CN103070842A - Preparation method of miglitol sustained release tablet - Google Patents
Preparation method of miglitol sustained release tablet Download PDFInfo
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- CN103070842A CN103070842A CN2013100439512A CN201310043951A CN103070842A CN 103070842 A CN103070842 A CN 103070842A CN 2013100439512 A CN2013100439512 A CN 2013100439512A CN 201310043951 A CN201310043951 A CN 201310043951A CN 103070842 A CN103070842 A CN 103070842A
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Abstract
The invention provides a preparation method of a miglitol sustained release tablet. The preparation method comprises the following steps of: I, adding miglitol, Na-montmorillonite and an acidity regulator into deionized water, and stirring uniformly to obtain a mixed solution; II, stirring the mixed solution, performing ion exchange on the miglitol and the Na-montmorillonite, and filtering, washing, drying, smashing and sieving in sequence to obtain a main material; and III, mixing the main material and auxiliary materials uniformly, and tableting to obtain the miglitol sustained release tablet. A preparation process of the method is simple, special equipment and process are not required, and the method is suitable for large-scale batch production. Specific to the defects of the conventional miglitol medicament administration way, a method for compounding the Na-montmorillonite and the miglitol is adopted, so that the in-vivo release rate of the miglitol is lowered, the utilization ratio of a miglitol medicament is increased remarkably, and the taking compliance of a patient is enhanced greatly.
Description
Technical field
The invention belongs to medical technical field, be specifically related to a kind of preparation method of miglitol slow releasing tablet.
Background technology
At present, in China along with expanding economy, people's living standard is greatly improved, diet and living habit are more diversified, people are when enjoying cuisines, the be careful in one's diet collocation problem of structure of few people, simultaneously because social work pressure is increasing, a lot of people lack effective physical exercise, therefore in recent years people because of chronic dietary improper and improperly the caused disease of living habit in gradually increase, this wherein the most outstanding disease just comprise type ii diabetes, type ii diabetes shows a rising trend as Chronic Non-Communicable Diseases.Up to the present, the quantity of whole world diabetics has risen to more than 2.3 hundred million people, and pre-estimation global diabetics number in 20 years will be increased to 3.5 hundred million people.The number that diabetes are died from the annual whole world just has about 3,000,000 people, and mortality rate also can be increased to more than 25% in year at Future Ten.In recent years, the diabetics number also increases comparatively fast in Asia and Africa, and China has become the second in the world diabetes big country that is only second to India, and prevalence is increased to more than 3.2% from less than 1%.Annual newly-increased diabetics number just has about 1,200,000, and patient crowd's number is huge.
Diabetes are to continue hyperglycemia as a kind of chronic general metabolic disease of its basic biochemical character, mainly be since in the body insulin secretion definitely lack or because health increases the insulin relative deficiency that causes to the demand of insulin, thereby or because insulin resistant causes a kind of syndrome take carbohydrate metabolism disturbance as sugar, protein and the fat metabolic disturbance led.Along with the course of disease prolongs the complication that can cause the histoorgans such as eye, nerve, blood vessel, kidney, it is the incretion metabolism disease of serious harm human body.
The treatment means of diabetes mainly comprises at present: the methods such as Diet Therapy, exercise therapy, orally-taken blood sugar reducing medicine and subcutaneous injection insulin, always constant for the research and development of type Ⅱdiabetes mellitus medicine in recent years, a lot of medicines are arranged or researching and developing or putting on market, such as sulfonylurea, biguanides, alpha-glucosidase inhibitor, aldose reductase inhibitor class and thiazolidinyl diones etc., but a lot of medicines are when having remarkable hypoglycemic effect, its side effect also has much and manifests, and the health of diabetics has been caused certain injury.
Miglitol (Miglitol) is is at first researched and developed the beginning of the eighties by Bayer Bitterfeld GmbH drugmaker as the type Ⅱdiabetes mellitus medicine of alpha-glucosidase inhibitor.The chemical name of miglitol (Miglitol) is: 1-(2-ethoxy)-2-(methylol)-3,4, and 5-piperidines triol, molecular formula is C8H17NO5, and molecular weight is 207.22, and structural formula is:
Because miglitol has multiple pharmacologically active, hypoglycemic effect is remarkable, and the characteristics such as toleration that side effect is little and good are a kind of highly effective and safe medicines for the treatment of type Ⅱdiabetes mellitus.
