CN115518049A - Ranitidine hydrochloride capsule and preparation method thereof - Google Patents
Ranitidine hydrochloride capsule and preparation method thereof Download PDFInfo
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- CN115518049A CN115518049A CN202211367211.XA CN202211367211A CN115518049A CN 115518049 A CN115518049 A CN 115518049A CN 202211367211 A CN202211367211 A CN 202211367211A CN 115518049 A CN115518049 A CN 115518049A
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- ranitidine hydrochloride
- mixed powder
- cyclodextrin
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- maltol
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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
- A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
- A61K31/34—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having five-membered rings with one oxygen as the only ring hetero atom, e.g. isosorbide
- A61K31/341—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having five-membered rings with one oxygen as the only ring hetero atom, e.g. isosorbide not condensed with another ring, e.g. ranitidine, furosemide, bufetolol, muscarine
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- 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
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
-
- 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
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- 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
- A61K47/40—Cyclodextrins; 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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4841—Filling excipients; Inactive ingredients
- A61K9/4858—Organic 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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4841—Filling excipients; Inactive ingredients
- A61K9/4866—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
- A61P1/04—Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P7/00—Drugs for disorders of the blood or the extracellular fluid
- A61P7/04—Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
Abstract
The invention discloses a ranitidine hydrochloride capsule and a preparation method thereof, and the ranitidine hydrochloride capsule specifically comprises ranitidine hydrochloride, anhydrous citric acid, maltol, a stabilizer, an adhesive and a lubricant; wherein the stabilizer is a cyclodextrin derivative. The ranitidine hydrochloride capsule provided by the invention has the advantages of smooth preparation process, good stability and no discoloration phenomenon, ensures the safety and effectiveness of taking by patients, and is suitable for industrial large-scale production.
Description
Technical Field
The invention belongs to the technical field of pharmaceutical preparations, and particularly relates to a ranitidine hydrochloride capsule and a preparation method thereof.
Background
Ranitidine hydrochloride is a powerful H2 receptor blocker developed by British Kulansu company, can block the activity of histamine in the stomach of a human body, promotes ulcer healing by competitively inhibiting histamine H2 receptors, is mainly used for clinically treating hyperacidity, heartburn, duodenal ulcer, benign gastric ulcer, postoperative ulcer, reflux esophagitis, zollinger-Ellison syndrome and the like, can be used for treating upper gastrointestinal hemorrhage by intravenous injection, and is a medicament which is most widely applied at present for treating ulcer diseases.
Ranitidine hydrochloride, with the chemical name of N' -methyl-N- [2[ [5- [ (dimethylamino) methyl-2-furyl ] methyl ] thio ] ethyl ] -2-nitro-1,1-ethylene diamine hydrochloride, has the structural formula:
ranitidine hydrochloride is white or yellow crystalline powder, has poor liquidity and strong hygroscopicity, and is unstable after moisture absorption, dark in color and low in content, so that the process operability in the preparation process of the preparation is poor. Meanwhile, the ranitidine hydrochloride is absorbed from the gastrointestinal tract quickly after being taken orally, and the peak time of the blood concentration is (t) max ) 1-2 hours, half-life (t) 1/2 ) The dosage of the ranitidine hydrochloride is 150mg, and the specification of a commercially available ranitidine hydrochloride capsule is 150mg, which means that a large amount of ranitidine hydrochloride with poor fluidity and easy moisture induction is used in the preparation process, and the preparation process is more difficult.
Therefore, the ranitidine hydrochloride capsule needs to be further researched to overcome the property defects of poor flowability, easy moisture induction and poor stability of ranitidine hydrochloride.
Disclosure of Invention
In view of the above, the invention provides a ranitidine hydrochloride capsule, which aims to solve the problems of unsmooth preparation process and poor stability caused by poor flowability and easy moisture absorption of ranitidine hydrochloride. The ranitidine hydrochloride capsule provided by the invention has the advantages of smooth preparation process, good stability and no discoloration phenomenon, ensures the safety and effectiveness of taking by patients, and is suitable for industrial large-scale production.
