CN116440074B - Potassium chloride oral preparation and preparation method thereof - Google Patents
Potassium chloride oral preparation and preparation method thereof Download PDFInfo
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- CN116440074B CN116440074B CN202310607544.3A CN202310607544A CN116440074B CN 116440074 B CN116440074 B CN 116440074B CN 202310607544 A CN202310607544 A CN 202310607544A CN 116440074 B CN116440074 B CN 116440074B
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- WCUXLLCKKVVCTQ-UHFFFAOYSA-M Potassium chloride Chemical compound [Cl-].[K+] WCUXLLCKKVVCTQ-UHFFFAOYSA-M 0.000 title claims abstract description 94
- 239000001103 potassium chloride Substances 0.000 title claims abstract description 47
- 235000011164 potassium chloride Nutrition 0.000 title claims abstract description 47
- 238000002360 preparation method Methods 0.000 title claims abstract description 37
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 claims abstract description 60
- 239000001509 sodium citrate Substances 0.000 claims abstract description 20
- NLJMYIDDQXHKNR-UHFFFAOYSA-K sodium citrate Chemical compound O.O.[Na+].[Na+].[Na+].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O NLJMYIDDQXHKNR-UHFFFAOYSA-K 0.000 claims abstract description 20
- 239000002562 thickening agent Substances 0.000 claims abstract description 20
- 239000000203 mixture Substances 0.000 claims abstract description 17
- 235000003599 food sweetener Nutrition 0.000 claims abstract description 14
- 239000003765 sweetening agent Substances 0.000 claims abstract description 14
- 239000000796 flavoring agent Substances 0.000 claims abstract description 11
- 239000000022 bacteriostatic agent Substances 0.000 claims abstract description 9
- 235000013355 food flavoring agent Nutrition 0.000 claims abstract description 9
- PEDCQBHIVMGVHV-UHFFFAOYSA-N glycerol group Chemical group OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 claims description 29
- 238000003756 stirring Methods 0.000 claims description 25
- 239000000686 essence Substances 0.000 claims description 24
- 238000000034 method Methods 0.000 claims description 19
- 239000004354 Hydroxyethyl cellulose Substances 0.000 claims description 18
- 229920000663 Hydroxyethyl cellulose Polymers 0.000 claims description 18
- 235000019447 hydroxyethyl cellulose Nutrition 0.000 claims description 18
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 17
- 108010011485 Aspartame Proteins 0.000 claims description 13
- 235000010357 aspartame Nutrition 0.000 claims description 13
- 239000000605 aspartame Substances 0.000 claims description 13
- IAOZJIPTCAWIRG-QWRGUYRKSA-N aspartame Chemical group OC(=O)C[C@H](N)C(=O)N[C@H](C(=O)OC)CC1=CC=CC=C1 IAOZJIPTCAWIRG-QWRGUYRKSA-N 0.000 claims description 13
- 229960003438 aspartame Drugs 0.000 claims description 13
- 235000011187 glycerol Nutrition 0.000 claims description 13
- 235000005976 Citrus sinensis Nutrition 0.000 claims description 12
- 240000002319 Citrus sinensis Species 0.000 claims description 12
- 239000001052 yellow pigment Substances 0.000 claims description 12
- WXMKPNITSTVMEF-UHFFFAOYSA-M sodium benzoate Chemical group [Na+].[O-]C(=O)C1=CC=CC=C1 WXMKPNITSTVMEF-UHFFFAOYSA-M 0.000 claims description 11
- 235000010234 sodium benzoate Nutrition 0.000 claims description 11
- 239000004299 sodium benzoate Substances 0.000 claims description 11
- 239000000049 pigment Substances 0.000 claims description 10
- 235000019640 taste Nutrition 0.000 claims description 8
- 229960001617 ethyl hydroxybenzoate Drugs 0.000 claims description 5
- NUVBSKCKDOMJSU-UHFFFAOYSA-N ethylparaben Chemical compound CCOC(=O)C1=CC=C(O)C=C1 NUVBSKCKDOMJSU-UHFFFAOYSA-N 0.000 claims description 5
- GYCKQBWUSACYIF-UHFFFAOYSA-N o-hydroxybenzoic acid ethyl ester Natural products CCOC(=O)C1=CC=CC=C1O GYCKQBWUSACYIF-UHFFFAOYSA-N 0.000 claims description 4
- 238000009472 formulation Methods 0.000 claims 3
- 239000003607 modifier Substances 0.000 claims 1
- 239000003002 pH adjusting agent Substances 0.000 claims 1
- 239000002994 raw material Substances 0.000 claims 1
- 229940073414 potassium chloride oral solution Drugs 0.000 description 13
- 229960005150 glycerol Drugs 0.000 description 12
