CN105434802A - Pharmaceutical composition for treating diabetes, and preparation method and application thereof - Google Patents

Pharmaceutical composition for treating diabetes, and preparation method and application thereof Download PDF

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CN105434802A
CN105434802A CN201510916113.0A CN201510916113A CN105434802A CN 105434802 A CN105434802 A CN 105434802A CN 201510916113 A CN201510916113 A CN 201510916113A CN 105434802 A CN105434802 A CN 105434802A
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pharmaceutical composition
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diabetes
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raw material
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陈雪琴
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/56Materials from animals other than mammals
    • A61K35/57Birds; Materials from birds, e.g. eggs, feathers, egg white, egg yolk or endothelium corneum gigeriae galli
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/29Berberidaceae (Barberry family), e.g. barberry, cohosh or mayapple
    • A61K36/296Epimedium
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/39Convolvulaceae (Morning-glory family), e.g. bindweed
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/48Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
    • A61K36/484Glycyrrhiza (licorice)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/73Rosaceae (Rose family), e.g. strawberry, chokeberry, blackberry, pear or firethorn
    • A61K36/736Prunus, e.g. plum, cherry, peach, apricot or almond
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/88Liliopsida (monocotyledons)
    • A61K36/896Liliaceae (Lily family), e.g. daylily, plantain lily, Hyacinth or narcissus
    • A61K36/8962Allium, e.g. garden onion, leek, garlic or chives
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/88Liliopsida (monocotyledons)
    • A61K36/896Liliaceae (Lily family), e.g. daylily, plantain lily, Hyacinth or narcissus
    • A61K36/8964Anemarrhena
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00Isolation 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
    • A61K2236/30Extraction of the material
    • A61K2236/33Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
    • A61K2236/331Extraction 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, decoction
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00Isolation 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
    • A61K2236/30Extraction of the material
    • A61K2236/33Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
    • A61K2236/333Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using mixed solvents, e.g. 70% EtOH
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00Isolation 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
    • A61K2236/30Extraction of the material
    • A61K2236/39Complex extraction schemes, e.g. fractionation or repeated extraction steps

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Abstract

The invention discloses a pharmaceutical composition for treating diabetes, and a preparation method and application thereof. The pharmaceutical composition for treating diabetes comprises the following raw materials by weight: inner shell membrane of fowl's egg, Prunus mume, Chinese garlic, rhizoma anemarrhenae, chicken's gizzard membrane, dodder seed, honey-fried licorice root and epimedium. The preparation method comprises the following concrete steps: weighing of the raw materials; alcohol extraction; water extraction; and preparation of the pharmaceutical composition. The invention provides application of the pharmaceutical composition in preparation of drugs used for treating diabetes. The pharmaceutical composition is capable of benefiting qi, nourishing yin, generating body fluid, clearing heat and reducing blood sugar; after administration of the pharmaceutical composition, blood sugar and urine sugar are effectively controlled, glycated serum protein obviously decreases, certain restoration effect is exerted on damage of alloxan to pancreas tissue, and no toxic and side effect is exerted; so the pharmaceutical composition provides a new option for a variety of symptoms caused by diabetes.

Description

A kind of pharmaceutical composition for the treatment of diabetes and its production and use
Technical field
The present invention relates to medical applications technical field, specifically a kind of pharmaceutical composition for the treatment of diabetes and its production and use.
Background technology
Diabetes are one of large difficult and complicated illness in the world three, and in decades, countries in the world have carried out long-term and unremitting research and development one after another.Treatment diabetes history there is twice important breakthrough: be the 1950's for the first time, first Chinese synthetic insulin, makes a stir all over the world; Second time is the appearance of biguanides and sulphanylureas oral antidiabetic drug, makes the blood glucose of diabetics be able to temporary transient control.Reach tens of kinds for clinical treatment Chinese medicine and western medicine used at present, but owing to also not having substantial breakthrough so far to diabetes pathology, etiological study, treatment diabetes are still in and control blood glucose, glucose in urine increases the stage and prevents the conceptual phase of comprehensive complication.In addition, patient's long-term taking Western medicine, can bring side effect to internal organs such as kidney, liver, the heart, spleen, stomaches.Domestic its drug effect of various pure Chinese medicinal preparations out newly developed is also all in and controls blood glucose, glucose in urine increases the stage, obtains convictive scientific basis without any a kind of medicine has repair to human pancreas tissue injury.