The invention provides a ranitidine hydrochloride capsule, which specifically comprises ranitidine hydrochloride, anhydrous citric acid, maltol, a stabilizer, an adhesive and a lubricant; wherein the stabilizer is a cyclodextrin derivative.
The invention discloses a ranitidine hydrochloride capsule, which is characterized in that a large amount of ranitidine hydrochloride with poor fluidity, strong hygroscopicity and poor stability is required to be used in the ranitidine hydrochloride capsule, and the special physicochemical properties of ranitidine hydrochloride bring great challenges to the preparation and storage of ranitidine hydrochloride capsules.
In the ranitidine hydrochloride capsule, the mass ratio of the anhydrous citric acid to the maltol is 1-3:1.
The research on the dosage of the anhydrous citric acid and the maltol shows that when the mass ratio of the anhydrous citric acid to the maltol is 1-3:1, the ranitidine hydrochloride capsule can obtain satisfactory effects on the preparation process and the stability. When the mass ratio of the citric acid anhydrous to the maltol is more than 3:1, the viscosity between the materials is large, and the fluidity of the obtained medicine mixed powder is slightly poor. When the mass ratio of the citric acid and the maltol is less than 1:1, the ranitidine hydrochloride capsule obtained has poor stability. Therefore, when the mass consumption ratio of the anhydrous citric acid to the maltol is 1-3:1, the stability of the ranitidine hydrochloride is ensured, the preparation process is smooth, and the product with qualified quality is obtained.
In the ranitidine hydrochloride capsule, the stability of the ranitidine hydrochloride capsule is further improved by adding the cyclodextrin derivative as the stabilizer, so that the ranitidine hydrochloride capsule is prevented from being degraded due to moisture absorption of the ranitidine hydrochloride in long-term storage. The cyclodextrin derivative is one or more of hydroxyethyl-beta-cyclodextrin, hydroxypropyl-beta-cyclodextrin, dihydroxypropyl-beta-cyclodextrin and methyl-beta-cyclodextrin.
In the ranitidine hydrochloride capsule, the adhesive is one or more selected from hydroxypropyl cellulose, hydroxypropyl methylcellulose, sodium carboxymethylcellulose and povidone.
In the ranitidine hydrochloride capsule, the lubricant is one or more selected from magnesium stearate, sodium stearyl fumarate, superfine silica powder and talcum powder.
The ranitidine hydrochloride capsule further comprises a diluent, wherein the diluent is selected from one or more of lactose, microcrystalline cellulose, mannitol, pregelatinized starch, calcium hydrophosphate, sorbitol, sucrose, calcium sulfate and calcium carbonate. The amount of diluent may be determined, inter alia, by the ordinary level of knowledge of a person skilled in the art.
The ranitidine hydrochloride capsule also comprises a disintegrant, wherein the disintegrant is selected from one or more of croscarmellose sodium, crospovidone, sodium carboxymethyl starch and low-substituted hydroxypropyl cellulose. The amount of disintegrant used may be, among others, determined according to the level generally recognized by those skilled in the art.
In the ranitidine hydrochloride capsule, the dosage of each component is as follows by mass: 150 parts of ranitidine hydrochloride, 3-8 parts of anhydrous citric acid, 1-4 parts of maltol, 1-4 parts of stabilizer, 2.5-5 parts of adhesive and 1-2.5 parts of lubricant; wherein the dosage of the ranitidine hydrochloride is calculated by ranitidine.
The invention also provides a preparation method of the ranitidine hydrochloride capsule, which comprises the following steps:
(1) Uniformly mixing ranitidine hydrochloride, anhydrous citric acid and maltol to obtain first mixed powder;
(2) Adding a stabilizer into the first mixed powder, and uniformly mixing to obtain second mixed powder;
(3) Granulating the second mixed powder by using an ethanol solution containing a binding agent to prepare medicinal granules;
(4) Mixing the medicinal granules with lubricant, and making into capsule.