- XMGQYMWWDOXHJM-UHFFFAOYSA-N limonene Chemical compound CC(=C)C1CCC(C)=CC1 XMGQYMWWDOXHJM-UHFFFAOYSA-N 0.000 description 12
- 239000007968 orange flavor Substances 0.000 description 12
- 230000008569 process Effects 0.000 description 12
- 239000008213 purified water Substances 0.000 description 11
- 238000012360 testing method Methods 0.000 description 10
- 235000015165 citric acid Nutrition 0.000 description 9
- 230000000052 comparative effect Effects 0.000 description 9
- 235000011083 sodium citrates Nutrition 0.000 description 9
- 210000004027 cell Anatomy 0.000 description 8
- 239000000243 solution Substances 0.000 description 8
- ZLMJMSJWJFRBEC-UHFFFAOYSA-N Potassium Chemical compound [K] ZLMJMSJWJFRBEC-UHFFFAOYSA-N 0.000 description 7
- 229910052700 potassium Inorganic materials 0.000 description 7
- 239000011591 potassium Substances 0.000 description 7
- 206010013911 Dysgeusia Diseases 0.000 description 6
- 208000019025 Hypokalemia Diseases 0.000 description 3
- 239000000463 material Substances 0.000 description 3
- 208000024896 potassium deficiency disease Diseases 0.000 description 3
- 235000005979 Citrus limon Nutrition 0.000 description 2
- 244000131522 Citrus pyriformis Species 0.000 description 2
- 239000004480 active ingredient Substances 0.000 description 2
- 230000015572 biosynthetic process Effects 0.000 description 2
- 229960004106 citric acid Drugs 0.000 description 2
- 239000003814 drug Substances 0.000 description 2
- 230000000694 effects Effects 0.000 description 2
- 239000003792 electrolyte Substances 0.000 description 2
- 235000019634 flavors Nutrition 0.000 description 2
- 238000002347 injection Methods 0.000 description 2
- 239000007924 injection Substances 0.000 description 2
- 230000003834 intracellular effect Effects 0.000 description 2
- 229960002816 potassium chloride Drugs 0.000 description 2
- 229910001414 potassium ion Inorganic materials 0.000 description 2
- 239000011734 sodium Substances 0.000 description 2
- 229960001790 sodium citrate Drugs 0.000 description 2
- 238000006467 substitution reaction Methods 0.000 description 2
- 210000001779 taste bud Anatomy 0.000 description 2
- XTWYTFMLZFPYCI-KQYNXXCUSA-N 5'-adenylphosphoric acid Chemical compound C1=NC=2C(N)=NC=NC=2N1[C@@H]1O[C@H](COP(O)(=O)OP(O)(O)=O)[C@@H](O)[C@H]1O XTWYTFMLZFPYCI-KQYNXXCUSA-N 0.000 description 1
- ZKHQWZAMYRWXGA-KQYNXXCUSA-J ATP(4-) Chemical compound C1=NC=2C(N)=NC=NC=2N1[C@@H]1O[C@H](COP([O-])(=O)OP([O-])(=O)OP([O-])([O-])=O)[C@@H](O)[C@H]1O ZKHQWZAMYRWXGA-KQYNXXCUSA-J 0.000 description 1
- 108091006112 ATPases Proteins 0.000 description 1
- 208000010444 Acidosis Diseases 0.000 description 1
- 102000057290 Adenosine Triphosphatases Human genes 0.000 description 1
- XTWYTFMLZFPYCI-UHFFFAOYSA-N Adenosine diphosphate Natural products C1=NC=2C(N)=NC=NC=2N1C1OC(COP(O)(=O)OP(O)(O)=O)C(O)C1O XTWYTFMLZFPYCI-UHFFFAOYSA-N 0.000 description 1
- ZKHQWZAMYRWXGA-UHFFFAOYSA-N Adenosine triphosphate Natural products C1=NC=2C(N)=NC=NC=2N1C1OC(COP(O)(=O)OP(O)(=O)OP(O)(O)=O)C(O)C1O ZKHQWZAMYRWXGA-UHFFFAOYSA-N 0.000 description 1
- 206010001497 Agitation Diseases 0.000 description 1
- 235000016068 Berberis vulgaris Nutrition 0.000 description 1
- 241000335053 Beta vulgaris Species 0.000 description 1
- 206010010904 Convulsion Diseases 0.000 description 1
- 244000163122 Curcuma domestica Species 0.000 description 1
- 235000003392 Curcuma domestica Nutrition 0.000 description 1
- FBPFZTCFMRRESA-FSIIMWSLSA-N D-Glucitol Natural products OC[C@H](O)[C@H](O)[C@@H](O)[C@H](O)CO FBPFZTCFMRRESA-FSIIMWSLSA-N 0.000 description 1
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 description 1
- FBPFZTCFMRRESA-JGWLITMVSA-N D-glucitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-JGWLITMVSA-N 0.000 description 1
- 206010059866 Drug resistance Diseases 0.000 description 1
- 235000016623 Fragaria vesca Nutrition 0.000 description 1
- 240000009088 Fragaria x ananassa Species 0.000 description 1
- 235000011363 Fragaria x ananassa Nutrition 0.000 description 1
- 208000002682 Hyperkalemia Diseases 0.000 description 1
- 240000007472 Leucaena leucocephala Species 0.000 description 1
- 235000010643 Leucaena leucocephala Nutrition 0.000 description 1
- 229930195725 Mannitol Natural products 0.000 description 1
- 208000010428 Muscle Weakness Diseases 0.000 description 1
