CN101756937A - Combined capsule with replaglinide solid preparation and dimethyldiguanide solid preparation - Google Patents
Combined capsule with replaglinide solid preparation and dimethyldiguanide solid preparation Download PDFInfo
- Publication number
- CN101756937A CN101756937A CN200910307784A CN200910307784A CN101756937A CN 101756937 A CN101756937 A CN 101756937A CN 200910307784 A CN200910307784 A CN 200910307784A CN 200910307784 A CN200910307784 A CN 200910307784A CN 101756937 A CN101756937 A CN 101756937A
- Authority
- CN
- China
- Prior art keywords
- capsule
- solid preparation
- metformin
- urea
- lage
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
Images
Landscapes
- Medicinal Preparation (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Abstract
The invention relates to a combined capsule filled with a replaglinide solid preparation and a dimethyldiguanide solid preparation. The combined capsule comprises a first capsule and a solid preparation in the first capsule, wherein the first capsule comprises an upper capsule body and a lower capsule body; and the solid preparation with an active component of replaglinide and the solid preparation with an active component of dimethyldiguanide are at least filled into the first capsule. Compared with the prior art, all components can not generate chemical change and produce a by-product so that the stability of a product is improved. The product of the invention is quite suitable for industrialized production and has favorable compliance of patients.
Description
Technical field the present invention relates to a kind of oral hard capsule, is filled with the complex capsule of Rui Lage urea solid preparation and metformin solid preparation in particularly a kind of capsule.
Background technology compound recipe Rui Lage urea metformin hydrochloride tablet is the product of Novo Nordisk Co.,Ltd, and its commodity are called PrandiMet, are used for the treatment of type 2 diabetes mellitus, comprises two kinds of specifications of Rui Lage urea/metformin hydrochloride 1mg/500mg and 2mg/500mg.This product be proved to be can reduce can not adopt the sharp urea of MAG and (or) metformin controls the blood glucose of the type 2 diabetes mellitus adult patient of hyperglycemia well.Drugs approved by FDA PrandiMet listing is based on Rui Lage urea/metformin hydrochloride 1mg/500mg, the Rui Lage urea of 2mg/500mg and corresponding dosage and metformin hydrochloride single medicine preparation share the bioequivalence data that are close, clinical research proves, PrandiMet can reduce HbA1 c concentration safely and effectively, the preparation that this product provides two medicines conveniently to take medicine in 1, auspicious glug urea stimulates pancreatic secretion insulin after the meal, thereby reduce by 2 hours after the meal blood glucose (PPG), metformin reduces hepatogenous blood glucose amount, thereby reduce fasting glucose (FPG), improve the natural reaction of human body insulin.
There is the possibility that contacts in two kinds of active component of metformin and Rui Lage urea in the above-mentioned dosage form.And the various active composition is all in same minimum preparation unit.
If active component contacts with each other, have following shortcoming: 1, because multicomponent mixing homogeneity degree influences, each composition is difficult to accurately quantitatively; When 2, product detects,, influence the qualitative and quantitative analysis result because the phase mutual interference is difficult for measuring each component content; 3, during long preservation, change because chemical compatibility may take place between each composition, be easy to generate by-product, reduce effect or increase side effect, product stability is not ideal enough.Because above-mentioned defective exists, there are many advantages although contain the existing compound recipe dosage form of Rui Lage urea, but still may cause harmful effect product quality and human body health.
Though can come the quality of strict control medicine in the pharmaceuticals industry by the GMP standard, find simple production technology to guarantee that the quality of medicine remains one of direction of drug research and development, also meets the aim of medicine GMP.
Summary of the invention
The invention provides a kind of complex capsule that metformin solid preparation and Rui Lage urea solid preparation are housed, do not contact mutually between the various active component in the capsule, thereby obtain stability complex capsule better, easy to process.
Complex capsule of the present invention is made up of the solid preparation in first capsule and first capsule, and the complex capsule that first capsule comprises is characterized in that, described solid preparation is the tablet or second capsule.
Preferred complex capsule of the present invention, wherein tablet is a coating.
Complex capsule of the present invention, wherein the coating of tablet is a different colours, described tablet is the identical cylinder of shape.
