CN108186636B - A kind of pharmaceutical composition for treating prediabetes - Google Patents
A kind of pharmaceutical composition for treating prediabetes Download PDFInfo
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- CN108186636B CN108186636B CN201810062698.8A CN201810062698A CN108186636B CN 108186636 B CN108186636 B CN 108186636B CN 201810062698 A CN201810062698 A CN 201810062698A CN 108186636 B CN108186636 B CN 108186636B
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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
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/4353—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom ortho- or peri-condensed with heterocyclic ring systems
- A61K31/4375—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom ortho- or peri-condensed with heterocyclic ring systems the heterocyclic ring system containing a six-membered ring having nitrogen as a ring heteroatom, e.g. quinolizines, naphthyridines, berberine, vincamine
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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
- A61K31/33—Heterocyclic compounds
- A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
- A61K31/35—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom
- A61K31/352—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having six-membered rings with one oxygen as the only ring hetero atom condensed with carbocyclic rings, e.g. methantheline
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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
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/7042—Compounds having saccharide radicals and heterocyclic rings
- A61K31/7048—Compounds having saccharide radicals and heterocyclic rings having oxygen as a ring hetero atom, e.g. leucoglucosan, hesperidin, erythromycin, nystatin, digitoxin or digoxin
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Abstract
The invention discloses a kind of pharmaceutical compositions for treating prediabetes comprising the raw material of following parts by weight: 5~15 parts of epiberberine, 10~20 parts of coptisine, 15~25 parts of palmatine, 20~35 parts of jamaicin, 10~15 parts of Astragaloside IV, II 0~10 parts of astragaloside, III 0~15 parts of astragaloside, 0~10 part of astragaloside I, 20~30 parts of calycosin glucoside, 0~20 part of onocerin, 0~18 part of ononin.The pharmaceutical composition provides new selection for the treatment of prediabetes, it changes prediabetes and lacks the status for effectively preventing drug, the clinical symptoms of prediabetes can be obviously improved, it is substantially reduced blood glucose and glycated hemoglobin levels, glycometabolism is adjusted, the progress of prediabetes is significantly prevented or delay.
Description
Technical field
The invention belongs to the field of Chinese medicines, and in particular to a kind of pharmaceutical composition for treating prediabetes and its preparation side
Method.
Background technique
Prediabetes are the important stages towards diabetes and complication, have invertibity and concealment, epidemiology
Research indicates that there are about 500,000,000 adults to be in prediabetes and in rising trend for current China.However, at present for diabetes before
Phase still lacks effective treatment means.Prediabetes belong to chronic metabolic class disease, and Chinese Traditional Medicine treats the Disease Clinical
Effect is definite, is listed in Advantages of TCM disease.
But in the Chinese medicine for treating prediabetes, what active constituent is and is combined into which kind of proportion new actually
Pharmaceutical composition is still not clear.Therefore it provides a kind of significant in efficacy, the drug of Chinese medicine active ingredient combinations has very heavy
The meaning wanted.
Summary of the invention
The purpose of the present invention is intended to develop a kind of active ingredient of Chinese herbs pharmaceutical composition for treating prediabetes, the drug
Composition can significantly improve the main clinic symptoms of prediabetes, can reduce blood glucose and glycated hemoglobin levels, have and adjust
Carbohydrate metabolism is saved, can significantly prevent or prediabetes is delayed to proceed to diabetes, and is not found apparent bad anti-
It answers, safety is good, is a kind of pharmaceutical composition for effectively preventing prediabetes.
In order to solve the above technical problem, the present invention provides following technical solutions:
A kind of pharmaceutical composition for treating prediabetes comprising the raw material of following parts by weight: epiberberine 5~15
Part, 10~20 parts of coptisine, 15~25 parts of palmatine, 20~35 parts of jamaicin, 10~15 parts of Astragaloside IV, astragaloside II 0
~10 parts, III 0~15 parts of astragaloside, 0~10 part of astragaloside I, 20~30 parts of calycosin glucoside, rest-harrow
0~20 part, 0~18 part of ononin of element.
