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CN105943860A - Medicine preparation for treating diabetes mellitus and preparation method thereof - Google Patents

Medicine preparation for treating diabetes mellitus and preparation method thereof Download PDF

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Publication number
CN105943860A
CN105943860A CN201610451605.1A CN201610451605A CN105943860A CN 105943860 A CN105943860 A CN 105943860A CN 201610451605 A CN201610451605 A CN 201610451605A CN 105943860 A CN105943860 A CN 105943860A
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parts
rhizoma
extract
pharmaceutical preparation
processed
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陈令浩
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Qingdao Chenda Biotechnology Co Ltd
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Qingdao Chenda Biotechnology Co Ltd
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    • 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)
    • A61K36/898Orchidaceae (Orchid family)
    • 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)
    • A61K36/23Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
    • 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)
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    • 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
    • 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
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    • 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)
    • A61K36/71Ranunculaceae (Buttercup family), e.g. larkspur, hepatica, hydrastis, columbine or goldenseal
    • 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)
    • A61K36/71Ranunculaceae (Buttercup family), e.g. larkspur, hepatica, hydrastis, columbine or goldenseal
    • A61K36/718Coptis (goldthread)
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    • A61K36/73Rosaceae (Rose family), e.g. strawberry, chokeberry, blackberry, pear or firethorn
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    • 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
    • A61K2236/50Methods involving additional extraction steps
    • A61K2236/51Concentration or drying of the extract, e.g. Lyophilisation, freeze-drying or spray-drying

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Abstract

The invention relates to a medicine preparation for treating diabetes mellitus and a preparation method thereof. The medicine preparation is prepared from the following traditional Chinese medicinal materials in parts by weight: 6-15 parts of rhizoma corydalis, 10-30 parts of cortex moutan, 5-14 parts of flos albiziae, 10-32 parts of fructus arctii, 4-11 parts of ginger processed pinellia, 10-24 parts of radices trichosanthis, 6-16 parts of herba centellae, 5-11 parts of orchis italica, 3-10 parts of coptis chinensis, 7-13 parts of fructus mume, 8-14 parts of licorice root and 3-9 parts of epipactis mairei. The medicine preparation is prepared from compatible medicinal materials, accords with traditional Chinese medicine and modern medicine theories, is used for balancing yin and yang, and has the effects of soothing blood vessels, protecting musculus cardiacus, relieving pain, diminishing inflammation, tonifying qi, nourishing blood, tranquilizing, tonifying kidneys and nourishing yin, so that medicinal efficacy and functions can be comprehensive, symptoms and root causes can be treated, and the medicinal materials are matched to achieve the aim of improving blood circulation.

Description

A kind of for pharmaceutical preparation treating diabetes and preparation method thereof
Technical field
The invention belongs to medical treatment field, relate to a kind of for treating preparations for diabetes and preparation method thereof.
Background technology
Diabetes have become the third-largest killer of the mankind, and whole world diabetics is 2.85 hundred million at present, and China's diabetics is about 92400000, pre-diabetic 1.48 hundred million, the significant damage brought to the mankind in view of diabetes, and World Health Organization (WHO) is referred to as For " disaster of 21 century ".Its harm the most perhaps will not allow patient do to fear, but the complication in later stage be very serious and Make diabetics the most worried, such as cardiovascular diseases, diabetic foot, to add up according to latest data, the diabetics of China is 1.14 hundred million are occupied first place in the world, and wherein the prevalence of diabetic foot has reached the 4% of the total number of patients of diabetes, more than 450 Ten thousand people.
Diabetic cardiopathy is the one of the main reasons that diabetics is lethal, especially in type 2 diabetes mellitus patient.Extensively The diabetic cardiopathy of justice includes coronary atherosclerotic heart disease (coronary heart disease), Diabetic myocardial infarction and diabetes Cardiovascular autonomic neuropathy etc..Diabetic cardiopathy normal onset compared with ND compares early, diabetics companion's hat Cardiopathia often shows as painless myocardial infarction, and infarct size is bigger, and wall-through infarction is many, and the many ratios of the state of an illness are more serious, prognosis ratio Poor, case fatality rate is higher;Such as coronarography and clinical coronary artery pathological changes of getting rid of, the heart that diabetics appearance is serious Restrain not normal cardiac hypertrophy pulmonary venous pleonaemia and congestive heart failure, especially refractory heart failure.
The traditional Chinese medical science is the traditional medicine of China, has played, in the historical development of China, the effect that can not be substituted.In recent years, the traditional Chinese medical science Also important, unique, irreplaceable effect is played in the field for the treatment of diabetes.National drug management board is the most There are Chinese patent medicine preparation and the some Chinese Patent Medicines preparation of the treatment diabetes included, such as diabetes pill, ginseng, astragalus diabetes capsule, ginseng stilbene fall Sugar granule, Jiangtangwan pill, Xiao Ke Lin sheet, YUQUAN WAN etc..
Up to now, the myocardial damage caused for diabetes there is no specific short at present, and first clinical treatment is to control DM, Then treat mainly for cardiac damage, arrhythmia, heart failure and antithrombotic.And due to some patients in early days And non-evident sympton, and all there is certain limitation in above-mentioned Therapeutic Method, can not stop effectively and timely it development. Western medicine medication is expensive and has dependency, and Chinese medicine does not reaches again significantly on therapeutic effect, drops hypoglycemic purpose immediately, Although Chinese medicine preparation also has much, but it is little to play effective effect.Therefore, in clinical practice in the urgent need to Searching can effectively prevent and treat newtype drug and the approach of diabetic cardiopathy, improves the treatment with substantial diabetic cardiopathy further Strategy.