Complex capsule, it is characterized in that described first capsule is No. 0 or No. 1 capsule, and first capsularly goes up utricule and following utricule is colourless.
Complex capsule of the present invention, wherein first capsule is No. 0 or No. 1 capsule, thus for the first capsular compliance that increases the patient attractive in appearance, the first capsular utricule of going up is colourless with following utricule.
In order to be fit to that mechanization is produced and to be convenient to be identified, but various tablets or the identical color difference of the second capsular shape in first capsule.
Particularly in order to adapt to the capsule filling machine that goes on the market and use, the shape of described various tablets is made into column type.Automatic capsule filling machine (KF-S50) such as Korea S INNOTECH SYSTEMS LTD. company.
Also in order to adapt to the slice, thin piece of different content active component, also can select the capsule of other models simultaneously.
The utilization of technique scheme, the present invention compared with prior art have following advantage:
1. because the active component in first capsule is not contacted each other; therefore chemistry 5 changes can not take place between each composition and produce by-product; especially for having the amido link of replacement that good protection is arranged on the ester bond of metformin and the N, the stability of product is improved.
2. owing to adopted the design of column type slice, thin piece and different colours, and the application of transparent softgel shell, make product of the present invention be fit to very much suitability for industrialized production, strengthened patient's compliance.
3. because the present invention adopts is active component film-making respectively, on the check of medicine and quality control, be more prone to.
Description of drawings
Accompanying drawing 1 is the axonometric chart of the complex capsule of embodiments of the invention 1.Wherein, 1, capsule body down; 2, go up capsule body; 3, first diformin tablet; 4, Rui Lage urea sheet; 5, second diformin tablet.
Accompanying drawing 2 is the exploded perspective view of the complex capsule of embodiment 1.1, following capsule body; 2, go up capsule body; 3, diformin tablet; 4, Rui Lage urea sheet; 5, amlodipine sheet.
Accompanying drawing 3 is the A-A cutaway view of the complex capsule of embodiment 1.Wherein, 1, capsule body down; 2, go up capsule body; 3, first diformin tablet; 4, Rui Lage urea sheet; 5, second diformin tablet.
Accompanying drawing 4 is the cutaway view of embodiments of the invention 2.Wherein, 1, capsule body down; 2, go up capsule body; 3, diformin tablet; 4, Rui Lage urea sheet.
The specific embodiment
Below in conjunction with drawings and Examples the present invention is further described:
Embodiment 1: shown in accompanying drawing 1-3, and the complex capsule of one first diformin tablet of filling, a Rui Lage urea sheet and one second diformin tablet in the seed capsules.The first capsule specification is No. 0.First capsule housing is by capsule body 1 and last capsule body 2 suits constitute down, the slice of cylinder of above-mentioned 3 different colours coatings is housed, is respectively first diformin tablet (containing metformin 250mg), Rui Lage urea (containing Rui Lage urea 1mg) and second diformin tablet (containing metformin 250mg).
First metformin is that yellow stomach dissolution type film-coat, Rui Lage urea sheet are that red film-coat, second metformin is black stomach dissolution type film-coat or all adopts identical color.
Embodiment 2: shown in accompanying drawing 4, and the complex capsule of a diformin tablet of filling and a Rui Lage urea sheet in the seed capsules.The first capsule specification is No. 0.First capsule housing is made of with last capsule body 2 suits following capsule body 1, and the slice of cylinder of above-mentioned 2 different colours coatings is housed, and is respectively diformin tablet (containing metformin 250mg), Rui Lage urea sheet (Rui Lage urea 1mg).Auspicious glug urea sheet is that yellow stomach dissolution type film-coat, diformin tablet are red film-coat.