- 206010028372 Muscular weakness Diseases 0.000 description 1
- 239000004376 Sucralose Substances 0.000 description 1
- CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 description 1
- 229930006000 Sucrose Natural products 0.000 description 1
- DPXJVFZANSGRMM-UHFFFAOYSA-N acetic acid;2,3,4,5,6-pentahydroxyhexanal;sodium Chemical compound [Na].CC(O)=O.OCC(O)C(O)C(O)C(O)C=O DPXJVFZANSGRMM-UHFFFAOYSA-N 0.000 description 1
- OIPILFWXSMYKGL-UHFFFAOYSA-N acetylcholine Chemical compound CC(=O)OCC[N+](C)(C)C OIPILFWXSMYKGL-UHFFFAOYSA-N 0.000 description 1
- 229960004373 acetylcholine Drugs 0.000 description 1
- 230000007950 acidosis Effects 0.000 description 1
- 208000026545 acidosis disease Diseases 0.000 description 1
- 230000009471 action Effects 0.000 description 1
- 230000000844 anti-bacterial effect Effects 0.000 description 1
- 230000002421 anti-septic effect Effects 0.000 description 1
- 230000006793 arrhythmia Effects 0.000 description 1
- 206010003119 arrhythmia Diseases 0.000 description 1
- 235000019606 astringent taste Nutrition 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 230000033228 biological regulation Effects 0.000 description 1
- 235000019658 bitter taste Nutrition 0.000 description 1
- 239000001768 carboxy methyl cellulose Substances 0.000 description 1
- 150000001768 cations Chemical class 0.000 description 1
- 210000000170 cell membrane Anatomy 0.000 description 1
- 238000006243 chemical reaction Methods 0.000 description 1
- 230000036461 convulsion Effects 0.000 description 1
- 239000013078 crystal Substances 0.000 description 1
- 235000003373 curcuma longa Nutrition 0.000 description 1
- 230000007547 defect Effects 0.000 description 1
- 230000007812 deficiency Effects 0.000 description 1
- 230000032798 delamination Effects 0.000 description 1
- 229940079593 drug Drugs 0.000 description 1
- 230000003804 effect on potassium Effects 0.000 description 1
- 235000010228 ethyl p-hydroxybenzoate Nutrition 0.000 description 1
- 239000004403 ethyl p-hydroxybenzoate Substances 0.000 description 1
- 230000005284 excitation Effects 0.000 description 1
- 210000003722 extracellular fluid Anatomy 0.000 description 1
- 150000002500 ions Chemical class 0.000 description 1
- 235000010355 mannitol Nutrition 0.000 description 1
- 239000000594 mannitol Substances 0.000 description 1
- 238000005259 measurement Methods 0.000 description 1
- 230000004060 metabolic process Effects 0.000 description 1
- 244000005700 microbiome Species 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 210000005036 nerve Anatomy 0.000 description 1
- 210000001640 nerve ending Anatomy 0.000 description 1
- 210000002569 neuron Anatomy 0.000 description 1
- 210000000056 organ Anatomy 0.000 description 1
- 230000003204 osmotic effect Effects 0.000 description 1
- 238000009138 potassium supplementation Methods 0.000 description 1
- 239000003755 preservative agent Substances 0.000 description 1
- 230000002335 preservative effect Effects 0.000 description 1
- 239000000047 product Substances 0.000 description 1
- 230000002633 protecting effect Effects 0.000 description 1
- 102000004169 proteins and genes Human genes 0.000 description 1
- 108090000623 proteins and genes Proteins 0.000 description 1
- CVHZOJJKTDOEJC-UHFFFAOYSA-N saccharin Chemical compound C1=CC=C2C(=O)NS(=O)(=O)C2=C1 CVHZOJJKTDOEJC-UHFFFAOYSA-N 0.000 description 1
- 150000003839 salts Chemical class 0.000 description 1
- 238000000926 separation method Methods 0.000 description 1
- 210000002027 skeletal muscle Anatomy 0.000 description 1
- 235000019812 sodium carboxymethyl cellulose Nutrition 0.000 description 1
- 229920001027 sodium carboxymethylcellulose Polymers 0.000 description 1
- 239000000600 sorbitol Substances 0.000 description 1
- 235000010356 sorbitol Nutrition 0.000 description 1
- 238000013112 stability test Methods 0.000 description 1
- 230000001954 sterilising effect Effects 0.000 description 1
- 235000019408 sucralose Nutrition 0.000 description 1
- BAQAVOSOZGMPRM-QBMZZYIRSA-N sucralose Chemical compound O[C@@H]1[C@@H](O)[C@@H](Cl)[C@@H](CO)O[C@@H]1O[C@@]1(CCl)[C@@H](O)[C@H](O)[C@@H](CCl)O1 BAQAVOSOZGMPRM-QBMZZYIRSA-N 0.000 description 1
- 239000005720 sucrose Substances 0.000 description 1
