CN106860412B - A kind of Sustained Release Preparations of Chinese Medicinal and preparation method thereof for treating diabetes and its complication - Google Patents

A kind of Sustained Release Preparations of Chinese Medicinal and preparation method thereof for treating diabetes and its complication Download PDF

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CN106860412B
CN106860412B CN201710104504.1A CN201710104504A CN106860412B CN 106860412 B CN106860412 B CN 106860412B CN 201710104504 A CN201710104504 A CN 201710104504A CN 106860412 B CN106860412 B CN 106860412B
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pill
release
chinese medicine
slow
minutes
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CN106860412A (en
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张芝庭
张涛涛
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GUIZHOU SHENQI PHARMACEUTICAL CO Ltd
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    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
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    • A61K36/185—Magnoliopsida (dicotyledons)
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    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/71—Ranunculaceae (Buttercup family), e.g. larkspur, hepatica, hydrastis, columbine or goldenseal
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    • A61K2236/30—Extraction of the material
    • A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
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Abstract

The invention discloses a kind of traditional Chinese medicine slow-releasing dripping pills and preparation method thereof for treating diabetes and its complication, are made of Chinese medicine material extract, slow-release material and other pharmaceutically acceptable auxiliary materials.A certain amount of slow-release material and other pharmaceutically acceptable auxiliary material compositions is added in the present invention, obtains through scientific design.Using raw material of the present invention and preparation method, sustained release agent stability obtained is good, avoid the loss of volatile effective component, it can be reduced medicining times, maintain that blood concentration is steady, extends holding time, reducing side effect for effective component, also have bioavilability high, it is significant in efficacy, the advantages that reducing medicining times and the compliance of patient can be improved.

Description

A kind of Sustained Release Preparations of Chinese Medicinal and preparation method thereof for treating diabetes and its complication
Technical field
The invention belongs to Chinese medicines, and in particular to a kind of Sustained Release Preparations of Chinese Medicinal for treating diabetes and its complication and its preparation Method.
Background technique
Diabetes are one group since insulin active severe lacks and the inappropriate raising of glycemic hormone, cause blood glucose excessively high, And cause sugar, fat and protein metabolism disorder so that the multi-pathogenesis such as body water, electrolyte and acid-base imbalance caused by with The lifelong participation metabolic disease that chronic hyperglycemia is characterized.Long-term blood glucose increases, big blood vessel, capilary be damaged and jeopardize the heart, brain, Kidney, peripheral nerve, eyes, foot etc., according to the statistics of the World Health Organization, diabetic complication are up to more than 100 kinds, are to be currently known simultaneously Send out a kind of most disease of disease.It is caused by cardiovascular and cerebrovascular that Diabetes Death person, which has more than half, and 10% is caused by nephropathy.Because of sugar The patient for urinating sick amputation is 10~20 times of non-diabetic.Clinical data shows 10 years or so after onset diabetes, will there is 30% A kind of complication can at least occur for~40% patient, and complication, once generating, drug therapy is difficult to reverse, therefore emphasizes to the greatest extent Early prevention diabetic complication.
Application technology obtains the research of the pharmaceutical dosage form of long effect and practices existing more than 40 years history.Especially oral sustained release Research and development with controlled-release solid dosage form has become an important directions of current medical industry development.Sustained release preparation (SRP) By delaying drug from the rate of releasing drug in the dosage form, the absorption rate that drug enters body is reduced, is more preferably controlled to play The preparation of therapeutic effect, its corresponding ordinary preparation compare, and administration frequency reduces half than ordinary preparation or reduced, 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 radix scutellariae, by the way that by the coptis, the extraction of turmeric ethyl alcohol, the dregs of a decoction are mentioned with red stilbene, Rehmannia glutinosa Libosch Water, the independent alcohol extracting of radix scutellariae Method is prepared, these medicinal materials are also Guizhou, the common seedling medicine of especially Miao ethnic group, Chongqing locality ethnic group.Coptis Miao is Wabge leenc naemx (transliteration is Wang Lian stem), red stilbene Miao are Dout hxaok (transliteration is confused for beans), turmeric Miao is Voh had (transliteration is that nest is breathed out), glutinous rehmannia Miao are Hfeex dab (transliteration is fertile clatter), radix scutellariae Miao is Hgeil ghab (transliteration For volume loud, high-pitched sound), which belongs to general formulation, and diabetes spp, to improve curative effect, increases in the chronic disease for needing long-term administration Patient medication compliance, inventor improve product of changing products.
Summary of the invention
In order to overcome the deficiencies of the prior art, the present invention provides a kind of traditional Chinese medicine slow-releasing systems for treating diabetes and its complication Agent and preparation method thereof.
The present invention is realized by following technical solution:
The present invention provides a kind of traditional Chinese medicine slow-releasing dripping pills for treating diabetes and its complication, it is characterised in that: according to weight Amount component calculates: being made of Chinese medicine material extract, slow-release material and other pharmaceutically acceptable auxiliary materials.
Preferably, the traditional Chinese medicine slow-releasing dripping pill for the treatment of diabetes and its complication provided by the invention, calculates according to weight: in Medicine raw extract and sustained release preparation proportion are 1:4~1:6 slow-release material.
