CN115040512B - Pharmaceutical composition and preparation method thereof - Google Patents
Pharmaceutical composition and preparation method thereof Download PDFInfo
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- CN115040512B CN115040512B CN202210901324.7A CN202210901324A CN115040512B CN 115040512 B CN115040512 B CN 115040512B CN 202210901324 A CN202210901324 A CN 202210901324A CN 115040512 B CN115040512 B CN 115040512B
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
- A61K31/4402—Non condensed pyridines; Hydrogenated derivatives thereof only substituted in position 2, e.g. pheniramine, bisacodyl
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
- A61K31/194—Carboxylic acids, e.g. valproic acid having two or more carboxyl groups, e.g. succinic, maleic or phthalic acid
-
- 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
- A61K33/06—Aluminium, calcium or magnesium; Compounds thereof, e.g. clay
- A61K33/08—Oxides; Hydroxides
-
- 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
- A61K47/02—Inorganic compounds
-
- 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
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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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
- A61K9/143—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with inorganic compounds
-
- 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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
- A61K9/146—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic macromolecular compounds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/12—Antidiarrhoeals
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
- Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
- Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
- Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
Abstract
The invention relates to the technical field of pharmaceutical preparations, in particular to a pharmaceutical composition and a preparation method thereof. The preparation method of the pharmaceutical composition comprises the following steps: s1, step: dispersing sodium picosulfate in a solvent to obtain a dispersion liquid; s2, step: mixing the dispersion liquid with bentonite to obtain a mixture; s3, step: mixing the mixture with magnesium oxide and citric acid to obtain a pharmaceutical composition; the mass ratio of the bentonite to the sodium picosulfate is more than 300 and less than or equal to 700, the sodium picosulfate is dispersed in a solvent and then mixed with the bentonite, the sodium picosulfate is completely absorbed and wrapped by utilizing the layered structure of the bentonite and then mixed with the magnesium oxide and the citric acid, the sodium picosulfate and the sodium citrate can be well isolated by the method, the dispersion of the sodium picosulfate is uniform, the thermal stability of the pharmaceutical composition is obviously improved, the sodium picosulfate content is obviously improved after the pharmaceutical composition is placed at a high temperature for 10 days, and the impurity content is obviously reduced.
Description
Technical Field
The invention relates to the technical field of pharmaceutical preparations, in particular to a pharmaceutical composition and a preparation method thereof.
Background
The compound sodium picosulfate granule is a new medicine developed by Huiling pharmaceutical company, and has the trade name: prepypik TM It is used for preparing intestinal tract cleaning before colonoscopy and X-ray examination. Market in China is 10 months in 2018. Specification of: each bag contains active ingredient sodium picosulfate 10mg, magnesium oxide 3.5g, citric acid 12.0g, and auxiliary material is potassium bicarbonate. After the product is dissolved, magnesium oxide and citric acid react to generate magnesium citrate to play a laxative role. Sodium picosulfate is a prodrug that is converted by bacteria to active metabolites in the colon after oral administration: bis (p-hydroxyphenyl) -pyridinyl-2-methane (BHPM) can directly stimulate intestinal mucosa, promote intestinal peristalsis, inhibit water absorption in intestinal tract, and exert diarrhea guiding effect. Compared with the traditional preparation such as polyethylene glycol, the product has less liquid consumption, good effect and higher compliance of patients.
