CN201701514U - Tablet capsule containing roxithromycin tablets and ambroxol hydrochloride tablets - Google Patents
Tablet capsule containing roxithromycin tablets and ambroxol hydrochloride tablets Download PDFInfo
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- CN201701514U CN201701514U CN2010202421661U CN201020242166U CN201701514U CN 201701514 U CN201701514 U CN 201701514U CN 2010202421661 U CN2010202421661 U CN 2010202421661U CN 201020242166 U CN201020242166 U CN 201020242166U CN 201701514 U CN201701514 U CN 201701514U
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- capsule
- tablet
- roxithromycin
- tablets
- ambroxol hydrochloride
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Abstract
The utility model relates to an oral administration hard capsule, in particular to a tablet capsule filled with roxithromycin tablets and ambroxol hydrochloride tablets in the capsule. The tablet capsule of the utility model consists of a capsule and tablets arranged in the capsule, wherein the capsule comprises an upper capsule body and a lower capsule body, and at least one tablet with the active ingredient of roxithromycin and at least one tablet with the active ingredient of ambroxol hydrochloride are filled in the capsule. Because active ingredients in the capsule are not in mutual contact, all ingredients can not generate chemical reaction or byproducts, the stability of the product can be improved, and particularly, degradation products generated after the contact of the roxithromycin and the ambroxol hydrochloride can be greatly reduced. In addition, the design of cylindrical tablets and different colors is adopted, and transparent capsule cases are adopted, so the products of the utility model are particularly suitable for industrial production, the compliance of the patients can be enhanced, at the same time, the utility model adopts active ingredients for respectively making the tablets, and the medicine examination and the quality control can be more easy.
Description
Technical field
This utility model relates to a kind of oral hard capsule, is filled with the tablet capsule of Roxithromycin sheet and ambroxol hydrochloride sheet in particularly a kind of capsule.
Background technology
The bacillary acute bronchitis that the treatment of Roxithromycin associating ambroxol hydrochloride sheet is caused by the Roxithromycin sensitive microbial, acute exacerbation, bronchopneumonia, typicality pathogen pneumonia, the bronchial asthma that merges bacterial infection or the bronchiectasis etc. of chronic bronchitis.
Roxithromycin is used for the caused infection of sensitive strain, especially upper and lower respiratory tract infection, otorhinolaryngology infection, genitals (except the gonococcal infection) and skin infection.
Ambroxol hydrochloride Ambroxol Hydrochloride, its chemical name is the amino 3.5-dibromo-benzyl of trans-4-[(2-) amino] the Hexalin hydrochlorate, be to be used for clinical a kind of mucolytic drugs early 1980s, its toxicity is low, eliminating the phlegm and to improve the pulmonary function effect strong, is one of the most frequently used expelling phlegm drugs.The structural formula of ambroxol hydrochloride is:
Molecular formula: C
13H
18Br
2N
2OHCl; Molecular weight: 414.57
The BIOSEARCH company of India develops the roxithromycin and ambroxol hydrochloride compound tablet in listing, trade name XEROBECT-AX, and specification is Roxithromycin 150mg: ambroxol hydrochloride 30mg.Domestic patent CN200410020717, CN200610007513 and CN200510073171 have reported that respectively Roxithromycin and ambroxol coexist as the dosage form of same preparation unit.
Yet two kinds of active component of Roxithromycin and ambroxol hydrochloride can produce a lot of potential safety hazards in same minimum preparation unit.If active component contacts with each other, also 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 Roxithromycin, but still may cause harmful effect product quality and human body health.
The utility model content
This utility model provides a kind of tablet capsule that Roxithromycin sheet and ambroxol hydrochloride sheet are housed, and does not contact mutually between the various active component in the capsule, thereby obtains stability tablet capsule better, easy to process.
Tablet capsule of the present utility model is made up of the tablet in capsule and the capsule, and capsule comprises utricule and following utricule, wherein in the capsule at least active component of filling be the tablet of Roxithromycin and active component of filling tablet that is ambroxol hydrochloride at least.