In aforementioned pharmaceutical compositions, epiberberine, coptisine, palmatine, jamaicin are that the coptis is active constituent, Radix Astragali first
Glycosides, astragaloside II, astragaloside III, astragaloside I, calycosin glucoside, onocerin, ononin are Radix Astragali
Active constituent.Wherein epiberberine, coptisine, palmatine, jamaicin, Astragaloside IV, calycosin glucoside are to control
It is indispensable in the composition of medicine for the treatment of prediabetes, performance is improved or reverting diabetes indication early period is particularly significant.
Preferably, the pharmaceutical composition of the treatment prediabetes includes the raw material of following parts by weight: epiberberine 10
Part, 15 parts of coptisine, 20 parts of palmatine, 30 parts of jamaicin, 10 parts of Astragaloside IV, II 5 parts of astragaloside, astragaloside III 10
Part, 5 parts of astragaloside I, 25 parts of calycosin glucoside, 10 parts of onocerin, 10 parts of ononin.
Preferably, the dosage form of described pharmaceutical composition is granule, capsule or tablet.
Preferably, the composition further includes pharmaceutic adjuvant, and pharmaceutic adjuvant includes starch, dextrin, microcrystalline cellulose, hydroxypropyl
One of ylmethyl cellulose is a variety of.
The beneficial effects of the present invention are: (1) pharmaceutical composition provides new selection for the treatment of prediabetes, change
Prediabetes lack the status for effectively preventing drug, can be obviously improved the clinical symptoms of prediabetes, hence it is evident that reduce
Blood glucose and glycated hemoglobin levels adjust glycometabolism, significantly prevent or delay the progress of prediabetes；(2) medicine group
It closes object and specifies the active constituent and proportion for improving prediabetes symptom in the coptis and Radix Astragali, do not find obvious bad anti-
It answers, there is good safety；(3) the drug combination preparation type is versatile and flexible, can be prepared according to different needs in blocks
Agent, capsule or granule etc. are convenient for oral dosage form, easy to use, are suitable for prediabetes long term administration and treat, are easy to
Received by patient.
Detailed description of the invention
Fig. 1 is the positive glucose clamp experiment result of hyperinsulinism of rat in the embodiment of the present invention 1；
Fig. 2 is the blood glucose level in 1 different disposal group of the embodiment of the present invention after rat administration；
Fig. 3 is the glycated hemoglobin levels in 1 different disposal group of the embodiment of the present invention after rat administration；
Fig. 4 is the variation of rat body weight in 1 different disposal group of the embodiment of the present invention；
Fig. 5 is the positive glucose clamp experiment result of hyperinsulinism of rat in the embodiment of the present invention 3；
Fig. 6 is the blood glucose level in 3 different disposal group of the embodiment of the present invention after rat administration；
Fig. 7 is the glycated hemoglobin levels in 3 different disposal group of the embodiment of the present invention after rat administration；
Fig. 8 is the variation of rat body weight in 3 different disposal group of the embodiment of the present invention.
Specific embodiment
Experimental method used in following embodiments is conventional method unless otherwise specified.
The materials, reagents and the like used in the following examples is commercially available unless otherwise specified.
Embodiment 1
A kind of pharmaceutical composition for treating prediabetes includes the raw material of following parts by weight: 5 parts of epiberberine, coptisine
10 parts, 15 parts of palmatine, 20 parts of jamaicin, 10 parts of Astragaloside IV, I10 parts of astragaloside, 20 parts of calycosin glucoside,
18 parts of ononin, 0.2 part of microcrystalline cellulose, 0.5 part of magnesium stearate, dry 1 part of starch.