There is provided at present a kind of definite effect, aobvious particularly important of the little Chinese medicine preparation of side reaction.
Summary of the invention
For the defect of prior art, the present invention be directed to treat at present the present situation of diabetes, it is provided that a kind for the treatment of and prevention is imitated The best pharmaceutical preparation, and have no side effect.
Specifically, the present invention is realized in.
Inventor provides a kind of prescriptions of Chinese medicine treating preparations for diabetes according to drug matching experience, including following Chinese medicine:
Rhizoma Corydalis, Cortex Moutan, Flos Albiziae, Fructus Arctii, Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens), Radix Trichosanthis, Herba Centellae, Herba Orchidis Latifoliae, Rhizoma Coptidis, Fructus Mume, sweet Purple careless, little is with a smile.
Each raw material dosage of prescription all has preferable curative effect, described formula and weight portion in the weight portion scope of the present invention: Rhizoma Corydalis 6-15 Part, Cortex Moutan 10-30 part, Flos Albiziae 5-14 part, Fructus Arctii 10-32 part, Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens) 4-11 part, Radix Trichosanthis 10-24 part, Herba Centellae 6-16 part, Herba Orchidis Latifoliae 5-11 part, Rhizoma Coptidis 3-10 part, Fructus Mume 7-13 part, Radix Glycyrrhizae 8-14 part, little purple have a smile on one's face 3-9 Part.
For having reached optimum effect, to described formula and weight portion be: Rhizoma Corydalis 10.5 parts, Cortex Moutan 20 parts, Flos Albiziae 9.5 parts, Fructus Arctii 21 parts, Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens) 7.5 parts, Radix Trichosanthis 17 parts, Herba Centellae 11 parts, Herba Orchidis Latifoliae 8 parts, Rhizoma Coptidis 6.5 parts, crow 10 parts of prunus mume (sieb.) sieb.et zucc., 11 parts of Radix Glycyrrhizae, little purple have a smile on one's face 6 parts.
Or:
Rhizoma Corydalis 11 parts, Cortex Moutan 21 parts, Flos Albiziae 10 parts, Fructus Arctii 21.5 parts, Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens) 8.5 parts, Radix Trichosanthis 17.5 parts, Herba Centellae 11.5 parts, Herba Orchidis Latifoliae 8.5 parts, Rhizoma Coptidis 7 parts, Fructus Mume 10.5 parts, 11.5 parts of Radix Glycyrrhizae, little purple have a smile on one's face 6.5 parts.
The function of each taste Chinese crude drug used in the pharmaceutical preparation of the treatment diabetes of the present invention is as follows:
Rhizoma Corydalis: bitter in the mouth, warm in nature, GUIXIN, spleen, liver, lung meridian.
Effect: have promoting blood circulation to remove blood stasis, the function of promoting the circulation of QI pain relieving.
Clinical practice: utilize the effect of corydalis tuber analgesic dissipating blood stasis clinically, is usually used in treating hepatocarcinoma, cancer of pancreas, pulmonary carcinoma etc..
Flos Albiziae: sweet in the mouth, property is put down.
Gui Jing: GUIXIN, Liver Channel.
Function cures mainly: resolving stagnation for tranquilization.For irritability, melancholy insomnia.
Fructus Arctii: acrid in the mouth, cold in nature.
Gui Jing: attach to the lung and stomach meridians.
Function cures mainly: dispelling wind and heat pathogens, lung qi dispersing rash, resolving toxin and disinhibiting the throat.For anemopyretic cold, cough with copious phlegm, measles, rubella, Laryngopharynx swelling and pain, mumps erysipelas, carbuncle sore tumefacting virus.
Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens): acrid in the mouth, temperature;Poisonous.
Gui Jing: return spleen, stomach, lung meridian.
Function cures mainly: drying dampness to eliminate phlegm, stopping nausea and vomiting by lowering the adverse flow of QI, dissolving lump and resolving mass.For abundant expectoration cough with asthma, phlegm retention vertigo and palpitation, dizziness due to wind-phlegm, Syncope due to accumulation of phlegm is had a headache, and vomits regurgitation, and breast gastral cavity painful abdominal mass is vexed, globus hystericus;Raw with external treatment carbuncle sucutaneous nodule.Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens) is used for stopping nausea and vomiting by lowering the adverse flow of QI.
Radix Trichosanthis: sweet in the mouth, micro-hardship, is slightly cold.
Gui Jing: attach to the lung and stomach meridians.
Function cures mainly: clearing away heat and promoting production of body fluid, detumescence and apocenosis.For calentura excessive thirst, lung-heat type cough, interior-heat quenches one's thirst, sore swollen toxin.
Rhizoma Coptidis: bitter in the mouth, cold in nature.
Gui Jing: GUIXIN, spleen, stomach, liver, gallbladder, large intestine channel.