A kind of optimal way of tablet capsule of the present utility model is, ambroxol hydrochloride tablet and Roxithromycin tablet wherein is housed respectively is 1,
The form of tablet capsule of the present utility model is that tablet is carried out coating preferably, coating solution be chosen as any selection of acceptable on the pharmaceutics.
Tablet of the present utility model also can be made variform special-shaped sheet with tablet in order to adapt to different medicament demands.
In order to be fit to that mechanization is produced and to be convenient to be identified, but the identical color difference of various figure of tablet in the 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.
Tablet capsule of the present utility model, wherein capsule is No. 0 or No. 1 capsule, and the capsular utricule of going up is colourless or translucent with following utricule.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, this utility model compared with prior art have following advantage:
1. because the active component in the capsule is not contacted each other, so chemistry 5 can not take place between each composition becomes and produce by-product, the stability of product is improved, reduced especially that Roxithromycin contacts with ambroxol hydrochloride and the catabolite that produces;
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 utility model be fit to very much suitability for industrialized production, strengthened patient's compliance;
3. because this utility model adopts is active component film-making respectively, on the check of medicine and quality control, be more prone to.
Description of drawings
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, Roxithromycin sheet; 4, ambroxol hydrochloride 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, Roxithromycin sheet; 4, ambroxol hydrochloride sheet.
The specific embodiment
Below in conjunction with drawings and Examples this utility model is further described:
Embodiment 1: shown in accompanying drawing 1-3, and ambroxol hydrochloride sheet of filling in the seed capsules; 4, the tablet capsule of Roxithromycin sheet.The capsule specification is No. 0.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 Roxithromycin sheet (containing Roxithromycin 150mg), ambroxol hydrochloride sheet (ambroxol-hydrochloride-containing 30mg).
The Roxithromycin sheet is that yellow stomach dissolution type film-coat, ambroxol sheet are red film-coat.
Embodiment 2: shown in accompanying drawing 4, and the tablet capsule of an ambroxol hydrochloride sheet of filling and a Roxithromycin sheet in the seed capsules.The capsule specification is No. 0.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 ambroxol hydrochloride sheet (ambroxol-hydrochloride-containing 15mg), Roxithromycin sheet (Roxithromycin 75mg).The ambroxol hydrochloride sheet is yellow stomach dissolution type film-coat.
Experimental example 1 carries out hot test (60 ℃), high wet test (RH75%), exposure experiments to light (3000LX) respectively with embodiment 1,2 prepared tablet capsules and carries out test in 10 days, the results are shown in Table 1-3:
Table 1, hot test
| |
||
| 0 day content | Ambroxol (%) | 99.21 |
| Roxithromycin (%) | 99.34 | |
| 0 day related substance | N-A873CL | 0.02 |
| N-AB773XX | 0.01 | |
| 5 days content | Ambroxol (%) | 99.32 |
| Roxithromycin (%) | 99.19 | |
| 5 days related substances | N-A873CL | 0.03 |
| N-AB773XX | 0.02 | |
| 10 days content | Ambroxol (%) | 99.37 |
| Roxithromycin (%) | 99.56 | |
| 10 days related substances | N-A873CL | 0.03 |
| N-AB773XX | 0.04 |
Annotate: content is sign content in the table, and related substance is with calculated by peak area
Table 2, high wet test
| |
||
| 0 day content | Ambroxol (%) | 99.21 |
| Roxithromycin (%) | 99.34 | |
| 0 day related substance | N-A873CL | 0.02 |
| N-AB773XX | 0.01 | |
| 5 days content | Ambroxol (%) | 99.36 |
| Roxithromycin (%) | 99.15 | |
| 5 days related substances | N-A873CL | 0.02 |
| N-AB773XX | 0.05 | |
| 10 days content | Ambroxol (%) | 99.33 |
| Roxithromycin (%) | 99.53 | |
| 10 days related substances | N-A873CL | 0.04 |
| N-AB773XX | 0.03 |
Annotate: content is sign content in the table, and related substance is with calculated by peak area
Table 3, exposure experiments to light
| |
||
| 0 day content | Ambroxol (%) | 99.21 |
| Roxithromycin (%) | 99.34 | |
| 0 day related substance | N-A873CL | 0.02 |
| N-AB773XX | 0.01 | |
| 5 days content | Ambroxol (%) | 99.35 |
| Roxithromycin (%) | 99.13 | |
| 5 days related substances | N-A873CL | 0.02 |
| N-AB773XX | 0.05 | |
| 10 days content | Ambroxol (%) | 99.36 |
| Roxithromycin (%) | 99.53 | |
| 10 days related substances | N-A873CL | 0.04 |
| N-AB773XX | 0.04 |
Annotate: content is sign content in the table, and related substance is with calculated by peak area.