The pharmaceutical composition of the treatment prediabetes the preparation method comprises the following steps:
First by epiberberine, coptisine, palmatine, jamaicin, Astragaloside IV, astragaloside I, calycosin glucose
Glycosides, ononin mix in proportion, are then proportionally added into microcrystalline cellulose, magnesium stearate, dry starch, pressure is packed into after mixing thoroughly
Tablet is made in piece machine.
Results of pharmacodynamic test
Experimental animal: healthy male Wistar rat, 5 week old, 30,160~180g, purchased from the experiment of Beijing dimension tonneau China
Zoo technical Co., Ltd raises in Beijing Shijitan Hospital, CMU animal building cleaning grade animal housing, temperature
At 20~25 DEG C, relative humidity (55 ± 15) %, ventilation is appropriate for control, and illumination is reasonable.
The preparation and experimental group of animal model: rat buys rear adaptable fed 7 days, is randomly divided into normal group and model
Group, Normal group 10, model group 20.Normal rats give normal rat in the entire experimental stage always and maintain to raise
Material, and model group rats give high-sugar-fat-diet in the formal beginning of experiment.After 5 weeks, normal group and the random picking 2 of model group
The positive glucose clamp experiment of hyperinsulinism is only carried out, rat insulin sensibility is verified.As a result as shown in Figure 1.
The equal fasting 12h of remaining rat after the positive glucose clamp experiment success of hyperinsulinism, normal rats are with 3mL/
0.1mmoL/L citric acid-sodium citrate buffer solution is injected intraperitoneally in the dosage of kg；1% chain is injected intraperitoneally by 30mg/kg for model group
Urea helps rhzomorph solution, and tail point blood sampling detection random blood sugar after 72 hours is higher than 11.1mmoL/L as diabetes mould with blood glucose value
The successful standard of type.It is randomly divided into normal group (Normal) after modeling success, model group (Control), tablet group (Tablet)
(n=8).Tablet group gives the tablet of clinical equivalent dosage, and normal group and model group give isometric distilled water.
Evaluation index: continue to feed 20 weeks after administration, the blood glucose of detection in every 4 weeks, while recording weight；It is before administration and real
A glycosylated hemoglobin (HbA1c) is respectively surveyed at the end of testing.
As a result: as shown in figs. 2 to 4, above-mentioned composition tablet can significantly reduce prediabetes animal after administration 20 weeks
Model blood glucose and glycated hemoglobin levels increase prediabetes rat body weight.
Embodiment 2
A kind of pharmaceutical composition for treating prediabetes includes the raw material of following parts by weight: 10 parts of epiberberine, the coptis
15 parts of alkali, 20 parts of palmatine, 30 parts of jamaicin, 10 parts of Astragaloside IV, II 5 parts of astragaloside, III 10 parts of astragaloside, Radix Astragali soap
I5 parts of glycosides, 25 parts of calycosin glucoside, 10 parts of onocerin, 10 parts of ononin, hydroxypropyl methyl cellulose 0.1
Part, 0.4 part of dextrin, dry 0.8 part of starch.
The pharmaceutical composition of the treatment prediabetes the preparation method comprises the following steps:
First by epiberberine, coptisine, palmatine, jamaicin, Astragaloside IV, astragaloside II, astragaloside III, Radix Astragali
Saponin I, calycosin glucoside, onocerin, ononin mix in proportion, are then proportionally added into hydroxypropyl methyl
Cellulose, dextrin, dry starch, are packed into tablet press machine after mixing thoroughly and tablet are made.
Embodiment 3
A kind of pharmaceutical composition for treating prediabetes includes the raw material of following parts by weight: 15 parts of epiberberine, the coptis
20 parts of alkali, 25 parts of palmatine, 35 parts of jamaicin, 15 parts of Astragaloside IV, II 10 parts of astragaloside, III 15 parts of astragaloside, Mao Rui
30 parts of isoflavones glucoside, 20 parts of onocerin, 0.2 part of calcium monohydrogen phosphate, 0.1 part of magnesium stearate, 0.2 part of starch, xylitol
0.2 part.