The product contains sodium picosulfate, magnesium oxide and citric acid as active ingredients, and potassium bicarbonate as auxiliary materials, wherein the sodium picosulfate accounts for 0.62 percent because of low content of the sodium picosulfate, and the materials are all salts and are easy to dissolve in water, so that granules with uniform content are difficult to obtain by using a general preparation technology, and a great challenge is provided for a preparation process. Patent CN101820859, "process for preparing a pharmaceutical product comprising citric acid, magnesium oxide, potassium bicarbonate and sodium picosulphate", discloses a formulation process comprising a pharmaceutical composition and intermediates obtained by this process in fine particles: a. applying (in a sprayable manner) a solution of sodium picosulphate to the surface of potassium bicarbonate to give granules 1; b. mixing magnesium oxide with citric acid, and adhering the magnesium oxide to the surface of the citric acid to obtain particles 2; c. and (3) mixing the particles 1 and 2 to obtain particles 3, and subpackaging the particles 3 to obtain the product. However, the research shows that the product obtained by the method has poor thermal stability, and the problems of reduced content of sodium picosulfate and increased content of impurities are easy to occur after the product is placed for a period of time.
Disclosure of Invention
Therefore, the technical problem to be solved by the invention is to overcome the defect of low thermal stability of the compound sodium picosulfate particles in the prior art, thereby providing a pharmaceutical composition and a preparation method thereof.
The invention provides a preparation method of a pharmaceutical composition containing sodium picosulfate, magnesium oxide and citric acid, which comprises the following steps:
s1, step: dispersing sodium picosulfate in a solvent to obtain a dispersion liquid;
s2, step: mixing the dispersion liquid with bentonite to obtain a mixture;
s3, step: mixing the mixture with magnesium oxide and citric acid to obtain a pharmaceutical composition; the mass ratio of the bentonite to the sodium picosulfate is more than 300 and less than or equal to 700.
Further, the mass ratio of bentonite to sodium picosulfate is 500.
Further, the solvent is glycerol.
The dispersion liquid obtained by adopting glycerin as a solvent can be well absorbed by bentonite to obtain a powdery mixture, and the dispersion liquid can be mixed with the bentonite for a small amount for many times. For example 3-5 times.
Further, in the step S3, the mixture further comprises the step of mixing with carrageenan before mixing with magnesium oxide and citric acid.
Further, the mass ratio of the sodium picosulfate to the carrageenan is 0.01:1-3, preferably 0.01:2.
Further, the mass ratio of the sodium picosulfate to the magnesium oxide to the citric acid is 0.01:3.5:12; and/or the mass ratio of the solvent to the bentonite is 1:5-7.
Further, in step S3, the method further comprises a step of mixing the mixture with a flavoring agent, preferably saccharin sodium and/or essence.
Further, the pharmaceutical composition contains 0.19-0.25wt% of saccharin sodium and 0.19-0.25wt% of essence.
Further, the mass content of the sodium picosulfate in the pharmaceutical composition is 0.039% -0.047%.
The invention also provides a pharmaceutical composition which is worthy of any one of the preparation methods.
The technical scheme of the invention has the following advantages:
1. the preparation method of the pharmaceutical composition provided by the invention comprises the following steps: s1, step: dispersing sodium picosulfate in a solvent to obtain a dispersion liquid; s2, step: mixing the dispersion liquid with bentonite to obtain a mixture; s3, step: mixing the mixture with magnesium oxide and citric acid to obtain a pharmaceutical composition, wherein the mass ratio of bentonite to sodium picosulfate is more than 300 and less than or equal to 700; through the three steps, the sodium picosulfate is dispersed in a solvent and then mixed with bentonite, the sodium picosulfate is completely absorbed and wrapped by utilizing the layered structure of the bentonite and then mixed with magnesium oxide and citric acid, the method and the control of the mass ratio of the bentonite to the sodium picosulfate can well isolate the sodium picosulfate from the sodium citrate, the sodium picosulfate is uniformly dispersed, the thermal stability of the pharmaceutical composition is obviously improved, and the thermal stability experimental result shows that the reduction degree of the sodium picosulfate content and the improvement degree of the impurity content of the pharmaceutical composition are obviously improved after the pharmaceutical composition is placed at high temperature for 10 days.
In the step S3, the mixture further comprises the step of mixing with carrageenan before mixing with magnesium oxide and citric acid, and the bentonite is further wrapped by the carrageenan after being absorbed, so that the research discovers that the bentonite and the carrageenan are matched for use, and the pharmaceutical composition has better thermal stability.