At present miglitol uses clinically mainly is conventional tablet and the disintegrating tablet studied, after taking for the patient, generally can there be the not free continuity of drug-eluting, after can causing like this medicine to enter in the body, medicine discharges in vivo in a large number in short time, absorption efficiency and bioavailability reduce, can cause certain tissue injury to old people and child simultaneously, increase dangerous.
Up to now, not yet find adopting sodium-based montmorillonite and miglitol is that the method research that raw material prepares the miglitol slow releasing tablet is seen in report.
Summary of the invention
Technical problem to be solved by this invention is to provide a kind of preparation method of miglitol slow releasing tablet for above-mentioned the deficiencies in the prior art.The method preparation technology is simple, need not special installation and technique, is suitable for large-scale batch production; The method is for the deficiency of existing miglitol drug administration mode, by adopting the compound method of sodium-based montmorillonite and miglitol to delay the speed that miglitol discharges in vivo, improve significantly the utilization rate of miglitol medicine, greatly increased the compliance that the patient takes.
For solving the problems of the technologies described above, the technical solution used in the present invention is: a kind of preparation method of miglitol slow releasing tablet is characterized in that the method may further comprise the steps:
The preparation method of above-mentioned a kind of miglitol slow releasing tablet is characterized in that the quality purity of miglitol described in the step 1 is not less than 99.9%, and the quality purity of described sodium-based montmorillonite is not less than 96%.
The preparation method of above-mentioned a kind of miglitol slow releasing tablet is characterized in that, the mass percent concentration of hydrochloric acid described in the step 1 is 5%～10%.
The preparation method of above-mentioned a kind of miglitol slow releasing tablet is characterized in that, temperature dry described in the step 2 is 40 ℃～60 ℃, and the time of described drying is 5h～7h.
The preparation method of above-mentioned a kind of miglitol slow releasing tablet is characterized in that, the mean diameter of major ingredient described in the step 2 is not more than 250 μ m.
The preparation method of above-mentioned a kind of miglitol slow releasing tablet is characterized in that, the tabletting process is 20 ℃～30 ℃ in ambient temperature in the step 3, and envionmental humidity is to carry out under 45%～65% the condition.
The preparation method of above-mentioned a kind of miglitol slow releasing tablet, it is characterized in that, adjuvant described in the step 3 by filler, disintegrating agent, help and collapse agent, lubricant, binding agent and correctives in mass ratio (5～30): (10～20): (10～20): (1～5): (5～10): (1～5) mixed preparing forms.
The preparation method of above-mentioned a kind of miglitol slow releasing tablet, it is characterized in that, described filler is that mannitol is or/and sal glauberi, described disintegrating agent is one or more in low-substituted hydroxypropyl cellulose, cross-linking sodium carboxymethyl cellulose, carboxymethyl starch sodium and the polyvinylpolypyrrolidone, describedly help that to collapse agent be microcrystalline Cellulose, described lubricant is one or more in micropowder silica gel, magnesium stearate and the Polyethylene Glycol, described binding agent is that mass percent concentration is 1%～5% hypromellose aqueous solution, and described correctives is that Mentholum is or/and fruit essence.
The usage and dosage of the miglitol slow releasing tablet of the present invention's preparation is: oral meal, and three times on the one, each 2～3, every 10mg～15mg, and every consumption per day is no more than 100mg; The quality percentage composition of major ingredient is 20%～50% in every miglitol slow releasing tablet, and surplus is adjuvant; Concrete medication can suitably be adjusted according to conditions of patients.