Function cures mainly: heat clearing and damp drying, eliminating fire and detoxication.For damp and hot feeling of fullness, vomit acid regurgitation, dysentery, jaundice, unconsciousness due to high fever, Hyperactivity of heart-fire, dysphoria and insomnia, heat in blood tells nosebleed, conjunctival congestion, and toothache is quenched one's thirst, carbuncle furuncle;External treatment eczema, eczema, auditory meatus Suppurate.It is burning hot that Rhizoma Coptidis (processed with wine) is apt to the clear part of the body cavity above the diaphragm housing the heart and lungs.Fructus Mume
Radix Glycyrrhizae: sweet in the mouth, property is put down.
Gui Jing: enter spleen, stomach, the heart, lung meridian.
Function cures mainly: invigorating the spleen and replenishing QI, heat-clearing and toxic substances removing, expelling phlegm for arresting cough, relieving spasm to stop pain.
Little purple is had a smile on one's face: sweet in the mouth, and property is put down.
Function cures mainly: promoting flow of QI and blood;Heat-clearing and toxic substances removing.Main cough due to lung-heat;Stagnation of QI chest pain;Vomit and diarrhoea;Painful and swollen testis;Rheumatism waist Bitterly;Traumatic injury;Sore and toxic
Herba Centellae: bitter in the mouth, cold in nature.
Gui Jing: return liver,spleen,kidney warp.
Function cures mainly: clearing away heat-damp and promoting diuresis, removing toxic substances and promoting subsidence of swelling.For jaundice due to damp-heat, heatstroke is suffered from diarrhoea, sand Stranguria stranguria with blood, carbuncle sore tumefacting virus, Injury from falling down.
Herba Orchidis Latifoliae: sweet in the mouth, property is put down.
Function cures mainly: heart tonifying, and the kidney invigorating is promoted the production of body fluid, and quenches the thirst, strengthening the spleen and stomach.
Irritated thirsty, anorexia, menoxenia.Asthenia anemia, dizzy, dim eyesight.Herba Orchidis Latifoliae, Radix seu Herba Spiranthis Lanceae, Rhizoma Polygonati, Each 3 money of Radix Polygoni Multiflori, are decocted in water for oral dose.
Fructus Litseae: acrid in the mouth, warm in nature.
Gui Jing: return spleen, stomach, kidney, bladder warp.
Effect: warming spleen and stomach for dispelling cold, promoting the circulation of QI to relieve pain, for cold syndrome of the stomach vomiting, coldness and pain in the epigastrium, colic of cold type suffers from abdominal pain, stagnancy of cold-damp, Turbid urine.
Cortex Moutan: bitter in the mouth, pungent, cold in nature.
Gui Jing: GUIXIN, liver, kidney channel.
Effect: clearing away heat and cooling blood, blood circulation promoting and blood stasis dispelling.Thermal man's nutrient blood, maculae caused by violent heat pathogen, hematemesis and epistaxis, night fever abating at dawn, lossless Hectic fever due to YIN-deficiency, amenorrhea dysmenorrhea, fall and flutter the pain of injury, carbuncle sore tumefacting virus.
Above material medicine is extracted is prepared as pharmaceutically acceptable preparation.Pharmaceutical dosage form of the present invention selected from granule, In capsule, tablet, injection, tincture, suppository, pill, syrup, mixture, powder, lotion, membrane, drop pill One.More preferably granule.
The preparation method of pharmaceutical preparation of the present invention is:
(1) getting it filled material, described medical material contains the raw medicinal herbs of following weight portion: Rhizoma Corydalis 6-15 part, Cortex Moutan 10-30 part, Flos Albiziae 5-14 part, Fructus Arctii 10-32 part, Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens) 4-11 part, Radix Trichosanthis 10-24 part, Herba Centellae 6-16 part, red door Blue 5-11 part, Rhizoma Coptidis 3-10 part, Fructus Mume 7-13 part, Radix Glycyrrhizae 8-14 part, little purple have a smile on one's face 3-9 part.
(2) by Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens) therein, Fructus Arctii, Rhizoma Corydalis, Cortex Moutan, Herba Centellae 70% alcohol reflux, reflux, extract, Twice, each 10-15 times of medical material weight, extract 1-2 hour every time, extracting solution cools, filters, merges;
(3) medicinal residues add other medical materials, the reflux, extract, that adds water twice, each 8-12 times of medical material weight, extract 1-2 little every time Time, extracting solution concentrating under reduced pressure, it is 65-75% that concentrated solution adds ethanol to containing alcohol weight, filters;
(4) (2) and (3) gained filtrate is merged, be condensed into extractum, cold drying, pulverize, add methyl Cellulose 7-19 part, sucrose 500-1200 part, after mix homogeneously, add appropriate 70-80% ethanol, make soft material, pelletize, wave Remove ethanol, 80 DEG C of spray drying, make granule, weight per package is 10g.
Preferably, the present invention provides the preparation method of a kind of granule, comprises the steps:
(1) getting it filled material, described medical material contains the raw medicinal herbs of following weight portion: Rhizoma Corydalis 11 parts, Cortex Moutan 21 parts, Herba Albiziae Spend 10 parts, Fructus Arctii 21.5 parts, Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens) 8.5 parts, Radix Trichosanthis 17.5 parts, Herba Centellae 11.5 parts, Herba Orchidis Latifoliae 8.5 parts, Rhizoma Coptidis 7 parts, Fructus Mume 10.5 parts, 11.5 parts of Radix Glycyrrhizae, little purple have a smile on one's face 6.5 parts.
