CN101313941A - Compound antihyperglycemic pellet preparation and preparation method thereof - Google Patents
Compound antihyperglycemic pellet preparation and preparation method thereof Download PDFInfo
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- CN101313941A CN101313941A CNA2008101229972A CN200810122997A CN101313941A CN 101313941 A CN101313941 A CN 101313941A CN A2008101229972 A CNA2008101229972 A CN A2008101229972A CN 200810122997 A CN200810122997 A CN 200810122997A CN 101313941 A CN101313941 A CN 101313941A
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Abstract
The invention relates to the Chinese traditional medicine preparation technical field, in particular to a compound fat-reducing micro-pill preparation and a preparation method thereof. The compound fat-reducing micro-pill preparation is prepared by main medicines, auxiliary materials and wetting agents, and the diameter of the micro-pill obtained is less than 2.5mm, wherein the mass ratio of the main medicines to the auxiliary materials is 1 to 1-10, and the preferable ratio is 1 to 1-5; the ratio of the volume of the wetting agents to the mass sum of the main medicines and the auxiliary materials is 1 to 0.5-10, and the preferable ratio is 1 to 0.5-5; and the micro-pill preparation is prepared by optimizing the prescription and the technology of the compound fat-reducing micro-pill preparation. The compound fat-reducing micro-pill preparation has the advantages of high spherical degree of the micro-pill, high finished product yield, good in vitro dissolving-out effect, stable curative effect, simple and convenient method and controllable quality, and improves the stability of the medicine.
Description
Technical field
The present invention relates to the Chinese medicine preparation preparing technical field, refer in particular to a kind of compound antihyperglycemic pellet preparation and preparation method thereof.
Background technology
The prescription of compound antihyperglycemic pellet derives from " Drug Standard of Ministry of Public Health of the Peoples Republic of China Chinese traditional patent formulation preparation ", with extractum and medicinal material coarse powder is main preparation technology's pure Chinese medicine compound tablet XINANNING sheet, for distinguished veteran doctors of TCM through proved recipe, effect with yin nourishing mind calming, disperse blood stasis and dredge collateral, blood fat reducing, the headache, dizziness, tinnitus, the heart that be used for that blood fat is too high, angina pectoris and hypertension cause are contrary to.Clinical practice for many years proves this side's determined curative effect, has no side effect, but life-time service.But because this tablet manufacturing technology is simple relatively, Chinese medical concrete extract stickiness is big, the easy moisture absorption, and reasons such as character instability need to add a large amount of adjuvants in the preparation process, so taking dose are big, take medicine, transport and carry to the patient to bring inconvenience.
Micropill is sphere or the class spherical preparation of diameter less than 2.5mm, compare with general formulation, micropill have drug loading big, can increase medicine stability, be easy to preserve and carry, can reduce advantage such as patient's medication dose, thereby more and more be subjected to people's favor.
Existing plurality of Chinese micropill application at present patent, as: Herba Hyperici perforati extract film coating pellet preparations and preparation technology thereof (application number: 02149750.8), micropill of six Chinese medicine materials including glutinous rehmannia and preparation method (application number: 03124453.X), a kind of preparation method of five-ester micropill (application number: 03117911.8), the preparation method of Yufengningxin micropill (application number: 03135459.9), compound Salviae Miltiorrhizae microsphere and its preparation (application number: 03135829.2), coronary salvia micro pill agent and preparation method thereof (application number: 200510020656.0), but with Radix Puerariae, Fructus Crataegi and Radix Polygoni Multiflori Preparata prepare antihyperglycemic pellet as a Chinese medicine compound and yet there are no report.
Summary of the invention
The objective of the invention is to solve the problem and shortage that above-mentioned existing preparation exists, a kind of compound antihyperglycemic pellet preparation is provided, it can increase medicine stability, is convenient to preserve and carry, and also can reduce the dosage that patient takes medicine, and production cost is lower simultaneously.
The present invention simultaneously also provides a kind of preparation method of compound antihyperglycemic pellet preparation, and method is simple for this, controllable product quality.
The present invention is achieved through the following technical solutions:
A kind of compound antihyperglycemic pellet preparation, it is formulated by principal agent, adjuvant and wetting agent, the micropill diameter that makes is less than 2.5mm, wherein the quality proportioning of principal agent and adjuvant is 1: 1～10, preferred 1: 1～5, the volume of wetting agent is 1: 0.5～10 with the ratio that principal agent adds adjuvant quality sum, preferred 1: 0.5～5.
