CN107028976A - Potassium citrate effervescent tablet mends potassium medicine and preparation method thereof - Google Patents

Potassium citrate effervescent tablet mends potassium medicine and preparation method thereof Download PDF

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Publication number
CN107028976A
CN107028976A CN201610075666.2A CN201610075666A CN107028976A CN 107028976 A CN107028976 A CN 107028976A CN 201610075666 A CN201610075666 A CN 201610075666A CN 107028976 A CN107028976 A CN 107028976A
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CN
China
Prior art keywords
potassium
effervescent tablet
medicine
mends
potassium citrate
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.)
Granted
Application number
CN201610075666.2A
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Chinese (zh)
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CN107028976B (en
CN107028976B8 (en
Inventor
孙华燕
徐风华
常中飞
李婕
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.)
Chinese PLA General Hospital
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孙华燕
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Priority to CN201610075666.2A priority Critical patent/CN107028976B8/en
Publication of CN107028976A publication Critical patent/CN107028976A/en
Publication of CN107028976B publication Critical patent/CN107028976B/en
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Publication of CN107028976B8 publication Critical patent/CN107028976B8/en
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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00Medicinal preparations containing inorganic active ingredients
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/185Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19Carboxylic acids, e.g. valproic acid
    • A61K31/192Carboxylic acids, e.g. valproic acid having aromatic groups, e.g. sulindac, 2-aryl-propionic acids, ethacrynic acid 
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0002Galenical forms characterised by the drug release technique; Application systems commanded by energy
    • A61K9/0007Effervescent
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2059Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin

Abstract

The present invention discloses a kind of potassium citrate effervescent tablet and mends potassium medicine, including the following raw material:Tartaric acid and/or citric acid and saleratus and/or potassium carbonate.