(2) by Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens) therein, Fructus Arctii, Rhizoma Corydalis, Cortex Moutan, Herba Centellae 70% alcohol reflux, reflux, extract, Twice, each 12 times of medical material weight, extract 2 hours every time, extracting solution cools, filters, merges;
(3) medicinal residues add other medical materials, the reflux, extract, that adds water twice, each 10 times of medical material weight, extract 1.5 little every time Time, extracting solution concentrating under reduced pressure, it is 70% that concentrated solution adds ethanol to containing alcohol weight, filters;
(4) (2) and (3) gained filtrate is merged, be condensed into extractum, cold drying, pulverize, add methyl Cellulose 14 parts, sucrose 800 parts, after mix homogeneously, add appropriate 70% ethanol, make soft material, pelletize, fling to ethanol, 80C Being spray-dried, make granule, weight per package is 10g.
It is highly preferred that
(1) getting it filled material, described medical material contains the raw medicinal herbs of following weight portion: Rhizoma Corydalis 10.5 parts, Cortex Moutan 20 parts, Herba Albiziae Spend 9.5 parts, Fructus Arctii 21 parts, Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens) 7.5 parts, Radix Trichosanthis 17 parts, Herba Centellae 11 parts, Herba Orchidis Latifoliae 8 parts, Rhizoma Coptidis 6.5 parts, Fructus Mume 10 parts, 11 parts of Radix Glycyrrhizae, little purple have a smile on one's face 6 parts.
(2) by Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens) therein, Fructus Arctii, Rhizoma Corydalis, Cortex Moutan, Herba Centellae 70% alcohol reflux, reflux, extract, two Secondary, each 12 times of medical material weight, extract 2 hours every time, extracting solution cools, filters, merges;
(3) medicinal residues add other medical materials, the reflux, extract, that adds water twice, each 10 times of medical material weight, extract 1.5 little every time Time, extracting solution concentrating under reduced pressure, it is 70% that concentrated solution adds ethanol to containing alcohol weight, filters;
(4) (2) and (3) gained filtrate is merged, be condensed into extractum, cold drying, pulverize, add Methyl cellulose Element 13 parts, sucrose 850 parts, after mix homogeneously, add appropriate 70% ethanol, make soft material, pelletize, fling to ethanol, 80C sprays Mist is dried, and makes granule, and weight per package is 10g.
Above preparation preparation diabetes in application, especially preparation treatment type 2 diabetes mellitus in application.
The present invention is that pure raw material of Chinese medicine medicine is made, scientific and reasonable, in zoology test, it is possible to significantly reduce the content of blood glucose, Side effect is less, and the Granular pesticide preparation method of the present invention is simple, it is easy to operation, is suitable for industrial mass production.
Specific embodiment
The detailed description of the invention of the following stated, the only present invention, protection scope of the present invention is not limited thereto, any familiar Those skilled in the art in the technical scope that the invention discloses, the change that can readily occur in or replacement, all should contain Within protection scope of the present invention.
Embodiment 1: a kind of granule for treating diabetes, containing the Chinese crude drug of following weight portion:
Rhizoma Corydalis 6 grams, Cortex Moutan 10 grams, Flos Albiziae 5 grams, Fructus Arctii 10 grams, Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens) 4 grams, Radix Trichosanthis 10 grams, accumulated snow Grass 6 grams, Herba Orchidis Latifoliae 5 grams, Rhizoma Coptidis 3 grams, Fructus Mume 7 grams, 8 grams of Radix Glycyrrhizae, little purple have a smile on one's face 3 grams.Preparation method include with Lower step:
(1) above-mentioned weight portion Chinese crude drug is taken;
(2) by Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens) therein, Fructus Arctii, Rhizoma Corydalis, Cortex Moutan, Herba Centellae 70% alcohol reflux, reflux, extract, two Secondary, each 10-15 times of medical material weight, extract 1-2 hour every time, extracting solution cools, filters, merges;
(3) medicinal residues add other medical materials, the reflux, extract, that adds water twice, each 8 times of medical material weight, extract 1 hour every time, carry Taking liquid concentrating under reduced pressure, it is 65% that concentrated solution adds ethanol to containing alcohol weight, filters;
(4) (2) and (3) gained filtrate is merged, be condensed into extractum, cold drying, pulverize, add methylcellulose 7 Part, sucrose 500 parts, after mix homogeneously, add appropriate 70% ethanol, make soft material, pelletize, fling to ethanol, 80 DEG C of spray dried Dry, make granule, weight per package is 10g.
Embodiment 2: a kind of granule for treating diabetes, containing the Chinese crude drug of following weight portion:
Rhizoma Corydalis 15 grams, Cortex Moutan 30 grams, Flos Albiziae 14 grams, Fructus Arctii 32 grams, Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens) 11 grams, Radix Trichosanthis 24 grams, Herba Centellae 16 grams, Herba Orchidis Latifoliae 11 grams, Rhizoma Coptidis 10 grams, Fructus Mume 13 grams, 14 grams of Radix Glycyrrhizae, little purple have a smile on one's face 9 grams.Preparation side Method comprises the following steps:
(1) above-mentioned weight portion Chinese crude drug is taken;
(2) by Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens) therein, Fructus Arctii, Rhizoma Corydalis, Cortex Moutan, Herba Centellae 70% alcohol reflux, reflux, extract, two Secondary, each 15 times of medical material weight, extract 2 hours every time, extracting solution cools, filters, merges;
(3) medicinal residues add other medical materials, the reflux, extract, that adds water twice, each 12 times of medical material weight, extract 2 hours every time, carry Taking liquid concentrating under reduced pressure, it is 75% that concentrated solution adds ethanol to containing alcohol weight, filters;
(4) (2) and (3) gained filtrate is merged, be condensed into extractum, cold drying, pulverize, add methylcellulose 19 Part, sucrose 1200 parts, after mix homogeneously, add appropriate 80% ethanol, make soft material, pelletize, fling to ethanol, 80 DEG C of sprayings Being dried, make granule, weight per package is 10g.
