CN111358768A - Potassium chloride sustained-release pellet preparation and preparation method thereof - Google Patents
Potassium chloride sustained-release pellet preparation and preparation method thereof Download PDFInfo
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- CN111358768A CN111358768A CN201811589466.4A CN201811589466A CN111358768A CN 111358768 A CN111358768 A CN 111358768A CN 201811589466 A CN201811589466 A CN 201811589466A CN 111358768 A CN111358768 A CN 111358768A
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- 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
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- 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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5005—Wall or coating material
- A61K9/501—Inorganic compounds
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- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5005—Wall or coating material
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- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5005—Wall or coating material
- A61K9/5021—Organic macromolecular compounds
- A61K9/5036—Polysaccharides, e.g. gums, alginate; Cyclodextrin
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- 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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5005—Wall or coating material
- A61K9/5021—Organic macromolecular compounds
- A61K9/5036—Polysaccharides, e.g. gums, alginate; Cyclodextrin
- A61K9/5042—Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of hydroxypropyl methylcellulose
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5073—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings
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- 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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Abstract
A potassium chloride sustained-release pellet preparation comprises the following components in percentage by mass: potassium chloride: 50% -65%, calcium phosphate: 20% -50%, stearic acid: 2% -10%, maltodextrin: 2% -5%, povidone K30: 1.5% -5%, sodium carboxymethylcellulose: 0.1% -0.25%, vegetable oil: 0.5% -2%; the preparation method comprises weighing the ingredients, and preparing sodium carboxymethylcellulose slurry; preparing soft materials, preparing wet granules, putting the wet granules into a wet granulation pot, dynamically adding the mixed calcium phosphate powder, maltodextrin powder and povidone K30 into the wet granules, and wrapping to obtain molded pellets; further rolling and tightly pumping the pellets, and finally drying and screening; the invention provides a method for preparing pellets by a simple and easy wet granulation mode; the method has the advantages of strong operability, high productivity, good curative effect, low toxic and side effects, and low cost.
Description
Technical Field
The invention relates to the technical field of biology and new medicines, in particular to a potassium chloride sustained-release pellet preparation and a preparation method thereof.
Background
Potassium chloride (KCl) is frequently used for compensating potassium deficiency in clinic, and is colorless, slender, rhombic, cubic crystal or white crystalline small-particle powder, like common salt in appearance, odorless, salty and astringent. Is easily dissolved in water, but is not dissolved in ethanol or ether, and magnesium chloride and sodium chloride can reduce the solubility in water. Potassium chloride is also a commonly used electrolyte balance regulating drug in clinic. Can be used for treating and preventing hypokalemia caused by various reasons, and can also be used for treating frequent, multiple premature beat or rapid arrhythmia caused by cardiac glycoside poisoning such as cardiac edema, renal edema, digitalis, etc. It is well known that potassium chloride is irritating to the gastrointestinal tract and often causes nausea, vomiting, abdominal discomfort and diarrhea. Therefore, potassium chloride can be considered as a sustained-release preparation. Sustained-release tablets of potassium chloride have been marketed in China, but are often found to cause gastrointestinal ulcers, bleeding and perforation due to local high concentrations of cationic potassium in the gastrointestinal system, and may aggravate the condition by further increased irritation of the gastrointestinal tract when gastrointestinal obstruction, esophageal stenosis, diverticulum, lack of intestinal tone.
With the gradual maturity of modern preparation process and the development of auxiliary materials, the micro-pills become an important direction for the development of sustained-release preparations. The pellet is a micro spherical entity with the diameter of about 1mm and composed of medicines and auxiliary materials. According to different treatment requirements, the pellet is a sustained-release and controlled-release pellet prepared by uniformly dispersing a dose of medicine in hundreds of microspheres. At present, the potassium chloride sustained-release pellets are prepared by directly coating potassium chloride crystals on a fluidized bed, the grain size of potassium chloride crystals can influence the preparation process, the particles can be adhered into granules, the coating weight is increased too much, the production process is difficult to control, the batch difference is large, and the yield is low.