Description

Potassium citrate effervescent tablet mends potassium medicine and preparation method thereof
Technical field
Potassium medicine and preparation method thereof is mended the present invention relates to a kind of potassium citrate effervescent tablet.
Background technology
Clinically the hypopotassaemia caused by a variety of causes such as organ failure is clinical common disease.Citric acid Potassium solution is the conventional benefit potassium oral drug in Hospital Drugs room, and the medicine kind is solution dosage, medication side during patient is in hospital Just, but the hypopotassaemia caused by organ failure etc. is chronic disease, Most patients need to take medicine for a long time.
At present, existing benefit potassium medicine has:Potassium chloride, mainly mends potassium by intravenous infusion approach;Liquor kalii citratis, oral way Mend potassium in footpath;Potassium citrate particle, oral route mends potassium.Potassium is mended in potassium chloride intravenous infusion, is not suitable for slight potassium deficiency patient and outpatient service is suffered from Person;Liquor kalii citratis agent patient discharge with there is inconvenience medicine more, and the solution effect phase is relatively short, need to add preservative, uncomfortable Closing the chronic treatment of patient needs.Potassium citrate granule, the easy moisture absorption, and dissolution of crystals speed is slower after the moisture absorption, patient takes Inconvenience.
The content of the invention
In view of the above-mentioned problems, the present invention provides a kind of orally kalium supplement medicine convenient to take, being easy to Influence Factors of Taking Medicine at Discharge, meet The potassium citrate effervescent tablet of patient clinical demand mends potassium medicine.
To reach above-mentioned purpose, potassium citrate effervescent tablet of the present invention mends potassium medicine, including the following raw material:Tartaric acid and/or Citric acid and sodium acid carbonate and/or sodium carbonate.
Further, in addition to following auxiliary material:Starch, mannitol, sucrose and/or lactose.
Further, in addition to following lubricant:PEG4000 and/or PEG6000.
Further, in addition to following adhesive:PVP ethanol solutions;PVP concentration 3 ~ 20%;Second alcohol concentration≤95%.
Further, it may also include following co-disintegrant:Sodium carboxymethyl starch.
Further, the raw material of following parts by weight is included:Citric acid 100 to 120, saleratus 120 to 200, lactose 20 To 50, mannitol 3 to 10, steviol glycoside 0.5 to 5, strawberry essence 0.5 to 2, PEG6000 5 to 10, sodium carboxymethyl starch 5 to 30。
Further, the raw material of following parts by weight is included:Citric acid 105, saleratus 138, lactose 22.5, mannitol 7.5th, steviol glycoside 3.75, strawberry essence 1.5, PEG6000 6, sodium carboxymethyl starch 15.
To reach above-mentioned purpose, the present invention prepares the method that potassium citrate effervescent tablet mends potassium medicine, including:
Take above-mentioned potassium citrate effervescent tablet to mend potassium medicine supplementary material and carry out 45 ~ 60 DEG C of dry 1 ~ 2h;
Citric acid is crushed, and crosses 100 mesh sieve, weighs 1150g, absolute ethyl alcohol PVP solution 24 mesh of granulation, 45 ~ 60 DEG C of 1 ~ 2h of drying;
Saleratus 1500g, lactose 300g, mannitol 50g, steviol glycoside 10g, strawberry essence 10g, cross 100 mesh sieves, PVP without Hydrous ethanol solution is pelletized, and crosses 24 mesh sieves, 45 ~ 60 DEG C of 1 ~ 2h of drying;
Take tartaric acid and/or citric acid and sodium acid carbonate and/or sodium carbonate to distinguish whole grain, cross 18 mesh sieves, then add respectively Each 30g of PEG6000, are well mixed;
The soda acid particle for mixing PEG6000 is mixed respectively again;
It is sufficiently mixed again with sodium carboxymethyl starch 150g;
Tabletting.
Beneficial effect
The present invention possesses following beneficial effect with prior art:
Potassium citrate effervescent tablet of the present invention mends potassium medicine, when effervescent tablet had both overcome conventional tablet active ingredient and needed by one section Between be disintegrated the deficiency that can just discharge, while solving, liquid preparation is inconvenient to carry, shortcoming apt to deteriorate, and effervescent tablet Flavouring is added, it is good in taste, it is easy to receive for patient.Common effervescent tablet is to reach effervesce effect, it usually needs addition accounts for piece Active ingredient accounting is not high in the gas-producing disintegrant of weight larger proportion, piece weight.The distinctive feature of potassium citrate effervescent tablet is, collapses Solution agent produces while playing a role and mends potassium composition, greatly improves piece weight utilization rate.
Embodiment
The present invention will be further described below.
Effervescent tablet is a kind of tablet containing gas-producing disintegrant.So-called gas-producing disintegrant be typically organic acid plus carbonate, The mixture of bicarbonate;Effervescent tablet dries moisture-free in itself, and two kinds of materials in gas-producing disintegrant are unionized to be occurred Reaction;But after effervescent tablet is put into water, acid-base reaction occurs for two kinds of materials, produces a large amount of bubbles(Carbon dioxide), make piece Agent is disintegrated rapidly, is administered orally in the form of clear solution.Feature is that drug-eluting is fast, and body absorption is rapid, bioavilability Height, pharmacological action plays faster and abundant and easy to carry.
The present invention can also contain potassium citrate, and disintegrant is wantonly two groups of acid in tartaric acid, citric acid and sodium acid carbonate, sodium carbonate Alkali source compatibility, auxiliary material can starch-containing, mannitol, sucrose, lactose etc., lubricant can be PEG4000, PEG6000 and other are water-soluble Property lubricant, can also contain disintegrating agent carboxymethyl base sodium starch, low-substituted hydroxypropyl cellulose.
Potassium citrate effervesce tablet recipe of the present invention:Citric acid 1050g;Saleratus 1387.5g;Lactose 225g;Mannitol 75g;Steviol glycoside 37.5g;Strawberry essence 15g;PEG6000 60g, sodium carboxymethyl starch 150g;3000g is made.
Preparation technology of the present invention:
Dry supplementary material 1h.
1. citric acid is crushed, cross 100 mesh sieve and weigh 1050g, the granulation of absolute ethyl alcohol PVP solution(24 mesh), 45 ~ 60 DEG C of bakings Dry 1 ~ 2h.
2. saleratus 1387.5g, lactose 225g, mannitol 75g, steviol glycoside 37.5g, strawberry essence 15g, cross 100 24 mesh sieves, 45 ~ 60 DEG C of 1 ~ 2h of drying are crossed in mesh sieve, PVP ethanol solutions granulation.
3. raw material distinguishes whole grain in taking above-mentioned 1 and 2,18 mesh sieves are crossed, then add each 30g of PEG6000 respectively, are well mixed.
4. the soda acid particle for mixing PEG6000 is mixed respectively again.
5. it is sufficiently mixed again with sodium carboxymethyl starch 150g
6. tabletting.
Piece weight:4g/ pieces
To the present invention it should be appreciated that embodiment described above, enters to the purpose of the present invention, technical scheme and beneficial effect Go further details of explanation, these are only embodiments of the invention, be not intended to limit the present invention, it is every in this hair Within bright spiritual principles, made any modification, equivalent substitution and improvements etc. should be included in protection scope of the present invention Within, the protection domain that protection scope of the present invention should be defined by claim is defined.

