CN108619289A - A kind of pharmaceutical composition purposes in the drug for preparing treatment diabetes B - Google Patents
A kind of pharmaceutical composition purposes in the drug for preparing treatment diabetes B Download PDFInfo
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- 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
- A61K36/718—Coptis (goldthread)
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- 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)
- A61K36/75—Rutaceae (Rue family)
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Abstract
The present invention provides purposes of the drug being prepared containing the bulk pharmaceutical chemicals that following weight matches in the drug for preparing treatment diabetes B：2 10 parts of the coptis, 1 10 parts of evodia rutaecarpa.The fasting blood-glucose (FPG), fasting insulin (FINS), OGTT2h blood glucose (OGTT2hPG) that the present composition can effectively improve diabetes B patient are horizontal, it has no adverse reaction, a kind of new selection is provided for clinical application.
Description
Technical field
The present invention relates to a kind of purposes of pharmaceutical composition in the drug for preparing treatment diabetes B.
Background technology
Diabetes are a kind of chronic metabolic derangements diseases of the multi-pathogenesis of high incidence, are clinically divided into 1 type, 2 types, wherein
It is in the majority with 2 type patients.Diabetes B is characterized in that periphery generates resistant function to insulin, and insulin is shown as in molecular level
It is combined rear signal transduction to lack with insulin receptor, persistent high blood sugar is caused to increase so as to cause oxidative stress, generated various slow
Property complication.
Since the cause of disease and pathogenesis of diabetes are not yet completely understood, effective causative treatments are also lacked at present.
The chemicals for having a plurality of types of anti-diabetes Bs in the market are used for clinical treatment, include mainly sulfonylurea, biguanides
Class, glucosidase inhibitor, Insulin sensitizing drugs, non-sulfonylurea promote islet secretion medicine and insulin, but these drugs are big
All there is the problems such as offer limited effectiveness, adverse reaction is apparent.
This disease belongs to the scope of traditional Chinese medicine " quenching one's thirst ".Chinese medicine thinks that " quenching one's thirst " is since the deficiency of Yin is scorching, and the five internal organs are weak
It is caused by drink more, mostly food, diuresis, body become thin characterized by illness.The cause of disease quenched one's thirst is caused to have eating and drinking without temperance, feelings will to lose
It adjusts, labor, which is intended to excessively and examines, assigns deficiency etc..Its interpretation of the cause, onset and process of an illness is mainly the scorching deficiency of Yin, and the five internal organs are weak.Pathogenic process is sheet with the deficiency of Yin,
Scorching is mark.The clinical research of the diabetes B of Chinese medicine treatment in recent years deepens continuously, and research has shown that natural drug active ingredient has
There is apparent blood sugar reducing function.Ding Yimin etc., " shadow of the berberine to diabetes B patient population leptin, adiponectin and insulin resistance
Ring ", medicine the 22nd interim berberine that discloses in 2013 in Jilin can reduce blood glucose, improve adiponectin, reduce leptin level, improve
Insulin resistance.Nie Xu is strong etc., " intervention effect of the Rutaecarpine to diabetes B obese rat " Chinese Pharmacological Bulletin
26th phase in 2010, which discloses Rutaecarpine, to be had the function of reducing blood fat.Application number：CN201611145495.2, invention name
Claim：A kind of Chinese medicine composition and preparation method thereof the patent application of prevention diabetes B discloses a kind of prevention diabetes B
Pharmaceutical composition, it is made of the raw material using following weight proportion：HERBA EPIMEDII 8-15, it thizoma curculiginis 8-15, fruit of Cherokee rose 8-15, covers
Basin 8-15, Semen Cuscutae 8-15, faenum graecum 8-15, stiff silkworm 8-15, earthworm 8-15, coptis 10-15, root bark of Chinese wolf-berry 16-20, root of Chinese trichosanthes
It is 10-15, Chinese cassia tree 2-5, sealwort 8-15, radix polygonati officinalis 8-15, corn stigma 8-15, Asiatic plantain 8-15, Ramulus euonymi 8-15, giant knotweed 10-15, red
Chinese herbaceous peony 10-15, Radix Salviae Miltiorrhizae 8-15.
Now have no the report coordinated the coptis and 2 taste medicine of evodia rutaecarpa for treating diabetes B.
Invention content
The technical solution of the present invention is to provide a kind of new applications of pharmaceutical composition.
The present invention provides the drug being prepared containing the bulk pharmaceutical chemicals that following weight matches prepare treatment diabetes and/
Or the purposes in the drug of improvement insulin resistance：2-10 parts of the coptis, 1-10 parts of evodia rutaecarpa.