Summary of the invention
The object of the present invention is to provide a kind of pharmaceutical composition for the treatment of diabetes and its production and use.
For achieving the above object, the invention provides following technical scheme:
Treat a pharmaceutical composition for diabetes, be made up of the following raw material according to weight portion: Membrana Follicularis ovi 20-30 part, FLOS MUME 20-30 part, Bulbus Allii Macrostemonis 15-20 part, Rhizoma Anemarrhenae 5-10 part, Endothelium Corneum Gigeriae Galli 5-10 part, Semen Cuscutae 3-5 part, Radix Glycyrrhizae Preparata 3-5 part, Herba Epimedii 1-3 part.
As the further scheme of the present invention: the pharmaceutical composition of described treatment diabetes, be made up of the following raw material according to weight portion: Membrana Follicularis ovi 22-28 part, FLOS MUME 22-28 part, Bulbus Allii Macrostemonis 16-19 part, Rhizoma Anemarrhenae 7-9 part, Endothelium Corneum Gigeriae Galli 7-9 part, Semen Cuscutae 3.5-4.5 part, Radix Glycyrrhizae Preparata 3.5-4.5 part, Herba Epimedii 1.5-2.5 part.
As the further scheme of the present invention: the pharmaceutical composition of described treatment diabetes, be made up of the following raw material according to weight portion: Membrana Follicularis ovi 25 parts, FLOS MUME 25 parts, Bulbus Allii Macrostemonis 18 parts, the Rhizoma Anemarrhenae 8 parts, Endothelium Corneum Gigeriae Galli 8 parts, Semen Cuscutae 4 parts, Radix Glycyrrhizae Preparata 4 parts, Herba Epimedii 2 parts.
The preparation method of the pharmaceutical composition of described treatment diabetes, concrete steps are as follows:
(1) feeding: take each raw material according to weight portion;
(2) alcohol extraction: each raw material is taken out half, extract 1-4 time at 70-90 DEG C of temperature with the ethanol that the concentration of the 5-8 times amount of medical material weight is 80-90%, each 20-40min, the extracting solution repeatedly obtained is merged, the sieve crossing below 2mm gets permeate, is concentrated into water content≤50% and obtains alcohol extract;
(3) water extraction: granule surplus stock being crushed to 0.5-1cm, doubly add water by the 10-20 of medical material weight again, heat to 95-105 DEG C of extraction 1-4 time, slow fire heating makes that maintenance is micro-boils, each water extraction 40-60min, merges the extracting solution repeatedly obtained, and crosses below 2mm sieve and gets permeate, standing 6-8h gets supernatant, will again supernatant concentration be dried to water content≤50% aqueous extract;
(4) pharmaceutical compositions: after above-mentioned alcohol extract and water extract mix homogeneously, adds adjuvant and prepares pharmaceutical composition.
As the further scheme of the present invention: carrying out sieve in described step (2) and step (3) when getting permeate, was all 150-250 μm of sieves.
As the further scheme of the present invention: the dosage form of described pharmaceutical composition is granule, powder, pill, capsule or tablet.
As the present invention's further scheme: the application of described pharmaceutical composition in preparation treatment diabetes medicament.
Compared with prior art, the invention has the beneficial effects as follows:
The present invention has supplementing QI and nourishing YIN, replenishing body fluid and clearing away heat pathogen, hypoglycemic effect is fallen, after taking, not only blood glucose, glucose in urine are effectively controlled, and glycated serum protein has obvious decline, certain repair is had to the pancreatic tissue damage that alloxan causes, not having toxic and side effects, is clinical treatment diabetes, and the various symptoms that diabetes-alleviating causes provide one and newly select.
Detailed description of the invention
Be described in more detail below in conjunction with the technical scheme of detailed description of the invention to this patent.
Embodiment 1
Treat a pharmaceutical composition for diabetes, be made up of the following raw material according to weight portion: Membrana Follicularis ovi 20 parts, FLOS MUME 20 parts, Bulbus Allii Macrostemonis 15 parts, the Rhizoma Anemarrhenae 5 parts, Endothelium Corneum Gigeriae Galli 5 parts, Semen Cuscutae 3 parts, Radix Glycyrrhizae Preparata 3 parts, Herba Epimedii 1 part.