Described principal agent is made up of Radix Puerariae extract, Fructus Crataegi extract and Radix Polygoni Multiflori Preparata extract, its quality proportioning is 1: (1.5～2.0): (0.1～0.5), quality percentage composition 〉=50% of the total flavones in the Radix Puerariae extract wherein, quality percentage composition 〉=50% of the total flavones in the Fructus Crataegi extract, in the Radix Polygoni Multiflori Preparata extract 2,3,5, quality percentage composition 〉=50% of 4 '-tetrahydroxystilbene-2-O-β-D-glucoside; Described adjuvant is the mixture of wherein a kind of in micropowder silica gel, microcrystalline Cellulose, ethyl cellulose, lactose, dextrin, starch, the mannitol or their any mass ratio; Described wetting agent is the mixture of wherein a kind of in water, ethanol, carboxymethylcellulose sodium solution, the Gonak or their arbitrary volume ratio.
Above-mentioned alcoholic solution weight percent concentration as wetting agent is 10%～90%.
The preparation method of a kind of compound antihyperglycemic pellet preparation of the present invention, step is as follows:
Get principal agent and adjuvant, mixing behind mistake 40～120 mesh sieves adds the wetting agent mixing then respectively, through the pelletize after drying, makes pellet preparations of the present invention.
Prilling process described in the preparation method of the present invention is for extruding round as a ball pill method, centrifugal granulating pill method, laminated type pill method, fluid bed pill method, stirring pill method, spheroidization pill method or fusion pill method fast; Described drying means is an atmosphere pressure desiccation, hypobaric drying method, vacuum freeze-drying method, fluid-bed drying, spray drying method or infrared drying.
A kind of compound antihyperglycemic pellet preparation provided by the invention has the following advantages:
1, can be distributed in the gastrointestinal tract extensively, equably after taking, increase the distribution area of medicine, thereby improve bioavailability, reduce local irritation on the gastrointestinal surface; 2, particle diameter is little, and its transhipment in gastrointestinal tract is subjected to food to carry the influence of the rhythm and pace of moving things very little, so gastric emptying rate is very little to its influence; 3, can make slow release or controlled release preparation by further coating, its drug release behavior is a summation of forming each micropill drug release behavior of a dosage, and the unlikely drug release behavior to whole preparation of the defective of indivedual micropills in preparation produces and has a strong impact on; 4, good fluidity, divided dose is accurate, is easy to filled capsules; 5, drug loading is big, can reduce patient's medication dose, can increase medicine stability, is convenient to preserve and carry; 6, roundness is good, good looking appearance, and external result of extraction is good, stable curative effect.
The preparation method of a kind of compound antihyperglycemic pellet preparation provided by the invention is simple and easy to do, and cost is lower, and is quality controllable, the product yield height.
Description of drawings
Figure is the external stripping curve figure of compound antihyperglycemic pellet preparation.
The specific embodiment
Below by specific embodiment the present invention is described, but the present invention is not limited in these embodiment.
Embodiment 1
Compound antihyperglycemic pellet preparation and preparation method thereof
Prescription is formed:
Principal agent (wherein Radix Puerariae extract: Fructus Crataegi extract: Radix Polygoni Multiflori Preparata extract is 1: 1.7: 0.3) 10g
Microcrystalline Cellulose 26g
Lactose 4g
50% ethanol 19mL
Preparation method:
Get principal agent, microcrystalline Cellulose and lactose by above-mentioned prescription, cross mixing behind 80 mesh sieves respectively, add 50% ethanol 19mL mixing, reuse extrude round as a ball pill method make diameter less than the microgranule of 2.5mm after in 40 ℃ of constant pressure and dries, promptly get compound antihyperglycemic pellet preparation of the present invention.
Embodiment 2
Compound antihyperglycemic pellet preparation and preparation method thereof
Prescription is formed:
Principal agent (wherein Radix Puerariae extract: Fructus Crataegi extract: Radix Polygoni Multiflori Preparata extract is 1: 1.5: 0.1) 15g
Microcrystalline Cellulose 25.5g
Dextrin 4.5g
85% ethanol 50mL
Preparation method:
Get principal agent, microcrystalline Cellulose and dextrin by above-mentioned prescription, cross mixing behind 100 mesh sieves respectively, add 85% ethanol 50mL mixing, reuse fluid bed pill method make diameter less than the microgranule of 2.5mm after in 50 ℃ of drying under reduced pressure, promptly get compound antihyperglycemic pellet preparation of the present invention.