It is further preferred that the bulk pharmaceutical chemicals weight proportion is：2 parts of the coptis, 1 part of evodia rutaecarpa.
Wherein, it is active constituent that the drug, which is by the coptis, the primary medicinal powder of evodia rutaecarpa or water or extractive with organic solvent,
The preparation that pharmaceutically acceptable auxiliary material or complementary ingredient are prepared is added.
The preparation is oral preparation.
Wherein, the oral preparation is granule, powder, pill, capsule, soft capsule, tablet or oral solution.
It is further preferred that the pill is pill, capsule is soft capsule.
The preparation method of the drug includes the following steps：
A, bulk pharmaceutical chemicals are weighed by weight ratio；
B, bulk pharmaceutical chemicals directly beat powder, or bulk pharmaceutical chemicals are added water to cook or organic solvent extracts, and pharmacy is added in extracting solution concentration
Upper acceptable auxiliary material or complementary ingredient are prepared into pharmaceutically common preparation.
The drug is the drug for treating diabetes B.
Wherein, the drug is the drug for treating the liver-cold type diabetes B of stomach energy.
Wherein, the drug is to reduce fasting blood-glucose, fasting insulin, OGTT2h blood glucose levels and/or insulin resistance
Drug.
Oneself generally acknowledges that " organic conception ", " diagnosis and treatment based on an overall analysis of the illness and the patient's condition ", " compound use ", " compound compatibility medication is such as used military forces " are Chinese medicine at present
Most scientific most effective several big advantages, wherein " compound compatibility medication is such as used military forces " is the original theory of traditional Chinese medicine of very science.In
Cure in prescription and medicine tight compatibility all linked with one another as arrayed troops for battle, be it better than western medicine formula effective treatment means.
TCM prescription theory thinks that each prescription is not only needed to select the suitable appropriate compatibility of drug according to etiology and pathogenesis, while also being answered
Meet the basic structure of prescription, i.e. the prescription compatibility of " monarch minister, helps, makes ", the prescription compatibility of so-called " monarch minister, helps, makes " is exactly
It establishes the scientific matching on the comprehensive judgement basis to the disease interpretation of the cause, onset and process of an illness.Middle medical square is integrated by too many levels, multiple target point
The biological mechanism of adjusting is looked into diabetes B and the such mechanism complicated difficult of dependence, doctor trained in Western medicine curative effect, the very difficult disease for the treatment of
Suffer from or symptom carries out control of withering, more preferable than Western medicine, more thorough therapeutic effect can be obtained, and this curative effect is built upon among the above
On the original theoretical definite guidance of doctor's tradition, prescription of the present invention has followed this principle.
Under tcm theory guidance, diabetes B category " is quenched one's thirst ", and the interpretation of the cause, onset and process of an illness is mainly the scorching deficiency of Yin, and the five internal organs are weak.It fell ill
For journey with the deficiency of Yin for this, scorching is mark.Reuse coptis bitter cold and be used as monarch drug in a prescription, rush down stomach energy clearly, stomach fire drop then its gas from；Evodia rutaecarpa is pungent
Heat, one energy warmly nourishing Yangqi；The two soothing liver-qi stagnation, so that irritability item reaches, pent-up must open, and spleen is transported strong；Three's harmonizing stomach and lowering adverse Qi, leads
Hot downlink；Four using corrigents are even cold with manufacture-yellow, make purging intense heat and without the cool disadvantage held back.Such medicine simply takes charge of the duty of minister, assistant altogether.Quan Fanghan
Heat and with (a cold heat, person's normal treatment of trembling with fear, hot person is from controlling), pungent bitter drop (arduous to be harmonious, let out middle residence and open, logical and can drop) of opening are gathered clearly altogether
Stomach warms up the benefits of liver.
Drug of the present invention is made of the coptis and two taste medicine of evodia rutaecarpa, is had the effect of " liver is warmed up in clearing stomach ", be can effectively improve 2 types
The fasting blood-glucose (FPG) of diabetic, fasting insulin (FINS), OGTT2h blood glucose (OGTT2hPG) are horizontal, reduce pancreas islet
Element is resisted, and is had no adverse reaction.Pharmaceutical composition medication of the present invention is simplified, and old side is new to be used, by theory of traditional Chinese medical science and modern medicine perfection knot
It closes, achievees the purpose that adjust the liver-cold type diabetes B patient's glycolipid metabolism of stomach energy, a kind of new choosing is provided for clinical application
It selects.
Obviously, the above according to the present invention is not being departed from according to the ordinary technical knowledge and customary means of this field
Under the premise of the above-mentioned basic fundamental thought of the present invention, the modification, replacement or change of other diversified forms can also be made.
