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Compound preparation containing DPP-IV (dipeptidyl peptidase-IV) inhibitor and type-II diabetes medicine and preparation method thereof

A diabetes drug and compound preparation technology, applied in the field of medicine, can solve the problems of increased risk of combination therapy, decreased patient compliance, increased drug dosage, etc., to achieve the effect of reducing the number of times of taking medicine, reducing the number of times of taking medicine, and improving compliance

Active Publication Date: 2013-09-11
QINGDAO HUANGHAI PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

If the drug used in combination is a general preparation, the drug release will be uneven, the "peak" and "trough" phenomenon of the blood drug concentration-time curve will be obvious, the therapeutic window will be narrow, and the side effects will increase significantly. Quantitatively "replenishing" the drug in combination to maintain a steady state of blood drug concentration will not only increase the dosage of the drug, but also greatly reduce the patient's compliance; For release preparations, patients not only need to take drugs containing DPP-IV inhibitors, but also take regular and quantitative doses of delayed-release preparations. The compliance is poor, missed doses are likely to occur, and the risk of combination therapy increases

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] Embodiment 1: repaglinide-saxagliptin compound preparation and preparation method thereof

[0031] Repaglinide-saxagliptin compound preparation specifically includes the following components (based on 1000 tablets):

[0032] Tablet prescription:

[0033]repaglinide 3 g

[0034] Hydroxypropyl Methyl Cellulose (K4M) 85g

[0035] Microcrystalline cellulose 30 g

[0036] Magnesium stearate 1 g

[0037] 95% ethanol solution containing 5% PVP 105 g

[0038] Immediate release coating formulation:

[0039] Saxagliptin 2.5g

[0040] Hypromellose E5 8 g

[0041] Croscarmellose Sodium 1.5 g

[0042] Talc powder 0.5g

[0043] 75% ethanol solution 250g

[0044] Aesthetic Coat Layer Prescription:

[0045] Opadry (pink) 12 g

[0046] Distilled water 108 g

[0047] The preparation method of repaglinide-saxagliptin compound preparation is as follows:

[0048] Mix repaglinide, hydroxypropylmethyl cellulose, and microcrystalline cellulose in equal increments, add a binder to...

Embodiment 2

[0051] Embodiment 2, gliclazide-saxagliptin compound preparation and preparation method thereof

[0052] The gliclazide-saxagliptin compound preparation specifically includes the following components (based on 1000 tablets):

[0053] Tablet prescription:

[0054] Gliclazide 30g

[0055] Microcrystalline Cellulose 60g

[0056] Hypromellose K100LV 85g

[0057] Micronized silica gel 1g

[0058] Magnesium Stearate 1g

[0059] Isolation gown layer prescription:

[0060] Hypromellose E5 6g

[0061] Polyethylene glycol 1g

[0062] Distilled water 50g

[0063] Immediate release coating formulation:

[0064] Saxagliptin 2.5g

[0065] Hypromellose E5 10g

[0066] Croscarmellose Sodium 2 g

[0067] Talc powder 1 g

[0068] 75% ethanol solution 350g

[0069] Aesthetic Coat Layer Prescription:

[0070] Opadry (red) 25 g

[0071] Distilled water 225g

[0072] The preparation method of the gliclazide-saxagliptin compound preparation is as follows:

[0073] Mix gliclazide, h...

Embodiment 3

[0077] Embodiment 3, metformin-vildagliptin compound preparation and its preparation

[0078] The metformin-vildagliptin compound preparation specifically includes the following components (based on 1000 tablets):

[0079] Tablet prescription:

[0080] Drug-containing layer

[0081] Metformin Hydrochloride 500g

[0082] Polyoxyethylene (N80) 80g

[0083] Hypromellose E5 8g

[0084] Magnesium Stearate 3g

[0085] booster layer

[0086] Polyoxyethylene (301) 70g

[0087] Sodium Alginate 30g

[0088] Sodium chloride 25g

[0089] Iron oxide red 1g

[0090] Functional coating layer prescription:

[0091] Cellulose acetate 72g

[0092] Macrogol 4000 6 g

[0093] Acetone 1200g

[0094] Distilled water 15g

[0095] Immediate release coating formulation:

[0096] Vildagliptin 50g

[0097] Hypromellose E5 30g

[0098] Croscarmellose Sodium 5 g

[0099] Magnesium stearate 1 g

[0100] Aesthetic Coat Layer Prescription:

[0101] Opadry (yellow) 50 g

[0102] Distilled...

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Abstract

The invention provides a compound preparation containing a DPP-IV (dipeptidyl peptidase-IV) inhibitor and a type-II diabetes medicine and a preparation method thereof. According to the invention, two effective pharmaceutical ingredients are respectively prepared into a quick-release part and a slow-release part (controlled-release part) and then prepared into the compound preparation finally; the problem of combining the DPP-IV inhibitor with other diabetes medicines is solved; compliance of patients is increased; the curative effects and durations of medicines are increased maximally; the compound preparation disclosed by the invention has good effects and practical significance for treating or preventing one or more symptoms, such as type-I diabetes, type-II diabetes, hyperglycemia and impaired glucose tolerance.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a compound preparation containing DPP-IV inhibitor and a second diabetes drug and a preparation method thereof. Background technique [0002] Diabetes mellitus (Diabetes mellitus) is a series of clinical syndromes caused by absolute or relative insufficiency of insulin in the body. At present, the treatment of diabetes is mainly diet control combined with hypoglycemic drugs (for type II diabetes) or insulin supplementation in combination to treat diabetes. [0003] Diabetes can cause a variety of complications, such as hypoglycemia (hypoglyccmia), ketoacidosis (ketoacidosis, DKA), non-ketone hyperosmolar coma. Serious long-term complications include: cardiovascular disease, chronic kidney failure (also known as diabetic nephropathy, the leading cause of hemodialysis in adults in developing countries), retinopathy (also known as diabetic eye disease, leading causes ...

Claims

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Application Information

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IPC IPC(8): A61K45/06A61K9/36A61K31/451A61K31/64A61K31/155A61K31/403A61P3/10
Inventor 祝少良张兴跃梁斅瑜刘晓华胡杰
Owner QINGDAO HUANGHAI PHARM CO LTD
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