In the preparation method of the ranitidine hydrochloride capsule, one or two of a disintegrant and a diluent can be selectively added in the step (2).
Compared with the prior art, the invention has the beneficial effects that:
the invention overcomes the problems of difficulty and poor stability of the preparation process caused by poor fluidity and strong hygroscopicity of the ranitidine hydrochloride by the coordination of the anhydrous citric acid, the maltol and the stabilizer cyclodextrin derivative, can improve the smoothness of the preparation process, increase the stability of the ranitidine hydrochloride capsule and avoid the problem of discoloration of the medicament after long-time storage.
Detailed Description
Example 1
The preparation method comprises the following steps:
(1) Uniformly mixing ranitidine hydrochloride, anhydrous citric acid and maltol to obtain first mixed powder;
(2) Adding hydroxypropyl-beta-cyclodextrin into the first mixed powder, and uniformly mixing to obtain second mixed powder;
(3) Granulating the second mixed powder by using an ethanol solution containing hydroxypropyl cellulose to prepare medicinal granules;
(4) Mixing the medicinal granules with magnesium stearate, and encapsulating.
Example 2
The preparation method comprises the following steps:
(1) Uniformly mixing ranitidine hydrochloride, anhydrous citric acid and maltol to obtain first mixed powder;
(2) Adding hydroxypropyl-beta-cyclodextrin and hydroxyethyl-beta-cyclodextrin into the first mixed powder, and uniformly mixing to obtain second mixed powder;
(3) Granulating the second mixed powder by using ethanol solution containing povidone to prepare medicinal granules;
(4) Mixing the medicinal granules with sodium stearyl fumarate, and making into capsule.
Example 3
The preparation method comprises the following steps:
(1) Uniformly mixing ranitidine hydrochloride, anhydrous citric acid and maltol to obtain first mixed powder;
(2) Adding methyl-beta-cyclodextrin into the first mixed powder, and uniformly mixing to obtain second mixed powder;
(3) Granulating the second mixed powder by using an ethanol solution containing sodium carboxymethylcellulose to prepare medicinal granules;
(4) Mixing the medicinal granules with magnesium stearate and aerosil, and encapsulating.
Example 4
The preparation method comprises the following steps:
(1) Uniformly mixing ranitidine hydrochloride, anhydrous citric acid and maltol to obtain first mixed powder;
(2) Adding hydroxypropyl-beta-cyclodextrin, lactose and crospovidone into the first mixed powder, and uniformly mixing to obtain second mixed powder;
(3) Granulating the second mixed powder by using an ethanol solution containing hydroxypropyl methyl cellulose to prepare medicinal granules;
(4) Mixing the medicinal granules with pulvis Talci, and making into capsule.
Example 5
The preparation method comprises the following steps:
(1) Uniformly mixing ranitidine hydrochloride, anhydrous citric acid and maltol to obtain first mixed powder;
(2) Adding the dihypropyl-beta-cyclodextrin, the pregelatinized starch, the calcium hydrophosphate and the sodium carboxymethyl starch into the first mixed powder, and uniformly mixing to obtain second mixed powder;
(3) Granulating the second mixed powder by using an ethanol solution containing hydroxypropyl cellulose and povidone to prepare medicinal granules;
(4) Mixing the medicinal granules with magnesium stearate, and encapsulating.
Example 6
The preparation method comprises the following steps:
(1) Uniformly mixing ranitidine hydrochloride, anhydrous citric acid and maltol to obtain first mixed powder;
(2) Adding hydroxyethyl-beta-cyclodextrin, microcrystalline cellulose, low-substituted hydroxypropyl cellulose and croscarmellose sodium into the first mixed powder, and uniformly mixing to obtain second mixed powder;
(3) Granulating the second mixed powder by using an ethanol solution containing hydroxypropyl cellulose to prepare medicinal granules;
(4) Mixing the medicinal granules with magnesium stearate, and encapsulating.
Comparative example
The preparation method is the same as example 1.