Traditional Chinese medicine slow-releasing dripping pill of the present invention, 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) 833 parts each, radix scutellariae (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 are in stearic acid, Brazil wax and polyethylene glycol One or more of mixtures.
Preferably, the slow-release material of sustained-release dropping pill of the present invention is the mixing of the ratio between stearic acid and polyethylene glycol 1:5 Object.
The traditional Chinese medicine slow-releasing dripping pill for the treatment of diabetes and its complication of the present invention, other auxiliary materials, which can be, to be collapsed Solve agent, filler, adhesive, wetting agent, lubricant, glidant, colorant, aromatic, sweetener, surfactant and inorganic One of auxiliary materials such as salt and several mixtures.
Traditional Chinese medicine slow-releasing dripping pill of the present invention, the Chinese medicine material extract preparation process are as follows:
1) take the coptis, turmeric using 60% ethyl alcohol as solvent by formula, impregnate 60 minutes, heating and refluxing extraction three times, first Secondary solvent dosage is 8~10 times of medicinal material weight, is extracted 60 minutes for the first time, second and third secondary solvent dosage is the 5 of medicinal material weight ~6 times, second and third each extraction 50 minutes merges medical fluid, and ethyl alcohol is recycled in filtration, is concentrated, and filters, and thick paste adds water to dissolve by heating Afterwards, it filtering, filtrate crosses large pore resin absorption column, and it is first eluted with water to the reaction of sugar and is negative, then use ethanol elution, recycling second Alcohol, being concentrated into relative density at 60 DEG C is 1.10~1.25, is dried in vacuo, and is crushed, spare；
2) it takes red stilbene, glutinous rehmannia and the coptis, the turmeric dregs of a decoction using water as solvent by formula, impregnates 60 minutes, heating and refluxing extraction Secondary, first time solvent dosage is 8~10 times of medicinal material weight, is extracted 80 minutes for the first time, second of solvent is medicine with weight 5~6 times of material amount, second of extraction 60 minutes merge medical fluid, and filtration stands 24 hours, and filtration is concentrated into the 1/ of original volume 2, it is filtered with inorganic ceramic membrane, the rate of filtration is 8~12L/h, collects filtrate, be concentrated into relative density is at 60 DEG C 1.10~1.25, it is dried in vacuo, crushes, it is spare；
3) take radix scutellariae using 60% ethyl alcohol as solvent by formula, first time solvent dosage is 6-8 times of medicinal material weight, impregnates 60 Minute, heating and refluxing extraction, 120 minutes for the first time, second of solvent dosage was 5~6 times of medicinal material weight, is heated to reflux and mentions It takes, second 100 minutes, merges medical fluid, filtration；Ethyl alcohol is recycled, concentration after thick paste adds water to dissolve by heating, filters, and filtrate is excessive Macroporous adsorbent resin column, be first eluted with water to sugar reaction be negative, then use ethanol elution, recycling ethyl alcohol, be concentrated to give extract, it is dense It is 1.10~1.25 that relative density, which is reduced to, at 60 DEG C, is dried in vacuo, and crushes, merges with said extracted object and mix to obtain the final product.
Traditional Chinese medicine slow-releasing dripping pill of the present invention, the pill the preparation method comprises the following steps:
(1) slow-release material is weighed, sufficiently melting mixes under condition of water bath heating, and Chinese medicine material extract is added, is adding It is stirred continuously 30min under heat condition, is sufficiently mixed uniformly；
(2) start pill dripping machine, preheat 30min, the feed liquid temperature that is arranged in instrument, material fill chassis temperature and condensation temperature or Cryogenic temperature starts the control button of each temperature, reaches show value；Feed liquid temperature should be consistent with chassis temperature；
(3) start pill dripping machine stirring system, control mixing speed, by the medical fluid of melting by feed opening, into pill dripping machine Batch can in, be stirred continuously 10min；
(4) condensate liquid liquid level adjusting knob is slowly opened, adjusts drop away from for 0.10~0.12cm；
(5) temperature to be condensed is up to after 4~8 DEG C, 80~90 DEG C of fluid temperature, and slowly the water dropper switch on twisting drop tank, is adjusted Section drop speed, and medical fluid is instilled in condensate liquid dimethicone with 30~40 drops/min speed；
(6) dripping pill reaches out ball mouth through cooling cycle system, collects sustained-release dropping pill；
(7) condensate liquid on sustained-release dropping pill surface is blotted to get sustained-release dropping pill of the present invention with filter paper and hospital gauze.
The invention has the benefit that a certain amount of slow-release material and other pharmaceutically acceptable auxiliary is added in the present invention Material composition, obtains through scientific design.Using raw material of the present invention and preparation method, sustained release agent stability obtained is good, The loss for avoiding volatile effective component can be reduced medicining times, maintain that blood concentration is steady, extends the maintenance of effective component Time reduces side effect, also has bioavilability height, significant in efficacy, reduces medicining times and the compliance of patient can be improved The advantages that.
Below by way of experimental example, the invention will be further described.
The Selection experiment of experimental example 1, preparation process:
Investigate influence of the present invention using different slow-release materials to manufactured dropping pill formulation release.