The mechanism of action of the miglitol slow releasing tablet of the present invention's preparation is: the present invention utilizes the principle of ion exchange to impel between miglitol and the sodium-based montmorillonite and interacts, but at first utilize the ion exchangeable that sodium ion has in the sodium-based montmorillonite, the miglitol cation that sodium ion and miglitol are formed in acidic aqueous solution carries out ion exchange, forms the complex that is composited by montorillonite clay and miglitol; After making the miglitol slow releasing tablet take this complex as matrix, enter after being taken by the patient in the gastric juice and intestinal juice in the human body, because gastric juice and intestinal juice all are the slant acidity environment in the human body, in gastric juice and the intestinal juice freely acid ion can carry out again ion exchange with complex, miglitol slowly is discharged in the gastro-intestinal Fluid environment in the human body, thereby the function of reducing blood sugar of performance miglitol reaches the effect that continues blood sugar lowering.Concrete mechanism of action reaction equation is as follows:
At first, miglitol is to form the miglitol cation in 2～4 the mixed solution at pH value, as the formula (1):
Express for ease of reaction equation, with the miglitol cation with miglitol
+Expression;
Secondly, be 20 ℃～50 ℃ with mixed solution in temperature, stir speed (S.S.) is to stir 1h～2h under the condition of 80r/min～150r/min, makes the sodium ion in miglitol cation and the sodium-based montmorillonite carry out ion-exchange reactions, obtain the miglitol montmorillonite composite, as the formula (2):
miglitol
++Na
+-MMT--→miglitol-MMT+Na
+ （2）
At last, make the miglitol slow releasing tablet take this complex as matrix after, enter after being taken by the patient in the gastric juice and intestinal juice in the human body, because gastric juice and intestinal juice all are the slant acidity environment in the human body, in gastric juice and the intestinal juice freely acid ion can carry out again ion exchange with the miglitol cation that is compound in the montorillonite clay in the miglitol slow releasing tablet, thereby miglitol is discharged in the gastro-intestinal Fluid environment in the human body, the performance blood sugar reducing function, as the formula (3):
miglitol-MMT+H
+--→H-MMT+miglitol
+ （3）。
It is that raw material prepares the miglitol slow releasing tablet that the present invention adopts miglitol and sodium-based montmorillonite, since miglitol and sodium-based montmorillonite all already maturation be applied to field of medicaments, and all through toxicological experiment proof avirulence, the present invention is only compound with both by ion exchange, finally by ion exchange miglitol is discharged again, there is no during this time other materials and participate, so the miglitol slow releasing tablet safety non-toxic of the present invention's preparation.
The present invention compared with prior art has the following advantages:
1, it is that raw material prepares the miglitol slow releasing tablet that the present invention adopts sodium-based montmorillonite, take full advantage of and be chemically inert silicate mineral in the sodium-based montmorillonite, be difficult for absorbing after having clothes, do not enter blood circulation, oral fool proof, non-toxic reaction, non-stimulated to skin, to nerve, breathing and digestive system are without distinguishing features such as impacts, and sodium-based montmorillonite self has the medicinal characteristic of antidiarrheal and antiphlogistic and bactericidal, and suitable cation exchange capacity (CEC), select absorption and the high advantages such as stationkeeping ability are arranged, behind the oral sodium-based montmorillonite of clinical confirmation, can cover equably whole enteric cavity surface, and keep more than 5 hours, therefore sodium-based montmorillonite is extraordinary slow-released carrier, and can not have side effects.
2, the present invention is directed to the deficiency of existing miglitol drug administration mode, delay the speed that miglitol discharges in vivo by the method that adopts sodium-based montmorillonite and miglitol to form complex, improve the utilization rate of miglitol medicine, greatly increase the compliance that the patient takes.
3, adopt the miglitol slow releasing tablet of the present invention's preparation to play effective inhibitory action to alpha-glucosidase, reduce saccharide in the degraded of gastropore and intestinal, delay the absorption of saccharide, thereby effectively control blood sugar content, more effectively bring into play the effect of miglitol treatment diabetes.
4, the miglitol slow releasing tablet that adopts the present invention's preparation through its pharmaceutical release time of slow release experiment confirm up to more than 5 hours, compare (its pharmaceutical release time is in 1 hour) with traditional miglitol oral cavity disintegration tablet, the miglitol slow releasing tablet of the present invention's preparation has obvious slow releasing function and slow release effect, slow-release time is long, good stability.
5, preparation method of the present invention is simple, need not special installation and technique, is suitable for large-scale batch production.