Embodiment 3
Compound antihyperglycemic pellet preparation and preparation method thereof
Prescription is formed:
Principal agent (wherein Radix Puerariae extract: Fructus Crataegi extract: Radix Polygoni Multiflori Preparata extract is 1: 2.0: 0.5) 13.5g
Starch 70g
Lactose 38g
20% ethanol 15mL
Preparation method:
Get principal agent, starch and lactose by above-mentioned prescription, cross mixing behind 40 mesh sieves respectively, add 20% ethanol 15mL mixing, reuse stir fast the pill method make diameter less than the microgranule of 2.5mm after in 45 ℃ of drying under reduced pressure, promptly get compound antihyperglycemic pellet preparation of the present invention.
Embodiment 4
Compound antihyperglycemic pellet preparation and preparation method thereof
Prescription is formed:
Principal agent (wherein Radix Puerariae extract: Fructus Crataegi extract: Radix Polygoni Multiflori Preparata extract is 1: 1.9: 0.2) 19g
Microcrystalline Cellulose 38g
Micropowder silica gel 29g
Water 22mL
Preparation method:
Get principal agent, microcrystalline Cellulose and micropowder silica gel by above-mentioned prescription, cross mixing behind 120 mesh sieves respectively, add entry 22mL mixing, reuse extrude round as a ball pill method make diameter less than the microgranule of 2.5mm after in 50 ℃ of drying under reduced pressure, promptly get compound antihyperglycemic pellet preparation of the present invention.
Embodiment 5
Compound antihyperglycemic pellet preparation and preparation method thereof
Prescription is formed:
Principal agent (wherein Radix Puerariae extract: Fructus Crataegi extract: Radix Polygoni Multiflori Preparata extract is 1: 1.6: 0.5) 17.5g
Starch 30.5g
Dextrin 8.5g
0.5% carboxymethylcellulose sodium solution 12mL
Preparation method:
Get principal agent, starch and dextrin by above-mentioned prescription, cross mixing behind 80 mesh sieves respectively, add 0.5% carboxymethylcellulose sodium solution 12mL mixing, reuse centrifugal granulating pill method make diameter less than the microgranule of 2.5mm after in 60 ℃ of constant pressure and dries, promptly get compound antihyperglycemic pellet preparation of the present invention.
The test of pesticide effectiveness of the foregoing description:
A kind of compound antihyperglycemic pellet preparation provided by the invention has good effect for reducing blood fat, proves that through animal experiment the test of pesticide effectiveness is reported as follows:
1, sample: compound antihyperglycemic pellet preparation
2, experimental animal: male SD rat (body weight 200 ± 20g)
3, test method:
(1) divides into groups and set up model
Get 70 of male SD rats, be divided into 7 groups at random, every group 10, set up blank group (feeding conventional feed), feeding high lipid food (85% conventional feed, 10% yolk powder, 5% Adeps Sus domestica, 0.5% cholate) to administration for all the other 6 groups finishes, wherein 5 groups give compound antihyperglycemic pellet preparation (embodiment 1, embodiment 2, embodiment 3, embodiment 4, embodiment 5), other 1 group as the high lipid food matched group.Except that the blank group, feed high lipid foods after 7 days for other 6 groups, gastric infusion totally 25 days, light fasting 16h administration last day 16 after, weigh, broken end is got blood, measures serum TC, TG, HDL-C value, the gained data are carried out statistical procedures.
(2) lipid determination
Centrifuging and taking serum is with enzymatic assays TC, TG, HDL-C value behind the blood coagulation.
4, result of the test
Table 1 compound antihyperglycemic pellet preparation is to the influence of TC, TG, HDL-C in the serum (n=10, x ± SD)
#P＜0.05, ##P＜0.01 and blank group ratio
* P＜0.05, * * P＜0.01 and high fat matched group ratio
Compare with the blank group, high fat matched group TC, TG obviously raise, and HDL-C obviously reduces.Compare with high fat matched group, compound antihyperglycemic pellet example of formulations 1, embodiment 2, embodiment 3, embodiment 4, embodiment 5 can both obviously reduce TC and TG, and HDL-C can obviously raise simultaneously.
Result of the test shows: a kind of compound antihyperglycemic pellet preparation provided by the invention has tangible effect for reducing blood fat.
Claims (10)
1, a kind of compound antihyperglycemic pellet preparation, it is characterized in that: form by principal agent, adjuvant, wetting agent, obtained micropill diameter is less than 2.5mm, and wherein the quality proportioning of principal agent and adjuvant is 1: 1～10, and the volume of wetting agent is 1: 0.5～10 with the ratio that principal agent adds adjuvant quality sum.
