CN106860412A - A kind of Sustained Release Preparations of Chinese Medicinal for treating diabetes and its complication and preparation method thereof - Google Patents
A kind of Sustained Release Preparations of Chinese Medicinal for treating diabetes and its complication and preparation method thereof Download PDFInfo
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- CN106860412A CN106860412A CN201710104504.1A CN201710104504A CN106860412A CN 106860412 A CN106860412 A CN 106860412A CN 201710104504 A CN201710104504 A CN 201710104504A CN 106860412 A CN106860412 A CN 106860412A
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/53—Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
- A61K36/539—Scutellaria (skullcap)
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/71—Ranunculaceae (Buttercup family), e.g. larkspur, hepatica, hydrastis, columbine or goldenseal
- A61K36/718—Coptis (goldthread)
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/80—Scrophulariaceae (Figwort family)
- A61K36/804—Rehmannia
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/88—Liliopsida (monocotyledons)
- A61K36/906—Zingiberaceae (Ginger family)
- A61K36/9066—Curcuma, e.g. common turmeric, East Indian arrowroot or mango ginger
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0002—Galenical forms characterised by the drug release technique; Application systems commanded by energy
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/2031—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
- A61K2236/331—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using water, e.g. cold water, infusion, tea, steam distillation or decoction
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
- A61K2236/333—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using mixed solvents, e.g. 70% EtOH
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/30—Extraction of the material
- A61K2236/39—Complex extraction schemes, e.g. fractionation or repeated extraction steps
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2236/00—Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
- A61K2236/50—Methods involving additional extraction steps
- A61K2236/51—Concentration or drying of the extract, e.g. Lyophilisation, freeze-drying or spray-drying
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- A—HUMAN NECESSITIES
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- A61K2236/50—Methods involving additional extraction steps
- A61K2236/55—Liquid-liquid separation; Phase separation
Landscapes
- Health & Medical Sciences (AREA)
- Natural Medicines & Medicinal Plants (AREA)
- Life Sciences & Earth Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Chemical & Material Sciences (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Medicinal Chemistry (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Alternative & Traditional Medicine (AREA)
- Mycology (AREA)
- Microbiology (AREA)
- Medical Informatics (AREA)
- Botany (AREA)
- Biotechnology (AREA)
- Neurosurgery (AREA)
- Biophysics (AREA)
- Molecular Biology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Medicines Containing Plant Substances (AREA)
- Medicinal Preparation (AREA)
Abstract
The invention discloses a kind of traditional Chinese medicine slow-releasing dripping pill for treating diabetes and its complication and preparation method thereof, it is made up of Chinese medicine material extract, slow-release material and other pharmaceutically acceptable auxiliary materials.The present invention adds a certain amount of slow-release material and other pharmaceutically acceptable auxiliary material compositions, is obtained through scientific design.Using raw material of the present invention and preparation method, obtained sustained release agent good stability, avoid the loss of volatile effective component, medicining times can be reduced, maintenance blood concentration is steady, extend holding time, reducing side effect for active ingredient, also have bioavilability high, it is evident in efficacy, the advantages of reducing medicining times and the compliance of patient can be improved.
Description
Technical field
The invention belongs to Chinese medicine, and in particular to a kind of Sustained Release Preparations of Chinese Medicinal and its preparation for treating diabetes and its complication
Method.
Background technology
Diabetes be one group due to insulin active severe lack and rise the inappropriate rising of C-21 cortico-steroid, cause blood sugar too high,
And cause sugar, fat and protein metabolism disorderly so that the multi-pathogenesis such as body water, electrolyte and acid-base imbalance cause with
The lifelong participation metabolic disease that chronic hyperglycemia is characterized.Long-term blood glucose increases, big blood vessel, capilary are damaged and jeopardize the heart, brain,
Kidney, peripheral nerve, eyes, foot etc., count according to the World Health Organization, and diabetic complication is up to kind more than 100, is to be currently known simultaneously
A kind of most disease of hair disease.Diabetes Death person has caused by more than half is cardiovascular and cerebrovascular, caused by 10% is nephropathy.Because of sugar
The patient of the sick amputation of urine is 10~20 times of non-diabetic.Clinical data shows 10 years or so after onset diabetes, will there is 30%
There is a kind of complication, and complication to I haven't seen you for ages once producing in~40% patient, drug therapy is difficult to reverse, therefore emphasizes to the greatest extent
Early prevention diabetic complication.
Application technology obtains existing more than the 40 years history of research and practice of the pharmaceutical dosage form of effect long.Particularly oral sustained release
The important directions that current medical industry develops are turned into the research and development of controlled-release solid formulation.Sustained release preparation (SRP)
By delaying medicine from the rate of releasing drug in the formulation, the absorption rate that medicine enters body is reduced, more preferably controlled so as to play
The preparation of therapeutic effect, its corresponding ordinary preparation compares, and administration frequency reduces half or reduced than ordinary preparation, and
The compliance of patient can be dramatically increased.
Important five yellow Yangyin Granules for the treatment of diabetes and its complication are by the southwest authentic medicinal herbs coptis, red at present
Stilbene, glutinous rehmannia, turmeric and the root of large-flowered skullcap, by by the coptis, turmeric ethanol extract, the dregs of a decoction with red stilbene, glutinous rehmannia water extraction, the independent alcohol extracting of the root of large-flowered skullcap
Method is prepared, and these medicinal materials are also Guizhou, Chongqing locality the ethnic group especially conventional seedling medicine of Miao ethnic group.Coptis Miao is
Wabge leenc naemx (transliteration is Wang Lian stems), red stilbene Miao are Dout hxaok (transliteration is confused for beans), turmeric Miao is
Voh had (transliteration is breathed out for nest), glutinous rehmannia Miao are Hgeil ghab (transliteration for Hfeex dab (transliteration is fertile clatter), root of large-flowered skullcap Miao
It is volume loud, high-pitched sound), the granule belongs to general formulation, and diabetes spp, to improve curative effect, increases in the chronic disease for needing long-term prescription
Patient medication compliance, inventor is improved product of changing products.