Embodiment 3: a kind of granule for treating diabetes, containing the Chinese crude drug of following weight portion:
Rhizoma Corydalis 10.5 grams, Cortex Moutan 20 grams, Flos Albiziae 9.5 grams, Fructus Arctii 21 grams, Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens) 7.5 grams, Radix Trichosanthis 17 grams, Herba Centellae 11 grams, Herba Orchidis Latifoliae 8 grams, Rhizoma Coptidis 6.5 grams, Fructus Mume 10 grams, 11 grams of Radix Glycyrrhizae, little purple have a smile on one's face 6 grams.Preparation side Method comprises the following steps:
(1) getting it filled material, described medical material contains the raw medicinal herbs of following weight portion: Rhizoma Corydalis 10.5 parts, Cortex Moutan 20 parts, Flos Albiziae 9.5 parts, Fructus Arctii 21 parts, Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens) 7.5 parts, Radix Trichosanthis 17 parts, Herba Centellae 11 parts, Herba Orchidis Latifoliae 8 parts, Rhizoma Coptidis 6.5 Part, Fructus Mume 10 parts, 11 parts of Radix Glycyrrhizae, little purple have a smile on one's face 6 parts.
(2) by Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens) therein, Fructus Arctii, Rhizoma Corydalis, Cortex Moutan, Herba Centellae 70% alcohol reflux, reflux, extract, twice, Each 12 times of medical material weight, extract 2 hours every time, and extracting solution cools, filters, merges;
(3) medicinal residues add other medical materials, the reflux, extract, that adds water twice, each 10 times of medical material weight, extract 1.5 hours every time, Extracting solution concentrating under reduced pressure, it is 70% that concentrated solution adds ethanol to containing alcohol weight, filters;
(4) (2) and (3) gained filtrate is merged, is condensed into extractum, cold drying, pulverizes, add methylcellulose 13 parts, Sucrose 850 parts, after mix homogeneously, adds appropriate 70% ethanol, makes soft material, pelletizes, and flings to ethanol, and 80C is spray-dried, Making granule, weight per package is 10g.
Embodiment 4: a kind of granule for treating diabetes, containing the Chinese crude drug of following weight portion:
Rhizoma Corydalis 11 grams, Cortex Moutan 21 grams, Flos Albiziae 10 grams, Fructus Arctii 21.5 grams, Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens) 8.5 grams, Radix Trichosanthis 17.5 grams, Herba Centellae 11.5 grams, Herba Orchidis Latifoliae 8.5 grams, Rhizoma Coptidis 7 grams, Fructus Mume 10.5 grams, 11.5 grams of Radix Glycyrrhizae, little purple have a smile on one's face 6.5 grams.
Preparation method comprises the following steps:
(1) getting it filled material, described medical material contains the raw medicinal herbs of following weight portion: Rhizoma Corydalis 11 parts, Cortex Moutan 21 parts, Flos Albiziae 10 Part, Fructus Arctii 21.5 parts, Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens) 8.5 parts, Radix Trichosanthis 17.5 parts, Herba Centellae 11.5 parts, Herba Orchidis Latifoliae 8.5 parts, Rhizoma Coptidis 7 parts, Fructus Mume 10.5 parts, 11.5 parts of Radix Glycyrrhizae, little purple have a smile on one's face 6.5 parts.
(2) by Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens) therein, Fructus Arctii, Rhizoma Corydalis, Cortex Moutan, Herba Centellae 70% alcohol reflux, reflux, extract, two Secondary, each 12 times of medical material weight, extract 2 hours every time, extracting solution cools, filters, merges;
(3) medicinal residues add other medical materials, the reflux, extract, that adds water twice, each 10 times of medical material weight, extract 1.5 hours every time, Extracting solution concentrating under reduced pressure, it is 70% that concentrated solution adds ethanol to containing alcohol weight, filters;
(4) (2) and (3) gained filtrate is merged, be condensed into extractum, cold drying, pulverize, add methylcellulose 14 Part, sucrose 800 parts, after mix homogeneously, add appropriate 70% ethanol, make soft material, pelletize, fling to ethanol, 80C spray dried Dry, make granule, weight per package is 10g.
Embodiment 5: pharmaceutical preparation of the present invention is at treatment type 2 diabetes mellitus pharmacodynamics test
Metformin is a line medication for the treatment of type 2 diabetes mellitus, and the present invention is used as treating the positive control test of diabetes.
5.1, rat modeling
SD rat adapt to 1 week after fasting overnight, through lumbar injection streptozotocin 65mg/Kg (0.1mmol/l, PH4.4 citric acid The solution of 2% (W/V) made by buffer), after 3 days, tail venous blood sampling surveys blood glucose >=16.7mmol/L is modeling success.