The pharmaceutical composition of the treatment prediabetes the preparation method comprises the following steps: first by above-mentioned epiberberine, coptisine, bar horse
Spit of fland, jamaicin, Astragaloside IV, astragaloside II, astragaloside III, calycosin glucoside, onocerin mix in proportion
It is even, it is then proportionally added into calcium monohydrogen phosphate, magnesium stearate, starch, xylitol, particle is made with 75% ethyl alcohol after mixing thoroughly, crosses 20
Mesh, 60 DEG C or less vacuum drying, whole grain are filled No. 1 capsule, are packed, examine, obtain qualified finished product.
Results of pharmacodynamic test
Experimental animal: healthy male Wistar rat, 5 week old, 30,150~170g, purchased from the experiment of Beijing dimension tonneau China
Zoo technical Co., Ltd raises in Beijing Shijitan Hospital, CMU animal building cleaning grade animal housing, temperature
At 20~25 DEG C, relative humidity (55 ± 15) %, ventilation is appropriate for control, and illumination is reasonable.
The preparation and experimental group of animal model: rat buys rear adaptable fed 7 days, is randomly divided into normal group and model
Group, normal group 10, model group 20.Normal rats give normal rat in the entire experimental stage always and maintain feed, and
Model group rats give high-sugar-fat-diet in the formal beginning of experiment.After 5 weeks, normal group and the random picking 2 of model group only into
The positive glucose clamp experiment of row hyperinsulinism verifies rat insulin sensibility.As a result as shown in Figure 5.
The equal fasting 12h of remaining rat after the positive glucose clamp experiment success of hyperinsulinism, normal rats are with 3mL/
0.1mmoL/L citric acid-sodium citrate buffer solution is injected intraperitoneally in the dosage of kg；1% chain is injected intraperitoneally by 30mg/kg for model group
Urea helps rhzomorph solution, and tail point blood sampling detection random blood sugar after 72 hours is higher than 11.1mmoL/L as diabetes mould with blood glucose value
The successful standard of type.Normal group (Normal), model group (Control), Capsules group (Capsule) are randomly divided into after modeling success
(n=8).Capsules group gives the capsule of clinical equivalent dosage, and normal group and model group give isometric distilled water.
Evaluation index: continue to feed 20 weeks after administration, the blood glucose of detection in every 4 weeks, while recording weight；It is before administration and real
A glycosylated hemoglobin (HbA1c) is respectively surveyed at the end of testing.
As a result: as can be seen from figures 6 to 8, capsule administration 20 weeks after can significantly reduce prediabetes animal model blood glucose and
Glycated hemoglobin levels increase prediabetes rat body weight.
Comparative example 1
A kind of pharmaceutical composition for treating prediabetes includes the raw material of following parts by weight: 15 parts of coptisine, palmatine
20 parts, 30 parts of jamaicin, 10 parts of Astragaloside IV, II 5 parts of astragaloside, III 10 parts of astragaloside, I5 parts of astragaloside, Mao Ruiyi
25 parts of flavones glucoside, 10 parts of ononin, 0.1 part of hydroxypropyl methyl cellulose, 0.4 part of dextrin, is done 10 parts of onocerin
0.8 part of dry starch.
The pharmaceutical composition of the treatment prediabetes the preparation method comprises the following steps:
First by coptisine, palmatine, jamaicin, Astragaloside IV, astragaloside II, astragaloside III, astragaloside I, hair
Stamen isoflavones glucoside, onocerin, ononin mix in proportion, be then proportionally added into hydroxypropyl methyl cellulose,
Dextrin, dry starch, are packed into tablet press machine after mixing thoroughly and tablet are made.
Above-mentioned composition tablet is after administration 20 weeks, blood glucose and glycosylated hemoglobin water with prediabetes animal model
It puts down compared to no significant difference.