The content of the invention
To overcome the deficiencies in the prior art, the invention provides a kind of traditional Chinese medicine slow-releasing system for treating diabetes and its complication
Agent and preparation method thereof.
The present invention is realized by following technical scheme：
The invention provides a kind of traditional Chinese medicine slow-releasing dripping pill for treating diabetes and its complication, it is characterised in that：According to weight
Amount component is calculated：It is made up of Chinese medicine material extract, slow-release material and other pharmaceutically acceptable auxiliary materials.
Preferably, the present invention is provided treatment diabetes and its traditional Chinese medicine slow-releasing dripping pill of complication, calculate according to weight：In
Medicine raw extract is 1 with sustained release preparation proportioning：4~1：6 slow-release materials.
Traditional Chinese medicine slow-releasing dripping pill of the present invention, its Chinese medicine raw extract, by weight, by the coptis (Miao：Wang Lian
Stem) 277 parts, red stilbene (Miao：Beans confuse), glutinous rehmannia (Miao：Fertile clatter), turmeric (Miao：Nest is breathed out) each 833 parts, the root of large-flowered skullcap (Miao：Volume
Loud, high-pitched sound) 555 parts be made.
Traditional Chinese medicine slow-releasing dripping pill of the present invention, the slow-release material is in stearic acid, Brazil wax and polyethylene glycol
The mixture of one or more.
Preferably, the slow-release material of sustained-release dropping pill of the present invention is the ratio between stearic acid and polyethylene glycol 1:5 mixing
Thing.
The traditional Chinese medicine slow-releasing dripping pill for the treatment of diabetes of the present invention and its complication, other described auxiliary materials can be collapsed
Solution agent, filler, adhesive, wetting agent, lubricant, glidant, colouring agent, aromatic, sweetener, surfactant and inorganic
A kind of and several mixture in the auxiliary materials such as salt.
Traditional Chinese medicine slow-releasing dripping pill of the present invention, the Chinese medicine material extract preparation technology is：
1) it is solvent to take the coptis, turmeric with 60% ethanol by formula, is soaked 60 minutes, heating and refluxing extraction three times, first
Secondary solvent consumption is 8~10 times of medicinal material weight, is extracted for the first time 60 minutes, and second and third solvent consumption is the 5 of medicinal material weight
~6 times, second and third time each to extract 50 minutes, merges liquid, filtration, reclaims ethanol, concentration, filtration, and thick paste adds water heating for dissolving
Afterwards, suction filtration, filtrate crosses large pore resin absorption column, first washes with water to the reaction of sugar and is negative, then with ethanol elution, reclaims second
Alcohol, it is 1.10~1.25 to be concentrated into relative density at 60 DEG C, and vacuum drying is crushed, standby；
2) red stilbene, glutinous rehmannia and the coptis, the turmeric dregs of a decoction are taken with water as solvent by formula, is soaked 60 minutes, heating and refluxing extraction
Secondary, first time solvent consumption is 8~10 times of medicinal material weight, is extracted 80 minutes for the first time, and second solvent weight is medicine
5~6 times of material amount, second extraction 60 minutes merges liquid, and filtration stands 24 hours, and filtration is concentrated into the 1/ of original volume
2, filtered with inorganic ceramic membrane, the rate of filtration is 8~12L/h, collects filtrate, and be concentrated into relative density is at 60 DEG C
1.10~1.25, vacuum drying is crushed, standby；
3) it is solvent to take the root of large-flowered skullcap with 60% ethanol by formula, and first time solvent consumption is 6-8 times of medicinal material weight, soaks 60
Minute, heating and refluxing extraction, 120 minutes for the first time, second solvent consumption was 5~6 times of medicinal material weight, is heated to reflux carrying
Take, second 100 minutes, merge liquid, filtration；Ethanol is reclaimed, concentration, thick paste adds water after heating for dissolving, and suction filtration, filtrate is excessive
Macroporous adsorbent resin post, first washes with water to the reaction of sugar and is negative, then with ethanol elution, reclaims ethanol, is concentrated to give extract, dense
It is 1.10~1.25 that relative density is reduced at 60 DEG C, and vacuum drying is crushed, and is merged mixing with said extracted thing and is obtained final product.
Traditional Chinese medicine slow-releasing dripping pill of the present invention, the preparation method of the pill is：
(1) slow-release material is weighed, fully melting is mixed under condition of water bath heating, adds Chinese medicine material extract, added
30min is stirred continuously under heat condition, is sufficiently mixed uniform；
(2) start pill dripping machine, preheat 30min, set the feed temperature in instrument, material fill chassis temperature and condensation temperature or
Cryogenic temperature, starts the control button of each temperature, reaches show value；Feed temperature should be consistent with chassis temperature；
(3) start pill dripping machine stirring system, control mixing speed, the liquid that will be melted passes through charge door, into pill dripping machine
Batch can in, be stirred continuously 10min；
(4) condensate liquid liquid level adjusting knob is slowly opened, regulation drop is away from being 0.10~0.12cm；
(5) temperature to be condensed up to after 4~8 DEG C, 80~90 DEG C of fluid temperature, adjust by the water dropper switch on slow twisting drop tank
Section drop speed, and by liquid with the speed instillation condensate liquid dimethicone of 30~40 drop/min；
(6) dripping pill reaches out ball mouthful through cooling cycle system, collects sustained-release dropping pill；
(7) condensate liquid on sustained-release dropping pill surface is blotted with filter paper and hospital gauze, sustained-release dropping pill of the present invention is obtained final product.
Beneficial effects of the present invention are：The present invention adds a certain amount of slow-release material and other are pharmaceutically acceptable auxiliary
Material composition, obtains through scientific design.Using raw material of the present invention and preparation method, obtained sustained release agent good stability,
The loss of volatile effective component is avoided, medicining times can be reduced, maintained that blood concentration is steady, extension active ingredient maintenance
Time, reduction side effect, it is also high with bioavilability, it is evident in efficacy, reduce medicining times and the compliance of patient can be improved
The advantages of.
