CN202568924U - Tablet capsule with losartan tablet and hydrochlorothiazide tablet - Google Patents

Tablet capsule with losartan tablet and hydrochlorothiazide tablet Download PDF

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Publication number
CN202568924U
CN202568924U CN 201220118400 CN201220118400U CN202568924U CN 202568924 U CN202568924 U CN 202568924U CN 201220118400 CN201220118400 CN 201220118400 CN 201220118400 U CN201220118400 U CN 201220118400U CN 202568924 U CN202568924 U CN 202568924U
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China
Prior art keywords
capsule
tablet
hydrochlorothiazide
losartan potassium
utility
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Expired - Fee Related
Application number
CN 201220118400
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Chinese (zh)
Inventor
吴光彦
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
HEILONGJIANG FUHE HUAXING PHARMACEUTICAL GROUP CO Ltd
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HEILONGJIANG FUHE HUAXING PHARMACEUTICAL GROUP CO Ltd
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Priority to CN 201220118400 priority Critical patent/CN202568924U/en
Application granted granted Critical
Publication of CN202568924U publication Critical patent/CN202568924U/en
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Abstract

The utility model relates to an oral hard capsule and particularly relates to a tablet capsule. According to the tablet capsule, a losartan potassium tablet and a hydrochlorothiazide tablet are filled in a capsule. The tablet capsule disclosed by the utility model comprises a capsule and tablets in the capsule, wherein the capsule comprises an upper capsule body and a lower capsule body, a tablet of which the active component is losartan potassium is at least filled in the capsule, and a tablet of which the active component is hydrochlorothiazide is at least filled in the capsule. The utility model provides a tablet capsule with a losartan potassium tablet and a hydrochlorothiazide tablet. Various active components in the capsule do not contact with each other, so that the tablet capsule which has better stability and is convenient to process is obtained. More importantly, the utility model provides a losartan potassium-hydrochlorothiazide compound preparation which can obtain related substances with qualified quality under the condition of no need of strictly controlling the related substances of an intermediate.