The specific implementation mode of form by the following examples remakes further specifically the above of the present invention
It is bright.But the range that this should not be interpreted as to the above-mentioned theme of the present invention is only limitted to example below.It is all to be based on the above of the present invention
The technology realized all belongs to the scope of the present invention.
Specific implementation mode
The preparation of 1 pharmaceutical composition of the present invention of embodiment
Take 2 parts of the coptis, 1 part of evodia rutaecarpa.Each flavour of a drug weigh according to quantity, are doped with enough water purifications, are cooked by slow fire 30 minutes or more.
After collecting decocting liquid, decoction 2 times is added water, merges each secondary decocting liquid to get decoction.
The preparation of 2 pharmaceutical composition of the present invention of embodiment
Decoction prepared by Example 1, after concentration, pelletizes after adding proper starch, dextrin mixing.
The preparation of 3 pharmaceutical composition of the present invention of embodiment
Take 2 parts of the coptis, 1 part of evodia rutaecarpa.Each flavour of a drug weigh according to quantity, are doped with enough water purifications, are cooked by slow fire 30 minutes or more.
After collecting decocting liquid, decoction 2 times is added water, merges each secondary decocting liquid, it is dry, after appropriate dextrin, soluble starch granulation is added,
Tabletting is to get tablet.
The preparation of 4 pharmaceutical composition of the present invention of embodiment
Take 2 parts of the coptis, 1 part of evodia rutaecarpa.Each flavour of a drug weigh according to quantity, are doped with enough water purifications, are cooked by slow fire 30 minutes or more.
After collecting decocting liquid, decoction 2 times is added water, merges each secondary decocting liquid, after dry, adds appropriate microcrystalline cellulose, after mixing, fills glue
Capsule is to get capsule.
Beneficial effects of the present invention are proved below by way of clinical observation.
The verification of 1 medicine composite for curing diabetes B of the present invention of test example
1 experiment material
1.1 experimental drug
1. pharmaceutical composition of the present invention takes 2 parts of the coptis, 1 part of evodia rutaecarpa.Each flavour of a drug weigh according to quantity, are doped with enough water purifications,
It is cooked by slow fire 30 minutes or more.After collecting decocting liquid, decoction 2 times is added water, merges each secondary decocting liquid to get decoction；2. taking Huang
Even 2 parts, enough water purifications are doped with, are cooked by slow fire 30 minutes or more.After collecting decocting liquid, decoction 2 times is added water, merges each secondary water
Decocting liquid is to get decoction；3. taking 1 part of evodia rutaecarpa, enough water purifications are doped with, are cooked by slow fire 30 minutes or more.After collecting decocting liquid, then
It adds water to cook 2 times, merges each secondary decocting liquid to get decoction.
1.2 patient data
Case selection：1. patient is all from April, 2015 in December, 2016 in Hospital Affiliated To Chengdu Traditional Chinese Medicine Univ door
It examines, is included in 48 altogether；2. meeting doctor trained in Western medicine diabetes B disease diagnostic criteria, life can take care of oneself without serious liver, kidney, the heart, brain disease
Disease, glycemic control is not good enough and glucostasis at least two is more than the moon；3. all patients meet stomach energy cold syndrome in the liver,liver-cold syndrome.
2 experimental methods
2.1 diagnostic criteria
Western medicine diagnostic criteria：The sugar formally announced with reference to (WHO) the diabetologist committee of the World Health Organization in 1999
The sick diagnostic criteria of urine.It is all that there is diabetic symptom (having diuresis, more drinks and inexplicable weight to decline), and meet following item
The one of part, you can be diagnosed as diabetes：1. fasting blood-glucose >=7.0mmol/L；2. random blood sugar >=11.1mmol/L；3. sugared resistance to
Amount experiment (OGTT) 2 hours blood glucose 11.1mmol/L.Non-diabetic symptom needs rechecking on some other day.
Stomach energy cold syndrome in the liver,liver-cold syndrome diagnostic criteria：With reference to National Standard of the People's Republic of China《Tcm clinical practice diagnosis and treatment term syndrome
Part》、《Diagnostics of Chinese Medicine》Draft the syndrome diagnostic criterion of diabetes B stomach energy cold syndrome in the liver,liver-cold syndrome：Need to meet simultaneously syndrome of heat in the stomach and
Syndrome of deficiency of liver yang.Syndrome of heat in the stomach：Burning pain in the epigastrium, thirst and desire for cold drink or rapid digestion of food and polyorexia, halitosis, gum redness or cusalgia, bleeding from the gum, oliguria
Huang, constipation；Syndrome of deficiency of liver yang：Two sides of body are swollen bored, and it is cool to fear cold limb, dizzy；With reference to tongue vein.