Claims (8)

1. a kind of potassium citrate effervescent tablet mends potassium medicine, it is characterised in that including the following raw material:Tartaric acid and/or citric acid with And saleratus and/or potassium carbonate.
2. potassium citrate effervescent tablet according to claim 1 mends potassium medicine, it is characterised in that also including following auxiliary material:Form sediment Powder, mannitol, sucrose and/or lactose, dextrin.
3. potassium citrate effervescent tablet according to claim 1 mends potassium medicine, it is characterised in that also include:Lubricant: PEG4000 and/or PEG6000.
4. potassium citrate effervescent tablet according to claim 1 mends potassium medicine, it is characterised in that also including following adhesive: PVP ethanol solutions;PVP concentration 3 ~ 20%;Second alcohol concentration≤95%.
5. potassium citrate effervescent tablet according to claim 1 mends potassium medicine, it is characterised in that may also include following auxiliary and collapses Solve agent:Sodium carboxymethyl starch or low-substituted hydroxypropyl methylcellulose.
6. potassium citrate effervescent tablet according to claim 1 mends potassium medicine, it is characterised in that include the original of following parts by weight Material:Citric acid 100 to 120, saleratus 120 to 200, lactose 20 to 50, mannitol 3 to 20, steviol glycoside 0.5 to 5, strawberry Essence 0.5 to 2, PEG6000 5 to 10, sodium carboxymethyl starch 5 to 30.
7. potassium citrate effervescent tablet according to claim 1 mends potassium medicine, it is characterised in that include the original of following parts by weight Material:Citric acid 105, saleratus 138, lactose 22.5, mannitol 7.5, steviol glycoside 3.75, strawberry essence 1.5, PEG6000 6th, sodium carboxymethyl starch 15g.
8. a kind of prepare the method that potassium citrate effervescent tablet mends potassium medicine, it is characterised in that including:
Take any described potassium citrate effervescent tablet of claim 1 to 7 to mend potassium medicine supplementary material and carry out 45 ~ 60 DEG C of dry 1 ~ 3h;
Citric acid is crushed, and crosses 100 mesh sieve, weighs 1050g, absolute ethyl alcohol PVP solution 24 mesh of granulation, 45 ~ 60 DEG C of drying 2h;
Saleratus 1387g, lactose 225g, mannitol 75g, steviol glycoside 37.5g, strawberry essence 15g, cross 100 mesh sieves, PVP Ethanol solution is pelletized, and crosses 24 mesh sieves, 45 ~ 60 DEG C of drying 2h;
18 mesh sieves are crossed, then add each 30g of PEG6000 respectively, are well mixed;
The soda acid particle for mixing PEG6000 is mixed respectively again;
It is sufficiently mixed again with sodium carboxymethyl starch 150g;
Tabletting.
CN201610075666.2A 2016-02-03 2016-02-03 Potassium supplementing potassium citrate effervescent tablet and its prepn Active CN107028976B8 (en)

Priority Applications (1)

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CN201610075666.2A CN107028976B8 (en) 2016-02-03 2016-02-03 Potassium supplementing potassium citrate effervescent tablet and its prepn