Below by way of experimental example, the invention will be further described.
The Selection experiment of experimental example 1, preparation technology:
Investigate the influence of dropping pill formulation release of the present invention using different slow-release materials to being made.
Using two methods of appendix C X first of Chinese Pharmacopoeia 2010 edition, using ethanol solution 500m1 as dissolution medium, rotating speed is
50 turns/min, operated according to this law, respectively in 0.25h, 0.75h, 2h, 3h, 4h, 5h, 6h, 8h, it is (automatic that lOh takes out solution 3m1
Fluid infusion), immediately by 0.22um miillpore filters, take filtrate 4u1 injection high performance liquid chromatographs and be measured, to press oil in dripping pill
Smart release calculates and draws curve as inspection target, as a result such as table 1：
The slow-release material Selection experiment result of table 1
Shown by table 1:The ratio between stearic acid, stearic acid and polyethylene glycol 1:5 mixing materials meet as sustained release retarding agent
It is required that.Wherein Brazil wax is obtained pill as sustained release retarding agent, and release rate is relatively low, should not individually select Brazil wax
Make sustained release retarding agent；Wherein the ratio between stearic acid and polyethylene glycol 1:5 mixing materials are obtained pill, are released the drug during beginning fast, reach
The purpose of quick acting, rate of releasing drug is more steady later, and blood concentration can more persistently maintained；Therefore the present invention is preferred is sustained
Retarding agent is:The ratio between stearic acid and polyethylene glycol 1:5 mixed accessories.
(2) Selection experiment of slow-release material consumption:
Using the preparation method of present invention process, Chinese medicine material extract is added to be discharged with pill is compared with slow-release material
The influence of degree, as a result such as table 2 below:
The Chinese medicine material extract of table 2 with release material mixture ratio Selection experiment result
Table 2 shows:When proportioning is 1:When 3, not enough, rate of releasing drug is too fast, and slow release effect is bad for drag；
When proportioning is 1:7 constantly, and drag is bigger than normal, and rate of releasing drug is excessively slow, it is difficult to maintains preferable blood concentration.Therefore,
It is 1 with slow-release material proportioning that the present invention chooses medicine raw extract:4~1:6, preferably 1:5.
Experimental example 2:Pill quality stability is checked:
Control group:Control group 1, control group 2 are respectively patent CN200510057171.9 disclosed embodiments 1, formula 3 and make
What Preparation Method was prepared；
Test group:Respectively the present invention implements the dripping pill that row 1, embodiment 4, embodiment 7 are made.
Investigation mode is:Berberine hydrochloride component content is with storage during dropping pill formulation is determined using accelerated stability test
The situation of change of time；The measure for being carried out for the dripping pill for just having prepared for wherein 0th month, after the 1st month for storage one month
The measure for carrying out, by that analogy, each experimental group dropping pill formulation tested uses identical storage method.Experimental result is such as
Table 3 below:
The Berberine hydrochloride study on the stability of table 3 is tested:
Shown by table 3:Dropping pill formulation obtained in two kinds of different process is stored into 6th month, and traditional handicraft prepares pill
The 73.8% of the dropping pill formulation for just preparing averagely is dropped to by content of berberine hydrochloride, and present invention employs slow release method
In dropping pill formulation obtained in preparation technology by content of berberine hydrochloride still for just prepared the 94.1% of pill.And decline
Trend tends to be steady.Illustrate accordingly:It is good using pill quality stability obtained in the present invention.
Experimental example 3:Release investigates experiment:
Investigation mode:Wood invention is obtained into dripping pill to be compared with common dripping pill, its vitro release situation is investigated, used
Two methods of appendix C X first of Chinese Pharmacopoeia 2010 edition, using ethanol solution 500m1 as dissolution medium, rotating speed is to be grasped according to this law
Make, respectively in 0.25h, 0.75h, 2h, 3h, 4h, 5h, 6h takes out solution 3m1 (automatic liquid supply), is filtered by 0.22um micropores immediately
Film, takes filtrate 4u1 injection high performance liquid chromatographs and is measured, and using Berberine hydrochloride release as inspection target, calculates simultaneously
Curve is drawn, as a result such as table 4 below:
The release of table 4 investigates experimental result
Shown by table 4:Quickly, basic release is finished common dripping pill rate of release within 2 hours, what the present invention was made
Pill drug release is more steady slow, and just drug release is finished after 10 hours, illustrates the pill being made of the invention relative to common
Pill, with preferable slow releasing function.
The sustained-release dropping pill that inventor is prepared to the present invention has carried out pharmacodynamic experiment, specific as follows：
1. data and method
1.1 clinical datas
1.1.1 physical data
All using Guizhou Province's traditional Chinese medical science Out-patient Department or unit patients.Observation 48, wherein treatment group 28, control group 20
Example.Treatment group male 11, women 17, average age 56.4 ± 7.0 years old, the course of disease 6.32 ± 5.14 years；Control group male 8
Example, women 12, average age 60.1 ± 6.93 years old, the course of disease 8.20 ± 4.25 years.Before treatment, two groups of patients in blood sugar, TC,
The lab index no significant difference such as TG, HDL-C, LDL-C, with comparativity.
1.1.2 diagnostic criteria
Case meets diabetes B and hyperlipidemia diagnostic criteria.Diabetes diagnosis were according to 2005《Diabetes mellitus in China refers to
South》：Diabetic symptom+random time plasma glucose levels >=11.1mmol/l (200mg/dl) or fasting plasma glucose
(FPG) in level >=7.0mmol/l (126mg/dl) or OGTT experiments, 2 hours PG levels >=11.1mmol/l (200mg/dl)；
Hyperlipidemia is diagnosed and criteria for classification is diagnosed with reference to national dyslipidemia in 1997 and treats what thematic scientific seminar formulated《Blood
Fat exception remedial proposal》Standard：
Plasma cholesterol (TC) ＞ 5.72mmol/L (220mg/dl), plasma triglyceride (TG) ＞ 1.7mmol/L
(150mg/dl), plasma low density lipoprotein cholesterol (LDL-C) ＞ 3.64mmol/L (140mg/dl), plasma high density fat egg
(HDL-C) ＜ 0.9mmol/L (35mg/dl) in vain.