Below in conjunction with drawings and Examples the present invention is described in further detail.
Description of drawings
Fig. 1 is the Cumulative release amount curve of miglitol slow releasing tablet in artificial simulation gastric juices of the embodiment of the invention 1 preparation.
Fig. 2 is the Cumulative release amount curve of miglitol slow releasing tablet in artificial simulation intestinal juice of the embodiment of the invention 1 preparation.
Fig. 3 is the Cumulative release amount curve of miglitol slow releasing tablet in artificial simulation gastric juices of the embodiment of the invention 2 preparations.
Fig. 4 is the Cumulative release amount curve of miglitol slow releasing tablet in artificial simulation intestinal juice of the embodiment of the invention 2 preparations.
Fig. 5 is the Cumulative release amount curve of miglitol slow releasing tablet in artificial simulation gastric juices of the embodiment of the invention 3 preparations.
Fig. 6 is the Cumulative release amount curve of miglitol slow releasing tablet in artificial simulation intestinal juice of the embodiment of the invention 3 preparations.
Fig. 7 is the Cumulative release amount curve of miglitol slow releasing tablet in artificial simulation gastric juices of the embodiment of the invention 4 preparations.
Fig. 8 is the Cumulative release amount curve of miglitol slow releasing tablet in artificial simulation intestinal juice of the embodiment of the invention 4 preparations.
Fig. 9 is the Cumulative release amount curve of miglitol slow releasing tablet in artificial simulation gastric juices of the embodiment of the invention 5 preparations.
Figure 10 is the Cumulative release amount curve of miglitol slow releasing tablet in artificial simulation intestinal juice of the embodiment of the invention 5 preparations.
The specific embodiment
The preparation method of present embodiment miglitol slow releasing tablet may further comprise the steps:
Partly prepare artificial simulation gastric juices according to two appendix of Chinese Pharmacopoeia version in 2005, concrete compound method is: the 9mL concentrated hydrochloric acid is added in about 800mL pure water, obtain pH value after stirring and be 1.2 artificial simulation gastric juices (Artificial Simulated Gastric Juice, ASGJ).Place artificial simulation gastric juices to carry out the test of miglitol Cumulative release amount the miglitol slow releasing tablet of present embodiment preparation, concrete method of testing is: utilize miglitol to have the characteristics of strong absworption peak in alkaline permanganate solution under visible light 610nm condition, at first be not less than 99.99% miglitol configuration standard liquid with mass concentration, pipette respectively not commensurability miglitol from titer to each volumetric flask with pipet, then all adding NaOH solution and the 2.5mL concentration that 1mL concentration is 0.5mol/L in each volumetric flask is the KMnO of 0.01mol/L
4Solution, shake up and be settled to scale with pure water, obtain being added with the miglitol standard solution of the variable concentrations of alkalinity potassium permanganate, after 23 ℃ of room temperatures leave standstill 25min, utilize ultraviolet-visible spectrophotometer under the 610nm condition, to measure respectively the absorbance of variable concentrations miglitol solution, thereby set up the standard curve of miglitol solution concentration and absorbance; To be added with afterwards in the every interval 15min of artificial simulation gastric juices of present embodiment miglitol slow releasing tablet～30min sampling 0.1mL to 10mL volumetric flask, the NaOH solution and the 2.5mL concentration that add respectively 1mL concentration again and be 0.5mol/L in each volumetric flask are the KMnO of 0.01mol/L
4Solution, shake up and be settled to scale with pure water, obtain the solution to be checked of different release times, after leaving standstill 25min under 23 ℃ of room temperatures, utilize ultraviolet-visible spectrophotometer under the 610nm condition, to measure respectively the absorbance of each solution to be checked, and the contrast standard curve, thereby obtain the Cumulative release amount rule of miglitol in artificial simulation gastric juices.Record thus the Cumulative release amount curve of miglitol slow releasing tablet in artificial simulation gastric juices of present embodiment preparation as shown in Figure 1.The miglitol slow releasing tablet of present embodiment preparation presents the feature of slow release in artificial simulation gastric juices as shown in Figure 1, and the cumulative release amount slowly increases, and the cumulative release time can reach more than 5 hours.