- 239000013589 supplement Substances 0.000 description 1
- 230000001502 supplementing effect Effects 0.000 description 1
- 230000002195 synergetic effect Effects 0.000 description 1
- 238000003786 synthesis reaction Methods 0.000 description 1
- 230000008719 thickening Effects 0.000 description 1
- 235000013976 turmeric Nutrition 0.000 description 1
- 239000000230 xanthan gum Substances 0.000 description 1
- 229920001285 xanthan gum Polymers 0.000 description 1
- 235000010493 xanthan gum Nutrition 0.000 description 1
- 229940082509 xanthan gum Drugs 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K33/00—Medicinal preparations containing inorganic active ingredients
- A61K33/14—Alkali metal chlorides; Alkaline earth metal chlorides
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/12—Carboxylic acids; Salts or anhydrides thereof
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K47/38—Cellulose; Derivatives thereof
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
- A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
- A61P3/12—Drugs for disorders of the metabolism for electrolyte homeostasis
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- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Epidemiology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Engineering & Computer Science (AREA)
- General Chemical & Material Sciences (AREA)
- Inorganic Chemistry (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Molecular Biology (AREA)
- Biochemistry (AREA)
- Diabetes (AREA)
- Hematology (AREA)
- Obesity (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Medicinal Preparation (AREA)
Abstract
The invention relates to the technical field of medicinal preparations, in particular to a potassium chloride oral preparation and a preparation method thereof. The potassium chloride oral preparation comprises potassium chloride, a bacteriostatic agent, a pH regulator, a flavoring agent, a thickening agent, a sweetener and essence, wherein the pH regulator is a mixture of citric acid and sodium citrate, and the mass ratio of the citric acid to the sodium citrate is 2:1-1:3.
Description
Technical Field
The invention relates to the technical field of medicinal preparations, in particular to a potassium chloride oral preparation and a preparation method thereof.
Background
Potassium chloride is an electrolyte replenishing drug. Potassium is the main cation in cells and is an important component for maintaining osmotic pressure in cells. The intracellular concentration is about 150 to 160mmol/L, and the extracellular fluid concentration is lower and is only 3.5 to 5.0mmol/L. The organism mainly depends on Na on cell membranes + 、K + ATPase to maintain intracellular and extracellular K + 、Na + Concentration difference.
The acid-base balance in the body has an effect on potassium metabolism, such as H in acidosis + Into cells, K is used to maintain the potential difference between the inside and outside of the cells + Is released outside the cell, and causes or aggravates hyperkalemia.
The normal concentration and concentration difference of the potassium ions in the cell and the outside of the cell have close relation with certain functions of the cell, and the potassium participates in the regulation of acid-base balance, so that the synthesis of sugar and protein and the conversion of the adenosine diphosphate into the adenosine triphosphate need a certain amount of potassium to participate in; potassium is involved in the process of excitation between nerves and their innervating organs, between neurons, and in the formation of nerve ending transmitters (acetylcholine); the content of potassium in the heart can influence the activity of the heart, the heart excitability is increased when the potassium is low, and the patients with clinical hypokalemia are mainly suffering from arrhythmia; potassium is an ion necessary to maintain normal skeletal muscle tone. Deficiency of potassium ions manifests as muscle weakness, convulsions, etc.
The current potassium supplementation regimen remains largely the traditional regimen of administering injections in a medical form. Thus, patients must go to the hospital for injection when supplementing salt, which is troublesome and has poor compliance.