Tcm syndrome standard：Organized to set up according to National Drug Administration in 2002《New Chinese medicine clinical research
Guideline》Chapter 10 Section three " new Chinese medicine treats the guideline of clinical investigations of diabetes " and Section four of chapter 2 " in
The guideline of clinical investigations of medicine Drugs in Therapy hyperlipidemia ", with reference to clinic, drafts this disease " deficiency of liver-yin and kidney-yin, phlegm-blood stasis stop up resistance card "
Standard.Primary symptom：Thirsty many drinks, body is fat, dizzy heavy, soreness and weakness of waist and knees.Secondary disease：Frequent urination, limb fiber crops are heavy, chest uncomfortable in chest
Bitterly, spontaneous sweating.Tongue vein：Tongue nature it is light it is dim have ecchymosis tongue white, or tongue is fat, tongue is satiny or few Tianjin, and forceless deep pulse or thin string are puckery.It is main above
Disease is indispensable 3, plus secondary disease 2, can be made a definite diagnosis with reference to tongue vein.
1.1.3 inclusive criteria
(1) diabetes B diagnostic criteria, the traditional Chinese medical science " deficiency of liver-yin and kidney-yin, phlegm-blood stasis stop up resistance card " CM syndrome differentiation criterion person are met.
(2) age between 30~70 years old, male or female.
(3) only has slight microvascular complication (urinary albumin excretion ratio ＜ 300mg/d, PVR≤1 phase).
(4) diabetes B is made a definite diagnosis more than 3 months.
(5) hypoglycemic medicine is used when entering group no more than 2 kinds, and insulin therapy person is not used.
(6) informed consent, aspiration is tested, obtains Informed Consent Form process and meets GCP stipulators.
1.1.4 exclusion standard
(1) blood glucose rise that the factor such as type 1 diabetes, liver diseases, gestation, medicine causes；
(2) nephrotic syndrome, hypothyroidism etc. other cause the disease of hyperlipidemia；
(3) age is below 30 years old or more than 70 years old；
(4) there are the serious acute complications such as Diabetic ketosis, DKA in nearly January or during medication；
(5) severe primary such as cardiovascular and cerebrovascular, liver, kidney, hemopoietic system disease, mental patient are associated with；Malignant tumour
Patient (unless surgery excision, more than 5 years without recurrence)；
(6) fasting blood-glucose >=18mmol/L or (and) 2 hours blood glucoses >=23mmol/L person after the meal；
(7) taking may influence the other drugs person of the observation index such as blood sugar, blood pressure, blood fat.
(8) judgement according to researcher, with reducing into group possibility or make into group other situations for complicating, building ring
Often variation etc. easily causes situation lost to follow-up in border.
(9) patient for participating in other drugs clinical research.
1.2 treatment methods
Withdraw all lipid-regulation medicines within 2 weeks before two groups of treatments, using Primary Care.
Primary Care is worked out with reference to Asian-Pacific area diabetes B policy group《Diabetes B practicality target with
Treatment》(third edition), carries out diet control and kinesiatrics, basic medication melbine, 500mg, 3 times/day.Melbine by
Institute of traditional Chinese medicine of Guizhou Province pharmaceutical chemists are provided, 500mg, three times a day, manufacturer：Fauna of Kunshan, Jiangsu Pei Li medicines Co., Ltd.
Treatment group：The embodiment 1 provided in Primary Care plus with the present invention, usage：Once a day.The course for the treatment of 4 weeks.
Control group：Only with Primary Care (diet, motion, melbine), it is not added with taking traditional Chinese medicine.The course for the treatment of 4 weeks.
Except test medication in addition to, prohibitted the use of during observation other treat this sick Chinese medicine and Western medicine and with this sick therapy-related
Other treatment.
1.3 observation index
1.3.1 blood sugar：Determined using intravenous glucose method.
1.3.2 FPI (FIns)：Using chemiluminescence immunoassay.
1.3.3 insulin sensitivity index (ISI) is evaluated：Calculated using improvement Insulin Sensitivity Index type formula, i.e. ISI
=1/FINSFPG.Insulin resistance (HOMA-IR) and β cell functions (HOMA- β cell) is evaluated to be assessed using equilibrium mode
Method formula：HOMA-IR=FINS × FPG/22.5, HOMA- β cell=20 × FINS/ (FPG-3.5).
1.3.4 blood T-CHOL (TC), triglyceride (TG), LDL-C (LDL-C), high density lipoprotein level
White cholesterol (HDL-C)：Using automatic clinical chemistry analyzer.
1.3.5 glycated serum protein is determined before and after treating：Using automatic clinical chemistry analyzer.
1.4 criterions of therapeutical effect
Organized to set up according to National Drug Administration in 2002《New Chinese medicine guideline of clinical investigations》It is made
The criterion of therapeutical effect ordered judges.
1.5 statistical methods
Descriptive statistic：Enumeration data represents that measurement data is used using composition ratio or rateRepresent；Statistical inference：
Statistical method has parametric test and non-parametric test, and specific method has Chi-square Test, paired t-test and the t of sample is checked in groups
Deng statistical software uses SPSS13.0.
2 treatment results
Chinese medicine syndrome integral compares before and after 2.1 two groups of treatments
Chinese medicine syndrome integral compares before and after 5 two groups of treatments of table
| Group | n | Before treatment | After treatment |
| Embodiment treatment group | 28 | 26.4 scholars 5.8 | |
| Control group | 20 | 24.7 scholars 4.3 |
Note：Compare with before treatmentΔP ＜ 0.01, compare after treatment between group#P ＜ 0.01.