Partly prepare artificial simulation intestinal juice according to two appendix of Chinese Pharmacopoeia version in 2005, the concrete configuration method is: potassium dihydrogen phosphate 6.8g is dissolved in the 500mL pure water, then be the sodium hydrate aqueous solution adjusting pH value to 6.8 of 0.4mol/L with concentration, add afterwards pure water and be settled to 1000mL, namely get artificial simulation intestinal juice (Artificial Simulated Intestinal Juice, ASIJ).Place artificial simulation intestinal juice to carry out the Cumulative release amount test miglitol slow releasing tablet of present embodiment preparation, method of testing is identical with the detection method of artificial simulation gastric juices, records the Cumulative release amount curve of miglitol slow releasing tablet in artificial simulation intestinal juice of present embodiment preparation as shown in Figure 2.The miglitol slow releasing tablet of present embodiment preparation presents the feature of slow release in artificial simulation intestinal juice as seen from the figure, and the cumulative release amount slowly increases, and the cumulative release time can reach more than 5 hours.
The preparation method of present embodiment miglitol slow releasing tablet may further comprise the steps:
Cumulative release amount curve in the miglitol slow releasing tablet artificial simulation gastric juices of employing present embodiment preparation as shown in Figure 3.The miglitol slow releasing tablet of present embodiment preparation presents the feature of slow release in artificial simulation gastric juices as shown in Figure 3, and the cumulative release amount slowly increases, and the cumulative release time can reach more than 5 hours.
Adopt the Cumulative release amount curve of miglitol slow releasing tablet in artificial simulation intestinal juice of present embodiment preparation as shown in Figure 4.The miglitol slow releasing tablet of present embodiment preparation presents the feature of slow release in artificial simulation intestinal juice as shown in Figure 4, and the cumulative release amount slowly increases, and the cumulative release time can reach more than 5 hours.
The preparation method of present embodiment miglitol slow releasing tablet may further comprise the steps:
Cumulative release amount curve in the miglitol slow releasing tablet artificial simulation gastric juices of employing present embodiment preparation as shown in Figure 5.The miglitol slow releasing tablet of present embodiment preparation presents the feature of slow release in artificial simulation gastric juices as shown in Figure 5, and the cumulative release amount slowly increases, and the cumulative release time can reach more than 5 hours.
Adopt the Cumulative release amount curve of miglitol slow releasing tablet in artificial simulation intestinal juice of present embodiment preparation as shown in Figure 6.The miglitol slow releasing tablet of present embodiment preparation presents the feature of slow release in artificial simulation intestinal juice as shown in Figure 6, and the cumulative release amount slowly increases, and the cumulative release time can reach more than 5 hours.
The preparation method of present embodiment miglitol slow releasing tablet may further comprise the steps:
Step 3, with tabletting behind major ingredient described in the step 2 and the adjuvant mix homogeneously, the tabletting process is 30 ℃ in ambient temperature, envionmental humidity is to carry out under 50% the condition, obtains the miglitol slow releasing tablet; The quality percentage composition of major ingredient is 40% in the described miglitol slow releasing tablet, and surplus is adjuvant; Described adjuvant by filler, disintegrating agent, help and collapsed agent, lubricant, binding agent and correctives 20: 16: 16 in mass ratio: mixed preparing formed in 2: 7: 2; Described filler is that mannitol is or/and sal glauberi, preferably be mixed at 3: 1 in mass ratio by mannitol and sal glauberi, described disintegrating agent is low-substituted hydroxypropyl cellulose, cross-linking sodium carboxymethyl cellulose, in carboxymethyl starch sodium and the polyvinylpolypyrrolidone one or more, preferably by low-substituted hydroxypropyl cellulose, cross-linking sodium carboxymethyl cellulose and carboxymethyl starch sodium are mixed in mass ratio at 2: 1: 1, describedly help that to collapse agent be microcrystalline Cellulose, described lubricant is micropowder silica gel, in magnesium stearate and the Polyethylene Glycol one or more, preferably be mixed at 2: 1 in mass ratio by micropowder silica gel and magnesium stearate, described binding agent is that mass percent concentration is 3% hypromellose aqueous solution, described correctives is Mentholum or/and fruit essence preferably is mixed in mass ratio by Mentholum and fruit essence at 1: 2.