Disclosure of Invention
The invention aims to provide a potassium chloride sustained-release pellet preparation and a preparation method thereof, which have strong operability and high productivity, and the prepared pellet has good curative effect, small toxic and side effect and lower manufacturing cost, thereby solving the technical problems.
In order to achieve the technical purpose and achieve the technical requirements, the invention adopts the technical scheme that: the potassium chloride sustained-release pellet preparation is characterized by comprising the following components in percentage by mass: potassium chloride: 50% -65%, calcium phosphate: 20% -50%, stearic acid: 2% -10%, maltodextrin: 2% -5%, povidone K30: 1.5% -5%, sodium carboxymethylcellulose: 0.1% -0.25%, vegetable oil: 0.5 to 2 percent.
Preferably, the potassium chloride is pulverized potassium chloride powder; the calcium phosphate is a slow-release material; the stearic acid is a secondary slow-release material; the vegetable oil is one or more of soybean salad oil, olive oil, rapeseed oil and walnut oil.
A preparation method of a potassium chloride sustained-release pellet preparation adopts wet granulation equipment to prepare the potassium chloride sustained-release pellet preparation, and is characterized by comprising the following steps:
a. weighing and proportioning according to a formula, and preparing the sodium carboxymethylcellulose into slurry with a certain concentration for later use;
b. b, putting the potassium chloride powder and the calcium phosphate powder into a wet mixing granulation pot for mixing, adding the sodium carboxymethyl cellulose slurry prepared in the step a, stirring and granulating to prepare a soft material;
c. making wet granules from the obtained soft material on a swinging granulator with a certain mesh number of screens;
d. putting the prepared wet granules into a wet granulation pot, starting equipment, simultaneously dynamically adding the mixed calcium phosphate powder, maltodextrin powder and povidone K30 into the wet materials, wrapping, rounding, arranging a wet granulator, stirring at a high speed, and cutting at a low speed to obtain formed pellets;
e. d, adding the mixed slurry of the residual sodium carboxymethyl cellulose slurry in the step a and the vegetable oil according to the formula amount into the pellets obtained in the step d, and further rounding and tightening the pellets;
f. e, dynamically adding stearic acid on the basis of the step e, polishing the pellets after the pellets are rolled and tightened, and further separating the pellets to obtain the rolled pellets;
g. drying the prepared pellets in a fluidized bed;
h. and screening the dried pellets by using two screens, taking the middle section as a finished product, and returning other oversize whole or crushed products and lower screening fine materials to the next batch as a mother nucleus to enter the process.
The invention has the beneficial effects; a potassium chloride sustained-release pellet preparation and its preparation method, potassium chloride sustained-release pellet can be in vivo slow uniform release medicament, avoid the blood too high, obtain the anticipated blood concentration, and can maintain longer acting time, avoid the bad reaction such as irritation to gastric mucosa; the preparation method creates an effective sustained-release material by selecting the sustained-release material, adopting the preparation technology of conventional wet granulation equipment and taking potassium chloride, calcium phosphate, zinc, maltodextrin, povidone K30, sodium carboxymethylcellulose, vegetable oil and stearic acid as raw materials; obtaining potassium chloride micro-pill preparation with slow release function; the invention provides a method for preparing pellets by a simple and easy wet granulation mode; the potassium chloride is prepared into a sustained-release pellet preparation and then is filled into a capsule shell, the release degree reaches not less than 60% in 4 hours and not less than 75% in 8 hours, the method has strong operability and high productivity, and the prepared pellet has the characteristics of good curative effect, small toxic and side effects and low manufacturing cost.
Detailed Description
In order to make the objects, technical solutions and advantageous technical effects of the present invention clearer, the present invention is further described in detail below with reference to specific embodiments;
the potassium chloride sustained-release pellet preparation is characterized by comprising the following components in percentage by mass: potassium chloride: 50% -65%, calcium phosphate: 20% -50%, stearic acid: 2% -10%, maltodextrin: 2% -5%, povidone K30: 1.5% -5%, sodium carboxymethylcellulose: 0.1% -0.25%, vegetable oil: 0.5 to 2 percent.