From table 5, after treatment, two groups of syndrome integrals significantly change (P ＜ 0.01) before relatively treating, and the course for the treatment of terminates
Afterwards, embodiment treatment group syndrome integral is substantially better than control group, there is significant difference (P ＜ 0.01).
Blood glucose target change before and after 2.2 two groups of treatments
Table 6 treats index change (mmol/l) of front and rear two groups of blood sugar
Note：Compare in group before and after treatment#Compare between P ＜ 0.01, group※P ＜ 0.01.
From table 6, two groups of FBG, PBG (2h) blood sugar have clear improvement (P ＜ 0.01) before and after treatment, compare between group and control
After treatment, embodiment treatment group hypoglycemic curative effect is better than control group, there is significant difference (P ＜ 0.01).
2.3 two groups of patient's glycated serum protein situations of change
Glycated serum protein compares before and after 7 two groups of treatments of table
| Group | n | Before treatment | After treatment |
| Treatment group | 28 | 341.1 scholars 24.2 | |
| Control group | 20 | 341 scholars 47.6 |
Note：Compare with before treatmentΔP ＜ 0.05,ΔΔP ＜ 0.01；Compare between group※P ＜ 0.05.
From table 7, there be between improvement (P ＜ 0.01), group after comparison therapy two groups of glycated serum proteins before and after treatment, real
Shi Li treatment groups hypoglycemic curative effect is better than control group, there is significant difference (P ＜ 0.01).
Blood Lipid before and after 2.4 two groups of treatments
Blood Lipid compares before and after 8 two groups of treatments of table
Note：Compare with before treatmentΔP ＜ 0.01,ΔΔP ＜ 0.05；Compare between group※P ＜ 0.05.
From table 8, TC, TG, LDL-C level decline after embodiment treatment group patient treatment, have aobvious with comparing before treatment
Sex differernce (P ＜ 0.01) is write, HDL-C compares rising (P ＜ 0.05) with before treatment；TC levels decline after control group patient treatment,
Comparing with before treatment has significant difference (P ＜ 0.01), and TG, LDL-C change with decline (P ＜ 0.05), HDL-C is compared before treatment
Change does not have notable difference.Compare between group, the improvement for the treatment of group TC and TG is superior to control group, there is significant difference (P ＜ 0.05).
The change of two groups of FPIs and insulin resistance index of correlation before and after 2.5 treatments
Islet function index of correlation compares before and after 9 two groups of treatments of table
Note：Compare with before treatmentΔP ＜ 0.05,ΔΔP ＜ 0.01；Compare between group※P ＜ 0.05.
From table 9, two groups of each index of correlation are improved in varying degrees (P ＜ 0.05~0.01) before and after treatment, wherein
The improvement degree of embodiment treatment group ISI, Homa-IR, Homa-B compares and has improvement (P ＜ 0.05~0.01) with before treatment,
Compare that there were significant differences (P ＜ 0.05) with control group
2.6 two groups of comparitive studies
The comparitive study that 10 two groups of table
Note：P ＜ 0.05
The embodiment treatment group totally 28 provided from table 10, the present invention, wherein effective 10, effective 16, invalid 2
Example, total effective rate is 92.9%；Control group totally 20, wherein effective 4, effective 11, invalid 5, total effective rate is 75%.
Test result indicate that the embodiment that the present invention is provided has the effect of preferably treatment diabetes, two groups relatively have significant difference
(P ＜ 0.05).
Specific embodiment
Embodiment 1
Prescription：Coptis 277g, each 833g of red stilbene, glutinous rehmannia, turmeric, root of large-flowered skullcap 555g Chinese medicine materials extract with release material mixture ratio
It is 1:4
The preparation method of Chinese medicine material extract
Technique：1) it is solvent to take the coptis, turmeric with 60% ethanol by formula, is soaked 60 minutes, heating and refluxing extraction three times,
First time solvent consumption is 8 times of medicinal material weight, is extracted for the first time 60 minutes, and second and third solvent consumption is the 5 of medicinal material weight
Times, second and third each extraction 50 minutes merges liquid, and ethanol is reclaimed in filtration, and concentration is filtered, and thick paste adds water after heating for dissolving,
Suction filtration, filtrate crosses large pore resin absorption column, first washes with water to the reaction of sugar and is negative, then with ethanol elution, reclaims ethanol, dense
It is 1.10~1.25 that relative density is reduced at 60 DEG C, and vacuum drying is crushed, standby；
2) red stilbene, glutinous rehmannia and the coptis, the turmeric dregs of a decoction are taken with water as solvent by formula, is soaked 60 minutes, heating and refluxing extraction
Secondary, first time solvent consumption is 8 times of medicinal material weight, is extracted 80 minutes for the first time, and second solvent weight is medicinal material amount
5 times, second extracts 60 minutes, merges liquid, and filtration stands 24 hours, and filtration is concentrated into the 1/2 of original volume, with inorganic
Ceramic membrane is filtered, and the rate of filtration is 8L/h, collects filtrate, and it is 1.10~1.25 to be concentrated into relative density at 60 DEG C, very
Sky dry, pulverize, standby；
3) it is solvent to take the root of large-flowered skullcap with 60% ethanol by formula, and first time solvent consumption is 6 times of medicinal material weight, soaks 60 points
Clock, heating and refluxing extraction, first time I20 minutes, second solvent consumption was 5~6 times of medicinal material weight, heating and refluxing extraction,
Second 100 minutes, merge liquid, filtration；Ethanol is reclaimed, concentration, thick paste adds water after heating for dissolving, and suction filtration, filtrate crosses macropore
Adsorption resin column, first washes with water to the reaction of sugar and is negative, then with ethanol elution, reclaims ethanol, is concentrated to give extract, concentrates
At 60 DEG C it is 1.10~1.25 to relative density, vacuum drying is crushed, and is merged mixing with said extracted thing and is obtained final product.