The preparation method of the pharmaceutical composition of described treatment diabetes, concrete steps are as follows:
(1) feeding: take each raw material according to weight portion;
(2) alcohol extraction: each raw material is taken out half, extract 1 time at 70 DEG C of temperature with the ethanol that the concentration of 5 times amount of medical material weight is 80%, each 20min, the extracting solution repeatedly obtained is merged, cross 150 μm of sieves and get permeate, being concentrated into water content is 50% obtain alcohol extract;
(3) water extraction: granule surplus stock being crushed to 0.5cm, add water by 10 times of medical material weight again, heat to 95 DEG C of extractions 1 time, slow fire heating makes that maintenance is micro-boils, each water extraction 40min, merges the extracting solution repeatedly obtained, and crosses 150 μm of sieves and gets permeate, standing 6h gets supernatant, will again supernatant concentration be dried to water content be 50% aqueous extract;
(4) pharmaceutical compositions: after above-mentioned alcohol extract and water extract mix homogeneously, adds adjuvant and prepares medicament composition granule agent.
Usage and dosage: oral.A 1-4g, 3 times on the one.
Embodiment 2
Treat a pharmaceutical composition for diabetes, be made up of the following raw material according to weight portion: Membrana Follicularis ovi 22 parts, FLOS MUME 22 parts, Bulbus Allii Macrostemonis 16 parts, the Rhizoma Anemarrhenae 7 parts, Endothelium Corneum Gigeriae Galli 7 parts, Semen Cuscutae 3.5 parts, Radix Glycyrrhizae Preparata 3.5 parts, Herba Epimedii 1.5 parts.
The preparation method of the pharmaceutical composition of described treatment diabetes, concrete steps are as follows:
(1) feeding: take each raw material according to weight portion;
(2) alcohol extraction: each raw material is taken out half, extract 2 times at 75 DEG C of temperature with the ethanol that the concentration of 5.5 times amount of medical material weight is 82%, each 25min, the extracting solution repeatedly obtained is merged, cross 180 μm of sieves and get permeate, being concentrated into water content is 45% obtain alcohol extract;
(3) water extraction: granule surplus stock being crushed to 0.6cm, add water by 12 times of medical material weight again, heat to 98 DEG C of extractions 2 times, slow fire heating makes that maintenance is micro-boils, each water extraction 45min, merges the extracting solution repeatedly obtained, and crosses 180 μm of sieves and gets permeate, standing 6.5h gets supernatant, will again supernatant concentration be dried to water content be 45% aqueous extract;
(4) pharmaceutical compositions: after above-mentioned alcohol extract and water extract mix homogeneously, adds adjuvant and prepares medicinal composition powders.
Usage and dosage: oral.A 1-4g, 3 times on the one.
Embodiment 3
Treat a pharmaceutical composition for diabetes, be made up of the following raw material according to weight portion: Membrana Follicularis ovi 25 parts, FLOS MUME 25 parts, Bulbus Allii Macrostemonis 18 parts, the Rhizoma Anemarrhenae 8 parts, Endothelium Corneum Gigeriae Galli 8 parts, Semen Cuscutae 4 parts, Radix Glycyrrhizae Preparata 4 parts, Herba Epimedii 2 parts.
The preparation method of the pharmaceutical composition of described treatment diabetes, concrete steps are as follows:
(1) feeding: take each raw material according to weight portion;
(2) alcohol extraction: each raw material is taken out half, extract 3 times at 80 DEG C of temperature with the ethanol that the concentration of 6.5 times amount of medical material weight is 85%, each 30min, the extracting solution repeatedly obtained is merged, cross 200 μm of sieves and get permeate, being concentrated into water content is 40% obtain alcohol extract;
(3) water extraction: granule surplus stock being crushed to 0.8cm, add water by 15 of medical material weight again, heat to 100 DEG C of extractions 3 times, slow fire heating makes that maintenance is micro-boils, each water extraction 50min, merges the extracting solution repeatedly obtained, and crosses 200 μm of sieves and gets permeate, standing 7h gets supernatant, will again supernatant concentration be dried to water content be 40% aqueous extract;
(4) pharmaceutical compositions: after above-mentioned alcohol extract and water extract mix homogeneously, adds adjuvant and prepares pharmaceutical composition pill.
Usage and dosage: oral.A 5-8g, 3 times on the one.