The steadiness of complex capsule of the present invention is described below in conjunction with the test example
Test example 1 is carried out hot test (60 ℃), high wet test (RH75%), exposure experiments to light (3000LX) respectively with embodiment 1,2 prepared complex capsules and is carried out test in 10 days, the results are shown in Table 1-3:
Table 1, hot test
| |
|
||
| 0 day content | Metformin (%) | ??99.56 | ??99.44 |
| Auspicious glug urea (%) | ??99.79 | ??100.1 | |
| 0 day related substance | Metformin (%) | ??0.31 | ??0.22 |
| 5 days content | Metformin (%) | ??99.43 | ??99.47 |
| Auspicious glug urea (%) | ??99.38 | ??100.1 | |
| 5 related substances | Metformin (%) | ??0.28 | ??0.18 |
| 10 days content | Metformin (%) | ??99.11 | ??99.23 |
| Auspicious glug urea (%) | ??99.33 | ??100.2 | |
| 10 days related substances | Metformin (%) | ??0.27 | ??0.17 |
Annotate: content is sign content in the table
Table 2, high wet test
| |
|
||
| 0 day content | Metformin (%) | ??99.56 | ??99.44 |
| Auspicious glug urea (%) | ??99.79 | ??100.1 | |
| 0 day related substance | Metformin (%) | ??0.31 | ??0.22 |
| 5 days content | Metformin (%) | ??99.46 | ??99.48 |
| Auspicious glug urea (%) | ??99.42 | ??99.32 | |
| 5 related substances | Metformin (%) | ??0.24 | ??0.30 |
| 10 days content | Metformin (%) | ??99.31 | ??99.76 |
| Auspicious glug urea (%) | ??99.43 | ??99.63 | |
| 10 days related substances | Metformin (%) | ??0.32 | ??0.35 |
Annotate: content is sign content in the table
Table 3, exposure experiments to light
| |
|
||
| 0 day content | Metformin (%) | ??99.23 | ??99.77 |
| Auspicious glug urea (%) | ??99.76 | ??99.79 | |
| 0 day related substance | Metformin (%) | ??0.38 | ??0.37 |
| 5 days content | Metformin (%) | ??99.44 | ??99.69 |
| Auspicious glug urea (%) | ??99.35 | ??99.39 | |
| 5 related substances | Metformin (%) | ??0.32 | ??0.38 |
| 10 days content | Metformin (%) | ??99.11 | ??99.26 |
| Auspicious glug urea (%) | ??99.33 | ??99.43 | |
| 10 days related substances | Metformin (%) | ??0.37 | ??0.32 |
Annotate: content is sign content in the table
Stability test is the result show, it is less relatively that embodiments of the invention obtain the generation of product related substance, and content does not reduce.Owing to be to measure respectively, detection method is easy, needn't consider compound medicine between the phase mutual interference.
Claims (7)
1. complex capsule, form by the solid preparation in first capsule and first capsule, first capsule comprises utricule and following utricule, it is characterized in that, in described first capsule at least active component of filling be the solid preparation of metformin and active component of filling solid preparation that is the Rui Lage urea at least.
2. complex capsule as claimed in claim 1 is characterized in that, active component of filling is a metformin in described first capsule solid preparation and the solid preparation that the Rui Lage urea is an active component.
3. complex capsule as claimed in claim 1 is characterized in that, active component of filling is a metformin in described first capsule solid preparation and the solid preparation that the Rui Lage urea is an active component.
4. as the described complex capsule of claim 1-3, it is characterized in that described solid preparation is the tablet or second capsule.
5. complex capsule as claimed in claim 4 is characterized in that described tablet is a coating.
6. complex capsule as claimed in claim 4 is characterized in that, the coating of described tablet is a different colours, and described tablet is the identical cylinder of shape.