The 10% potassium chloride solution is an oral electrolyte supplement in clinic and is mainly used for treating and preventing hypokalemia caused by various reasons. Because 10% potassium chloride oral solution prepared by hospital preparation belongs to non-terminal sterilizing preparation and is easy to be polluted by microorganism to deteriorate, 10mL (1000 mL) of preservative 5% ethyl hydroxybenzoate solution is added into the prescription of 10% potassium chloride solution received by Chinese hospital preparation standard (western medicine preparation) -1 The content of the ethylparaben is 0.05% to ensure the quality of the preparation. However, the 10% potassium chloride oral solution is found to be not stable enough in storage and application, and particularly, a lot of small crystals are easy to precipitate below 20 ℃ so that the preparation property is not qualified.
Oral solutions commonly used in the market suffer from drug resistance of patients due to bitter taste and aftertaste. Accordingly, there is a need in the art for new methods to overcome the current problems.
Therefore, it is necessary to develop an oral preparation of potassium chloride and a preparation method thereof, which can solve the above technical problems.
Disclosure of Invention
The invention aims to overcome the defects of the prior art and provide a potassium chloride oral preparation with good taste, no aftertaste and high stability and a preparation method thereof.
The invention is realized by the following technical scheme:
the oral potassium chloride preparation comprises potassium chloride, a bacteriostatic agent, a pH regulator, a flavoring agent, a thickening agent, a sweetener and essence, wherein the pH regulator is a mixture of citric acid and sodium citrate, the mass ratio of the citric acid to the sodium citrate is 2:1-1:3, and the pH value can be adjusted to 3-5 by the synergistic effect of the citric acid and the sodium citrate, so that the bacteriostatic agent can be kept in an optimal antiseptic pH range.
Preferably, the mass ratio of the citric acid to the sodium citrate is 1:1-1:2.
Preferably, the potassium chloride oral preparation comprises 8-12% of potassium chloride, 0.05-0.2% of bacteriostat, 0.8-1.2% of pH regulator, 2-6% of flavoring agent, 0.2-0.6% of thickening agent, 0.4-0.8% of sweetener and 0.1-0.3% of essence according to weight volume percentage concentration.
The meaning of the term "weight volume percent concentration" is: each 100mL of oral preparation comprises 8-12g of potassium chloride, 0.05-0.2g of bacteriostat, 0.8-1.2g of pH regulator, 2-6g of flavoring agent, 0.2-0.6g of thickening agent, 0.4-0.8g of sweetener and 0.1-0.3g of essence.
More preferably, the composition comprises 8-12% of potassium chloride, 0.07-0.1% of bacteriostat, 0.8-1.0% of pH regulator, 3-4% of corrigent, 0.3-0.4% of thickener, 0.5-0.6% of sweetener and 0.2-0.3% of essence according to weight volume percentage concentration.
Preferably, the bacteriostatic agent comprises sodium benzoate.
Preferably, the thickener is one or more of hydroxyethyl cellulose, glucose-delta-lactone, acacia and sodium carboxymethyl cellulose.
More preferably, the thickener is a mixture of hydroxyethyl cellulose and glucose-delta-lactone, and the mass ratio of the hydroxyethyl cellulose to the glucose-delta-lactone is 8:1-2.5:1.
More preferably, the mass ratio of hydroxyethyl cellulose to glucose-delta-lactone is 5:1 to 3:1.
The thickener provided by the invention has good thickening, binding, film forming and water protecting properties, so that the solution has a little viscosity, but has good fluidity. When the patient is orally taken, the taste buds on the tongue cannot immediately feel the astringency of the potassium chloride solution when the taste buds are contacted with the solution due to the film forming property of the thickener.
In addition, due to the action of the sweetener, the effect of obviously improving the taste can be achieved. Therefore, when the active ingredients and the auxiliary materials are mixed within a reasonable proportion range, the prepared oral preparation has good taste and no aftertaste, and can improve the compliance of patients.
Preferably, the flavoring agent comprises one or more of glycerin, sorbitol and mannitol.
Preferably, the sweetener comprises one or more of aspartame, sucrose, sucralose and sodium saccharin.
Preferably, the essence comprises one or more of sweet orange flavor, strawberry flavor and lemon flavor.
The invention also relates to a preparation method of the potassium chloride oral preparation, which comprises the following steps:
(1) Adding potassium chloride, a pH regulator, a bacteriostatic agent, a flavoring agent and a sweetener into water to obtain a mixture A;
(2) And adding the thickener and the essence, and stirring uniformly.
Preferably, the potassium chloride oral preparation further comprises pigment.
More preferably, the potassium chloride oral preparation also comprises pigment 0.005-0.02% according to the weight volume percentage concentration.
More preferably, the potassium chloride oral preparation also comprises pigment 0.01-0.02% according to the weight volume percentage concentration.
More preferably, the pigment comprises one or more of sunset yellow, beet red, turmeric and lemon yellow.