Embodiment 4
Treat a pharmaceutical composition for diabetes, be made up of the following raw material according to weight portion: Membrana Follicularis ovi 28 parts, FLOS MUME 28 parts, Bulbus Allii Macrostemonis 19 parts, the Rhizoma Anemarrhenae 9 parts, Endothelium Corneum Gigeriae Galli 9 parts, Semen Cuscutae 4.5 parts, Radix Glycyrrhizae Preparata 4.5 parts, Herba Epimedii 2.5 parts.
The preparation method of the pharmaceutical composition of described treatment diabetes, concrete steps are as follows:
(1) feeding: take each raw material according to weight portion;
(2) alcohol extraction: each raw material is taken out half, extract 4 times at 85 DEG C of temperature with the ethanol that the concentration of 7 times amount of medical material weight is 88%, each 35min, the extracting solution repeatedly obtained is merged, cross 220 μm of sieves and get permeate, being concentrated into water content is 35% obtain alcohol extract;
(3) water extraction: granule surplus stock being crushed to 0.9cm, add water by 18 times of medical material weight again, heat to 102 DEG C of extractions 4 times, slow fire heating makes that maintenance is micro-boils, each water extraction 55min, merges the extracting solution repeatedly obtained, and crosses 220 μm of sieves and gets permeate, standing 7.5h gets supernatant, will again supernatant concentration be dried to water content be 35% aqueous extract;
(4) pharmaceutical compositions: after above-mentioned alcohol extract and water extract mix homogeneously, adds adjuvant and prepares medicament composition capsule agent.
Usage and dosage: oral.A 1-3g, 3 times on the one.
Embodiment 5
Treat a pharmaceutical composition for diabetes, be made up of the following raw material according to weight portion: Membrana Follicularis ovi 30 parts, FLOS MUME 30 parts, Bulbus Allii Macrostemonis 20 parts, the Rhizoma Anemarrhenae 10 parts, Endothelium Corneum Gigeriae Galli 10 parts, Semen Cuscutae 5 parts, Radix Glycyrrhizae Preparata 5 parts, Herba Epimedii 3 parts.
The preparation method of the pharmaceutical composition of described treatment diabetes, concrete steps are as follows:
(1) feeding: take each raw material according to weight portion;
(2) alcohol extraction: each raw material is taken out half, extract 2 times at 90 DEG C of temperature with the ethanol that the concentration of 8 times amount of medical material weight is 90%, each 40min, the extracting solution repeatedly obtained is merged, cross 250 μm of sieves and get permeate, being concentrated into water content is 30% obtain alcohol extract;
(3) water extraction: granule surplus stock being crushed to 1cm, add water by 20 times of medical material weight again, heat to 95-105 DEG C of extraction 2 times, slow fire heating makes that maintenance is micro-boils, each water extraction 60min, merges the extracting solution repeatedly obtained, and crosses 250 μm of sieves and gets permeate, standing 8h gets supernatant, will again supernatant concentration be dried to water content be 30% aqueous extract;
(4) pharmaceutical compositions: after above-mentioned alcohol extract and water extract mix homogeneously, adds adjuvant and prepares medicinal composition tablets.
Usage and dosage: oral.A 2-5g, 3 times on the one.
Comparative example 1
Treat a pharmaceutical composition for diabetes, be made up of the following raw material according to weight portion: FLOS MUME 22 parts, Bulbus Allii Macrostemonis 16 parts, the Rhizoma Anemarrhenae 7 parts, Endothelium Corneum Gigeriae Galli 7 parts, Semen Cuscutae 3.5 parts, Radix Glycyrrhizae Preparata 3.5 parts, Herba Epimedii 1.5 parts.
The preparation method of the pharmaceutical composition of described treatment diabetes, concrete steps are as follows:
(1) feeding: take each raw material according to weight portion;
(2) alcohol extraction: each raw material is taken out half, extract 2 times at 75 DEG C of temperature with the ethanol that the concentration of 5.5 times amount of medical material weight is 82%, each 25min, the extracting solution repeatedly obtained is merged, cross 180 μm of sieves and get permeate, being concentrated into water content is 45% obtain alcohol extract;
(3) water extraction: granule surplus stock being crushed to 0.6cm, add water by 12 times of medical material weight again, heat to 98 DEG C of extractions 2 times, slow fire heating makes that maintenance is micro-boils, each water extraction 45min, merges the extracting solution repeatedly obtained, and crosses 180 μm of sieves and gets permeate, standing 6.5h gets supernatant, will again supernatant concentration be dried to water content be 45% aqueous extract;
(4) pharmaceutical compositions: after above-mentioned alcohol extract and water extract mix homogeneously, adds adjuvant and prepares medicinal composition powders.