The potassium chloride is crushed potassium chloride powder; the calcium phosphate is a slow-release material; the stearic acid is a secondary slow-release material; the vegetable oil is one or more of soybean salad oil, olive oil, rapeseed oil and walnut oil.
A preparation method of a potassium chloride sustained-release pellet preparation adopts wet granulation equipment to prepare the potassium chloride sustained-release pellet preparation, and is characterized by comprising the following steps:
a. weighing and proportioning according to a formula, and preparing the sodium carboxymethylcellulose into slurry with a certain concentration for later use;
b. b, putting the potassium chloride powder and the calcium phosphate powder into a wet mixing granulation pot for mixing, adding the sodium carboxymethyl cellulose slurry prepared in the step a, stirring and granulating to prepare a soft material;
c. making wet granules from the obtained soft material on a swinging granulator with a certain mesh number of screens;
d. putting the prepared wet granules into a wet granulation pot, starting equipment, simultaneously dynamically adding the mixed calcium phosphate powder, maltodextrin powder and povidone K30 into the wet materials, wrapping, rounding, arranging a wet granulator, stirring at a high speed, and cutting at a low speed to obtain formed pellets;
e. d, adding the mixed slurry of the residual sodium carboxymethyl cellulose slurry in the step a and the vegetable oil according to the formula amount into the pellets obtained in the step d, and further rounding and tightening the pellets;
f. e, dynamically adding stearic acid on the basis of the step e, polishing the pellets after the pellets are rolled and tightened, and further separating the pellets to obtain the rolled pellets;
g. drying the prepared pellets in a fluidized bed;
h. and screening the dried pellets by using two screens, taking the middle section as a finished product, and returning other oversize whole or crushed products and lower screening fine materials to the next batch as a mother nucleus to enter the process.
The invention is implemented specifically as follows: example 1
The formulation of the present invention comprises the components shown in Table 1
A preparation method of a sustained-release potassium chloride pellet preparation comprises the following steps:
firstly, weighing sodium carboxymethylcellulose in a formula to prepare slurry with the concentration of 1%; then weighing the ingredients according to the formula, dividing the ingredients into one, two and three piles according to the table 1, and stacking for later use; then putting the first heap of potassium chloride and calcium phosphate material into a wet mixing granulation pot for mixing, adding 90% of sodium carboxymethylcellulose slurry with the concentration of 1%, stirring and granulating to prepare a soft material; then the obtained soft material is made into wet granules by a swinging granulator with a 20-mesh screen; then putting the wet granules into a wet granulation pot, starting the equipment, simultaneously dynamically adding the calcium phosphate powder, the maltodextrin powder and the povidone K30 which are mixed in the second pile into the wet materials, wrapping the wet materials into a smooth ball, arranging a wet granulator to stir at a high speed, and chopping the wet granules at a low speed to obtain formed pellets; mixing the rest 10% sodium carboxymethylcellulose slurry with 1% concentration with vegetable oil in the same equipment, adding the formed slurry, and further rolling and tightly pumping the pellet; finally, stearic acid is dynamically added, the pellets are polished, and meanwhile, the pellets are further separated and become round pellets; drying the prepared pellets in a fluidized bed; and sieving the dried pellets by using a 18-mesh and 40-mesh standard sieve, and returning the oversize granules or crushed products sieved by the 18-mesh sieve and the sieved fine materials sieved by the 40-mesh sieve to the next batch as parent seeds to enter a pill making process.
The finished pellets obtained were filled to 850 mg/pellet with a 00# extended gelatin capsule shell and passed the test, and the dissolution data after 4 hours and 8 hours are shown in table 2:
and (4) conclusion: from the data, each grain is equal to or less than 60 percent in 4 hours; the mass requirement of more than or equal to 75 percent in 8 hours.