2. According to the preparation method of the pharmaceutical composition provided by the invention, researches show that the heat stability of the pharmaceutical composition can be further improved by controlling the mass ratio of bentonite to sodium picosulfate to be 500.
3. According to the preparation method of the pharmaceutical composition provided by the invention, researches show that the heat stability of the pharmaceutical composition can be further improved by controlling the mass ratio of the sodium picosulfate to the carrageenan to be 0.01:1-3, especially 0.01:2.
Detailed Description
The following examples are provided for a better understanding of the present invention and are not limited to the preferred embodiments described herein, but are not intended to limit the scope of the invention, any product which is the same or similar to the present invention, whether in light of the present teachings or in combination with other prior art features, falls within the scope of the present invention.
The specific experimental procedures or conditions are not noted in the examples and may be followed by the operations or conditions of conventional experimental procedures described in the literature in this field. The reagents or apparatus used were conventional reagent products commercially available without the manufacturer's knowledge. Wherein the essence is powder orange essence, and is purchased from the food technology development limited company of Huabao peacock in Jiangxi province.
Example 1
The present example provides a pharmaceutical composition comprising sodium picosulfate, magnesium oxide and citric acid, formulated as follows:
the preparation method comprises the following steps: dispersing sodium picosulfate in glycerol to obtain a dispersion; evenly mixing the dispersion liquid with bentonite for 3 times to obtain a mixture, wherein the mixture is in a powder shape; adding carrageenan into the mixture, and mixing for 4min at the rotating speed of 12 rpm; adding magnesium oxide, citric acid, saccharin sodium and essence, and mixing at 12rpm for 5min.
Example 2
The present example provides a pharmaceutical composition comprising sodium picosulfate, magnesium oxide and citric acid, formulated as follows:
the preparation method comprises the following steps: dispersing sodium picosulfate in glycerol to obtain a dispersion; evenly mixing the dispersion liquid with bentonite for 3 times to obtain a mixture, wherein the mixture is in a powder shape; adding magnesium oxide, citric acid, saccharin sodium and essence into the mixture, and mixing at 12rpm for 5min.
Example 3
The present example provides a pharmaceutical composition comprising sodium picosulfate, magnesium oxide and citric acid, formulated as follows:
the preparation method is the same as in example 1.
Example 4
The present example provides a pharmaceutical composition comprising sodium picosulfate, magnesium oxide and citric acid, formulated as follows:
the preparation method is the same as in example 1.
Example 5
The present example provides a pharmaceutical composition comprising sodium picosulfate, magnesium oxide and citric acid, formulated as follows:
the preparation method is the same as in example 1.
Comparative example 1
The present comparative example provides a pharmaceutical composition comprising sodium picosulfate, magnesium oxide and citric acid, which is formulated as follows:
the preparation method comprises the following steps: mixing sodium picosulfate, magnesium oxide, citric acid, saccharin sodium and essence at 12rpm for 5min.
Comparative example 2
The present comparative example provides a pharmaceutical composition comprising sodium picosulfate, magnesium oxide and citric acid, which is formulated as follows:
the preparation method comprises the following steps: mixing sodium picosulfate with carrageenan, and mixing for 4min at a rotation speed of 12 rpm; adding magnesium oxide, citric acid, saccharin sodium and essence into the mixture, and mixing at 12rpm for 5min.
Comparative example 3
The present comparative example provides a pharmaceutical composition comprising sodium picosulfate, magnesium oxide and citric acid, which is formulated as follows:
the preparation method comprises the following steps: a. dissolving sodium picosulfate in 50mg of water to obtain a sodium picosulfate solution, applying the sodium picosulfate solution to the surface of potassium bicarbonate by adopting a fluidized bed, and drying to obtain particles 1;
b. mixing magnesium oxide with citric acid, and adhering the mixed magnesium oxide to the surface of the citric acid to obtain particles 2;
c. and (3) mixing the particles 1 and 2 to obtain particles 3, and subpackaging the particles 3 to obtain the product.