Using 2010 editions two the first methods of appendix C X of Chinese Pharmacopoeia, using ethanol solution 500m1 as dissolution medium, revolving speed is It 50 turns/min, is operated according to this law, respectively in 0.25h, 0.75h, 2h, 3h, 4h, 5h, 6h, it is (automatic that 8h, lOh take out solution 3m1 Fluid infusion), pass through 0.22um miillpore filter immediately, takes filtrate 4u1 injection high performance liquid chromatograph to be measured, to press oil in dripping pill Smart release calculates and draws curve as inspection target, as a result such as table 1:
1 slow-release material Selection experiment result of table
Shown by table 1: the ratio between stearic acid, stearic acid and polyethylene glycol 1:5 mixing material meet as sustained release retarding agent It is required that.Wherein pill is made as sustained release retarding agent in Brazil wax, and release rate is lower, should not individually select Brazil wax Make sustained release retarding agent；Wherein pill is made in the ratio between stearic acid and polyethylene glycol 1:5 mixing material, and drug release is fast when beginning, reaches The purpose of quick acting, later rate of releasing drug is more steady, can more blood concentration be made persistently to maintain；Therefore the preferred sustained release of the present invention Retarding agent are as follows: the ratio between stearic acid and polyethylene glycol 1:5 mixed accessories.
(2) Selection experiment of slow-release material dosage:
Using the preparation method of present invention process, Chinese medicine material extract and slow-release material is added and is discharged with pill is compared The influence of degree, as a result such as the following table 2:
2 Chinese medicine material extract of table and release material mixture ratio Selection experiment result
Table 2 is shown: when proportion is 1:3, drag is inadequate, and rate of releasing drug is too fast, and slow release effect is bad；
When matching as 1:7 constantly, drag is bigger than normal, and rate of releasing drug is excessively slow, it is difficult to maintain ideal blood concentration.Therefore, It is 1:4~1:6, preferably 1:5 that the present invention, which chooses medicine raw extract and slow-release material to match,.
Experimental example 2: pill quality stability is examined:
Control group: control group 1, control group 2 are respectively patent CN200510057171.9 disclosed embodiment 1,3 system of formula What Preparation Method was prepared；
Test group: being respectively implementation column 1 of the present invention, embodiment 4, dripping pill made of embodiment 7.
Investigation mode are as follows: Berberine hydrochloride component content is measured in dropping pill formulation using accelerated stability test with storage The situation of change of time；It is wherein within 0th month the measurement that the dripping pill just prepared carries out, after the 1st month is storage one month The measurement of progress, and so on, each experimental group dropping pill formulation tested is all made of identical storage method.Experimental result is such as The following table 3:
The test of 3 Berberine hydrochloride study on the stability of table:
Shown as table 3: dropping pill formulation made from two kinds of different process is stored into 6th month, and traditional handicraft prepares pill The 73.8% of the dropping pill formulation just prepared is averagely fallen to by content of berberine hydrochloride, and present invention employs slow release methods It is still the 94.1% of the pill just prepared by content of berberine hydrochloride in dropping pill formulation made from preparation process.And decline Trend tends to be steady.It illustrates accordingly: good using pill quality stability produced by the present invention.
Experimental example 3: release investigates experiment:
Investigation mode: wood is invented into obtained dripping pill and is compared with common dripping pill, its vitro release situation is investigated, uses 2010 editions two the first methods of appendix C X of Chinese Pharmacopoeia, using ethanol solution 500m1 as dissolution medium, revolving speed is to grasp according to this law Make, respectively in 0.25h, 0.75h, 2h, 3h, 4h, 5h, 6h take out solution 3m1 (automatic liquid supply), filter immediately by 0.22um micropore Film takes filtrate 4u1 injection high performance liquid chromatograph to be measured, using Berberine hydrochloride release as inspection target, calculates simultaneously Curve is drawn, as a result such as the following table 4:
4 release of table investigates experimental result
Shown by table 4: quickly, release finishes common dripping pill rate of release substantially within 2 hours, made of the present invention Pill drug release is more steady, and slowly just drug release finishes after 10 hours, illustrates that pill is relative to common made of the present invention Pill has preferable slow releasing function.
The sustained-release dropping pill that inventor is prepared the present invention has carried out pharmacodynamic experiment, specific as follows:
1. data and method
1.1 clinical data
1.1.1 general information
All using Guizhou Province's Chinese medicine Out-patient Department or unit patients.48 are observed, 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 glucose, TC, The lab index no significant difference such as TG, HDL-C, LDL-C, is comparable.
1.1.2 diagnostic criteria
Case meets diabetes B and hyperlipidemia diagnostic criteria." diabetes mellitus in China referred to diabetes diagnosis according to 2005 South ": diabetic symptom+any time plasma glucose levels >=11.1mmol/l (200mg/dl) or fasting plasma glucose (FPG) in level >=7.0mmol/l (126mg/dl) or OGTT test, 2 hours PG levels >=11.1mmol/l (200mg/dl)； " the blood that hyperlipidemia diagnosis and classification standard were formulated referring to national dyslipidemia diagnosing and treating special topic scientific seminar in 1997 Rouge 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 rouge egg White (HDL-C) < 0.9mmol/L (35mg/dl).