5.2, medication and observation index:
The diabetes rat of Cheng Mo is randomly divided into model group, metformin 125mg/Kg group and the A (granule of embodiment 1 10g/kg), B (the granule 10g/kg of embodiment 2), C (the granule 10g/kg of embodiment 3), D (embodiment 4 Granule 10g/kg) often organize 10.Separately take 10 and be only used as controlled trial, adapt to one week, gastric infusion after detection blood glucose, every day one Secondary, medicine all becomes suspension to be administered with normal saline, drinking-water of the most freely ingesting during experiment, 15 days experimental periods.Giving Medicine the 7th, 14 days, fasting 2 hours after administration, tail venous blood sampling one-touchultra blood glucose meter measures blood glucose, and detection is big simultaneously The body weight of Mus.
5.3, statistical procedures:
Statistic software SPSS 16.0 is added up, result such as table 1.
The change of blood glucose after medication respectively organized by table 1
Note:
$p < 0.05 is compared with blank group;$$p < 0.01;
#p < 0.05 is compared with model group;##p < 0.05
@P < 0.05 compared with positive controls.
As it can be seen from table 1 matched group is compared with model group, there is significant difference, this method model modeling success be described, Test each group compared with model group, be respectively provided with significant difference, the therapeutic effect of the granule of embodiments of the invention 3 preparation Most preferably, and when ground 14 days, compared with positive controls, there is significant difference.
Observe animal two weeks after grouping, at the end of administration, often organize the appetite of Mus, drinking-water, body weights.Body weight change= Body weight before body weight-administration after medication 14 days;The total of consumption is often organized at the end of medication after appetite, amount of drinking water=beginning medication to 14 day Amount.
Table 2 body weight, appetite, amount of drinking water information slip
Note:
$p < 0.05 is compared with blank group;$$p < 0.01;
#p < 0.05 is compared with model group;##p < 0.05
@P < 0.05 compared with positive controls.
From table 2, model group has significant difference, positive controls and pharmaceutical preparation group of the present invention with the contrast of blank group Having significant difference with model control group, and C group of the present invention is substantially better than positive controls, it is poor that the two has statistics Different P < 0.05, therefore the pharmaceutical preparation of the present invention is suitable for further genralrlization application.
Embodiment 6:
6.1, physical data
My institute accepts 312 patients for medical treatment altogether from March ,-2016 in March, 2012, therefrom selects 300 example patients to enter research, divides at random For matched group and experimental group, sex between two groups, age, the state of an illness there are no significant difference (P > 0.05).
6.2, diagnostic criteria:
Western medicine diagnose: type 2 diabetes mellitus diagnostic criteria: sick with reference to the diabetes of publication on the Diabetes Care magazine in July, 1997 Because of credit type standard, all diagnostic criterias meeting diabetes, insulin release test result meets the one of following condition and i.e. examines Break as type 2 diabetes mellitus.
(1) it is that main companion's relative insulin is not enough with insulin resistant;
(2) insulin substantially lacks companion's insulin resistant;
Tcm diagnosis: Chinese medical discrimination diagnostic criteria: deficiency of both QI and YIN or double heat syndrome:
(1) primary symptom: fatigue and weakness, thirst and liking drink, the most hungry polyphagia, frequent micturition;
(2) secondary disease: dysphoria with feverish sensation in the chest palms and soles, spontaneous perspiration or night sweat, breathe hard lazy speech, cardiopalmus, constipation;
(3) tongue arteries and veins: red tongue with a little fluid or corpulent tongue are big, thready pulse or count accurately.
Indispensable 1 of above primary symptom, adds time disease 2, the most diagnosable with reference to tongue arteries and veins.
6.3, therapeutic scheme
Test group: the granule of the embodiment of the present invention 3, each 10g, every day 2 times, takes with meal, 3 weeks courses for the treatment of;
Matched group: blood sugar lowering Tongmai Tablet, one time 3~4,3 times on the one, 3 weeks courses for the treatment of, take with meal.
Forbid during test merging and apply other blood sugar lowering Western medicine, merge Western medicine Uniform provisions as follows:
Moderate state of an illness experimenter: metformin hydrochloride 0.5g 2 times/day, takes with meal;
Severe state of an illness experimenter: metformin hydrochloride 1g 2 times/day, takes with meal.
6.4, diagnosis and curative effect index:
Curative effect index: symptom, sign, fasting glucose, post-prandial glycemia, glycolated hemoglobin, glycated serum protein.
Secondary efficacy index: blood fat, lectin from hemolymph.
Safety indexes: routine blood test, routine urinalysis, just routine, electrocardiogram, liver function, renal function.
Diagnostic result index:
Fasting glucose curative effect obvious effective rate: 7:30 did not took food and measured the concentration of blood glucose before and be decreased obviously morning.
Post-prandial glycemia obvious effective rate: after dining 2 little constantly, measure blood glucose concentration be decreased obviously.
Tcm symptom obvious effective rate: primary symptom shape reduces more than 2, secondary symptom reduces 1 and is significant effective;
Cure rate: return to one's perfect health, within 6 months, call-on back by phone does not recur.
Detailed results is shown in Table 3.