Comparative example 2
A kind of pharmaceutical composition for treating prediabetes includes the raw material of following parts by weight: 10 part, bar horse of epiberberine
20 parts of spit of fland, 30 parts of jamaicin, 10 parts of Astragaloside IV, II 5 parts of astragaloside, III 10 parts of astragaloside, I5 parts of astragaloside, Mao Rui
25 parts of isoflavones glucoside, 10 parts of onocerin, 10 parts of ononin, 0.1 part of hydroxypropyl methyl cellulose, 0.4 part of dextrin,
Dry 0.8 part of starch.
The pharmaceutical composition of the treatment prediabetes the preparation method comprises the following steps:
First by epiberberine, palmatine, jamaicin, Astragaloside IV, astragaloside II, astragaloside III, astragaloside I,
Calycosin glucoside, onocerin, ononin mix in proportion, are then proportionally added into hydroxypropyl methyl fiber
Element, dextrin, dry starch, are packed into tablet press machine after mixing thoroughly and tablet are made.
Above-mentioned composition tablet is after administration 20 weeks, blood glucose and glycosylated hemoglobin water with prediabetes animal model
It puts down compared to no significant difference.
Comparative example 3
A kind of pharmaceutical composition for treating prediabetes includes the raw material of following parts by weight: 10 parts of epiberberine, the coptis
15 parts of alkali, 30 parts of jamaicin, 10 parts of Astragaloside IV, II 5 parts of astragaloside, III 10 parts of astragaloside, I5 parts of astragaloside, Mao Rui
25 parts of isoflavones glucoside, 10 parts of onocerin, 10 parts of ononin, 0.1 part of hydroxypropyl methyl cellulose, 0.4 part of dextrin,
Dry 0.8 part of starch.
The pharmaceutical composition of the treatment prediabetes the preparation method comprises the following steps:
First by epiberberine, coptisine, jamaicin, Astragaloside IV, astragaloside II, astragaloside III, astragaloside I,
Calycosin glucoside, onocerin, ononin mix in proportion, are then proportionally added into hydroxypropyl methyl fiber
Element, dextrin, dry starch, are packed into tablet press machine after mixing thoroughly and tablet are made.
Above-mentioned composition tablet is after administration 20 weeks, blood glucose and glycosylated hemoglobin water with prediabetes animal model
It puts down compared to no significant difference.
Comparative example 4
A kind of pharmaceutical composition for treating prediabetes includes the raw material of following parts by weight: 10 parts of epiberberine, the coptis
15 parts of alkali, 20 parts of palmatine, 10 parts of Astragaloside IV, II 5 parts of astragaloside, III 10 parts of astragaloside, I5 parts of astragaloside, Mao Rui
25 parts of isoflavones glucoside, 10 parts of onocerin, 10 parts of ononin, 0.1 part of hydroxypropyl methyl cellulose, 0.4 part of dextrin,
Dry 0.8 part of starch.
The pharmaceutical composition of the treatment prediabetes the preparation method comprises the following steps:
First by epiberberine, coptisine, palmatine, Astragaloside IV, astragaloside II, astragaloside III, astragaloside I,
Calycosin glucoside, onocerin, ononin mix in proportion, are then proportionally added into hydroxypropyl methyl fiber
Element, dextrin, dry starch, are packed into tablet press machine after mixing thoroughly and tablet are made.
Above-mentioned composition tablet is after administration 20 weeks, blood glucose and glycosylated hemoglobin water with prediabetes animal model
It puts down compared to no significant difference.
Comparative example 5
A kind of pharmaceutical composition for treating prediabetes includes the raw material of following parts by weight: 10 parts of epiberberine, the coptis
15 parts of alkali, 20 parts of palmatine, 30 parts of jamaicin, II 5 parts of astragaloside, III 10 parts of astragaloside, I5 parts of astragaloside, Mao Ruiyi
25 parts of flavones glucoside, 10 parts of ononin, 0.1 part of hydroxypropyl methyl cellulose, 0.4 part of dextrin, is done 10 parts of onocerin
0.8 part of dry starch.