Tcm syndrome standard: " the new Chinese medicine clinical research organized to set up according to National Drug Administration in 2002 Guideline " Section four of the chapter 10 third section guideline of clinical investigations of diabetes " new Chinese medicine treatment " and chapter 2 " in The guideline of clinical investigations of medicine Drugs in Therapy hyperlipidemia " drafts this disease " deficiency of liver-yin and kidney-yin, phlegm-blood stasis stop up resistance card " in conjunction with clinic Standard.Primary symptom: polydipsia, body is fat, dizzy heavy, soreness and weakness of waist and knees.Minor symptom: 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 whitish tongue or tongue is fat, tongue fur is satiny or few saliva, forceless deep pulse or thin string are puckery.It is above main Disease is 3 indispensable, adds minor symptom 2, can make a definite diagnosis referring to tongue vein.
1.1.3 it is included in standard
(1) meet diabetes B diagnostic criteria, Chinese medicine " deficiency of liver-yin and kidney-yin, phlegm-blood stasis stop up resistance card " CM syndrome differentiation criterion person.
(2) age between 30~70 years old, male or female.
(3) only have slight microvascular complication (urinary albumin excretion ratio < 300mg/d, retinopathy≤1 phase).
(4) it makes a definite diagnosis diabetes B 3 months or more.
(5) it is no more than 2 kinds using hypoglycemic medicine when entering group, and insulin therapy person is not used.
(6) informed consent, aspiration is tested, obtains informed consent form process and meets GCP stipulator.
1.1.4 exclusion criteria
(1) blood glucose rise caused by the factors such as type 1 diabetes, liver diseases, gestation, drug；
(2) nephrotic syndrome, hypothyroidism etc. other cause the disease of hyperlipidemia；
(3) age was at 30 years old or less or 70 years old or more；
(4) nearly January is interior or duration of medication has the serious acutes complications such as Diabetic ketosis, ketoacidosis；
(5) severe primaries such as cardiovascular and cerebrovascular, liver, kidney, hemopoietic system disease, mental patient are associated with；Malignant tumour Patient (unless excision of having performed the operation, 5 years or more without recurrence)；
(6) fasting blood-glucose >=18mmol/L or (and) postprandial 2 hours blood glucose >=23mmol/L persons；
(7) the other drugs person that may influence the observation index such as blood glucose, blood pressure, blood lipid is being taken.
(8) according to the judgement of researcher, with reduce into group possibility or make into group complicate other situations, building ring Border, which often changes etc., easily causes situation lost to follow-up.
(9) patient of other drugs clinical research is being participated in.
1.2 treatment method
Withdraw all lipid-regulation medicines within 2 weeks before two groups of treatments, is all made of Primary Care.
Primary Care referring to Asian-Pacific area diabetes B policy group work out " the practical target of diabetes B with Treatment " (third edition), progress diet control and kinesiatrics, basic medication melbine, 500mg, 3 times/day.Melbine by Institute of traditional Chinese medicine, Guizhou Province pharmaceutical chemists provide, 500mg, three times a day, manufacturer: Fauna of Kunshan, Jiangsu Pei Li drug Co., Ltd.
Treatment group: add in Primary Care with embodiment 1 provided by the invention, usage: once a day.The course for the treatment of 4 weeks.
Control group: it only with Primary Care (diet, movement, melbine), is not added and takes traditional Chinese medicine.The course for the treatment of 4 weeks.
In addition to testing medication, other Chinese medicines and Western medicine and related to the treatment of this disease for treating this disease are forbidden to use during observation Other treatment.
1.3 observation index
1.3.1 it blood glucose: is measured using intravenous glucose method.
1.3.2 fasting insulin (FIns): chemiluminescence immunoassay is used.
1.3.3 it evaluates insulin sensitivity index (ISI): being calculated using improvement Insulin Sensitivity Index type formula, i.e. ISI =1/FINSFPG.Insulin resistance (HOMA-IR) and β cell function (HOMA- β cell) is evaluated to assess using equilibrium mode Method formula: HOMA-IR=FINS × FPG/22.5, HOMA- β cell=20 × FINS/ (FPG-3.5).
1.3.4 blood total cholesterol (TC), triglyceride (TG), low density lipoprotein cholesterol (LDL-C), high density lipoprotein level White cholesterol (HDL-C): automatic clinical chemistry analyzer is used.
1.3.5 pretherapy and post-treatment glycated serum protein measurement: automatic clinical chemistry analyzer is used.
1.4 criterion of therapeutical effect
" the new Chinese medicine guideline of clinical investigations " organized to set up according to National Drug Administration in 2002 is made The criterion of therapeutical effect ordered determines.
1.5 statistical method
Descriptive statistic: enumeration data indicates that measurement data is used using composition ratio or rateIt indicates；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 examined in groups SPSS13.0 is used Deng, statistical software.
2 treatment results
2.1 two groups of pretherapy and post-treatment Chinese medicine syndrome integrals compare
5 two groups of pretherapy and post-treatment Chinese medicine syndrome integrals of table compare
Group n Before treatment After treatment
Embodiment treatment group 28 26.4 scholar 5.8 16.1 scholar 4.6Δ#
Control group 20 24.7 scholar 4.3 20.7 scholar 3.2Δ
Note: compared with before treatmentΔP < 0.01, comparison among groups after treatment#P < 0.01.
By table 5 as it can be seen that 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).