2.2 cases are grouped
Subject is specified from 1~96 number using the completely random block functions of DPS statistical softwares by medical sequence
Sample number is 96, and grouping group number is 3, and it is (yellow that patient is randomly divided into the coptis+evodia rutaecarpa group：Wu=2:1), coptis group, Wu Zhu
Cornel group (every group each 32).
2.3 therapy
The equal strict implement diabetic diet of all patients and exercise therapy, on the basis of prolonged administration of drugs is constant,
Carry out following treatment：
(1) coptis+evodia rutaecarpa group：Coptis invention formulation is applied alone, by the raw material dosage and method described in 1 method of embodiment
It prepares, by Hospital Affiliated To Chengdu Traditional Chinese Medicine Univ, Chinese medicine pharmacy provides, daily 1 dose, three times a day, takes orally.
(2) coptis group：2 parts of the coptis is applied alone, by described in 1 method of embodiment raw material dosage and method prepare, by Chengdu
Chinese medicine pharmacy of medical pharmaceutical university affiliated hospital provides, daily 1 dose, three times a day, takes orally.
(3) evodia rutaecarpa group：1 part of evodia rutaecarpa is applied alone, by described in 1 method of embodiment raw material dosage and method prepare, by
All Chinese medicine pharmacy of affiliated hospital of university of TCM provides, daily 1 dose, three times a day, takes orally.
All patients be observed continuously 4 weeks it is as a treatment course, if anomalous variation occurs in patient blood glucose, that is, do respective handling.
2.4 observation index
(1) safety indexes：Heart rate, breathing, blood pressure (treatment each survey in 0,2,4 week is primary)；Blood, urine, stool routine chemical examination, the heart
Electrograph, hepatic and renal function (treatment each inspection in 0,4 week is primary).Adverse events are reported at any time.
(2) parameters for observation on effect：Fasting blood-glucose (FPG), fasting insulin (FINS), OGTT2h blood glucose (OGTT2hPG).
It is detected within the 0th, 4 week respectively at treatment, and calculates HOMA-IR.According to formula insulin resistance index (HOMA-IR)=FPG ×
FINS/22.5 calculates HOMA-IR.
Blood sugar detection described above uses venous plasma glucose oxidase method.
2.5 the standard of curative effect evaluation
Reference《New Chinese medicine guideline of clinical investigations》Criterion of therapeutical effect.
(1) effective：Symptom disappears substantially after treatment, and fasting blood-glucose ＜ 7.2mmol/L or blood glucose relatively treat preceding decline 30%
More than；
(2) effectively：Symptom is obviously improved after treatment, and fasting blood-glucose ＜ 8.3mmol/L or blood glucose relatively treat preceding decline 10%
More than；
(3) invalid：Symptom is not improved after treatment, and blood glucose, which declines, does not reach above-mentioned standard.
2.6 statistical method
Test data is for statistical analysis using SPSS21.0 statistical softwares.Statistical check mode is as follows：Measurement data t inspections
It tests, variance analysis or rank sum test；Enumeration data uses Chi-square Test, ranked data to use rank sum test.All statistics inspections
It tests and is all made of two-sided test, with P>0.05 indicates no significant difference, P<0.05 indicates that difference is statistically significant, P<
0.01 expression difference is statistically significant.
3 experimental results
Each group patient cases' performance compares：The coptis+evodia rutaecarpa group, coptis group, evodia rutaecarpa group are respectively included in 32 people, each group
Case completes number of cases：29、24、25.Each group case performance uses pearson χ2Inspection carries out analysis comparison, knot
Fruit P=0.238 ＞ 0.05 prompt each group to be included in the no significant difference of case performance.Each group case performance
It is comparable.
Change of blood sugar before and after 3.1 drug therapies
Experimental result is as shown in table 1：
Change of blood sugar before and after 1 each group drug therapy of table (mmol/L)
Note：△P<0.05☆P<Before 0.01vs treatments；▲P<0.05★P<The 0.01vs coptiss+evodia rutaecarpa group.
The results are shown in Table 1：After pharmaceutical intervention 4 weeks, each group FPG, OGTT2hPG declines before relatively treating obviously, through system
Credit analysis is counted, there is significant difference (P<0.01)；Compare after treatment：The coptis+evodia rutaecarpa group blood glucose fall bigger, is better than
Other groups have significant difference (P through statistical analysis<0.01).