Angle of repose test
The first mixed powders in examples and comparative examples were measured for the angle of repose using a powder particle flowability analyzer (model FT-104 BA) and the results were as follows:
from the above data, examples 1 to 6 and comparative examples 2 and 5 have a small angle of repose, are excellent in powder flowability, and are suitable for industrial mass production. In comparative examples 1 and 3, the citric acid and maltol were not added simultaneously, and the mixed powder had a large angle of repose and poor powder flowability, and was not suitable for industrial production.
Moisture absorption test
Taking a glass dryer with the bottom filled with the saturated solution of ammonium sulfate, placing a weighing bottle in the dryer, and placing the dryer in a constant temperature box for 48 hours until the humidity is constant. Taking 2g of the first mixed powder in the examples and the comparative examples, placing the first mixed powder in a weighing bottle, precisely weighing, opening a bottle cap, placing the bottle cap on the upper part of a dryer, placing the bottle cap in a constant-temperature constant-humidity incubator at 25 ℃ for 24 hours, weighing, and calculating the moisture absorption rate.
Calculating the formula: moisture absorption rate = (weight of medicinal powder after moisture absorption-weight of medicinal powder before moisture absorption)/weight of medicinal powder before moisture absorption x 100%. The results were as follows:
as is clear from the above data, examples 1 to 6 and comparative examples 2 and 4 are low in hygroscopicity; in comparative examples 1 and 3, anhydrous citric acid and maltol were not added at the same time, the hygroscopicity of the mixed powder was strong, the instability of the prepared ranitidine hydrochloride capsule was increased, and it was not suitable for industrial production.
Stability survey
The ranitidine hydrochloride capsules prepared in the examples and the comparative examples are continuously placed for 6 months at the conditions of high temperature of 40 ℃ and relative humidity of 75% +/-5%, and whether the contents of the capsules change color or not is observed in 0 month and 6 months, and the results of detecting the total impurity content (%) by HPLC are as follows:
accelerated test investigation is carried out on the samples obtained in the above examples and comparative examples, and it is found that in examples 1 to 6 of the present invention, the ranitidine hydrochloride capsule obtained by the coordination of anhydrous citric acid, maltol and cyclodextrin derivatives has good stability, and the increase of total impurities can be well controlled after the accelerated test, so as to ensure the medication safety of patients.
Claims (10)
1. A ranitidine hydrochloride capsule is characterized by comprising ranitidine hydrochloride, anhydrous citric acid, maltol, a stabilizer, a binder and a lubricant; wherein the stabilizer is a cyclodextrin derivative.
2. The ranitidine hydrochloride capsule according to claim 1, characterised in that the mass ratio of anhydrous citric acid to maltol is 1-3:1.
3. The ranitidine hydrochloride capsule of claim 1, wherein the cyclodextrin derivative is one or more of hydroxyethyl-beta-cyclodextrin, hydroxypropyl-beta-cyclodextrin, dihydroxypropyl-beta-cyclodextrin and methyl-beta-cyclodextrin.
4. The ranitidine hydrochloride capsule according to claim 1, characterized in that the binder is selected from one or more of hydroxypropyl cellulose, hydroxypropyl methylcellulose, sodium carboxymethyl cellulose, povidone.
5. The ranitidine hydrochloride capsule according to claim 1, characterized in that the lubricant is one or more selected from magnesium stearate, sodium stearyl fumarate, aerosil and talc.
6. The ranitidine hydrochloride capsule according to claim 1, further comprising a diluent selected from one or more of lactose, microcrystalline cellulose, mannitol, pregelatinized starch, dibasic calcium phosphate, sorbitol, sucrose, calcium sulfate, and calcium carbonate.
7. The ranitidine hydrochloride capsule according to claim 1, further comprising a disintegrant, wherein the disintegrant is one or more selected from the group consisting of croscarmellose sodium, crospovidone, sodium carboxymethyl starch, and low substituted hydroxypropyl cellulose.