2.2 two groups of pretherapy and post-treatment blood glucose target variations
The index of 6 pretherapy and post-treatment two groups of blood glucose of table changes (mmol/l)
Note: before and after treatment in group relatively#P < 0.01, comparison among groups※P < 0.01.
By table 6 as it can be seen that pretherapy and post-treatment two groups of FBG, PBG (2h) blood glucose has clear improvement (P < 0.01), comparison among groups are controlled 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
7 two groups of pretherapy and post-treatment glycated serum proteins of table compare
Group n Before treatment After treatment
Treatment group 28 341.1 scholars 24.2 163.4 scholars 34.9ΔΔ*
Control group 20 341 scholars 47.6 237 scholars 15.2Δ
Note: compared with before treatmentΔP < 0.05,ΔΔP < 0.01；Comparison among groups※P < 0.05.
It is real after comparison among groups treatment by table 7 as it can be seen that pretherapy and post-treatment two groups of glycated serum proteins have improvement (P < 0.01) Shi Li treatment group hypoglycemic curative effect is better than control group, there is significant difference (P < 0.01).
2.4 two groups of pretherapy and post-treatment Blood Lipids
8 two groups of pretherapy and post-treatment Blood Lipids of table compare
Note: compared with before treatmentΔP < 0.01,ΔΔP < 0.05；Comparison among groups※P < 0.05.
By table 8 as it can be seen that TC, TG, LDL-C level decline after embodiment treatment group patient treatment, have compared with before treatment aobvious It writes sex differernce (P < 0.01), HDL-C increases (P < 0.05) compared with before treatment；TC level declines after control group patient treatment, Have significant difference (P < 0.01) compared with before treatment, TG, LDL-C decline (P < 0.05) compared with before treatment, HDL-C changes Change does not have notable difference.The improvement of comparison among groups, treatment group TC and TG is superior to control group, there is significant difference (P < 0.05).
The variation of 2.5 pretherapy and post-treatment two groups of fasting insulin and insulin resistance index of correlation
9 two groups of table pretherapy and post-treatment islet function indexs of correlation compare
Note: compared with before treatmentΔP < 0.05,ΔΔP < 0.01；Comparison among groups※P < 0.05.
By table 9 as it can be seen that pretherapy and post-treatment two groups of each index of correlation are improved in varying degrees (P < 0.05~0.01), wherein The improvement degree of embodiment treatment group ISI, Homa-IR, Homa-B have improvement (P < 0.05~0.01) compared with before treatment, There were significant differences compared with the control group (P < 0.05)
2.6 two groups of curative effects compare
The curative effect that 10 two groups of table compares
Note: P < 0.05
By table 10 as it can be seen that embodiment treatment group provided by the invention totally 28, wherein effective 10, effective 16, invalid 2 Example, total effective rate 92.9%；Control group totally 20, wherein effective 4, effective 11, invalid 5, total effective rate 75%. The experimental results showed that embodiment provided by the invention has the function of preferably treating 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 and release material mixture ratio at radix scutellariae 555g Chinese medicine material extract For 1:4
The preparation method of Chinese medicine material extract
Technique: 1) taking the coptis, turmeric using 60% ethyl alcohol as solvent by formula, impregnate 60 minutes, heating and refluxing extraction three times, First time solvent dosage is 8 times of medicinal material weight, is extracted 60 minutes for the first time, second and third secondary solvent dosage is the 5 of medicinal material weight Times, second and third each extraction 50 minutes merges medical fluid, and ethyl alcohol is recycled in filtration, is concentrated, it filters, after thick paste adds water to dissolve by heating, It filters, filtrate crosses large pore resin absorption column, is first eluted with water to the reaction of sugar and is negative, then uses ethanol elution, and recycling ethyl alcohol is dense It is 1.10~1.25 that relative density, which is reduced to, at 60 DEG C, is dried in vacuo, and is crushed, spare；
2) it takes red stilbene, glutinous rehmannia and the coptis, the turmeric dregs of a decoction using water as solvent by formula, impregnates 60 minutes, heating and refluxing extraction Secondary, first time solvent dosage is 8 times of medicinal material weight, is extracted 80 minutes for the first time, second of solvent is medicinal material amount with weight 5 times, second extracts 60 minutes, merges medical fluid, and filtration stands 24 hours, and filtration is concentrated into the 1/2 of original volume, use is inorganic Ceramic membrane is filtered, rate of filtration 8L/h, collects filtrate, and being concentrated into relative density at 60 DEG C is 1.10~1.25, very Sky dry, pulverize, spare；
3) take radix scutellariae using 60% ethyl alcohol as solvent by formula, first time solvent dosage is 6 times of medicinal material weight, impregnates 60 points Clock, heating and refluxing extraction, first time I20 minute, second solvent dosage are 5~6 times of medicinal material weight, heating and refluxing extraction, Second 100 minutes, merge medical fluid, filtration；Ethyl alcohol is recycled, concentration after thick paste adds water to dissolve by heating, filters, and filtrate crosses macropore Adsorption resin column, be first eluted with water to sugar reaction be negative, then use ethanol elution, recycle ethyl alcohol, be concentrated to give extract, concentration Be 1.10~1.25 at 60 DEG C to relative density, be dried in vacuo, crush, merge with said extracted object and mix to obtain the final product.