The therapeutic effect of table 3 observation group and matched group compares
Test group is better than matched group to 2 hours blood glucoses after the meal, fasting glucose, the curative effect of tcm symptom, has significant difference.This Invention treatment by Chinese herbs type 2 diabetes mellitus (deficiency of both QI and YIN hold concurrently heat syndrome) is safely and effectively.
Safety results: extraction matched group and each 50 examples of observation group, does not observes on inspection to the heart, Liver and kidney function, blood System has anomalous effects and other untoward reaction.Test finds that the observation group target cell sensitivity to insulin is apparently higher than comparison Group, observation group's antagonism insulin resistant has preferably effect.
6.5, classical clinical case
Case 1: cattle, female 55 years old, Shandong Zibo people, over 2015, my institute checks, suffers from diabetes and takes Western medicine in 5 years always Treatment, Therapeutic Method mainly takes metformin, and blood glucose raises repeatedly, and patient engenders depression, the phenomenon such as short-tempered, After get off my institute's treatment in the advice of son, take the Drug therapy of embodiments of the invention 3, persistently taking for 1 course for the treatment of, Blood glucose is gradually lowered, and mood takes a turn for the better, and continues to take 2 courses for the treatment of, and blood glucose recovers normal substantially, and health body weight substantially increases, and 6 Individual month Effect of follow-up visit by telephone, patient continues to take.
Case 2: Hao, man 47 years old, Pingyi, shandong Province people, suffer from diabetes medical history for a long time, by excessive districts and cities examination in hospital It is diagnosed as type 2 diabetes mellitus, takes Or Metformin In Treating the treatment of auxiliary injection insulin, start curative effect substantially, but there is medicine Thing dependency and least, lives agonizing.Patient's private prosecution fatigue and weakness, thirst and liking drink, frequent micturition at night, Patient height 180cm, but body weight only has 56.5 kilograms, and body weight also has the trend gradually alleviated, and comes my institute upon somebody's introduction and checks treatment, With the granule of the embodiment of the present invention 3,1 course for the treatment of, blood glucose improves significantly, and gradually recovers normal, and 6 months through electricity Words are paid a return visit, and patient still takes continuing, and body weight increases to 63 kilograms.

Claims (10)

1. one kind for treating the pharmaceutical preparation of diabetes, it is characterised in that includes following Chinese crude drug: Rhizoma Corydalis, Cortex Moutan, Flos Albiziae, Fructus Arctii, Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens), Radix Trichosanthis, Herba Centellae, Herba Orchidis Latifoliae, Rhizoma Coptidis, Fructus Mume, Radix Glycyrrhizae, little purple are with a smile.
Pharmaceutical preparation the most according to claim 1, it is characterised in that the weight portion of described Chinese crude drug is: Rhizoma Corydalis 6-15 part, Cortex Moutan 10-30 part, Flos Albiziae 5-14 part, Fructus Arctii 10-32 part, Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens) 4-11 part, Radix Trichosanthis 10-24 part, Herba Centellae 6-16 Part, Herba Orchidis Latifoliae 5-11 part, Rhizoma Coptidis 3-10 part, Fructus Mume 7-13 part, Radix Glycyrrhizae 8-14 part, little purple have a smile on one's face 3-9 part.
Pharmaceutical preparation the most according to claim 1, it is characterised in that the weight portion of described Chinese crude drug is: Rhizoma Corydalis 10.5 parts, Cortex Moutan 20 parts, Flos Albiziae 9.5 parts, Fructus Arctii 21 parts, Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens) 7.5 parts, Radix Trichosanthis 17 parts, Herba Centellae 11 parts, Herba Orchidis Latifoliae 8 Part, Rhizoma Coptidis 6.5 parts, Fructus Mume 10 parts, 11 parts of Radix Glycyrrhizae, little purple have a smile on one's face 6 parts.
Pharmaceutical preparation the most according to claim 1, it is characterised in that the weight portion of described Chinese crude drug is: Rhizoma Corydalis 11 parts, Cortex Moutan 21 parts, Flos Albiziae 10 parts, Fructus Arctii 21.5 parts, Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens) 8.5 parts, Radix Trichosanthis 17.5 parts, Herba Centellae 11.5 parts, Herba Orchidis Latifoliae 8.5 parts, Rhizoma Coptidis 7 parts, Fructus Mume 10.5 parts, 11.5 parts of Radix Glycyrrhizae, little purple have a smile on one's face 6.5 parts.
Pharmaceutical preparation the most according to claim 1, it is characterised in that described pharmaceutical preparation is selected from granule, capsule, sheet One in agent, injection, tincture, suppository, pill, syrup, mixture, powder, lotion, membrane, drop pill.
Pharmaceutical preparation the most according to claim 5, it is characterised in that described pharmaceutical preparation is granule.
