (AREA)
- Natural Medicines & Medicinal Plants (AREA)
- Life Sciences & Earth Sciences (AREA)
- Public Health (AREA)
- Chemical & Material Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Veterinary Medicine (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Alternative & Traditional Medicine (AREA)
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- Medical Informatics (AREA)
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- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
The invention discloses a kind of medicament for reducing dexamethasone acetate tablets clinical side effects, belong to technical field of pharmaceuticals.The medicament is made up of component A and component B, and the component A is dexamethasone acetate tablets；Component B includes that ford nervilia leaf, gooseintestine sarwort herb, grossedentate clematis root, runcinate knotweed herb, florida waltheria root and stem are made.Clinical tests prove that, the medicament not only has preferable curative effect to treatment ulcerative colitis, and significantly reduces side effect.
Description
Technical field
The present invention relates to pharmaceutical techniques field, more particularly to a kind of medicine for reducing dexamethasone acetate tablets clinical side effects
Agent.
Background technology
Ulcerative colitis, also known as chronic nonspecific ulcerative colitis or colitis idiopathic ulcerative, is a kind of normal
The not clear nonspecific inflammation of the reason for chronic intestinal disease seen is also a kind of multifactor, multi-level.Lesion is main in colon
Mucous membrane and submucosa, be distributed in continuity diffusivity, majority involves rectum and sigmoid colon.Main clinical manifestation is abdomen
Bitterly, diarrhoea, mucopurulent bloody stool, tenesmus etc., some patientss have parenteral performance, such as joint, liver and gall tubing disease and eyes, skin
The damage of skin；Course of disease protracted course of disease, weight；The age bracket of morbidity is main between 20-50 Sui, but the sex without conspicuousness
Difference.It is main to the treatment modern medicine of this disease with anti-inflammatory, suppress immune response, anti symptom treatment and supportive treatment, effect is not very
Ideal, and toxic and side effect is big.Inventor's continuous summing up experience in clinical practice for many years, develops one kind and treats exedens knot
The preparation of enteritis, said preparation is not only evident in efficacy, and has no toxic side effect, and in actual therapeutic, is easily accepted by patients.
The content of the invention
It is an object of the invention to provide a kind of medicament for reducing dexamethasone acetate tablets clinical side effects.
The purpose of the present invention is achieved through the following technical solutions, the reduction dexamethasone acetate tablets clinical side effects
Medicament is made up of component A and component B, and the component A is dexamethasone acetate tablets 3mg；Component B includes 20 parts of ford nervilia leaf, chicken tripe
45 parts of intestines grass, 25 parts of grossedentate clematis root, 30 parts of runcinate knotweed herb, 50 parts of florida waltheria root and stem.
Preparation method：Dexamethasone acetate tablets are ground into powdery standby；The medicinal material in component B is assorted, suitable quantity of water is added, first
After with intense fire ebuillition of heated, filtered after using slow fire heating half an hour instead, the acetic acid of powdery is ground into addition in the liquid after filtering
Dexamethasone tablet, the heating of continuation slow fire obtains final product preparation of the invention in 20 minutes after stirring evenly.
Fang Zhong：Ford nervilia leaf clearing heat and moistening lung, scattered stasis of blood removing toxic substances；Gooseintestine sarwort herb anti-inflammation；The grossedentate clematis root promoting flow of qi and blood circulation, wind-dispelling
Wet, analgesic；Runcinate knotweed herb is clearing heat and detoxicating, activating blood circulation and reducing swelling；Florida waltheria root and stem dispelling wind and eliminating dampness, eliminating inflammation and expelling toxin.
Specific embodiment
Preparation of the invention is made up of component A and component B, and the component A is dexamethasone acetate tablets 3mg；Component B includes
Ford nervilia leaf 20g, gooseintestine sarwort herb 45g, grossedentate clematis root 25g, runcinate knotweed herb 30g, florida waltheria root and stem 50g, first grind dexamethasone acetate tablets
Powdering is standby；The medicinal material in component B is assorted, suitable quantity of water is added, after elder generation is with intense fire ebuillition of heated, slow fire heating half an hour is used instead
After filter, be ground into the dexamethasone acetate tablets of powdery to being added in the liquid after filtering, continuation slow fire heats 20 points after stirring evenly
Clock obtains final product preparation of the invention.