2, compound antihyperglycemic pellet preparation according to claim 1, the quality proportioning that it is characterized in that described principal agent and adjuvant is 1: 1～5, the volume of wetting agent is 1: 0.5～5 with the ratio that principal agent adds adjuvant quality sum.
3, compound antihyperglycemic pellet preparation according to claim 1 and 2, it is characterized in that: described principal agent is made up of Radix Puerariae extract, Fructus Crataegi extract and Radix Polygoni Multiflori Preparata extract.
4, compound antihyperglycemic pellet preparation according to claim 3, the quality proportioning that it is characterized in that Radix Puerariae extract, Fructus Crataegi extract and the Radix Polygoni Multiflori Preparata extract of described composition principal agent is 1: (1.5～2.0): (0.1～0.5), quality percentage composition 〉=50% of the total flavones in the Radix Puerariae extract wherein, quality percentage composition 〉=50% of the total flavones in the Fructus Crataegi extract, in the Radix Polygoni Multiflori Preparata extract 2,3,5, quality percentage composition 〉=50% of 4 '-tetrahydroxystilbene-2-O-β-D-glucoside.
5, compound antihyperglycemic pellet preparation according to claim 1 and 2 is characterized in that described adjuvant is the mixture of a kind of in micropowder silica gel, microcrystalline Cellulose, ethyl cellulose, lactose, dextrin, starch, the mannitol or their any mass ratio.
6, compound antihyperglycemic pellet preparation according to claim 1 and 2 is characterized in that described wetting agent is the mixture of a kind of in water, ethanol, carboxymethylcellulose sodium solution, the Gonak or their arbitrary volume ratio.
7, compound antihyperglycemic pellet preparation according to claim 6 is characterized in that described alcoholic solution weight percent concentration is 10%～90%.
8, according to the described compound antihyperglycemic pellet preparation of claim 1～7, its preparation method, step is as follows:
Get principal agent and adjuvant, mixing behind mistake 40～120 mesh sieves adds the wetting agent mixing then respectively, through the pelletize after drying, makes pellet preparations of the present invention.
9, compound antihyperglycemic pellet preparation according to claim 8 is characterized in that described prilling process is for extruding round as a ball pill method, centrifugal granulating pill method, laminated type pill method, fluid bed pill method, stirring pill method, spheroidization pill method or fusion pill method fast.
10, compound antihyperglycemic pellet preparation according to claim 8 is characterized in that described drying means is an atmosphere pressure desiccation, hypobaric drying method, vacuum freeze-drying method, fluid-bed drying, spray drying method or infrared drying.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA2008101229972A CN101313941A (en) | 2008-06-20 | 2008-06-20 | Compound antihyperglycemic pellet preparation and preparation method thereof |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA2008101229972A CN101313941A (en) | 2008-06-20 | 2008-06-20 | Compound antihyperglycemic pellet preparation and preparation method thereof |
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| CNA2008101229972A Pending CN101313941A (en) | 2008-06-20 | 2008-06-20 | Compound antihyperglycemic pellet preparation and preparation method thereof |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102525943A (en) * | 2012-01-05 | 2012-07-04 | 金陵药业股份有限公司 | Micro-pill and preparation method thereof |
| CN103251043A (en) * | 2012-03-23 | 2013-08-21 | 山东德圣医药科技有限公司 | Auxiliary hypolipidemic health-care food |
| CN115400167A (en) * | 2022-09-27 | 2022-11-29 | 上海博翰堂医疗器械科技有限公司 | Hard capsule assisting in reducing blood fat and preparation method thereof |
-
2008
- 2008-06-20 CN CNA2008101229972A patent/CN101313941A/en active Pending
Cited By (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102525943A (en) * | 2012-01-05 | 2012-07-04 | 金陵药业股份有限公司 | Micro-pill and preparation method thereof |
| CN102525943B (en) * | 2012-01-05 | 2014-07-16 | 金陵药业股份有限公司 | Micro-pill and preparation method thereof |
| CN103251043A (en) * | 2012-03-23 | 2013-08-21 | 山东德圣医药科技有限公司 | Auxiliary hypolipidemic health-care food |
| CN115400167A (en) * | 2022-09-27 | 2022-11-29 | 上海博翰堂医疗器械科技有限公司 | Hard capsule assisting in reducing blood fat and preparation method thereof |
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Open date: 20081203 |