The invention also relates to a preparation method of the potassium chloride oral preparation, which comprises the following steps:
(1) Adding potassium chloride, a pH regulator, a bacteriostatic agent, a flavoring agent and a sweetener into water to obtain a mixture A;
(2) Adding thickener, essence and pigment, and stirring.
The beneficial effects of the invention are as follows:
the invention provides a potassium chloride oral preparation for preventing and treating hypokalemia. The effective component of the oral preparation is potassium chloride, and the auxiliary materials comprise pH regulator, bacteriostat, corrigent, thickener, sweetener, essence and pigment. The invention improves the taste and has no aftertaste by optimizing the composition of the thickening agent and the composition of the pH regulator. The preparation of the invention has excellent stability and good antibacterial effect.
Detailed Description
The invention will be further described with reference to specific embodiments, and advantages and features of the invention will become apparent from the description. These examples are merely exemplary and do not limit the scope of the invention in any way. It will be understood by those skilled in the art that various changes and substitutions of details and forms of the technical solution of the present invention may be made without departing from the spirit and scope of the present invention, but these changes and substitutions fall within the scope of the present invention. The active ingredient potassium chloride and other medical auxiliary materials are all commercially available.
Example 1:
the process comprises the following steps: adding the prescribed amount of potassium chloride, citric acid, sodium citrate, sodium benzoate, glycerin and aspartame into 70% of the prescribed amount of purified water, stirring uniformly, adding hydroxyethyl cellulose, glucose-delta-lactone, sweet orange flavor essence and sunset yellow pigment, continuously stirring uniformly, and then using a 500ml volumetric flask to fix the volume until the scale is uniformly shaken, thus obtaining the potassium chloride oral solution.
Example 2:
the process comprises the following steps: adding the prescribed amount of potassium chloride, citric acid, sodium citrate, sodium benzoate, glycerin and aspartame into 70% of the prescribed amount of purified water, stirring uniformly, adding hydroxyethyl cellulose, glucose-delta-lactone, sweet orange flavor essence and sunset yellow pigment, continuously stirring uniformly, and then using a 500ml volumetric flask to fix the volume until the scale is uniformly shaken, thus obtaining the potassium chloride oral solution.
Example 3:
the process comprises the following steps: the process steps of the embodiment are as follows: adding the prescribed amount of potassium chloride, citric acid, sodium citrate, ethyl hydroxybenzoate, glycerol and aspartame into 70% of the prescribed amount of purified water, stirring uniformly, adding hydroxyethyl cellulose, glucose-delta-lactone, sweet orange flavor essence and sunset yellow pigment, continuously stirring uniformly, and then using a 500ml volumetric flask to fix the volume until the scale is shaken uniformly to prepare the potassium chloride oral solution.
Example 4:
the process comprises the following steps: the process steps of the embodiment are as follows: adding the prescribed amount of potassium chloride, citric acid, sodium citrate, sodium benzoate, glycerin and aspartame into 70% of the prescribed amount of purified water, stirring uniformly, adding hydroxyethyl cellulose, glucose-delta-lactone, sweet orange flavor essence and sunset yellow pigment, continuously stirring uniformly, and then using a 500ml volumetric flask to fix the volume until the scale is uniformly shaken, thus obtaining the potassium chloride oral solution.
Example 5:
the process comprises the following steps: the process steps of the embodiment are as follows: adding the prescribed amount of potassium chloride, citric acid, sodium citrate, ethyl hydroxybenzoate, glycerol and aspartame into 70% of the prescribed amount of purified water, stirring uniformly, adding hydroxyethyl cellulose, glucose-delta-lactone, sweet orange flavor essence and sunset yellow pigment, continuously stirring uniformly, and then using a 500ml volumetric flask to fix the volume until the scale is shaken uniformly to prepare the potassium chloride oral solution.
Example 6:
the process comprises the following steps: the process steps of the embodiment are as follows: adding the prescribed amount of potassium chloride, citric acid, sodium citrate, sodium benzoate, glycerin and aspartame into 70% of the prescribed amount of purified water, stirring uniformly, adding hydroxyethyl cellulose, glucose-delta-lactone, sweet orange flavor essence and sunset yellow pigment, continuously stirring uniformly, and then using a 500ml volumetric flask to fix the volume until the scale is uniformly shaken, thus obtaining the potassium chloride oral solution.
Example 7:
the process comprises the following steps: adding the prescribed amount of potassium chloride, citric acid, sodium citrate, sodium benzoate, glycerin and aspartame into 70% of the prescribed amount of purified water, stirring uniformly, adding hydroxyethyl cellulose, glucose-delta-lactone, sweet orange flavor essence and sunset yellow pigment, continuously stirring uniformly, and then using a 500ml volumetric flask to fix the volume until the scale is uniformly shaken, thus obtaining the potassium chloride oral solution.
