CN105496967B - Ranitidine hydrochloride controlled release dry suspensoid agent and preparation method thereof - Google Patents
Ranitidine hydrochloride controlled release dry suspensoid agent and preparation method thereof Download PDFInfo
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- CN105496967B CN105496967B CN201510969953.3A CN201510969953A CN105496967B CN 105496967 B CN105496967 B CN 105496967B CN 201510969953 A CN201510969953 A CN 201510969953A CN 105496967 B CN105496967 B CN 105496967B
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- ranitidine hydrochloride
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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
- A61K9/146—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
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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
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0002—Galenical forms characterised by the drug release technique; Application systems commanded by energy
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- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
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- Life Sciences & Earth Sciences (AREA)
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- General Health & Medical Sciences (AREA)
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- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
The invention discloses ranitidine hydrochloride controlled release dry suspensoid agents and preparation method thereof.Said preparation contains ranitidine hydrochloride and pharmaceutically acceptable polymer.The hydrochloric ranitidine 10 90% of said preparation by weight percentage, auxiliary material are 10 90%, and surplus is other auxiliary materials.The auxiliary material of controlled-release function is played as cation exchange resin and methylcellulose, ethyl cellulose, acrylic resin, hypromellose one or more therein.Compared with quick releasing formulation, controlled release preparation of the present invention can keep effective blood drug concentration in 24 hours, improve curative effect, and toxic side effect is small, takes, is easy to carry, and number is taken in reduction.Compared with sustained release preparation, controlled release preparation of the present invention can keep more stably blood concentration in 24 hours, improve curative effect, and toxic side effect is small.This preparation only needs be administered once for one day.Controlled release preparation of the present invention will be used clinically for treatment benign gastric ulcer, duodenal ulcer.
Description
Technical field
The present invention relates to treatment benign gastric ulcer, the ranitidine hydrochloride controlled release dry suspensoid agent of duodenal ulcer and its
Preparation method.
Background technology
Ranitidine hydrochloride be N '-methyl-N- (2- (((5- (（Dimethylamino）Methyl) -2- furyls)-methyl)
It is thio) ethyl) -2- nitro -1,1- ethylene diamine hydrochlorides.This product is off-white color or light yellow crystalline powder；There is foreign odor；
Mildly bitter flavor band is puckery；Easily deliquescence darkens after the moisture absorption.t1/2About 2-3h.It is readily soluble in water or methanol, it omits in ethanol
It is molten.It is potent, the long-acting H of one kind2Receptor antagonist, acts on 5-8 times stronger than Cimetidine, and action time is long compared with the latter, and one
Secondary dosage energy gastric acid secretion inhibiting can effectively inhibit gastric acid secretion caused by basic hydrochloric acid in gastric juice and gastrin stimulation up to 12 hours,
Reduce the activity of hydrochloric acid in gastric juice and gastric enzyme.Clinically it is mainly used for treating duodenal ulcer, gastric ulcer, postoperative ulcer.Also can be used for
The upper gastrointestinal bleeding of steroid-induced and the diseases such as exedens indigestion and chronic colitis.It is mainly used for treating stomach, 12
The diseases such as Duodenalulcer, price is cheap on the market for ranitidine, and number of users is numerous, before being ranked always in similar drug
Thatch.Adverse reaction generation is less, occasionally there is constipation, diarrhea, abdominal distension, headache, dizziness etc., and it is good to take tolerance for a long time.
General preparation often needs be administered several times within one, is administered 2 times within 1st such as conventional tablet, 1 tablet once（150mg/ pieces）.Cause
Pain, the reasons patient such as dislike trouble can consciously or unconsciously change Dosing Regimens, miss once or twice, the drug in blood plasma and tissue
Level concentration rises and falls big, even if continuing medication, treatment concentration is also not achieved in a short time, can only repeated drug taking could rebuild treatment water
It is flat, it had not only wasted drug but also had delayed treatment.