Description

The tablet capsule of losartan sheet and hydrochlorothiazide tablet is housed
Technical field
This utility model relates to a kind of oral hard capsule, is filled with the tablet capsule of Losartan Potassium sheet and hydrochlorothiazide tablet in particularly a kind of capsule.
Background technology
Losastan potassium/hydrochlorothiazide tablets; English name: Losaartan Potassium and Hydrochlorothiazide Tablets (Hyzaar); Be during, fail the patient of abundant controlling blood pressure can use these article instead and carry out therapeutic alliance by the hydrochlorothiazide single therapy of Mo Shadong research and development or Losartan Potassium single therapy.
At present, cause that for the losartan potassium hydrochlorothiazide compound preparation main cause of quality is the related substance item, go beyond the scope through regular meeting, and approaching basically with the principal agent peak in the liquid phase collection of illustrative plates that detects to this type impurity, and general being difficult for removes.General this area all is high to the prescription of intermediate; Relate to recrystallization, the washing of water-soluble, ether, ice bath downward modulation pH value, ethyl acetate extraction, concentrate, 95% dissolve with ethanol, drip the step of a plurality of complicacies such as potassium hydroxide, activated carbon decolorizing, filtration, cooling, just possibly reach prescription.
The utility model content
This utility model provides a kind of tablet capsule that Losartan Potassium sheet and hydrochlorothiazide tablet are housed; Do not contact mutually between the various active component in the capsule; Thereby obtain stability tablet capsule better, easy to process, what is more important provides a kind of does not need strict control intermediate related substance can obtain the up-to-standard losartan potassium hydrochlorothiazide compound preparation of related substance.
The tablet capsule of this 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 Losartan Potassium and active component of filling tablet that is hydrochlorothiazide at least.
A kind of optimal way of the tablet capsule of this utility model is, it is 1 that Aquazide H wherein is housed, and it is 2 that the Losartan Potassium tablet is housed, and Aquazide H is positioned in the middle of 2 tablets of Losartan Potassium tablets, and 2 tablets of Losartan Potassium tablets are spaced apart.
The form of the tablet capsule of this utility model is that tablet is carried out coating preferably, coating solution be chosen as any selection of acceptable on the pharmaceutics.
The tablet of this utility model also can be processed variform special-shaped sheet with tablet in order to adapt to different medicament demands.
For be fit to that mechanization produces be convenient to be identified, but the identical color of the various figure of tablet in the capsule is different.
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.
The tablet capsule of this 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; Therefore chemistry 5 changes can not take place between each composition and produce by-product; The stability of product is improved; Especially reduce Losartan Potassium and contacted the catabolite that the back produces with hydrochlorothiazide, made the related substance of product of this utility model meet the human body safety range;
2. owing to adopted the design of column type slice, thin piece and different colours, and the application of transparent softgel shell, make the very suitable suitability for industrialized production of product of this utility model to have 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 1 is the axonometric chart of complex capsule of the embodiment 1 of this utility model.Wherein, 1, capsule body down; 2, go up capsule body; 3, the first Losartan Potassium sheet; 4, hydrochlorothiazide tablet; 5, the second Losartan Potassium sheet.
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, the first Losartan Potassium sheet; 4, hydrochlorothiazide tablet; 5, the second Losartan Potassium 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, the first Losartan Potassium sheet; 4, hydrochlorothiazide tablet; 5, the second Losartan Potassium sheet.
Accompanying drawing 4 is the cutaway view of the embodiment 2 of this utility model.Wherein, 1, capsule body down; 2, go up capsule body; 3, hydrochlorothiazide tablet; 4, Losartan Potassium sheet.
The specific embodiment
Below in conjunction with accompanying drawing and embodiment this utility model is further described:
Embodiment 1: shown in accompanying drawing 1-3, and hydrochlorothiazide tablet of filling in the seed capsules; The tablet capsule of two Losartan Potassium sheets.The capsule specification is No. 0.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 the first Losartan Potassium sheet (containing Losartan Potassium 50mg), hydrochlorothiazide tablet (containing hydrochlorothiazide 25mg) and the second Losartan Potassium sheet (containing Losartan Potassium 50mg).
First hydrochlorothiazide tablet is that yellow stomach dissolution type film-coat, Losartan Potassium sheet are that red film-coat, second hydrochlorothiazide tablet is black stomach dissolution type film-coat or all adopts identical color.
Embodiment 2: shown in accompanying drawing 4, and the tablet capsule of a hydrochlorothiazide tablet of filling and a Losartan Potassium sheet in the seed capsules.The capsule specification is No. 0.Capsule housing is made up 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 hydrochlorothiazide tablet (containing hydrochlorothiazide 50mg), Losartan Potassium sheet (Losartan Potassium 12.5mg).Hydrochlorothiazide tablet is yellow stomach dissolution type film-coat.Capsule is contained in the transparent pp bottle packing.
Describe below in conjunction with 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 tablet capsules and is carried out test in 10 days.Determination of related substances adopts the HPLC method, on Kromasil C18 (250mm * 4.6mm, 5 μ m) post, is mobile phase with acetonitrile-0.1% phosphoric acid solution (50: 50), detects flow velocity 1.0mlmin in 230nm -1
Table 1 hot test (60 ℃)
Figure DEST_PATH_GDA00002028126700051
Annotate: content is sign content in the table, and related substance is with calculated by peak area
The high wet test of table 2 (RH75%)
Figure DEST_PATH_GDA00002028126700061
Annotate: content is sign content in the table, and related substance is with calculated by peak area
Table 3 exposure experiments to light (3000LX)
Figure DEST_PATH_GDA00002028126700071
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 the embodiment of this 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; Tablet by in capsule and the capsule is formed, and capsule comprises utricule and following utricule, it is characterized in that; In the said capsule at least active component of filling be the tablet of Losartan Potassium and active component of filling tablet that is hydrochlorothiazide at least.
2. tablet capsule as claimed in claim 1 is characterized in that, said hydrochlorothiazide tablet is 1, and said Losartan Potassium sheet is 2, and hydrochlorothiazide tablet is positioned in the middle of 2 Losartan Potassium sheets.
3. according to claim 1 or claim 2 tablet capsule is characterized in that said tablet is a coating.
4. tablet capsule as claimed in claim 3 is characterized in that, the coating of said tablet is a different colours, and said tablet is the identical cylinder of shape.
5. tablet capsule as claimed in claim 1 is characterized in that, said capsule is No. 0 or No. 1 capsule, and the capsular utricule of going up is colourless or translucent with following utricule.
CN 201220118400 2012-03-27 2012-03-27 Tablet capsule with losartan tablet and hydrochlorothiazide tablet Expired - Fee Related CN202568924U (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CN 201220118400 CN202568924U (en) 2012-03-27 2012-03-27 Tablet capsule with losartan tablet and hydrochlorothiazide tablet

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
CN 201220118400 CN202568924U (en) 2012-03-27 2012-03-27 Tablet capsule with losartan tablet and hydrochlorothiazide tablet

Publications (1)

Publication Number Publication Date
CN202568924U true CN202568924U (en) 2012-12-05

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Family Applications (1)

Application Number Title Priority Date Filing Date
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Country Status (1)

Country Link
CN (1) CN202568924U (en)

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C14 Grant of patent or utility model
GR01 Patent grant
CF01 Termination of patent right due to non-payment of annual fee

Granted publication date: 20121205

Termination date: 20180327

CF01 Termination of patent right due to non-payment of annual fee