8. The ranitidine hydrochloride capsule according to claim 1, characterized in that the dosage of each component is in parts by mass: 150 parts of ranitidine hydrochloride, 3-8 parts of anhydrous citric acid, 1-4 parts of maltol, 1-4 parts of stabilizer, 2.5-5 parts of adhesive and 1-2.5 parts of lubricant; wherein the dosage of ranitidine hydrochloride is calculated by ranitidine.
9. A method of preparing the ranitidine hydrochloride capsule of claim 1, characterized in that the method comprises the following steps:
(1) Uniformly mixing ranitidine hydrochloride, anhydrous citric acid and maltol to obtain first mixed powder;
(2) Adding a stabilizer into the first mixed powder, and uniformly mixing to obtain second mixed powder;
(3) Granulating the second mixed powder by using an ethanol solution containing a binding agent to prepare medicinal granules;
(4) Mixing the medicinal granules with lubricant, and making into capsule.
10. The method for preparing ranitidine hydrochloride capsules according to claim 9, wherein one or both of a disintegrant and a diluent can be optionally added in the step (2).
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202211367211.XA CN115518049B (en) | 2022-11-03 | 2022-11-03 | Ranitidine hydrochloride capsule and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202211367211.XA CN115518049B (en) | 2022-11-03 | 2022-11-03 | Ranitidine hydrochloride capsule and preparation method thereof |
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| Publication Number | Publication Date |
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| CN115518049A true CN115518049A (en) | 2022-12-27 |
| CN115518049B CN115518049B (en) | 2023-02-17 |
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Citations (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5456918A (en) * | 1988-09-20 | 1995-10-10 | Glaxo Group Limited | Ranitidine pharmaceutical compositions |
| US5728401A (en) * | 1997-04-16 | 1998-03-17 | Ranbaxy Laboratories, Ltd. | Effervescent ranitidine formulations |
| JP2001342185A (en) * | 2000-06-02 | 2001-12-11 | Nichiko Pharmaceutical Co Ltd | Film-coated ranitidine hydrochloride tablet |
| CN1488345A (en) * | 2003-07-31 | 2004-04-14 | 雅来（佛山）制药有限公司 | Ranitidine hydrochloride capsule producing process |
| WO2006072878A1 (en) * | 2005-01-07 | 2006-07-13 | Ranbaxy Laboratories Limited | Oral dosage forms of sertraline having controlled particle size and processes for their preparation |
| CN101623258A (en) * | 2009-07-23 | 2010-01-13 | 海南美大制药有限公司 | Ranitidine hydrochloride lipidosome capsule and new application thereof |
| CN101862320A (en) * | 2010-06-29 | 2010-10-20 | 郝志艳 | Solid preparation of ranitidine hydrochloride/bismuth potassium citrate medicinal composition |
-
2022
- 2022-11-03 CN CN202211367211.XA patent/CN115518049B/en active Active
Patent Citations (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5456918A (en) * | 1988-09-20 | 1995-10-10 | Glaxo Group Limited | Ranitidine pharmaceutical compositions |
| US5728401A (en) * | 1997-04-16 | 1998-03-17 | Ranbaxy Laboratories, Ltd. | Effervescent ranitidine formulations |
| JP2001342185A (en) * | 2000-06-02 | 2001-12-11 | Nichiko Pharmaceutical Co Ltd | Film-coated ranitidine hydrochloride tablet |
| CN1488345A (en) * | 2003-07-31 | 2004-04-14 | 雅来（佛山）制药有限公司 | Ranitidine hydrochloride capsule producing process |
| WO2006072878A1 (en) * | 2005-01-07 | 2006-07-13 | Ranbaxy Laboratories Limited | Oral dosage forms of sertraline having controlled particle size and processes for their preparation |
| CN101623258A (en) * | 2009-07-23 | 2010-01-13 | 海南美大制药有限公司 | Ranitidine hydrochloride lipidosome capsule and new application thereof |
| CN101862320A (en) * | 2010-06-29 | 2010-10-20 | 郝志艳 | Solid preparation of ranitidine hydrochloride/bismuth potassium citrate medicinal composition |
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| CN115518049B (en) | 2023-02-17 |
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