Oral sustained-release preparation is meant can extend drug effect in vivo, reduce a kind of newtype drug system of medicining times
Agent has many advantages, such as to reduce toxic side effect, improves the tolerance of patient and provide the blood concentration of lasting stability.But suitable for child
And the dosage form and preparation of the particular patients 's such as old man are very limited.Due to this kind of patient and difference of the adult in physiological function,
Other than the difference of dosage, the compliance of requirement and medication to dosage form also has a different requirements, oral controlled-release tablet or
The solid pharmaceutical preparations Chang Yinwei such as capsule mouthfeels are uncomfortable or dysphagia and the problems such as be not easy divided dose, and lead to such patient's
Take inconvenience, influence the completion of normal therapeutic scheme and the performance of drug effect, some film control formula pieces or sustained release tablets split it is broken after take,
Serious side effects even occur.And in contrast, the agent of controlled release dry suspensoid agent have absorb it is fast, can divided dose take, be readily packaged
The characteristics of transporting, easily being received by old man and children.Therefore controlled release dry suspensoid agent in good taste and that drug effect can be extended is researched and developed
Paid much attention to by medicament scholar and clinician.
Although controlled release preparation, particularly controlled release dry suspensoid agent have more advantage relative to common sustained release preparation and have obtained medicament
Scholar and the great attention of clinician, but the prior art only has the sustained release preparation of ranitidine hydrochloride, can only achieve external body
Interior slow release effect can not reach controlled-release effect and so that in vivo release is more steady, and adverse reaction smaller there is not yet hydrochloric acid thunder Buddhist nun
For fourth controlled release preparation, less there are the controlled release dry suspensoid agents of ranitidine hydrochloride.Applicant believes that this is at least partly because salt
Certain physical properties of sour ranitidine are unfavorable, therefore prepare hydrochloric acid for being prepared as conventional controlled release dry suspensoid agent
The controlled release dry suspensoid agent of ranitidine technically has bigger difficulty to those skilled in the art.
The present inventor passes through creatively simultaneously using two kinds of technologies of ion exchange and WURST fluidized bed coatings film
Carry out Drug controlled release, the ranitidine hydrochloride controlled release dry suspensoid agent of realizing controlled-release has unexpectedly been obtained, so that hydrochloric acid
Blood concentration is more steady in ranitidine body, and drug effect is more longlasting.
Invention content
The present invention is directed to by creatively simultaneously using two kinds of technologies of ion exchange and coating membrane come Drug controlled release,
The ranitidine hydrochloride novel controlled release dry suspensoid agent being administered once for a kind of one day is prepared, patient need to only take once i.e. daily
It can reach therapeutic effect.The present invention is directed to the deficiency of existing preparation, and hydrochloric acid thunder is determined according to one consumption per day of sustained release preparation has been listed
Buddhist nun replaces fourth 300mg, to ensure the validity of novel formulation.A large amount of preparation research is carried out further according to the property of ranitidine hydrochloride,
Complete the development work for the controlled release dry suspensoid agent that is administered once for 1st.The invention mainly comprises main ingredient, retarding agent, impregnating agent, increasings
Mould other auxiliary material compositions such as agent, suspension.
Slow-release material selected by the present invention may be selected from cation exchange resin and methylcellulose, ethyl cellulose, and third
Olefin(e) acid resin, hypromellose one or more therein.
Impregnating agent may be selected from one or more of methylcellulose, glycerine, PEG4000 etc..
Plasticizer may be selected from one or more of diethyl phthalate, dibutyl sebacate, PEG400 etc..
Suspension may be selected from one or more of PVP, HPMC, tragcanth, Carbopol, Avicel RC591 etc..
Corrigent may be selected from mannitol, xylitol, Stevioside, lactose, fructose, sucrose, protein sugar, maltitol, Radix Glycyrrhizae
Glucin, Sodium Cyclamate, gelatin, Aspartame, flavoring banana essence, flavoring pineapple essence, vanillic aldehyde, fragrant citrus essence, flavoring orange essence,
Mint Essence, ginseng essence, strawberry essence, citric acid, citric acid etc..
In order to ensure the stabilization of main ingredient, appropriate antioxidant and preservative etc. can also be added.
Ranitidine hydrochloride controlled release dry suspensoid agent provided by the invention, by weight percentage said preparation are by as follows into grouping
Into：
Ranitidine hydrochloride 10-90%；
Play the auxiliary material 10-90% of controlled-release function；
Other auxiliary material surpluses.The sum of percentage of above each component is 100%.