Usage and dosage: oral.A 5-8g, 3 times on the one.
Comparative example 2
Treat a pharmaceutical composition for diabetes, be made up of the following raw material according to weight portion: Membrana Follicularis ovi 28 parts, Bulbus Allii Macrostemonis 19 parts, the Rhizoma Anemarrhenae 9 parts, Endothelium Corneum Gigeriae Galli 9 parts, Semen Cuscutae 4.5 parts, Radix Glycyrrhizae Preparata 4.5 parts, Herba Epimedii 2.5 parts.
The preparation method of the pharmaceutical composition of described treatment diabetes, concrete steps are as follows:
(1) feeding: take each raw material according to weight portion;
(2) alcohol extraction: each raw material is taken out half, extract 4 times at 85 DEG C of temperature with the ethanol that the concentration of 7 times amount of medical material weight is 88%, each 35min, the extracting solution repeatedly obtained is merged, cross 220 μm of sieves and get permeate, being concentrated into water content is 35% obtain alcohol extract;
(3) water extraction: granule surplus stock being crushed to 0.9cm, add water by 18 times of medical material weight again, heat to 102 DEG C of extractions 4 times, slow fire heating makes that maintenance is micro-boils, each water extraction 55min, merges the extracting solution repeatedly obtained, and crosses 220 μm of sieves and gets permeate, standing 7.5h gets supernatant, will again supernatant concentration be dried to water content be 35% aqueous extract;
(4) pharmaceutical compositions: after above-mentioned alcohol extract and water extract mix homogeneously, adds adjuvant and prepares medicament composition capsule agent.
Usage and dosage: oral.A 1-3g, 3 times on the one.
Embodiment 6
Clinical trial
(1) subjects: adopt the present invention to treat 420 routine patients altogether, wherein man 240 example, female 180 example; The oldest person 68 years old, age reckling 16 years old.
(2) diagnostic criteria: 1) have diabetic symptom, possess following any one can be diagnosed as diabetes: 1. fasting glucose >=7.8mmol/L; 2. whenever blood glucose >=11.1mmol/L in a day; 3. fasting glucose < 7.8mmol/L, but oral 75g glucose tolerance test 2 hours blood glucose > 11.1mmol/L;
2) non-diabetic symptom, possess following any one can be diagnosed as diabetes: 1. twice fasting glucose >=7.8mmol/L; 2. first time oral 75g glucose tolerance test 1 and 2 hours blood glucoses all >=11.1mmol/L, repeats an a glucose tolerance test 2 hours blood glucoses >=11.1mmol/L or repetition fasting glucose >=7.8mmol/L.
3) impaired glucose tolerance, fasting glucose < 7.8mmol/L, 2 hours blood glucoses person between 7.8-11.1mmol/L after oral 75g glucose.
(3) Therapeutic Method: man 240 example, the routine patient of female 180 are equally divided into six groups, often group man 40 example, female 30 example, one group, two groups, three groups and four groups are test group, one group, two groups, three groups and Four composition do not take the pharmaceutical composition of the treatment diabetes of the present invention that embodiment 1-embodiment 4 prepares, five groups and six groups is matched group, five groups and the six groups pharmaceutical compositions taken comparative example 1 and comparative example 2 respectively and prepare, method of administration is one after each meal every day, one day 3 times, a dose is 2-5g, within 30 days, is a course for the treatment of.
(4) standard is treated
Cure: blood fat maintenance is normal, blood glucose empty stomach is with long-term maintenance after the meal or close in range of normal value, blood pressure maintenance normally;
Take a turn for the better: blood fat, blood glucose empty stomach and after the meal numerical value and blood pressure are all close to normal value;
Invalid: before and after medication, symptom is without change.