Cumulative release amount curve in the miglitol slow releasing tablet artificial simulation gastric juices of employing present embodiment preparation as shown in Figure 7.The miglitol slow releasing tablet of present embodiment preparation presents the feature of slow release in artificial simulation gastric juices as shown in Figure 7, and the cumulative release amount slowly increases, and the cumulative release time can reach more than 5 hours.
Adopt the Cumulative release amount curve of miglitol slow releasing tablet in artificial simulation intestinal juice of present embodiment preparation as shown in Figure 8.The miglitol slow releasing tablet of present embodiment preparation presents the feature of slow release in artificial simulation intestinal juice as shown in Figure 8, and the cumulative release amount slowly increases, and the cumulative release time can reach more than 5 hours.
The preparation method of present embodiment miglitol slow releasing tablet may further comprise the steps:
Step 3, with tabletting behind major ingredient described in the step 2 and the adjuvant mix homogeneously, the tabletting process is 22 ℃ in ambient temperature, envionmental humidity is to carry out under 65% the condition, obtains the miglitol slow releasing tablet; The quality percentage composition of major ingredient is 50% in the described miglitol slow releasing tablet, and surplus is adjuvant; Described adjuvant by filler, disintegrating agent, help and collapsed agent, lubricant, binding agent and correctives 15: 12: 20 in mass ratio: mixed preparing formed in 4: 6: 3; Described filler is that mannitol is or/and sal glauberi, preferably be mixed at 3: 1 in mass ratio by mannitol and sal glauberi, described disintegrating agent is low-substituted hydroxypropyl cellulose, cross-linking sodium carboxymethyl cellulose, in carboxymethyl starch sodium and the polyvinylpolypyrrolidone one or more, preferably by cross-linking sodium carboxymethyl cellulose, carboxymethyl starch sodium and polyvinylpolypyrrolidone are mixed in mass ratio at 3: 2: 1, describedly help that to collapse agent be microcrystalline Cellulose, described lubricant is micropowder silica gel, in magnesium stearate and the Polyethylene Glycol one or more, preferably by micropowder silica gel, magnesium stearate and Polyethylene Glycol are mixed in mass ratio at 1: 3: 2, described binding agent is that mass percent concentration is 1% hypromellose aqueous solution, described correctives is Mentholum or/and fruit essence preferably is mixed in mass ratio by Mentholum and fruit essence at 1: 4.
Cumulative release amount curve in the miglitol slow releasing tablet artificial simulation gastric juices of employing present embodiment preparation as shown in Figure 9.The miglitol slow releasing tablet of present embodiment preparation presents the feature of slow release in artificial simulation gastric juices as shown in Figure 9, and the cumulative release amount slowly increases, and the cumulative release time can reach more than 5 hours.
Adopt the Cumulative release amount curve of miglitol slow releasing tablet in artificial simulation intestinal juice of present embodiment preparation as shown in figure 10.The miglitol slow releasing tablet of present embodiment preparation presents the feature of slow release in artificial simulation intestinal juice as shown in Figure 10, and the cumulative release amount slowly increases, and the cumulative release time can reach more than 5 hours.
The above only is preferred embodiment of the present invention, is not that the present invention is imposed any restrictions.Every any simple modification, change and equivalence of above embodiment being done according to the invention technical spirit changes, and all still belongs in the protection domain of technical solution of the present invention.