Example 8
The process comprises the following steps: adding the prescribed amount of potassium chloride, citric acid, sodium citrate, sodium benzoate, glycerin and aspartame into 70% of the prescribed amount of purified water, stirring uniformly, adding hydroxyethyl cellulose, glucose-delta-lactone, sweet orange flavor essence and sunset yellow pigment, continuously stirring uniformly, and then using a 500ml volumetric flask to fix the volume until the scale is uniformly shaken, thus obtaining the potassium chloride oral solution.
Comparative example 1
The difference from example 1 is only that the thickener composition is different, only 1.5g of hydroxyethylcellulose is contained, no glucose-delta-lactone is contained, and the rest conditions are the same.
The process comprises the following steps: adding the prescribed amount of potassium chloride, citric acid, sodium citrate, sodium benzoate, glycerin and aspartame into 70% of the prescribed amount of purified water, stirring uniformly, adding hydroxyethyl cellulose, sweet orange flavor essence and sunset yellow pigment, continuously stirring uniformly, and then using a 500ml volumetric flask to fix the volume until the scale is shaken uniformly to prepare the potassium chloride oral solution.
Comparative example 2
The difference from example 1 is only that the thickener composition is different, only 1.5g of glucose-delta-lactone is contained, no hydroxyethylcellulose is contained, and the rest conditions are the same.
The process comprises the following steps: adding the prescribed amount of potassium chloride, citric acid, sodium citrate, sodium benzoate, glycerin and aspartame into 70% of the prescribed amount of purified water, stirring uniformly, adding glucose-delta-lactone, sweet orange flavor essence and sunset yellow pigment, continuously stirring uniformly, and then using a 500ml volumetric flask to fix the volume until the scale is shaken uniformly to prepare the potassium chloride oral solution.
Comparative example 3
The only difference from example 1 is the composition of the thickener, the remaining conditions being the same.
The process comprises the following steps: the process steps of the embodiment are as follows: adding the prescribed amount of potassium chloride, citric acid, sodium citrate, sodium benzoate, glycerin and aspartame into 70% of the prescribed amount of purified water, stirring uniformly, adding xanthan gum, orange flavor essence and sunset yellow pigment, continuously stirring uniformly, and then using a 500ml volumetric flask to fix the volume until the scale is uniformly shaken, thus obtaining the potassium chloride oral solution.
Test example 1
Viscosity test
Specifically, viscosity measurements were performed on the above examples and comparative examples, as shown in table 1:
TABLE 1 results of viscosity test
Note that: viscosity test conditions: rotor number Bowler fly-DV 2TRVTJ0-21, rotational speed: 200rpm, temperature: 40 ℃.
Test example 2
Mouthfeel testing
Specifically, the above examples and comparative examples were scored for mouthfeel as shown in table 2:
table 2 mouthfeel test scoring
| Examples | Scoring person 1 | Scoring person 2 | Scoring person 3 | Scoring person 4 | Scoring person 5 |
| Example 1 | Excellent (excellent) | Excellent (excellent) | Excellent (excellent) | Excellent (excellent) | Excellent (excellent) |
| Example 2 | Excellent (excellent) | Excellent (excellent) | Excellent (excellent) | Excellent (excellent) | Excellent (excellent) |
| Example 3 | Difference of difference | In (a) | In (a) | In (a) | Difference of difference |
| Example 4 | In (a) | Difference of difference | Difference of difference | Difference of difference | Difference of difference |
| Example 5 | Excellent (excellent) | Excellent (excellent) | Excellent (excellent) | Excellent (excellent) | Excellent (excellent) |
| Example 6 | Excellent (excellent) | Excellent (excellent) | Excellent (excellent) | Excellent (excellent) | Excellent (excellent) |
| Example 7 | Excellent (excellent) | Excellent (excellent) | Excellent (excellent) | Excellent (excellent) | Excellent (excellent) |
| Example 8 | Excellent (excellent) | Excellent (excellent) | Excellent (excellent) | Excellent (excellent) | Excellent (excellent) |
| Comparative example 1 | Difference of difference | In (a) | Difference of difference | In (a) | Difference of difference |
| Comparative example 2 | In (a) | Difference of difference | Difference of difference | In (a) | Difference of difference |
| Comparative example 3 | Difference of difference | Difference of difference | Difference of difference | In (a) | Difference of difference |
Note that: preferably: the taste is excellent, and no aftertaste is generated; in (a): the taste is general and slightly bitter. The difference is: has poor taste and serious aftertaste.