The experiment results show that drug of the present invention can significantly improve the fasting blood-glucose and OGTT2hPG levels of patient, and it is better than
The coptis, evodia rutaecarpa is applied alone.
Insulin and insulin resistance index variation before and after 3.2 drug therapies
Experimental result is as shown in table 2：
Insulin and insulin resistance index change table before and after 2 drug therapy of the present invention of table
Note：△P<0.05☆P<Before 0.01vs treatments；▲P<0.05★P<The 0.01vs coptiss+evodia rutaecarpa group.
The results are shown in Table 2：After pharmaceutical intervention 4 weeks, FINS, HOMA-IR decline before relatively treating obviously, through statistics
Analysis has significant difference (P<0.01)；Compare after treatment：The above index fall bigger of the coptis+evodia rutaecarpa group is better than it
His group has significant difference (P through statistical analysis<0.01).
Experimental result explanation：Drug of the present invention can significantly improve the Fasting insulin level of patient, improve insulin and support
Anti- index, and be better than that the coptis, evodia rutaecarpa is applied alone.
It is efficient after 3.3 drug therapies
Experimental result is as shown in table 3：
After 3 each group drug therapy of table efficient (example (%))
The results are shown in Table 3：After pharmaceutical intervention 4 weeks, the total effective rate of the coptis+evodia rutaecarpa group be above be applied alone the coptis,
Evodia rutaecarpa group all has statistical significance (P through statistical analysis<0.05).
All subjects do not occur the allergic reactions such as fash, fever, and every life during clinical observation in 4 weeks
Sign is steady, and pretherapy and post-treatment blood, urine, feces are conventional, electrocardiogram and hepatic and renal function no abnormality seen.It is all enter group research a case treatment
Serious adverse events do not occur for whole process, occasionally have it is weak, receive the discomforts such as poor, irritated, diarrhea, gasteremphraxis, done not taking other drugs
Voluntarily alleviate in the case of pre-.
To sum up, the present composition can effectively improve fasting blood-glucose (FPG), the fasting insulin of diabetes B patient
(FINS), OGTT2h blood glucose (OGTT2hPG) is horizontal, reduces insulin resistance, has no adverse reaction, one is provided for clinical application
The new selection of kind.
Claims (10)
1. the drug that the bulk pharmaceutical chemicals containing following weight proportioning are prepared is supported in preparation treatment diabetes and/or improvement insulin
Purposes in anti-drug：2-10 parts of the coptis, 1-10 parts of evodia rutaecarpa.
2. purposes according to claim 1, it is characterised in that：The bulk pharmaceutical chemicals weight proportion is：2 parts of the coptis, Wu Zhu
1 part of cornel.
3. purposes according to claim 1 or 2, it is characterised in that：The drug is by the primary medicinal powder of the coptis, evodia rutaecarpa
Or water or extractive with organic solvent are active constituent, and the system that pharmaceutically acceptable auxiliary material or complementary ingredient are prepared is added
Agent.
4. according to the purposes described in claim 1-3 any one, it is characterised in that：The preparation is oral preparation.
5. purposes according to claim 4, it is characterised in that：The oral preparation is granule, powder, pill, glue
Wafer, soft capsule, tablet or oral solution.
6. purposes according to claim 5, it is characterised in that：The pill is pill, and capsule is soft capsule.
7. purposes according to claim 1, it is characterised in that：The preparation method of the drug includes the following steps：
A, bulk pharmaceutical chemicals are weighed by weight ratio；
B, bulk pharmaceutical chemicals directly beat powder, or bulk pharmaceutical chemicals are added water to cook or organic solvent extracts, and extracting solution concentration, addition pharmaceutically may be used
The auxiliary material of receiving or complementary ingredient are prepared into pharmaceutically common preparation.
8. purposes according to claim 1, it is characterised in that：The drug is the drug for treating diabetes B.
9. purposes according to claim 8, it is characterised in that：The drug is the treatment liver-cold type diabetes B of stomach energy
Drug.
10. purposes according to claim 8 or claim 9, it is characterised in that：The drug is to reduce fasting blood-glucose, empty stomach pancreas islet
The drug of element, OGTT2h blood glucose levels and/or insulin resistance.
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Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102526672A (en) * | 2012-02-03 | 2012-07-04 | 东莞广州中医药大学中医药数理工程研究院 | Traditional Chinese medicine composition, applications and preparation method |
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2017
- 2017-09-21 CN CN201710861370.8A patent/CN108619289A/en active Pending
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102526672A (en) * | 2012-02-03 | 2012-07-04 | 东莞广州中医药大学中医药数理工程研究院 | Traditional Chinese medicine composition, applications and preparation method |
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Application publication date: 20181009 |