Claims (8)
1. the preparation method of a miglitol slow releasing tablet is characterized in that, the method may further comprise the steps:
Step 1, miglitol, sodium-based montmorillonite are added in the deionized water with acidity regulator, obtain pH value after stirring and be 2～4 mixed solution; The concentration of miglitol is 0.8g/L～1.3g/L in the described mixed solution, and the concentration of sodium-based montmorillonite is 4.5g/L～5.5g/L; Described acidity regulator is hydrochloric acid;
Step 2, be 20 ℃～50 ℃ with mixed solution described in the step 1 in temperature, stir speed (S.S.) is to stir 1h～2h under the condition of 80r/min～150r/min to make miglitol and sodium-based montmorillonite carry out ion exchange, then the mixed solution after the ion exchange filtered successively, wash, dry, the processing of pulverizing and sieve, obtain major ingredient;
Step 3, with tabletting behind major ingredient described in the step 2 and the pharmaceutically acceptable adjuvant mix homogeneously, obtain the miglitol slow releasing tablet; The quality percentage composition of major ingredient is 20%～50% in the described miglitol slow releasing tablet, and surplus is adjuvant.
2. the preparation method of a kind of miglitol slow releasing tablet according to claim 1 is characterized in that, the quality purity of miglitol described in the step 1 is not less than 99.9%, and the quality purity of described sodium-based montmorillonite is not less than 96%.
3. the preparation method of a kind of miglitol slow releasing tablet according to claim 1 is characterized in that, the mass percent concentration of hydrochloric acid described in the step 1 is 5%～10%.
4. the preparation method of a kind of miglitol slow releasing tablet according to claim 1 is characterized in that, temperature dry described in the step 2 is 40 ℃～60 ℃, and the time of described drying is 5h～7h.
5. the preparation method of a kind of miglitol slow releasing tablet according to claim 1 is characterized in that, the mean diameter of major ingredient described in the step 2 is not more than 250 μ m.
6. the preparation method of a kind of miglitol slow releasing tablet according to claim 1 is characterized in that, the tabletting process is 20 ℃～30 ℃ in ambient temperature in the step 3, and envionmental humidity is to carry out under 45%～65% the condition.
7. the preparation method of a kind of miglitol slow releasing tablet according to claim 1, it is characterized in that, adjuvant described in the step 3 by filler, disintegrating agent, help and collapse agent, lubricant, binding agent and correctives in mass ratio (5～30): (10～20): (10～20): (1～5): (5～10): (1～5) mixed preparing forms.
8. the preparation method of a kind of miglitol slow releasing tablet according to claim 7, it is characterized in that, described filler is that mannitol is or/and sal glauberi, described disintegrating agent is low-substituted hydroxypropyl cellulose, cross-linking sodium carboxymethyl cellulose, in carboxymethyl starch sodium and the polyvinylpolypyrrolidone one or more, describedly help that to collapse agent be microcrystalline Cellulose, described lubricant is micropowder silica gel, in magnesium stearate and the Polyethylene Glycol one or more, described binding agent is that mass percent concentration is 1%～5% hypromellose aqueous solution, and described correctives is that Mentholum is or/and fruit essence.
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104940940A (en) * | 2015-07-15 | 2015-09-30 | 山东司邦得制药有限公司 | Montmorillonite compound slow-release preparation, gliclazide sustained release tablet and preparation method and application thereof |
| CN114469944A (en) * | 2022-03-02 | 2022-05-13 | 鲁南新时代生物技术有限公司 | Miglitol preparation and preparation method thereof |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1615862A (en) * | 2003-11-10 | 2005-05-18 | 浙江医药股份有限公司新昌制药厂 | Miglitol oral disintegration tablet for treating diabetes II and its preparing method |
| CN101422426A (en) * | 2008-12-12 | 2009-05-06 | 南方医科大学 | Nitroimidazoles medicine nano montmorillonite sustained-release agent and preparation method thereof |
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Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1615862A (en) * | 2003-11-10 | 2005-05-18 | 浙江医药股份有限公司新昌制药厂 | Miglitol oral disintegration tablet for treating diabetes II and its preparing method |
| CN101422426A (en) * | 2008-12-12 | 2009-05-06 | 南方医科大学 | Nitroimidazoles medicine nano montmorillonite sustained-release agent and preparation method thereof |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104940940A (en) * | 2015-07-15 | 2015-09-30 | 山东司邦得制药有限公司 | Montmorillonite compound slow-release preparation, gliclazide sustained release tablet and preparation method and application thereof |
| CN114469944A (en) * | 2022-03-02 | 2022-05-13 | 鲁南新时代生物技术有限公司 | Miglitol preparation and preparation method thereof |
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