(5) therapeutic outcome: how to take effect after 30 days after taking medicine in the routine case of patient 280,2-3 the course for the treatment of cures; Wherein cure 240 examples, effective 20 examples, effective 15 examples, invalid 5 examples, total effective rate reaches 98.2%, and therapeutic outcome is as shown in table 1:
Table 1: clinical trial therapeutic outcome
As shown in Table 1, the average effectiveness level adopting treatment diabetic composition of the present invention to carry out treating reaches 98.2%, the effective percentage of the pharmaceutical composition adopting comparative example to prepare only has 77.65%, therefore, between pharmaceutical composition of the present invention, there is synergistic function, add the effective percentage of pharmaceutical composition.
Model case:
(1) Lee, man, 62 years old, suffer from diabetes 6 years, blood glucose GLU16.8mmol/l when taking Western medicine blood pressure lowering in the past, take Chinese medicine of the present invention simultaneously Western medicine dose reduce by half, 15 days measure blood glucose is afterwards GLU7.5mmol/l, and take Chinese medicine of the present invention 1 first quarter moon, Western medicine is all withdrawn, measurement blood glucose is GLU6.5mmol/l, follows up a case by regular visits to and have no recurrence after 1 year.
(2) case 4, Liu so-and-so, female, 43 years old, suffer from diabetes 3 years, blood glucose GLU8.8mmol/l when taking Western medicine blood pressure lowering, Western medicine takes Chinese medicine of the present invention after all withdrawing, taking Chinese medicine of the present invention, to measure blood glucose after 3 months be GLU6.1mmol/l, and rehabilitation, follows up a case by regular visits to after 1 year and have no recurrence.
(3) Shen, man, 18 years old, suffer from diabetes 1 year, blood glucose GLU7.8mmol/l when taking Western medicine blood pressure lowering, Western medicine takes Chinese medicine of the present invention after all withdrawing, measuring blood glucose after taking Chinese medicine of the present invention 2 first quarter moons is GLU5.8mmol/l, and rehabilitation is followed up a case by regular visits to after 1 year and had no recurrence.
The present invention finds that in a large amount of clinical practices it has the effect of significant treatment diabetes, and namely Chinese medicine composition of the present invention causes the therapeutical effect of diabetes rat model to chain phleomycin, and existing by main effect experiment, details are as follows:
1, animal model
The Wistar rat of body weight 180-20g 200, male and female half and half, rat is normally fed and within 1 week, first feeds with high-calorie feed (Adeps Sus domestica 15%, sucrose 12%, yolk powder 10%, casein 7%, cholesterol 10%, sodium cholate 0.2%, calcium bicarbonate 0.6%, stone powder 0.4%, Mus maintain material 44.8%), after 4 weeks, fasting 12h, tail vein surveys fasting glucose, weighs.Lumbar injection 1% chain phleomycin (STZ) 80mg/kg, STZ are dissolved in pH4.2, and in 0.1mol/L citric acid-sodium citrate buffer, each dose is finished in 10min.Blank group rats by intraperitoneal injection equal-volume citric acid one sodium citrate buffer solution, normal raising, within 10 days, dock afterwards and get blood survey whole blood sugar, with blood glucose value horizontal > 10.0mmol/L person for modeling success, with blood glucose value horizontal > 15.0mmol/L person for stable type.
2, grouping and administration
Stable type modeling success rat is divided into model control group according to blood sugar level, pioglitazone group, Chinese medicine composition low dose group, Chinese medicine composition high dose group, dosage group totally 5 groups in Chinese medicine composition at random, and often organize 8, each group gives following medicine respectively:
Model control group: gavage gives equal-volume normal saline;
Pioglitazone group: gavage gives pioglitazone 3mg/kgd;
Chinese medicine low dose group: the crude drug amount that gavage gives embodiment 1 preparation is the Chinese medicinal composition granules of 1.2g/kgd;
Dosage group in Chinese medicine: it is the Chinese medicine composition pill of 3.6g/kgd that gavage gives crude drug amount prepared by embodiment 3;
Chinese medicine high dose group: it is the Chinese medicine composition composition powders of 7.2g/kgd that gavage gives crude drug amount prepared by embodiment 2;
Above-mentioned administration group is administered once every day, continuous 10 weeks.Blood sampling measures blood glucose, urine micro protein and glycolated hemoglobin after blood glucose before administration, administration.
3. assay method
1) mensuration of blood glucose:
After stable type modeling success rat random packet, according to dosage gastric infusion, continuous 10 weeks, normally raises.All rats detect fasting glucose (FBG) respectively at getting weekly tail vein in 4 weeks before administration and after administration.The blood sample of taking-up is put into protein precipitant, and after room temperature places 7min, centrifugal 5min (3000r/min), gets supernatant, surveys whole blood sugar with glucose oxidase method.