Comparative example 4
The present example provides a pharmaceutical composition comprising sodium picosulfate, magnesium oxide and citric acid, formulated as follows:
the preparation method is the same as in example 1.
Experimental example 1
Thermal stability experiments: the pharmaceutical compositions prepared in the above examples and comparative examples were left at a high temperature of 60 ℃ for 10 days, respectively, and the contents of the related substances (impurity a and impurity B) and sodium picosulfate contained before and after the placement of each group of pharmaceutical compositions were determined, specifically: weighing the pharmaceutical compositions of each example and comparative example according to unit prescription, respectively placing the pharmaceutical compositions into 200ml measuring flask, adding 0.063mol/L dipotassium hydrogen phosphate solution (pH is regulated to 4.5 by phosphoric acid) 35ml, shaking to disperse, performing ultrasonic treatment for 5 minutes until the pharmaceutical compositions are completely and uniformly mixed, cooling, adding 35ml of acetonitrile, sufficiently shaking and performing ultrasonic treatment for 5 minutes, cooling, diluting to a scale by phosphate buffer solution with pH of 4.5, shaking uniformly, filtering, and taking the subsequent filtrate as a sample solution; taking a proper amount of reference substances of impurity A (CAS 32500-19-9) and impurity B (CAS 603-41-8), precisely weighing, and using acetonitrile: the phosphate buffer solution (volume ratio: 35:165) at pH4.5 was dissolved and diluted to prepare a solution containing 0.075. Mu.g of impurity A and 0.075. Mu.g of impurity B per 1ml, as a control solution. The blank samples were prepared by the same procedure except for sodium picosulfate, and the blank sample was weighed and prepared into a blank sample solution according to the test sample solution preparation method. According to high performance liquid chromatography (rule 0512 of Chinese pharmacopoeia 2020 edition), using C 8 ChromatographyColumn: linear gradient elution was performed with 0.062mol/L dipotassium hydrogen phosphate solution (pH adjusted to 4.5 by phosphoric acid) -acetonitrile (volume ratio 86:14) as mobile phase A and 0.063mol/L dipotassium hydrogen phosphate solution (pH adjusted to 4.5 by phosphoric acid) -acetonitrile (volume ratio 40:60) as mobile phase B, with the gradient elution procedure shown in the following table:
the flow rate is 1.5ml per minute; the column temperature was 30℃and the detection wavelength was 230nm. Taking 100 mu l of each of the sample solution, the reference substance solution and the blank sample solution, respectively injecting into a liquid chromatograph, recording a chromatogram, calculating the contents of sodium picosulfate, impurity A and impurity B according to an external standard method and the peak area of the blank sample without counting chromatographic peaks, wherein the total impurity content (%) = the content of the impurity A and the content of the impurity B, and the result is shown in the following table:
table 1 related substances and results of sodium picosulfate content (%)
As can be seen from the results of the above table, compared with comparative examples 1 to 4, the content of sodium picosulfate in the pharmaceutical compositions prepared in examples 1 to 5 of the present invention was significantly improved after 10 days of high temperature standing, and the total impurity content was significantly reduced or the degree of reduction in the content of sodium picosulfate and the degree of improvement in the total impurity content were significantly improved, indicating that the thermal stability was significantly improved. Example 1 in comparison with examples 2, 3 and 4, it is clear that the present invention can further improve the stability of the product by using bentonite in combination with carrageenan or limiting the mass ratio of sodium picosulfate to carrageenan within a preferred range. Example 1 it is understood by comparing example 5 that the present invention can further improve the stability of the product by limiting the mass ratio of sodium picosulfate to bentonite within a preferred range.