Dripping pill preparation process
(1) slow-release material is weighed, sufficiently melting mixes under condition of water bath heating, and Chinese medicine material extract is added, is adding It is stirred continuously 30min under heat condition, is sufficiently mixed uniformly；
(2) start pill dripping machine, preheat 30min, the feed liquid temperature that is arranged in instrument, material fill chassis temperature and condensation temperature or Cryogenic temperature starts the control button of each temperature, reaches show value；Feed liquid temperature should be consistent with chassis temperature；
(3) start pill dripping machine stirring system, control mixing speed, by the medical fluid of melting by feed opening, into pill dripping machine Batch can in, be stirred continuously 10min；
(4) condensate liquid liquid level adjusting knob is slowly opened, adjusts drop away from for 0.10~0.12cm；
(5) temperature to be condensed is up to after 4~8 DEG C, 80~90 DEG C of fluid temperature, and slowly the water dropper switch on twisting drop tank, is adjusted Section drop speed, and medical fluid is instilled in condensate liquid dimethicone with 30~40 drops/min speed；
(6) dripping pill reaches out ball mouth through cooling cycle system, collects sustained-release dropping pill；
(7) condensate liquid on sustained-release dropping pill surface is blotted to get sustained-release dropping pill of the present invention with filter paper and hospital gauze.
Embodiment 2
Prescription: coptis 277g, each 833g of red stilbene, glutinous rehmannia, turmeric and release material mixture ratio at radix scutellariae 555g Chinese medicine material extract For 1:4
The preparation method of Chinese medicine material extract:
1) take the coptis, turmeric using 60% ethyl alcohol as solvent by formula, impregnate 60 minutes, heating and refluxing extraction three times, first Secondary solvent dosage is I0 times of medicinal material weight, is extracted 60 minutes for the first time, second and third secondary solvent dosage is 6 times of medicinal material weight, Second and third each extraction 50 minutes, merges medical fluid, and ethyl alcohol is recycled in filtration, is concentrated, and filters, and after thick paste adds water to dissolve by heating, takes out Filter, filtrate crosses large pore resin absorption column, is first eluted with water to the reaction of sugar and is negative, then uses ethanol elution, recycles ethyl alcohol, is concentrated It is 1.10~1.25 at 60 DEG C to relative density, is dried in vacuo, crushes, it is spare；
2) it takes red stilbene, glutinous rehmannia and the coptis, the turmeric dregs of a decoction using water as solvent by formula, impregnates 60 minutes, heating and refluxing extraction Secondary, first time solvent dosage is 10 times of medicinal material weight, is extracted 80 minutes for the first time, second of solvent is medicinal material amount with weight 6 times, second extracts 60 minutes, merges medical fluid, and filtration stands 24 hours, and filtration is concentrated into the 1/2 of original volume, use is inorganic Ceramic membrane is filtered, rate of filtration 12L/h, collects filtrate, and being concentrated into relative density at 60 DEG C is 1.10~1.25, very Sky dry, pulverize, spare；
3) take radix scutellariae using 60% ethyl alcohol as solvent by formula, first time solvent dosage is 6-8 times of medicinal material weight, impregnates 60 Minute, heating and refluxing extraction, first time I20 minute, 6 times for medicinal material weight of second solvent dosage, heating and refluxing extraction, the Secondary 100 minutes, merge medical fluid, filtration；Ethyl alcohol is recycled, concentration after thick paste adds water to dissolve by heating, filters, and filtrate crosses macropore suction Attached resin column, be first eluted with water to sugar reaction be negative, then use ethanol elution, recycling ethyl alcohol, be concentrated to give extract, be concentrated into Relative density is 1.10~1.25 at 60 DEG C, is dried in vacuo, and crushes, merges with said extracted object and mix to obtain the final product.
Preparation process thereof
(1) slow-release material is weighed, sufficiently melting mixes under condition of water bath heating, and Chinese medicine material extract is added, is adding It is stirred continuously 30min under heat condition, is sufficiently mixed uniformly；
(2) start pill dripping machine, preheat 30min, the feed liquid temperature that is arranged in instrument, material fill chassis temperature and condensation temperature or Cryogenic temperature starts the control button of each temperature, reaches show value；Feed liquid temperature should be consistent with chassis temperature；
(3) start pill dripping machine stirring system, control mixing speed, by the medical fluid of melting by feed opening, into pill dripping machine Batch can in, be stirred continuously 10min；
(4) condensate liquid liquid level adjusting knob is slowly opened, adjusts drop away from for 0.10~0.12cm；
(5) temperature to be condensed is up to after 4~8 DEG C, 80~90 DEG C of fluid temperature, and slowly the water dropper switch on twisting drop tank, is adjusted Section drop speed, and medical fluid is instilled in condensate liquid dimethicone with 30~40 drops/min speed；
(6) dripping pill reaches out ball mouth through cooling cycle system, collects sustained-release dropping pill；
(7) condensate liquid on sustained-release dropping pill surface is blotted to get sustained-release dropping pill of the present invention with filter paper and hospital gauze.