Dripping pill preparation technology
(1) slow-release material is weighed, fully melting is mixed under condition of water bath heating, adds Chinese medicine material extract, added
30min is stirred continuously under heat condition, is sufficiently mixed uniform；
(2) start pill dripping machine, preheat 30min, set the feed temperature in instrument, material fill chassis temperature and condensation temperature or
Cryogenic temperature, starts the control button of each temperature, reaches show value；Feed temperature should be consistent with chassis temperature；
(3) start pill dripping machine stirring system, control mixing speed, the liquid that will be melted passes through charge door, into pill dripping machine
Batch can in, be stirred continuously 10min；
(4) condensate liquid liquid level adjusting knob is slowly opened, regulation drop is away from being 0.10~0.12cm；
(5) temperature to be condensed up to after 4~8 DEG C, 80~90 DEG C of fluid temperature, adjust by the water dropper switch on slow twisting drop tank
Section drop speed, and by liquid with the speed instillation condensate liquid dimethicone of 30~40 drop/min；
(6) dripping pill reaches out ball mouthful through cooling cycle system, collects sustained-release dropping pill；
(7) condensate liquid on sustained-release dropping pill surface is blotted with filter paper and hospital gauze, sustained-release dropping pill of the present invention is obtained final product.
Embodiment 2
Prescription：Coptis 277g, each 833g of red stilbene, glutinous rehmannia, turmeric, root of large-flowered skullcap 555g Chinese medicine materials extract with release material mixture ratio
It is 1:4
The preparation method of Chinese medicine material extract：
1) it is solvent to take the coptis, turmeric with 60% ethanol by formula, is soaked 60 minutes, heating and refluxing extraction three times, first
Secondary solvent consumption is I0 times of medicinal material weight, extracts 60 minutes for the first time, and second and third solvent consumption is 6 times of medicinal material weight,
Second and third each extraction 50 minutes, merges liquid, and ethanol is reclaimed in filtration, and concentration is filtered, and thick paste adds water after heating for dissolving, takes out
Filter, filtrate crosses large pore resin absorption column, first washes with water to the reaction of sugar and is negative, then with ethanol elution, reclaims ethanol, concentration
At 60 DEG C it is 1.10~1.25 to relative density, vacuum drying is crushed, standby；
2) red stilbene, glutinous rehmannia and the coptis, the turmeric dregs of a decoction are taken with water as solvent by formula, is soaked 60 minutes, heating and refluxing extraction
Secondary, first time solvent consumption is 10 times of medicinal material weight, is extracted 80 minutes for the first time, and second solvent weight is medicinal material amount
6 times, second extracts 60 minutes, merges liquid, and filtration stands 24 hours, and filtration is concentrated into the 1/2 of original volume, with inorganic
Ceramic membrane is filtered, and the rate of filtration is 12L/h, collects filtrate, and it is 1.10~1.25 to be concentrated into relative density at 60 DEG C, very
Sky dry, pulverize, standby；
3) it is solvent to take the root of large-flowered skullcap with 60% ethanol by formula, and first time solvent consumption is 6-8 times of medicinal material weight, soaks 60
Minute, heating and refluxing extraction, first time I20 minute, second solvent consumption was 6 times of medicinal material weight, heating and refluxing extraction, the
Secondary 100 minutes, merge liquid, filtration；Ethanol is reclaimed, concentration, thick paste adds water after heating for dissolving, suction filtration, filtrate crosses macropore suction
Attached resin column, first washes with water to the reaction of sugar and is negative, then with ethanol elution, reclaims ethanol, is concentrated to give extract, is concentrated into
Relative density is 1.10~1.25 at 60 DEG C, and vacuum drying is crushed, and is merged mixing with said extracted thing and is obtained final product.
Preparation process thereof
(1) slow-release material is weighed, fully melting is mixed under condition of water bath heating, adds Chinese medicine material extract, added
30min is stirred continuously under heat condition, is sufficiently mixed uniform；
(2) start pill dripping machine, preheat 30min, set the feed temperature in instrument, material fill chassis temperature and condensation temperature or
Cryogenic temperature, starts the control button of each temperature, reaches show value；Feed temperature should be consistent with chassis temperature；
(3) start pill dripping machine stirring system, control mixing speed, the liquid that will be melted passes through charge door, into pill dripping machine
Batch can in, be stirred continuously 10min；
(4) condensate liquid liquid level adjusting knob is slowly opened, regulation drop is away from being 0.10~0.12cm；
(5) temperature to be condensed up to after 4~8 DEG C, 80~90 DEG C of fluid temperature, adjust by the water dropper switch on slow twisting drop tank
Section drop speed, and by liquid with the speed instillation condensate liquid dimethicone of 30~40 drop/min；
(6) dripping pill reaches out ball mouthful through cooling cycle system, collects sustained-release dropping pill；
(7) condensate liquid on sustained-release dropping pill surface is blotted with filter paper and hospital gauze, sustained-release dropping pill of the present invention is obtained final product.
Embodiment 3
Prescription：Coptis 277g, each 833g of red stilbene, glutinous rehmannia, turmeric, root of large-flowered skullcap 555g Chinese medicine materials extract with release material mixture ratio
It is 1:4
The preparation method of Chinese medicine material extract:
1) it is solvent to take the coptis, turmeric with 60% ethanol by formula, is soaked 60 minutes, heating and refluxing extraction three times, first
Secondary solvent consumption is 9 times of medicinal material weight, is extracted for the first time 60 minutes, and second and third solvent consumption is the 5.5 of medicinal material weight
Times, second and third each extraction 50 minutes merges liquid, and ethanol is reclaimed in filtration, and concentration is filtered, and thick paste adds water after heating for dissolving,
Suction filtration, filtrate crosses large pore resin absorption column, first washes with water to the reaction of sugar and is negative, then with ethanol elution, reclaims ethanol, dense
It is 1.10~1.25 that relative density is reduced at 60 DEG C, and vacuum drying is crushed, standby；
2) red stilbene, glutinous rehmannia and the coptis, the turmeric dregs of a decoction are taken with water as solvent by formula, is soaked 60 minutes, heating and refluxing extraction
Secondary, first time solvent consumption is 9 times of medicinal material weight, is extracted 80 minutes for the first time, and second solvent weight is medicinal material amount
5.5 times, second extracts 60 minutes, merges liquid, and filtration stands 24 hours, and filtration is concentrated into the 1/2 of original volume, with nothing
Machine ceramic membrane is filtered, and the rate of filtration is 10L/h, collects filtrate, and it is 1.10~1.25 to be concentrated into relative density at 60 DEG C,
Vacuum drying, crushes, standby；
3) it is solvent to take the root of large-flowered skullcap with 60% ethanol by formula, and first time solvent consumption is 6-8 times of medicinal material weight, soaks 60
Minute, heating and refluxing extraction, first time I20 minute, second solvent consumption was 5.5 times of medicinal material weight, heating and refluxing extraction,
Second 100 minutes, merge liquid, filtration；Ethanol is reclaimed, concentration, thick paste adds water after heating for dissolving, and suction filtration, filtrate crosses macropore
Adsorption resin column, first washes with water to the reaction of sugar and is negative, then with ethanol elution, reclaims ethanol, is concentrated to give extract, concentrates
At 60 DEG C it is 1.10~1.25 to relative density, vacuum drying is crushed, and is merged mixing with said extracted thing and is obtained final product.