It is apparent that the above examples are given by way of illustration only and are not limiting of the embodiments. Other variations or modifications of the above teachings will be apparent to those of ordinary skill in the art. It is not necessary here nor is it exhaustive of all embodiments. While still being apparent from variations or modifications that may be made by those skilled in the art are within the scope of the invention.
Claims (10)
1. A process for the preparation of a pharmaceutical composition comprising sodium picosulphate, magnesium oxide and citric acid, comprising the steps of:
s1, step: dispersing sodium picosulfate in a solvent to obtain a dispersion liquid;
s2, step: mixing the dispersion liquid with bentonite to obtain a mixture;
s3, step: mixing the mixture with magnesium oxide and citric acid to obtain a pharmaceutical composition; the mass ratio of the bentonite to the sodium picosulfate is more than 300 and less than or equal to 700; the solvent is glycerol.
2. The preparation method according to claim 1, wherein the mass ratio of bentonite to sodium picosulfate is 500.
3. The process according to claim 1 or 2, wherein in step S3 the mixture further comprises a step of mixing with carrageenan before mixing with magnesium oxide and citric acid.
4. The preparation method according to claim 1 or 2, wherein the mass ratio of the sodium picosulfate to the carrageenan is 0.01:1-3.
5. The preparation method according to claim 4, wherein the mass ratio of the sodium picosulfate to the carrageenan is 0.01:2.
6. The preparation method according to claim 1 or 2, wherein the mass ratio of sodium picosulfate, magnesium oxide and citric acid is 0.01:3.5:12; and/or the mass ratio of the solvent to the bentonite is 1:5-7.
7. The method according to claim 1 or 2, wherein step S3 further comprises the step of mixing the mixture with a flavoring agent, wherein the flavoring agent is saccharin sodium and/or essence.
8. The method of claim 7, wherein the pharmaceutical composition comprises 0.19-0.25wt% saccharin sodium and 0.19-0.25wt% flavoring.
9. The preparation method according to claim 1 or 2, wherein the mass content of sodium picosulfate in the pharmaceutical composition is 0.039% -0.047%.
10. A pharmaceutical composition obtainable by the process of any one of claims 1 to 9.
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| AU2004229464A1 (en) * | 2003-04-08 | 2004-10-28 | Progenics Pharmaceuticals, Inc. | Combination therapy for constipation comprising a laxative and a peripheral opioid antagonist |
| US7687075B2 (en) * | 2003-11-19 | 2010-03-30 | Salix Pharmaceuticals, Ltd. | Colonic purgative composition with soluble binding agent |
| EP2207526B1 (en) * | 2007-10-12 | 2017-11-22 | Ferring International Center S.A. | Process for the manufacure of a pharmaceutical product comprising citric acid, magnesium oxide, potassium bicarbonate and sodium picosulfate, pharmaceutical composition comprising granules obtained by such process and intermediate products thereof |
| CN101406457A (en) * | 2007-10-12 | 2009-04-15 | 辉凌国际制药（瑞士）有限公司 | Process for the manufacture of a pharmaceutical product |
| JP5414233B2 (en) * | 2008-09-30 | 2014-02-12 | 小林製薬株式会社 | Oral composition |
| JP5452056B2 (en) * | 2009-03-31 | 2014-03-26 | 小林製薬株式会社 | Oral medicine |
| WO2016015055A1 (en) * | 2014-07-25 | 2016-01-28 | Ironwood Pharmaceuticals, Inc. | Colon cleansing compositions |
| CN112603927A (en) * | 2020-12-21 | 2021-04-06 | 苏州二叶制药有限公司 | A pharmaceutical composition containing sodium picosulfate, magnesium oxide, citric acid and potassium bicarbonate, and its preparation method |
| CN113648327B (en) * | 2021-08-24 | 2023-03-28 | 山东京卫制药有限公司 | Pharmaceutical composition and preparation method thereof |
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