The pharmaceutical composition of the treatment prediabetes the preparation method comprises the following steps:
First by epiberberine, coptisine, palmatine, jamaicin, astragaloside II, astragaloside III, astragaloside I, hair
Stamen isoflavones glucoside, onocerin, ononin mix in proportion, be then proportionally added into hydroxypropyl methyl cellulose,
Dextrin, dry starch, are packed into tablet press machine after mixing thoroughly and tablet are made.
Above-mentioned composition tablet is after administration 20 weeks, blood glucose and glycosylated hemoglobin water with prediabetes animal model
It puts down compared to no significant difference.
Comparative example 6
A kind of pharmaceutical composition for treating prediabetes includes the raw material of following parts by weight: 10 parts of epiberberine, the coptis
15 parts of alkali, 20 parts of palmatine, 30 parts of jamaicin, 10 parts of Astragaloside IV, II 5 parts of astragaloside, III 10 parts of astragaloside, Radix Astragali soap
I5 parts of glycosides, 10 parts of onocerin, 10 parts of ononin, 0.1 part of hydroxypropyl methyl cellulose, 0.4 part of dextrin, dry starch 0.8
Part.
The pharmaceutical composition of the treatment prediabetes the preparation method comprises the following steps:
First by epiberberine, coptisine, palmatine, jamaicin, Astragaloside IV, astragaloside II, astragaloside III, Radix Astragali
Saponin I, onocerin, ononin mix in proportion, are then proportionally added into hydroxypropyl methyl cellulose, dextrin, dry shallow lake
Powder is packed into tablet press machine after mixing thoroughly and tablet is made.
Above-mentioned composition tablet is after administration 20 weeks, blood glucose and glycosylated hemoglobin water with prediabetes animal model
It puts down compared to no significant difference.
Above-mentioned technical proposal only embodies the optimal technical scheme of technical solution of the present invention, those skilled in the art
The principle of the present invention is embodied to some variations that some of them part may be made, belongs to the scope of protection of the present invention it
It is interior.
Claims (4)
1. a kind of pharmaceutical composition for treating prediabetes, which is characterized in that it is made of the raw material of following parts by weight: table is small
5~15 parts of bark of a cork tree alkali, 10~20 parts of coptisine, 15~25 parts of palmatine, 20~35 parts of jamaicin, 10~15 parts of Astragaloside IV, Huang
II 0~10 parts of stilbene saponin(e, III 0~15 parts of astragaloside, 0~10 part of astragaloside I, calycosin glucoside 20~30
Part, 0~20 part of onocerin, 0~18 part of ononin.
2. the pharmaceutical composition for the treatment of prediabetes according to claim 1, which is characterized in that it is by following parts by weight
Raw material composition: 10 parts of epiberberine, 15 parts of coptisine, 20 parts of palmatine, 30 parts of jamaicin, 10 parts of Astragaloside IV, Radix Astragali soap
II 5 parts of glycosides, III 10 parts of astragaloside, 5 parts of astragaloside I, 25 parts of calycosin glucoside, 10 parts of onocerin, awns handle
10 parts of glycosides of flower.
3. the pharmaceutical composition for the treatment of prediabetes according to claim 1 or 2, which is characterized in that the medicine group
The dosage form for closing object is granule, capsule or tablet.
4. the pharmaceutical composition for the treatment of prediabetes according to claim 1 or 2, which is characterized in that the composition
It further include pharmaceutic adjuvant, pharmaceutic adjuvant includes one of starch, dextrin, microcrystalline cellulose, hydroxypropyl methyl cellulose or more
Kind.
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| HPLC-DAD法同时测定黄芪中4种异黄酮和黄芪甲苷的含量;冯祖飞等;《中药材》;20100930;第33卷(第9期);第1425-1427页 * |
| HPLC-ELSD 法同时测定黄芪及金芪降糖片中5 种皂苷类成分的含量;丁菲菲等;《中药材》;20150131;第38卷(第1期);第156-159页 * |
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