Example 2:
the formulations of the present invention include the components shown in Table 3
A preparation method of a sustained-release potassium chloride pellet preparation comprises the following steps: firstly, weighing sodium carboxymethylcellulose in a formula to prepare slurry with the concentration of 1%; then weighing the ingredients according to the formula, dividing the ingredients into one, two and three piles according to the table 3, and stacking for later use;
then putting the first pile of Vitamin C (VC), calcium phosphate and zinc oxide materials into a wet mixing granulation pot for mixing, adding 90% of sodium carboxymethyl cellulose slurry with the concentration of 1%, stirring and granulating to prepare a soft material; then the obtained soft material is made into wet granules by a swinging granulator with a 20-mesh screen; then putting the wet granules into a wet granulation pot, starting the equipment, simultaneously dynamically adding the calcium phosphate powder, the maltodextrin powder and the povidone K30 which are mixed in the second pile into the wet materials, wrapping the wet materials into a smooth ball, arranging a wet granulator to stir at a high speed, and chopping the wet granules at a low speed to obtain formed pellets; then mixing the rest 10% sodium carboxymethylcellulose slurry with the concentration of 1% with the vegetable oil in the formula amount in the same equipment, adding the formed slurry, and further rounding and tightly pumping the pellets; finally, stearic acid is dynamically added, the pellets are polished, and meanwhile, the pellets are further separated and become round pellets; drying the prepared pellets in a fluidized bed; and sieving the dried pellets by using a 18-mesh and 40-mesh standard sieve, and returning the oversize granules or crushed products sieved by the 18-mesh sieve and the sieved fine materials sieved by the 40-mesh sieve to the next batch as parent seeds to enter a pill making process.
The finished pellets obtained were filled to 850 mg/pellet with a 00# extended gelatin capsule shell and passed the test, and the dissolution data after 4 hours and 8 hours are shown in table 4:
and (4) conclusion: from the data, each grain is equal to or less than 60 percent in 4 hours; the mass requirement of more than or equal to 75 percent in 8 hours.
Example 3:
the formulations of the present invention include the components shown in Table 5
A preparation method of a sustained-release potassium chloride pellet preparation comprises the following steps: firstly, weighing sodium carboxymethylcellulose in a formula to prepare slurry with the concentration of 1%; then weighing the ingredients according to the formula, dividing the ingredients into one, two and three piles according to the table 5, and stacking for later use; then putting the first pile of Vitamin C (VC), calcium phosphate and zinc oxide materials into a wet mixing granulation pot for mixing, adding 90% of sodium carboxymethyl cellulose slurry with the concentration of 1%, stirring and granulating to prepare a soft material; then, the obtained soft material is made into wet granules by a swinging granulator with a 20-mesh screen; putting the wet granules into a wet granulation pot, starting the equipment, simultaneously dynamically adding the calcium phosphate powder, the maltodextrin powder and the povidone K30 which are mixed in the second pile into the wet materials, wrapping the wet materials into a smooth ball, arranging a wet granulator to stir at a high speed, and chopping the wet granules at a low speed to obtain formed pellets; then mixing the rest 10% sodium carboxymethylcellulose slurry with the concentration of 1% with the vegetable oil in the formula amount in the same equipment, adding the formed slurry, and further rounding and tightly pumping the pellets; finally, stearic acid is dynamically added, the pellets are polished, and meanwhile, the pellets are further separated and become round pellets; drying the prepared pellets in a fluidized bed; and sieving the dried pellets by using a 18-mesh and 40-mesh standard sieve, and returning the oversize granules or crushed products sieved by the 18-mesh sieve and the sieved fine materials sieved by the 40-mesh sieve to the next batch as parent seeds to enter a pill making process.
The finished pellets obtained were filled to 850 mg/pellet with a 00# extended gelatin capsule shell and passed the test, and the dissolution data after 4 hours and 8 hours are shown in table 6:
and (4) conclusion: from the data, each grain is equal to or less than 60 percent in 4 hours; the mass requirement of more than or equal to 75 percent in 8 hours.
The foregoing examples are given solely for the purpose of illustrating the invention and are not to be construed as limiting the embodiments, and other variations and modifications in form thereof will be suggested to those skilled in the art upon reading the foregoing description, and it is not necessary or necessary to exhaustively enumerate all embodiments and all such obvious variations and modifications are deemed to be within the scope of the invention.