Preparation process thereof
(1) slow-release material is weighed, fully melting is mixed under condition of water bath heating, adds Chinese medicine material extract, added
30min is stirred continuously under heat condition, is sufficiently mixed uniform；
(2) start pill dripping machine, preheat 30min, set the feed temperature in instrument, material fill chassis temperature and condensation temperature or
Cryogenic temperature, starts the control button of each temperature, reaches show value；Feed temperature should be consistent with chassis temperature；
(3) start pill dripping machine stirring system, control mixing speed, the liquid that will be melted passes through charge door, into pill dripping machine
Batch can in, be stirred continuously 10min；
(4) condensate liquid liquid level adjusting knob is slowly opened, regulation drop is away from being 0.10~0.12cm；
(5) temperature to be condensed up to after 4~8 DEG C, 80~90 DEG C of fluid temperature, adjust by the water dropper switch on slow twisting drop tank
Section drop speed, and by liquid with the speed instillation condensate liquid dimethicone of 30~40 drop/min；
(6) dripping pill reaches out ball mouthful through cooling cycle system, collects sustained-release dropping pill；
(7) condensate liquid on sustained-release dropping pill surface is blotted with filter paper and hospital gauze, sustained-release dropping pill of the present invention is obtained final product.
Embodiment 4
Prescription：Coptis 277g, each 833g of red stilbene, glutinous rehmannia, turmeric, root of large-flowered skullcap 555g Chinese medicine materials extract with release material mixture ratio
It is 1:5
The preparation method of Chinese medicine material extract：Extract is prepared by the method for embodiment 1.
Preparation process thereof：Sustained-release dropping pill is prepared by the method for embodiment 1.
Embodiment 5
Prescription：Coptis 277g, each 833g of red stilbene, glutinous rehmannia, turmeric, root of large-flowered skullcap 555g Chinese medicine materials extract with release material mixture ratio
It is 1:5
The preparation method of Chinese medicine material extract：Extract is prepared by the method for embodiment 2.
Preparation process thereof：Sustained-release dropping pill is prepared by the method for embodiment 2.
Embodiment 6
Prescription：Coptis 277g, each 833g of red stilbene, glutinous rehmannia, turmeric, root of large-flowered skullcap 555g Chinese medicine materials extract with release material mixture ratio
It is 1:5
The preparation method of Chinese medicine material extract：Extract is prepared by the method for embodiment 3.
Preparation process thereof：Sustained-release dropping pill is prepared by the method for embodiment 3.
Embodiment 7
Prescription：Coptis 277g, each 833g of red stilbene, glutinous rehmannia, turmeric, root of large-flowered skullcap 555g Chinese medicine materials extract with release material mixture ratio
It is 1:6
The preparation method of Chinese medicine material extract：Extract is prepared by the method for embodiment 1.
Preparation process thereof：Sustained-release dropping pill is prepared by the method for embodiment 1.
Embodiment 8
Prescription：Coptis 277g, each 833g of red stilbene, glutinous rehmannia, turmeric, root of large-flowered skullcap 555g Chinese medicine materials extract with release material mixture ratio
It is 1:6
The preparation method of Chinese medicine material extract：Extract is prepared by the method for embodiment 2.
Preparation process thereof：Sustained-release dropping pill is prepared by the method for embodiment 2.
Embodiment 9
Prescription：Coptis 277g, each 833g of red stilbene, glutinous rehmannia, turmeric, root of large-flowered skullcap 555g Chinese medicine materials extract with release material mixture ratio
It is 1:6
The preparation method of Chinese medicine material extract：Extract is prepared by the method for embodiment 3.
Preparation process thereof：Sustained-release dropping pill is prepared by the method for embodiment 3.
Although above having used general explanation, specific embodiment and experiment, the present invention is made to retouch in detail
State, but on the basis of the present invention, some modifications or improvement can be made to it, this is to those skilled in the art aobvious and easy
See.Therefore, these modifications or improvements without departing from theon the basis of the spirit of the present invention, belong to claimed
Scope.
Claims (8)
1. a kind of traditional Chinese medicine slow-releasing dripping pill for treating diabetes and its complication, it is characterised in that：Calculated according to composition by weight：In
Medicine raw extract, slow-release material and other pharmaceutically acceptable auxiliary materials are made.
2. according to the treatment diabetes and its traditional Chinese medicine slow-releasing dripping pill of complication described in claim 1, it is characterised in that：According to weight
Amount is calculated：Chinese medicine material extract is 1 with sustained release preparation proportioning：4~1：6 slow-release materials.
3. the traditional Chinese medicine slow-releasing dripping pill according to claim 1 and 2, it is characterised in that the Chinese medicine material extract, by weight
Part meter, by the coptis (Miao：Wang Lian stems) 277 parts, red stilbene (Miao：Beans confuse), glutinous rehmannia (Miao：Fertile clatter), turmeric (Miao：Nest is breathed out)
Each 833 parts, the root of large-flowered skullcap (Miao：Volume loud, high-pitched sound) 555 parts be made.