Embodiment 3
Prescription: coptis 277g, each 833g of red stilbene, glutinous rehmannia, turmeric and release material mixture ratio at radix scutellariae 555g Chinese medicine material extract For 1:4
The preparation method of Chinese medicine material extract:
1) take the coptis, turmeric using 60% ethyl alcohol as solvent by formula, impregnate 60 minutes, heating and refluxing extraction three times, first Secondary solvent dosage is 9 times of medicinal material weight, is extracted 60 minutes for the first time, second and third secondary solvent dosage is the 5.5 of medicinal material weight Times, second and third each extraction 50 minutes merges medical fluid, and ethyl alcohol is recycled in filtration, is concentrated, it filters, after thick paste adds water to dissolve by heating, It filters, filtrate crosses large pore resin absorption column, is first eluted with water to the reaction of sugar and is negative, then uses ethanol elution, and recycling ethyl alcohol is dense It is 1.10~1.25 that relative density, which is reduced to, at 60 DEG C, is dried in vacuo, and is crushed, spare；
2) it takes red stilbene, glutinous rehmannia and the coptis, the turmeric dregs of a decoction using water as solvent by formula, impregnates 60 minutes, heating and refluxing extraction Secondary, first time solvent dosage is 9 times of medicinal material weight, is extracted 80 minutes for the first time, second of solvent is medicinal material amount with weight 5.5 times, second extracts 60 minutes, merges medical fluid, and filtration stands 24 hours, and filtration is concentrated into the 1/2 of original volume, with nothing Machine ceramic membrane is filtered, rate of filtration 10L/h, collects filtrate, and being concentrated into relative density at 60 DEG C is 1.10~1.25, Vacuum drying crushes, spare；
3) take radix scutellariae using 60% ethyl alcohol as solvent by formula, first time solvent dosage is 6-8 times of medicinal material weight, impregnates 60 Minute, heating and refluxing extraction, first time I20 minute, 5.5 times for medicinal material weight of second solvent dosage, heating and refluxing extraction, Second 100 minutes, merge medical fluid, filtration；Ethyl alcohol is recycled, concentration after thick paste adds water to dissolve by heating, filters, and filtrate crosses macropore Adsorption resin column, be first eluted with water to sugar reaction be negative, then use ethanol elution, recycle ethyl alcohol, be concentrated to give extract, concentration Be 1.10~1.25 at 60 DEG C to relative density, be dried in vacuo, crush, merge with said extracted object and mix to obtain the final product.
Preparation process thereof
(1) slow-release material is weighed, sufficiently melting mixes under condition of water bath heating, and Chinese medicine material extract is added, is adding It is stirred continuously 30min under heat condition, is sufficiently mixed uniformly；
(2) start pill dripping machine, preheat 30min, the feed liquid temperature that is arranged in instrument, material fill chassis temperature and condensation temperature or Cryogenic temperature starts the control button of each temperature, reaches show value；Feed liquid temperature should be consistent with chassis temperature；
(3) start pill dripping machine stirring system, control mixing speed, by the medical fluid of melting by feed opening, into pill dripping machine Batch can in, be stirred continuously 10min；
(4) condensate liquid liquid level adjusting knob is slowly opened, adjusts drop away from for 0.10~0.12cm；
(5) temperature to be condensed is up to after 4~8 DEG C, 80~90 DEG C of fluid temperature, and slowly the water dropper switch on twisting drop tank, is adjusted Section drop speed, and medical fluid is instilled in condensate liquid dimethicone with 30~40 drops/min speed；
(6) dripping pill reaches out ball mouth through cooling cycle system, collects sustained-release dropping pill；
(7) condensate liquid on sustained-release dropping pill surface is blotted to get sustained-release dropping pill of the present invention with filter paper and hospital gauze.
Embodiment 4
Prescription: coptis 277g, each 833g of red stilbene, glutinous rehmannia, turmeric and release material mixture ratio at radix scutellariae 555g Chinese medicine material extract For 1:5
The preparation method of Chinese medicine material extract: extract is prepared by 1 method of embodiment.
Preparation process thereof: sustained-release dropping pill is prepared by 1 method of embodiment.
Embodiment 5
Prescription: coptis 277g, each 833g of red stilbene, glutinous rehmannia, turmeric and release material mixture ratio at radix scutellariae 555g Chinese medicine material extract For 1:5
The preparation method of Chinese medicine material extract: extract is prepared by 2 method of embodiment.
Preparation process thereof: sustained-release dropping pill is prepared by 2 method of embodiment.
Embodiment 6
Prescription: coptis 277g, each 833g of red stilbene, glutinous rehmannia, turmeric and release material mixture ratio at radix scutellariae 555g Chinese medicine material extract For 1:5
The preparation method of Chinese medicine material extract: extract is prepared by 3 method of embodiment.
Preparation process thereof: sustained-release dropping pill is prepared by 3 method of embodiment.
Embodiment 7
Prescription: coptis 277g, each 833g of red stilbene, glutinous rehmannia, turmeric and release material mixture ratio at radix scutellariae 555g Chinese medicine material extract For 1:6
The preparation method of Chinese medicine material extract: extract is prepared by 1 method of embodiment.
Preparation process thereof: sustained-release dropping pill is prepared by 1 method of embodiment.
Embodiment 8
Prescription: coptis 277g, each 833g of red stilbene, glutinous rehmannia, turmeric and release material mixture ratio at radix scutellariae 555g Chinese medicine material extract For 1:6
The preparation method of Chinese medicine material extract: extract is prepared by 2 method of embodiment.