7. the method for the pharmaceutical preparation prepared described in claim 1-5, it is characterised in that comprise the following steps:
1) getting it filled material, described medical material contains the raw medicinal herbs of following weight portion: Rhizoma Corydalis 6-15 part, Cortex Moutan 10-30 part, Flos Albiziae 5-14 part, Fructus Arctii 10-32 part, Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens) 4-11 part, Radix Trichosanthis 10-24 part, Herba Centellae 6-16 part, Herba Orchidis Latifoliae 5-11 Part, Rhizoma Coptidis 3-10 part, Fructus Mume 7-13 part, Radix Glycyrrhizae 8-14 part, little purple have a smile on one's face 3-9 part;
2) by Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens) therein, Fructus Arctii, Rhizoma Corydalis, Cortex Moutan, Herba Centellae 70% alcohol reflux, reflux, extract, twice, often Secondary 10-15 times of medical material weight, extracts 1-2 hour every time, and extracting solution cools, filters, merges;
3) medicinal residues add other medical materials, the reflux, extract, that adds water twice, each 8-12 times of medical material weight, extract 1-2 hour every time, carry Taking liquid concentrating under reduced pressure, it is 65-75% that concentrated solution adds ethanol to containing alcohol weight, filters;
4) by 2 and 3) merging of gained filtrate, it is condensed into extractum, cold drying, pulverizes, add methylcellulose 7-19 part, sugarcane Sugar 500-1200 part, after mix homogeneously, adds appropriate 70-80% ethanol, makes soft material, pelletizes, flings to ethanol, 80 DEG C of sprayings Being dried, make granule, weight per package is 10g.
8. the method for the pharmaceutical preparation prepared described in claim 1, it is characterised in that comprise the following steps:
1) getting it filled material, described medical material contains the raw medicinal herbs of following weight portion: Rhizoma Corydalis 11 parts, Cortex Moutan 21 parts, Flos Albiziae 10 parts, Fructus Arctii 21.5 parts, Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens) 8.5 parts, Radix Trichosanthis 17.5 parts, Herba Centellae 11.5 parts, Herba Orchidis Latifoliae 8.5 parts, Rhizoma Coptidis 7 parts, Fructus Mume 10.5 parts, 11.5 parts of Radix Glycyrrhizae, little purple have a smile on one's face 6.5 parts;
2) by Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens) therein, Fructus Arctii, Rhizoma Corydalis, Cortex Moutan, Herba Centellae 70% alcohol reflux, reflux, extract, twice, Each 12 times of medical material weight, extract 2 hours every time, and extracting solution cools, filters, merges;
3) medicinal residues add other medical materials, the reflux, extract, that adds water twice, each 10 times of medical material weight, extract 1.5 hours every time, carry Taking liquid concentrating under reduced pressure, it is 70% that concentrated solution adds ethanol to containing alcohol weight, filters;
4) by 2) and the merging of (3) gained filtrate, it is condensed into extractum, cold drying, pulverizes, add methylcellulose 14 parts, Sucrose 800 parts, after mix homogeneously, adds appropriate 70% ethanol, makes soft material, pelletizes, and flings to ethanol, and 80C is spray-dried, Making granule, weight per package is 10g.
9. the method for the pharmaceutical preparation prepared described in claim 1, it is characterised in that comprise the following steps:
1) getting it filled material, described medical material contains the raw medicinal herbs of following weight portion: Rhizoma Corydalis 10.5 parts, Cortex Moutan 20 parts, Flos Albiziae 9.5 Part, Fructus Arctii 21 parts, Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens) 7.5 parts, Radix Trichosanthis 17 parts, Herba Centellae 11 parts, Herba Orchidis Latifoliae 8 parts, Rhizoma Coptidis 6.5 parts, Fructus Mume 10 parts, 11 parts of Radix Glycyrrhizae, little purple have a smile on one's face 6 parts;
2) by Rhizoma Pinelliae (processed with Rhizoma Zingiberis Recens) therein, Fructus Arctii, Rhizoma Corydalis, Cortex Moutan, Herba Centellae 70% alcohol reflux, reflux, extract, twice, often Secondary 12 times of medical material weight, extract 2 hours every time, and extracting solution cools, filters, merges;
3) medicinal residues add other medical materials, the reflux, extract, that adds water twice, each 10 times of medical material weight, extract 1.5 hours every time, carry Taking liquid concentrating under reduced pressure, it is 70% that concentrated solution adds ethanol to containing alcohol weight, filters;
4) by 2) and 3) merging of gained filtrate, it is condensed into extractum, cold drying, pulverizes, add methylcellulose 13 parts, sugarcane Sugar 850 parts, after mix homogeneously, adds appropriate 70% ethanol, makes soft material, pelletizes, and flings to ethanol, and 80C is spray-dried, system Becoming granule, weight per package is 10g.
Pharmaceutical preparation the most according to claim 1, it is characterised in that described pharmaceutical preparation is in preparation treatment diabetes medicament Application.
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Publication number Priority date Publication date Assignee Title
CN113476557A (en) * 2021-08-01 2021-10-08 江苏省中医药研究院 Traditional Chinese medicine compound composition with effect of treating diabetic cardiac autonomic neuropathy and preparation method thereof

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101357181A (en) * 2007-08-02 2009-02-04 天津天士力制药股份有限公司 Medicine for treating diabetes containing Radix Bupleurum and preparation method thereof

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101357181A (en) * 2007-08-02 2009-02-04 天津天士力制药股份有限公司 Medicine for treating diabetes containing Radix Bupleurum and preparation method thereof

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN113476557A (en) * 2021-08-01 2021-10-08 江苏省中医药研究院 Traditional Chinese medicine compound composition with effect of treating diabetic cardiac autonomic neuropathy and preparation method thereof
CN113476557B (en) * 2021-08-01 2022-03-25 江苏省中医药研究院 Traditional Chinese medicine compound composition with effect of treating diabetic cardiac autonomic neuropathy and preparation method thereof

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Application publication date: 20160921