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CN107028976A true CN107028976A (en) 2017-08-11
CN107028976B CN107028976B (en) 2021-11-19
CN107028976B8 CN107028976B8 (en) 2022-01-14

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Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3337404A (en) * 1965-06-28 1967-08-22 Merck & Co Inc Effervescent potassium composition
US3903255A (en) * 1971-05-17 1975-09-02 Rohm & Haas Effervescent potassium chloride tablet
US3970750A (en) * 1974-10-08 1976-07-20 Sandoz, Inc. Effervescent potassium chloride composition
CN101130067A (en) * 2007-07-20 2008-02-27 北京世纪博康医药科技有限公司 Preparation for replenishing collagen and method of preparing the same
CN102058480A (en) * 2009-11-17 2011-05-18 天津天士力制药股份有限公司 Oral effervescent tablet and preparation method thereof
WO2012056476A1 (en) * 2010-10-25 2012-05-03 Manu Chaudhary A detoxifier herbal formulation
CN102552462A (en) * 2012-01-12 2012-07-11 中山火炬职业技术学院 Effervescent preparation as well as preparation method and application thereof
CN103931984A (en) * 2014-01-21 2014-07-23 中国人民解放军第三军医大学 Effervescent tablet used for in-time physical power replenishment in exercise, and applications thereof

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3337404A (en) * 1965-06-28 1967-08-22 Merck & Co Inc Effervescent potassium composition
US3903255A (en) * 1971-05-17 1975-09-02 Rohm & Haas Effervescent potassium chloride tablet
US3970750A (en) * 1974-10-08 1976-07-20 Sandoz, Inc. Effervescent potassium chloride composition
CN101130067A (en) * 2007-07-20 2008-02-27 北京世纪博康医药科技有限公司 Preparation for replenishing collagen and method of preparing the same
CN102058480A (en) * 2009-11-17 2011-05-18 天津天士力制药股份有限公司 Oral effervescent tablet and preparation method thereof
WO2012056476A1 (en) * 2010-10-25 2012-05-03 Manu Chaudhary A detoxifier herbal formulation
CN102552462A (en) * 2012-01-12 2012-07-11 中山火炬职业技术学院 Effervescent preparation as well as preparation method and application thereof
CN103931984A (en) * 2014-01-21 2014-07-23 中国人民解放军第三军医大学 Effervescent tablet used for in-time physical power replenishment in exercise, and applications thereof

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
ABOLFAZL ASLANI,ET AL: ""Formulation, Characterization and Physicochemical Evaluation of Potassium Citrate Effervescent Tablets"", 《ADVANCED PHARMACEUTICAL BULLETIN》 *
NOMAX INC: "《Effer-K 10 泡腾片说明书》", 30 January 2013 *

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CN107028976B8 (en) 2022-01-14

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GR01 Patent grant
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Effective date of registration: 20211117

Address after: 100853 Fuxing Road 28, Beijing, Haidian District

Patentee after: CHINESE PLA GENERAL Hospital

Address before: 100841 Administration Bureau, No. 19, Middle West Third Ring Road, Haidian District, Beijing

Patentee before: Sun Huayan

CI03 Correction of invention patent
CI03 Correction of invention patent

Correction item: Patentee|Address|Patent agency|Agent

Correct: PLA General Hospital|100853 Fuxing Road 28, Beijing, Haidian District|Changchun Keyu Patent Agency Co., Ltd. 22001|Ma Baolai

False: Sun Huayan|100841 Administration Bureau, No. 19, Middle West Third Ring Road, Haidian District, Beijing;N/A

Number: 47-02

Volume: 37

Correction item: Patentee|Address|Patent agency|Agent

Correct: PLA General Hospital|100853 Fuxing Road 28, Beijing, Haidian District|Changchun Keyu Patent Agency Co., Ltd. 22001|Ma Baolai

False: Sun Huayan|100841 Administration Bureau, No. 19, Middle West Third Ring Road, Haidian District, Beijing;N/A

Number: 47-02

Page: The title page

Volume: 37