4. traditional Chinese medicine slow-releasing dripping pill according to claim 1 and 2, it is characterised in that the slow-release material is stearic acid, Brazil
The mixture of one or more in palm wax and polyethylene glycol.
5. sustained-release dropping pill according to claim 5, it is characterised in that：Described slow-release material is stearic acid and polyethylene glycol
The ratio between 1:5 mixture.
6. according to the treatment diabetes and its traditional Chinese medicine slow-releasing dripping pill of complication described in claim 1, it is characterised in that：Described
Other auxiliary materials can be disintegrant, filler, adhesive, wetting agent, lubricant, glidant, colouring agent, aromatic, sweetener,
A kind of and several mixture in the auxiliary material such as surfactant and inorganic salts.
7. the traditional Chinese medicine slow-releasing dripping pill according to any one of Claims 1 to 4, it is characterised in that the Chinese medicine material extract
Preparation technology is：
1) it is solvent to take the coptis, turmeric with 60% ethanol by formula, is soaked 60 minutes, heating and refluxing extraction three times, molten for the first time
Matchmaker's consumption is 8~10 times of medicinal material weight, is extracted for the first time 60 minutes, and second and third solvent consumption is the 5~6 of medicinal material weight
Times, second and third each extraction 50 minutes merges liquid, and ethanol is reclaimed in filtration, and concentration is filtered, and thick paste adds water after heating for dissolving,
Suction filtration, filtrate crosses large pore resin absorption column, first washes with water to the reaction of sugar and is negative, then with ethanol elution, reclaims ethanol, dense
It is 1.10~1.25 that relative density is reduced at 60 DEG C, and vacuum drying is crushed, standby；
2) red stilbene, glutinous rehmannia and the coptis, the turmeric dregs of a decoction are taken with water as solvent by formula, are soaked 60 minutes, heating and refluxing extraction is secondary,
First time solvent consumption is 8~10 times of medicinal material weight, is extracted 80 minutes for the first time, and second solvent weight is medicinal material amount
5~6 times, second extraction 60 minutes merges liquid, and filtration stands 24 hours, and filtration is concentrated into the 1/2 of original volume, with nothing
Machine ceramic membrane is filtered, and the rate of filtration is 8~12L/h, collects filtrate, be concentrated into relative density at 60 DEG C for 1.10~
1.25, vacuum drying is crushed, standby；
3) it is solvent to take the root of large-flowered skullcap with 60% ethanol by formula, and first time solvent consumption is 6-8 times of medicinal material weight, soaks 60 points
Clock, heating and refluxing extraction, 120 minutes for the first time, second solvent consumption was 5~6 times of medicinal material weight, heating and refluxing extraction,
Second 100 minutes, merge liquid, filtration；Ethanol is reclaimed, concentration, thick paste adds water after heating for dissolving, and suction filtration, filtrate crosses macropore
Adsorption resin column, first washes with water to the reaction of sugar and is negative, then with ethanol elution, reclaims ethanol, is concentrated to give extract, concentrates
At 60 DEG C it is 1.10~1.25 to relative density, vacuum drying is crushed, and is merged mixing with said extracted thing and is obtained final product.
8. traditional Chinese medicine slow-releasing dripping pill according to claim 1 and 2, it is characterised in that the preparation method of the pill is：
(1) slow-release material is weighed, fully melting is mixed under condition of water bath heating, Chinese medicine material extract is added, in fire-bar
30min is stirred continuously under part, is sufficiently mixed uniform；
(2) start pill dripping machine, preheat 30min, the feed temperature in instrument, material are set and fill chassis temperature and condensation temperature or refrigeration
Temperature, starts the control button of each temperature, reaches show value；Feed temperature should be consistent with chassis temperature；
(3) start pill dripping machine stirring system, control mixing speed, the liquid that will be melted passes through charge door, into the material of pill dripping machine
In tank, 10min is stirred continuously；
(4) condensate liquid liquid level adjusting knob is slowly opened, regulation drop is away from being 0.10~0.12cm；
(5) temperature to be condensed is up to after 4~8 DEG C, 80~90 DEG C of fluid temperature, the water dropper switch on slow twisting drop tank, regulation drop
Speed, and by liquid with the speed instillation condensate liquid dimethicone of 30~40 drop/min；
(6) dripping pill reaches out ball mouthful through cooling cycle system, collects sustained-release dropping pill；
(7) condensate liquid on sustained-release dropping pill surface is blotted with filter paper and hospital gauze, sustained-release dropping pill of the present invention is obtained final product.
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Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1724065A (en) * | 2005-07-15 | 2006-01-25 | 中国人民解放军第三军医大学第二附属医院 | Medicine of treatment diabetes and preparation method thereof |
| CN105535460A (en) * | 2016-01-07 | 2016-05-04 | 天津市康瑞药业有限公司 | Traditional Chinese medicine dropping pills for treating mild type 2 diabetes and preparation method thereof |
-
2017
- 2017-02-24 CN CN201710104504.1A patent/CN106860412B/en active Active
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1724065A (en) * | 2005-07-15 | 2006-01-25 | 中国人民解放军第三军医大学第二附属医院 | Medicine of treatment diabetes and preparation method thereof |
| CN105535460A (en) * | 2016-01-07 | 2016-05-04 | 天津市康瑞药业有限公司 | Traditional Chinese medicine dropping pills for treating mild type 2 diabetes and preparation method thereof |
Non-Patent Citations (3)
| Title |
|---|
| 夏海建等: "正交试验法优化黄芩苷缓释滴丸的制备工艺", 《中华中医药杂志》 * |
| 方瑜等: "姜黄素缓释滴丸的制备及体外释放度考察", 《中药材》 * |
| 李群力等: "姜素缓释滴丸的制备及其6-姜酚的定量测定", 《中成药》 * |
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