2) mensuration of microalbumin in urinating:
The glacial acetic acid solution (pH2.8) of reagent: 10% (v/v), 0.303mol/L glycine-glacial acetic acid buffer (pH3.0), bromophenol blue (1.924mmol/L) stock solution, bromophenol blue (0.231mmol/L) developer.
The collection of specimen and detection: in the 1st, 3,5,7 and 10 week rat is put in metabolic cage respectively and raises, collect 12 hours overnight urine, accurate recording urine volume.Get 4ml, after sodium azide process, centrifugal (2000r/min) 10min, get supernatant and put one 20 DEG C of Refrigerator store urinaryalbumin to be measured, the albumin standards 400 getting respective concentration, in the cup of correspondence, respectively adds 200 developers, mixing, with ultraviolet spectrophotometer, under 600nm, measure absorbance A.
3) mensuration of glycolated hemoglobin:
Grouping, administration are with 1), fasting 12h after last administration, etherization, eye socket gets blood, measures glycolated hemoglobin by description in test kit.
4, result
The impact of Chinese medicine composition blood glucose in diabetic rats of the present invention, microdose urine protein, glycolated hemoglobin is as shown in table 2:
Table 2 Chinese medicine composition of the present invention is on the impact (X ± S, n=8) of blood glucose in diabetic rats, microdose urine protein, glycolated hemoglobin
* compare with pioglitazone group, P < 0.05, ## compares with pioglitazone group, P < 0.01;
* compare with model control group, P < 0.05, * * compares with model control group, P < 0.01.
Above-mentioned experimental result shows, on in blood glucose in diabetic rats, microdose urine protein, the affecting of glycolated hemoglobin, pioglitazone group and Chinese medicine composition of the present invention are respectively organized has significant difference with model control group, and Chinese medicine composition of the present invention is respectively organized to compare with model control group pole significant difference.
In addition, experimental result also shows, each group of Chinese medicine composition of the present invention, compared with pioglitazone group, have pole significant difference, but curative effect and dosage does not have positive correlation in reduction blood glucose; Compared with model control group, the glycolated hemoglobin no difference of science of statistics after the administration of pioglitazone group, the saccharification hemoglobin content that Chinese medicine composition of the present invention is respectively organized all has significant difference, and wherein in Chinese medicine, dosage group has pole significant difference; In Chinese medicine high dose group and Chinese medicine, the urine micro protein content of dosage group has significant difference.
The present invention has supplementing QI and nourishing YIN, replenishing body fluid and clearing away heat pathogen, hypoglycemic effect is fallen, after taking, not only blood glucose, glucose in urine are effectively controlled, and glycated serum protein has obvious decline, certain repair is had to the pancreatic tissue damage that alloxan causes, not having toxic and side effects, is clinical treatment diabetes, and the various symptoms that diabetes-alleviating causes provide one and newly select.
Above the better embodiment of this patent is explained in detail, but this patent is not limited to above-mentioned embodiment, in the ken that one skilled in the relevant art possesses, various change can also be made under the prerequisite not departing from this patent aim.

Claims (7)

1. treat the pharmaceutical composition of diabetes for one kind, it is characterized in that, be made up of the following raw material according to weight portion: Membrana Follicularis ovi 20-30 part, FLOS MUME 20-30 part, Bulbus Allii Macrostemonis 15-20 part, Rhizoma Anemarrhenae 5-10 part, Endothelium Corneum Gigeriae Galli 5-10 part, Semen Cuscutae 3-5 part, Radix Glycyrrhizae Preparata 3-5 part, Herba Epimedii 1-3 part.
2. the pharmaceutical composition for the treatment of diabetes according to claim 1, it is characterized in that, be made up of the following raw material according to weight portion: Membrana Follicularis ovi 22-28 part, FLOS MUME 22-28 part, Bulbus Allii Macrostemonis 16-19 part, Rhizoma Anemarrhenae 7-9 part, Endothelium Corneum Gigeriae Galli 7-9 part, Semen Cuscutae 3.5-4.5 part, Radix Glycyrrhizae Preparata 3.5-4.5 part, Herba Epimedii 1.5-2.5 part.