Claims (3)
1. The potassium chloride sustained-release pellet preparation is characterized by comprising the following components in percentage by mass: potassium chloride: 50% -65%, calcium phosphate: 20% -50%, stearic acid: 2% -10%, maltodextrin: 2% -5%, povidone K30: 1.5% -5%, sodium carboxymethylcellulose: 0.1% -0.25%, vegetable oil: 0.5 to 2 percent.
2. The potassium chloride sustained-release pellet preparation according to claim 1, wherein the potassium chloride is pulverized potassium chloride powder; the calcium phosphate is a slow-release material; the stearic acid is a secondary slow-release material; the vegetable oil is one or more of soybean salad oil, olive oil, rapeseed oil and walnut oil.
3. A preparation method of a potassium chloride sustained-release pellet preparation adopts wet granulation equipment to prepare the potassium chloride sustained-release pellet preparation, and is characterized by comprising the following steps:
a. weighing and proportioning according to a formula, and preparing the sodium carboxymethylcellulose into slurry with a certain concentration for later use;
b. b, putting the potassium chloride powder and the calcium phosphate powder into a wet mixing granulation pot for mixing, adding the sodium carboxymethyl cellulose slurry prepared in the step a, stirring and granulating to prepare a soft material;
c. making wet granules from the obtained soft material on a swinging granulator with a certain mesh number of screens;
d. putting the prepared wet granules into a wet granulation pot, starting equipment, simultaneously dynamically adding the mixed calcium phosphate powder, maltodextrin powder and povidone K30 into the wet materials, wrapping, rounding, arranging a wet granulator, stirring at a high speed, and cutting at a low speed to obtain formed pellets;
e. d, adding the mixed slurry of the residual sodium carboxymethyl cellulose slurry in the step a and the vegetable oil according to the formula amount into the pellets obtained in the step d, and further rounding and tightening the pellets;
f. e, dynamically adding stearic acid on the basis of the step e, polishing the pellets after the pellets are rolled and tightened, and further separating the pellets to obtain the rolled pellets;
g. drying the prepared pellets in a fluidized bed;
h. and screening the dried pellets by using two screens, taking the middle section as a finished product, and returning other oversize whole or crushed products and lower screening fine materials to the next batch as a mother nucleus to enter the process.
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN113082003A (en) * | 2021-05-10 | 2021-07-09 | 浙江新维士生物科技有限公司 | Vitamin C sustained-release pellets and capsules and preparation method thereof |
| CN115581683A (en) * | 2022-10-26 | 2023-01-10 | 平昌县人民医院 | Potassium chloride instant capsule and preparation process thereof |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102961363A (en) * | 2012-12-14 | 2013-03-13 | 河南中帅医药科技发展有限公司 | Potassium chloride slow release capsule |
| CN106491565A (en) * | 2016-12-16 | 2017-03-15 | 江苏艾兰得营养品有限公司 | A kind of vitamin C zincification sustained-release pellet preparation and preparation method thereof |
| CN107823189A (en) * | 2017-11-25 | 2018-03-23 | 杭州高成生物营养技术有限公司 | A kind of chlorination potassium sustained-release pellet and preparation method and application |
-
2018
- 2018-12-25 CN CN201811589466.4A patent/CN111358768A/en active Pending
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102961363A (en) * | 2012-12-14 | 2013-03-13 | 河南中帅医药科技发展有限公司 | Potassium chloride slow release capsule |
| CN106491565A (en) * | 2016-12-16 | 2017-03-15 | 江苏艾兰得营养品有限公司 | A kind of vitamin C zincification sustained-release pellet preparation and preparation method thereof |
| CN107823189A (en) * | 2017-11-25 | 2018-03-23 | 杭州高成生物营养技术有限公司 | A kind of chlorination potassium sustained-release pellet and preparation method and application |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN113082003A (en) * | 2021-05-10 | 2021-07-09 | 浙江新维士生物科技有限公司 | Vitamin C sustained-release pellets and capsules and preparation method thereof |
| CN115581683A (en) * | 2022-10-26 | 2023-01-10 | 平昌县人民医院 | Potassium chloride instant capsule and preparation process thereof |
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Application publication date: 20200703 |