The significantly reduced mouthfeel of examples 3 and 4 in Table 2 compared to example 2 demonstrates that the ratio of hydroxyethylcellulose and glucose-delta-lactone has a significant impact on mouthfeel, both ratios having to be within the specified ranges of the present invention to achieve excellent mouthfeel.
Test example 3
Stability test
The products of the above examples and comparative examples were further subjected to a test for stability by standing at a high temperature of 60℃for 10d and 30d, and the results are shown in Table 3.
TABLE 3 stability and pH test
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Note that: no delamination and no water separation are indicative of stability.
The foregoing detailed description is directed to one of the possible embodiments of the present invention, which is not intended to limit the scope of the invention, but is to be accorded the full scope of all such equivalents and modifications so as not to depart from the scope of the invention.
Claims (5)
1. The potassium chloride oral preparation is characterized by comprising the following raw materials in percentage by weight and volume: 8-12% of potassium chloride, 0.05-0.2% of bacteriostat, 0.8-1.2% of pH regulator, 2-6% of corrigent, 0.2-0.6% of thickener, 0.4-0.8% of sweetener, 0.1-0.3% of essence, 0.005-0.02% of pigment and the balance of water; the pH regulator is a mixture of citric acid and sodium citrate, and the mass ratio of the citric acid to the sodium citrate is 2:1-1:3;
the thickener is a mixture of hydroxyethyl cellulose and glucose-delta-lactone, and the mass ratio of the hydroxyethyl cellulose to the glucose-delta-lactone is 5:1-3:1;
the bacteriostatic agent is sodium benzoate or ethyl hydroxy benzoate, and the flavoring agent is glycerol; the sweetener is aspartame, the essence is sweet orange essence, and the pigment is sunset yellow pigment.
2. The oral potassium chloride formulation according to claim 1, wherein the concentration by weight and volume percent is 8-12% of potassium chloride, 0.07-0.1% of a bacteriostatic agent, 0.8-1.0% of a pH adjuster, 3-4% of a taste modifier, 0.3-0.4% of a thickener, 0.5-0.6% of a sweetener and 0.2-0.3% of an essence.
3. The potassium chloride oral formulation according to claim 1, wherein the mass ratio of citric acid to sodium citrate is 1:1-1:2.
4. The oral potassium chloride formulation according to claim 1, wherein the pigment is 0.01-0.02% by weight volume percentage concentration.
5. A method for preparing the potassium chloride oral preparation according to any one of claims 1 to 4, comprising the steps of:
(1) Adding potassium chloride, a pH regulator, a bacteriostatic agent, a flavoring agent and a sweetener into water to obtain a mixture A;
(2) Adding thickener, essence and pigment, and stirring.
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| WO1999020238A1 (en) * | 1997-10-23 | 1999-04-29 | Warner-Lambert Company | Metal ion-containing oral products with reduced astringency |
| JP2002104997A (en) * | 2000-09-26 | 2002-04-10 | Kyorin Pharmaceut Co Ltd | Agent for easily taking food or medicine |
| WO2019094568A1 (en) * | 2017-11-09 | 2019-05-16 | Isp Investments Llc | Thickener systems for oral care compositions and a method for preparing the same |
| CN114601793A (en) * | 2022-03-16 | 2022-06-10 | 广东九明制药有限公司 | Oral solution of ambroxol and preparation method thereof |
| CN115969783A (en) * | 2023-02-20 | 2023-04-18 | 哈尔滨誉衡制药有限公司 | Potassium chloride oral liquid and preparation method thereof |
Family Cites Families (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US9737609B2 (en) * | 2014-08-20 | 2017-08-22 | Professional Compounding Centers Of America (Pcca) | Natural suspending agent including a synergistic blend of xanthan gum and konjac powder for oral pharmaceutical suspensions |
| EP3811930A1 (en) * | 2019-10-24 | 2021-04-28 | Authenda Pharmaceuticals AG | Oral gliptin compositions and method for preparation thereof |
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Patent Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO1999020238A1 (en) * | 1997-10-23 | 1999-04-29 | Warner-Lambert Company | Metal ion-containing oral products with reduced astringency |
| JP2002104997A (en) * | 2000-09-26 | 2002-04-10 | Kyorin Pharmaceut Co Ltd | Agent for easily taking food or medicine |
| WO2019094568A1 (en) * | 2017-11-09 | 2019-05-16 | Isp Investments Llc | Thickener systems for oral care compositions and a method for preparing the same |
| CN114601793A (en) * | 2022-03-16 | 2022-06-10 | 广东九明制药有限公司 | Oral solution of ambroxol and preparation method thereof |
| CN115969783A (en) * | 2023-02-20 | 2023-04-18 | 哈尔滨誉衡制药有限公司 | Potassium chloride oral liquid and preparation method thereof |
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