3. according to the pharmaceutical composition of the arbitrary described treatment diabetes of claim 1-2, it is characterized in that, be made up of the following raw material according to weight portion: Membrana Follicularis ovi 25 parts, FLOS MUME 25 parts, Bulbus Allii Macrostemonis 18 parts, the Rhizoma Anemarrhenae 8 parts, Endothelium Corneum Gigeriae Galli 8 parts, Semen Cuscutae 4 parts, Radix Glycyrrhizae Preparata 4 parts, Herba Epimedii 2 parts.
4. a preparation method for the pharmaceutical composition of the treatment diabetes as described in as arbitrary in claim 1-2, it is characterized in that, concrete steps are as follows:
(1) feeding: take each raw material according to weight portion;
(2) alcohol extraction: each raw material is taken out half, extract 1-4 time at 70-90 DEG C of temperature with the ethanol that the concentration of the 5-8 times amount of medical material weight is 80-90%, each 20-40min, the extracting solution repeatedly obtained is merged, the sieve crossing below 2mm gets permeate, is concentrated into water content≤50% and obtains alcohol extract;
(3) water extraction: granule surplus stock being crushed to 0.5-1cm, doubly add water by the 10-20 of medical material weight again, heat to 95-105 DEG C of extraction 1-4 time, slow fire heating makes that maintenance is micro-boils, each water extraction 40-60min, merges the extracting solution repeatedly obtained, and crosses below 2mm sieve and gets permeate, standing 6-8h gets supernatant, will again supernatant concentration be dried to water content≤50% aqueous extract;
(4) pharmaceutical compositions: after above-mentioned alcohol extract and water extract mix homogeneously, adds adjuvant and prepares pharmaceutical composition.
5. the preparation method of the pharmaceutical composition for the treatment of diabetes according to claim 4, is characterized in that, carrying out sieve in described step (2) and step (3) when getting permeate, was all 150-250 μm of sieves.
6. the preparation method of the pharmaceutical composition for the treatment of diabetes according to claim 4, is characterized in that, the dosage form of described pharmaceutical composition is granule, powder, pill, capsule or tablet.
7. one kind as arbitrary in claim 1-2 as described in pharmaceutical composition preparation treatment diabetes medicament in application.
CN201510916113.0A 2015-12-04 2015-12-04 Pharmaceutical composition for treating diabetes, and preparation method and application thereof Pending CN105434802A (en)

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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN105902880A (en) * 2016-05-25 2016-08-31 广西百琪药业有限公司 Medicine composition for treating diabetes mellitus due to qi-yin deficiency
CN106174531A (en) * 2016-08-24 2016-12-07 纪天国 A kind of health food and preparation method thereof
CN107158309A (en) * 2017-07-18 2017-09-15 深圳嘉禄保健食品有限公司 A kind of resolving sputum of drying, the Chinese medicine composition of liver-protecting sober-up and preparation method thereof

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101428113A (en) * 2008-05-26 2009-05-13 郭业新 Traditional Chinese medicine preparation for treating type II diabetes and preparation method thereof
CN103463522A (en) * 2012-06-06 2013-12-25 青岛信立德中药技术研究开发有限公司 Traditional Chinese medicine composition for treating diabetes
CN104645066A (en) * 2013-11-26 2015-05-27 邵艳艳 Traditional Chinese medicine capable of nourishing yin, tonifying vital energy and reducing blood glucose

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101428113A (en) * 2008-05-26 2009-05-13 郭业新 Traditional Chinese medicine preparation for treating type II diabetes and preparation method thereof
CN103463522A (en) * 2012-06-06 2013-12-25 青岛信立德中药技术研究开发有限公司 Traditional Chinese medicine composition for treating diabetes
CN104645066A (en) * 2013-11-26 2015-05-27 邵艳艳 Traditional Chinese medicine capable of nourishing yin, tonifying vital energy and reducing blood glucose

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN105902880A (en) * 2016-05-25 2016-08-31 广西百琪药业有限公司 Medicine composition for treating diabetes mellitus due to qi-yin deficiency
CN106174531A (en) * 2016-08-24 2016-12-07 纪天国 A kind of health food and preparation method thereof
CN107158309A (en) * 2017-07-18 2017-09-15 深圳嘉禄保健食品有限公司 A kind of resolving sputum of drying, the Chinese medicine composition of liver-protecting sober-up and preparation method thereof

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