Preparation process thereof: sustained-release dropping pill is prepared by 2 method of embodiment.
Embodiment 9
Prescription: coptis 277g, each 833g of red stilbene, glutinous rehmannia, turmeric and release material mixture ratio at radix scutellariae 555g Chinese medicine material extract For 1:6
The preparation method of Chinese medicine material extract: extract is prepared by 3 method of embodiment.
Preparation process thereof: sustained-release dropping pill is prepared by 3 method of embodiment.
Although above having used general explanation, specific embodiment and test, the present invention is made to retouch in detail State, but on the basis of the present invention, it can be made it is some modify or improve, this is aobvious and easy to those skilled in the art See.Therefore, these modifications or improvements without departing from theon the basis of the spirit of the present invention, belong to claimed Range.

Claims (4)

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；
Calculate according to weight: Chinese medicine material extract and sustained release preparation match as 1:4~1:6 slow-release material；
The Chinese medicine material extract, by weight, by 277 parts of the coptis, each 833 parts of red stilbene, glutinous rehmannia, turmeric, 555 parts of radix scutellariae It is made；
The slow-release material is the mixture of one or more of stearic acid, Brazil wax and polyethylene glycol；
The pill the preparation method comprises the following steps:
(1) slow-release material is weighed, sufficiently melting mixes under condition of water bath heating, Chinese medicine material extract is added, in fire-bar It is stirred continuously 30min under part, is sufficiently mixed uniformly；
(2) start pill dripping machine, preheat 30min, feed liquid temperature, material filling chassis temperature and condensation temperature or refrigeration in instrument are set Temperature starts the control button of each temperature, reaches show value；Feed liquid temperature should be consistent with chassis temperature；
(3) start pill dripping machine stirring system, control mixing speed, by the medical fluid of melting by feed opening, into the material of pill dripping machine In tank, it is stirred continuously 10min；
(4) condensate liquid liquid level adjusting knob is slowly opened, adjusts drop away from for 0.10~0.12cm；
(5) temperature to be condensed is up to after 4~8 DEG C, 80~90 DEG C of fluid temperature, and slowly the water dropper switch on twisting drop tank, adjusts drop Speed, and medical fluid is instilled in condensate liquid dimethicone with 30~40 drops/min speed；
(6) dripping pill reaches out ball mouth through cooling cycle system, collects sustained-release dropping pill；
(7) condensate liquid on sustained-release dropping pill surface is blotted to get sustained-release dropping pill with filter paper and hospital gauze.
2. sustained-release dropping pill according to claim 1, it is characterised in that: the slow-release material is stearic acid and polyethylene glycol The ratio between 1:5 mixture.
3. the traditional Chinese medicine slow-releasing dripping pill for the treatment of diabetes described in accordance with the claim 1 and its complication, it is characterised in that: described Other auxiliary materials can be disintegrating agent, filler, adhesive, wetting agent, lubricant, glidant, colorant, aromatic, sweetener, One of auxiliary materials such as surfactant and inorganic salts and several mixtures.
4. traditional Chinese medicine slow-releasing dripping pill according to claim 1, which is characterized in that the Chinese medicine material extract preparation process Are as follows:
1) it takes the coptis, turmeric using 60% ethyl alcohol as solvent by formula, impregnates 60 minutes, heating and refluxing extraction is three times, molten for the first time Matchmaker's dosage is 8~10 times of medicinal material weight, is extracted 60 minutes for the first time, second and third secondary solvent dosage is the 5~6 of medicinal material weight Times, second and third each extraction 50 minutes merges medical fluid, and ethyl alcohol is recycled in filtration, is concentrated, it filters, after thick paste adds water to dissolve by heating, It filters, filtrate crosses large pore resin absorption column, is first eluted with water to the reaction of sugar and is negative, then uses ethanol elution, and recycling ethyl alcohol is dense It is 1.10~1.25 that relative density, which is reduced to, at 60 DEG C, is dried in vacuo, and is crushed, spare；
2) it taking red stilbene, glutinous rehmannia and the coptis, the turmeric dregs of a decoction using water as solvent by formula, impregnates 60 minutes, heating and refluxing extraction is secondary, First time solvent dosage is 8~10 times of medicinal material weight, is extracted 80 minutes for the first time, second of solvent is medicinal material amount with weight 5~6 times, second of extraction 60 minutes merges medical fluid, 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, it is dried in vacuo, crushes, it is spare；
3) take radix scutellariae using 60% ethyl alcohol as solvent by formula, first time solvent dosage is 6-8 times of medicinal material weight, impregnates 60 points Clock, heating and refluxing extraction, 120 minutes for the first time, second solvent dosage was 5~6 times of medicinal material weight, heating and refluxing extraction, Second 100 minutes, merge medical fluid, filtration；Ethyl alcohol is recycled, concentration after thick paste adds water to dissolve by heating, filters, and filtrate crosses macropore Adsorption resin column, be first eluted with water to sugar reaction be negative, then use ethanol elution, recycle ethyl alcohol, be concentrated to give extract, concentration Be 1.10~1.25 at 60 DEG C to relative density, be dried in vacuo, crush, merge with said extracted object and mix to obtain the final product.
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Publication number Priority date Publication date Assignee Title
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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

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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

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