Toxicity test
1st, experimental animal cleaning grade healthy SD female rats 44, weight (201 ± 4) g, as chronic toxicity；
Cleaning grade health Kunming female small white mouse 32, weight (22 ± 2) g, as acute toxicological experiment.Feed with normal diet, it is general
Logical drinking-water.Room temperature is controlled in (25 ± 2) DEG C, humidity (52 ± 3) %, natural lighting.
2nd, acute toxicological experiment is randomly divided into 2 groups from cleaning grade health Kunming female small white mouse 32, preparation group and
Each 16 of blank control group.Preparation group is converted to the dosage of small white mouse by adult normal's oral dose, and invention formulation 2 is gavaged daily
It is secondary.Blank control group gives the sodium chloride injection of 1mL/20g weights 0.9% to gavage.
3rd, long term toxicity test cleaning grade healthy SD female rats 44, are randomly divided into 4 groups, Normal group and preparation
Group it is small, in, it is heavy dose of each 11.Control group gives the sodium chloride injection of 1ml/20g weights 0.9%, preparation group it is small, in,
Heavy dose of group of be that adult normal consumption is converted to rat dosage 10,20,40 times, are gastric infusion, and 2 times a day, experiment week
Phase is 3 months.
4th, acute toxicity testing result small white mouse is being administered in 7d without death, to observation post administration mouse outward appearance, hair color, light
Damp normal, social action, reaction are normal, ingest, drain normal.Artificial putting to death is dissected after 7d, observes its heart, liver, spleen
Dirty, lungs, kidney, brain, ovary, uterus are showed no exception.Pathological examination：Yihong of haematine one (HE) is dyeed, and Chinese medicine group is dirty
Device surface is smooth, institutional framework aligned orderly, and cell size, form are normal, and endochylema, karyon dyeing are clear, with blank control group
Comparing difference is not statistically significant (P ＞ 0.05).
5th, chronic toxicity result preparation group it is small, in, outward appearance, the hair color of heavy dose of group and rats in normal control group,
Social action, excitant etc. and not statistically significant to comparing differences such as surrounding environment, food, the interest of water (P ＞ 0.05).
Increase the equal nothing of weight comparing difference after (P ＜ 0.05), but 4 groups of experiments before weight relatively this group experiment after 4 groups of rat experiments
Statistical significance (P ＞ 0.05), blood cytology index, blood biochemical analysis index, important organ coefficient ratio after 4 groups of rat experiments
(P ＞ 0.05) not statistically significant compared with difference.After death important organ row staining pathologic section is checked at 4 groups of rats, HE dyeing.
Preparation group Rats Organs and Tissues institutional framework aligned orderly, cell size, form are normal, and endochylema, karyon dyeing are clear, with normal control
Group comparing difference is not statistically significant (P ＞ 0.05).
Toxicity test shows that the medicament for reducing dexamethasone acetate tablets clinical side effects of the present invention is administered large and small
Toxic reaction is had no after white mouse.
Clinical data
1st, in this Out-patient Department and inpatient, selection is light, moderate, severe patient 120 for physical data, wherein man 75
Example, female 45；Age 21-62 Sui, course of disease 2-36 month, average 19 months；The state of an illness is slight 60, moderate 30, severe 30.
On the basis of patient knows the inside story and be voluntary, patient is divided into 3 groups by us；Take invention formulation for preparation group, individually take group
Divide A treatments is control group；Individually take component B treatments is treatment group；Each group compares nothing in physical data such as age, sexes
Statistical significance (P ＞ 0.05), with comparativity.
2nd, diagnostic criteria (1) Western medicine diagnostic criteria：It is " chronic non-with reference to the whole nation of Taiyuan in 1993InfectionPropertyEnteron aisleDiseaseLearn ArtSeminar " standard.(2) tcm diagnosis standard：Reference《Chinese medicineClinical Researches of New Drugs guideline》(May the 1st edition in 2002).
3rd, treatment method preparation group is taken the medicament as obtained in embodiment of the present invention and is treated, and a point morning and evening takes twice
With；The medicinal material that treatment group is assorted in component B is traditionally made medicament and is treated, and a point morning and evening takes twice；Control group is pressed
Conventional method is taken component A and is treated, and the person of being in a bad way follows the doctor's advice the meal with wine amount of adding；Each group 5 days as one therapeutic course, each group patient is equal
Comparitive study is carried out after 2 courses for the treatment of of treatment.