7. complex capsule as claimed in claim 1 is characterized in that, described first capsule is No. 0 or No. 1 capsule, and the first capsular utricule of going up is colourless with following utricule.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN200910307784A CN101756937A (en) | 2009-09-26 | 2009-09-26 | Combined capsule with replaglinide solid preparation and dimethyldiguanide solid preparation |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN200910307784A CN101756937A (en) | 2009-09-26 | 2009-09-26 | Combined capsule with replaglinide solid preparation and dimethyldiguanide solid preparation |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN101756937A true CN101756937A (en) | 2010-06-30 |
Family
ID=42488421
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN200910307784A Pending CN101756937A (en) | 2009-09-26 | 2009-09-26 | Combined capsule with replaglinide solid preparation and dimethyldiguanide solid preparation |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN101756937A (en) |
-
2009
- 2009-09-26 CN CN200910307784A patent/CN101756937A/en active Pending
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| Ahmad et al. | Extraction and UHPLC–DAD detection of undeclared substances in market‐available dietary supplements and slimming products in Eastern region, Saudi Arabia: An application of principal component analysis | |
| CN201524269U (en) | Combined capsule loaded with replaglinide solid preparation and metformin solid preparation | |
| CN101756937A (en) | Combined capsule with replaglinide solid preparation and dimethyldiguanide solid preparation | |
| CN109655544B (en) | Quality control method of metformin hydrochloride and preparation thereof | |
| CN106860446B (en) | Compound amino acid injection 19AA-I composition for children and method for reducing oxygen content of compound amino acid injection | |
| CN103356623A (en) | Novel ferrous fumarate and folic acid compound capsule | |
| CN202568926U (en) | Tablet capsule filled with alogliptin solid preparation and pioglitazone solid preparation | |
| CN202010289U (en) | Combined capsule containing hydrochlorothiazide solid formulation and aliskiren solid formulation | |
| CN202568930U (en) | Tablet capsule with repaglinide solid preparation and dimethyldiguanide solid preparation | |
| CN202568934U (en) | Tablet capsule filled with glipizide solid preparations and metformin solid preparations | |
| CN202568929U (en) | Tablet capsules containing rosiglitazone solid preparation and metformin solid preparation | |
| CN101700237A (en) | Combined capsule filled with hydrochlorothiazide solid preparation and Aliskiren solid preparation | |
| CN202568931U (en) | Novel compound capsule containing ferrous fumarate and folic acid | |
| CN103356621A (en) | Novel capsule filled with alogliptin solid preparation and pioglitazone solid preparation | |
| CN202568927U (en) | Novel capsule containing Roflumilast solid preparation and Formoterol solid preparation | |
| CN203970949U (en) | The tablet capsule of Omeprazole and Sodium Bicarbonate Tablets is housed | |
| CN202146449U (en) | Capsule with Lopinavir tablets and Ritonavir tablets | |
| CN103356661A (en) | Novel capsule filled with metformin hydrochloride solid preparation and glipizide solid preparation | |
| CN102008467A (en) | Tablet capsule filled with amoxicillin tablets and ambroxol hydrochloride tablets | |
| CN102274231A (en) | Capsules filled with lopinavir tablets and ritonavir tablets | |
| CN201701513U (en) | Tablet capsule filled with cefalexin tablets and ambroxol hydrochloride tablets | |
| CN201701512U (en) | Tablets capsule containing loratadine tablets and ambroxol hydrochloride tablets | |
| CN102018694A (en) | Tablet capsule loaded with salbutamol sulfate tablet and ambroxol hydrochloride tablet | |
| CN103356502A (en) | Novel capsule filled with rosiglitazone solid preparation and metformin solid preparation | |
| CN101584680A (en) | Tablet capsule containing clopidogrel hydrogen sulfate salt tablets and acetylsalicylic acid tablets |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| C06 | Publication | ||
| PB01 | Publication | ||
| ASS | Succession or assignment of patent right |
Owner name: HEILONGJIANG FUHE HUAXING PHARMACY GROUP CO., LTD. Free format text: FORMER OWNER: WU GUANGYAN Effective date: 20110523 |
|
| C41 | Transfer of patent application or patent right or utility model | ||
| TA01 | Transfer of patent application right |
Effective date of registration: 20110523 Address after: 151100 Heilongjiang Zhaodong Taiping Road 34, Heilongjiang Dilong pharmaceutical Limited by Share Ltd Applicant after: Heilongjiang Fuhe Huaxing Pharmaceutical Group Co., Ltd. Address before: 151100 Heilongjiang Zhaodong Taiping Road 34, Heilongjiang Dilong pharmaceutical Limited by Share Ltd Applicant before: Wu Guangyan |
|
| C02 | Deemed withdrawal of patent application after publication (patent law 2001) | ||
| WD01 | Invention patent application deemed withdrawn after publication |
Application publication date: 20100630 |