Stability test is the result show, it is less relatively that embodiment of the present utility model obtains 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 (5)
1. tablet capsule, be made up of the tablet in capsule and the capsule, capsule comprises utricule and following utricule, it is characterized in that, in the described capsule at least active component of filling be the tablet of Roxithromycin and active component of filling tablet that is ambroxol hydrochloride at least.
2. tablet capsule as claimed in claim 1 is characterized in that, described Roxithromycin sheet is 1, and described ambroxol hydrochloride sheet is 1.
3. tablet capsule as claimed in claim 1 or 2 is characterized in that described tablet is a coating.
4. tablet capsule as claimed in claim 3 is characterized in that, the coating of described tablet is a different colours, and described tablet is the identical cylinder of shape.
5. tablet capsule as claimed in claim 1 is characterized in that, described capsule is No. 0 or No. 1 capsule, and the capsular utricule of going up is colourless or translucent with following utricule.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2010202421661U CN201701514U (en) | 2010-06-30 | 2010-06-30 | Tablet capsule containing roxithromycin tablets and ambroxol hydrochloride tablets |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2010202421661U CN201701514U (en) | 2010-06-30 | 2010-06-30 | Tablet capsule containing roxithromycin tablets and ambroxol hydrochloride tablets |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN201701514U true CN201701514U (en) | 2011-01-12 |
Family
ID=43438657
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN2010202421661U Expired - Fee Related CN201701514U (en) | 2010-06-30 | 2010-06-30 | Tablet capsule containing roxithromycin tablets and ambroxol hydrochloride tablets |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN201701514U (en) |
-
2010
- 2010-06-30 CN CN2010202421661U patent/CN201701514U/en not_active Expired - Fee Related
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| C14 | Grant of patent or utility model | ||
| GR01 | Patent grant | ||
| 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: 20110603 |
|
| C41 | Transfer of patent application or patent right or utility model | ||
| COR | Change of bibliographic data |
Free format text: CORRECT: ADDRESS; FROM: 151100 HEILONGJIANG FUHE HUAXING PHARMACEUTICAL GROUP CO., LTD., NO. 34, TAIPING ROAD, ZHAODONG CITY, SUIHUA CITY, HEILONGJIANG PROVINCE TO: 151100 HEILONGJIANG FUHE HUAXING PHARMACEUTICAL GROUP CO., LTD., NO. 34, TAIPING ROAD, ZHAODONG CITY, HEILONGJIANG |
|
| TR01 | Transfer of patent right |
Effective date of registration: 20110603 Address after: 151100 Heilongjiang Zhaodong Taiping Road 34, Heilongjiang Dilong pharmaceutical Limited by Share Ltd Patentee after: Heilongjiang Fuhe Huaxing Pharmaceutical Group Co., Ltd. Address before: 151100 Suihua City, Heilongjiang province Zhaodong City, Taiping Road, No. 34 Heilongjiang Dilong pharmaceutical Limited by Share Ltd Patentee before: Wu Guangyan |
|
| CF01 | Termination of patent right due to non-payment of annual fee |
Granted publication date: 20110112 Termination date: 20160630 |
|
| CF01 | Termination of patent right due to non-payment of annual fee |