4th, curative effect determinate standard recovery from illness：Ulcer disappearance after patient's treatment, pain disappears, and stool recovers normal, and nothing rushes down following table
It is existing, intestinal mucosa injury recovery；Alleviate：Ulcer healing ＞ 60% after patient's treatment, pain relief, stool shaping；It is invalid：Patient
Pain, diarrhoea performance are not improved after treatment, ulcer healing degree ＜ 60%.
5th, comparative result see the table below after each group treats 2 courses for the treatment of.
| Group | Number of cases | Day dose (g) | Recovery from illness | Alleviate | It is invalid | Side effect | Total effective rate (%) |
| Preparation group | 40 | 170g+3mg | 28 | 10 | 1 | 0 | 97.5 |
| Control group | 40 | 6mg | 10 | 16 | 14 | 9 | 65.0 |
| Treatment group | 40 | 190g | 6 | 18 | 16 | 2 | 60.0 |
By experimental result it is recognized that while the amount of component A is less than control group in preparation group, the amount of component B is less than treatment group, but
It is to achieve preferable therapeutic effect, total effective rate is apparently higher than control group and treatment group, it is often more important that toxicity reduction, it is nontoxic
Side effect occurs；And there are 4 increased weights, 3 edemas of lower extremity, 1 n and V in control group；There is 1 body weight in treatment group
Increase, 1 n and V；It follows that each medicine has synergistic function, clinic popularization and application after compatibility.
When carrying out follow-up to treatment group patient, wherein after thering are 4 patient's reflections to take preparation of the invention, it is not only exedens
Colitis has obtained effective treatment, and the allergic reaction for often breaking out also is disappeared.There are 2 patients to say and " enter tree every time
Lin Hou, just occurs cutaneous anaphylaxis, plays pimple, and pole is itched；After preparation of the invention is taken, above phenomenon disappears ".Separately
2 patient's readmes " are usually eaten shrimp, during grasshopper, can occur pain of itching in 10-20 minutes, red pimple then occur, feel skin
There is thermal sensation, its pain is unbearably；After preparation of the invention is taken, ulcerative colitis is not only cured, and, when they do not note
Meaning eats shrimp again, during grasshopper, allergic reaction does not occur ".After obtaining this information, we are right immediately using preparation of the invention
20 autopaths and 24 had allergies patient to be treated, and recovery is being just in 15-30 minute after 20 autopaths' medications
Often, 24 had allergies patient take medicine after carry out allergic condition stimulation, there is not allergic reaction；Follow-up 3 years, above patient
Do not occur allergic reaction.It follows that preparation of the invention is taken, it is not only evident in efficacy to treatment ulcerative colitis, and
And allergic disease is acted on elimination, clinic popularization and application.
Claims (2)
1. it is a kind of reduce dexamethasone acetate tablets clinical side effects medicament, it is characterised in that the medicament is by component A and component B systems
Into the component A is dexamethasone acetate tablets 3mg；Component B includes 20 parts of ford nervilia leaf, 45 parts of gooseintestine sarwort herb, grossedentate clematis root 25
Part, 30 parts of runcinate knotweed herb, 50 parts of florida waltheria root and stem.
2. the preparation method of a kind of medicament for reducing dexamethasone acetate tablets clinical side effects as claimed in claim 1, it is special
Levy is that dexamethasone acetate tablets are ground into powdery is standby；The medicinal material in component B is assorted, suitable quantity of water is added, is first heated with intense fire
After boiling, filtered after using slow fire heating half an hour instead, the dexamethasone acetate tablets of powdery be ground into addition in the liquid after filtering,
The heating of continuation slow fire obtains final product preparation of the invention in 20 minutes after stirring evenly.
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| CN201710102338.1A CN106860463A (en) | 2017-02-15 | 2017-02-15 | A kind of medicament for reducing dexamethasone acetate tablets clinical side effects |
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| CN105287561A (en) * | 2015-11-25 | 2016-02-03 | 上海交通大学医学院附属瑞金医院 | Pharmaceutical composition for treating ulcerative colitis |
| CN105326788A (en) * | 2015-11-10 | 2016-02-17 | 成都中牧生物药业有限公司 | Preparation method of dexamethasone sodium phosphate for injection |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105326788A (en) * | 2015-11-10 | 2016-02-17 | 成都中牧生物药业有限公司 | Preparation method of dexamethasone sodium phosphate for injection |
| CN105287561A (en) * | 2015-11-25 | 2016-02-03 | 上海交通大学医学院附属瑞金医院 | Pharmaceutical composition for treating ulcerative colitis |
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Application publication date: 20170620 |