Preferably, the auxiliary material of above-mentioned controlled-release function be cation exchange resin and methylcellulose, ethyl cellulose, third
Olefin(e) acid resin, hypromellose one or more therein.
Preferably, other auxiliary materials are one or more in retarding agent, impregnating agent, plasticizer and suspending agent.
It is further preferred that the preparation is solid dry suspensoid agent.
Present invention simultaneously provides the method for being used to prepare above-mentioned ranitidine hydrochloride controlled release dry suspensoid agent, including following step
Suddenly：
1）Prepare the load medicated resin for being loaded with ranitidine hydrochloride；
2）Impregnate the load medicated resin；
3）It prepares and carries loblolly tree lipid microvesicle；
4）Dry suspensoid agent is prepared using above-mentioned load loblolly tree lipid microvesicle.
Description of the drawings
Fig. 1 is the In-vitro release curves figure of ranitidine hydrochloride controlled release dry suspensoid agent prepared according to embodiment 1；
Fig. 2 is the beagle dogs according to ranitidine hydrochloride controlled release dry suspensoid agent prepared by embodiment 1 and commercially available sustained release tablets
Internal releasing curve diagram.
Specific embodiment
Preparation process:
1. the preparation of medical resin
Cation exchange resin is added in into suitable deionized water, adds in drug mixing under stiring, timing sampling measures
The concentration of drug in solution.When drug concentration no longer time to time change, that is, balance to be achieved, resin is washed with deionized water
The unbonded drug on surface is drying to obtain load medicated resin at 40 DEG C -60 DEG C.
2. the dipping of medical resin
It takes load medicated resin appropriate, in the aqueous solution for the PEG4000 for adding in 20%, stirs 0.5 hour, drying and screening must impregnate
Medical resin.
3. the preparation of medical resin micro-capsule
Using bottom spraying type fluid unit, the medical resin 150g of 180~200 μm of dipping is put into fluidising chamber, is made
With the spray gun of nozzle diameter 1mm, adjusting air quantity makes particle be adjusted in fluidising chamber in preferable fluidized state, atomization gas pressure
0.2Mpa is at the uniform velocity pumped into coating solution with constant flow pump, makes coating solution atomizing effect good, continuous coating Non-intermittent drying time, really
Substantially without adhesion phenomenon between particulate in guarantor's coating process.
4. the preparation of medical resin micro-capsule dry suspensoid agent
Take drug-resin micro-capsule a certain amount of, suspending agent（PVP, HPMC, tragcanth, Carbopol, Avicel RC591
One or more of Deng）In right amount, it is uniformly mixed up to drug-resin controlled release dry suspensoid agent.In addition, in order to improve dry suspensoid agent
Taste, appropriate corrigent can also be added, such as mannitol, xylitol, Stevioside, lactose, fructose, sucrose, protein sugar, malt
Sugar alcohol, glycyrrhizin, Sodium Cyclamate, gelatin, Aspartame, flavoring banana essence, flavoring pineapple essence, vanillic aldehyde, fragrant citrus essence,
Flavoring orange essence, Mint Essence, ginseng essence, strawberry essence, citric acid, citric acid etc..It, can be in order to ensure the stabilization of main ingredient
Add appropriate antioxidant and preservative etc..
The present invention is further illustrated and its unrestricted range in following embodiment intention.
Embodiment
According to aforementioned preparation process, the ranitidine hydrochloride controlled release dry suspensoid agent of the present invention is prepared using following prescriptions.
Embodiment 1：
Ranitidine hydrochloride: 300mg
AmberliteIRP64: 280mg
PEG4000： 20mg
PEG400: 3mg
Diethyl phthalate: 2mg
EC(20cps) 16mg
Carbopol(934P) 10mg
Aspartame 10mg
Embodiment 2：
Ranitidine hydrochloride: 300mg
Amberlite IRP69: 320mg
PEG4000： 40mg
PEG400: 3mg
Diethyl phthalate: 2mg
Eudragit RS100 20mg
Eudragit RL100 20mg
PVP(K30) 15mg
HPMC(K4M) 10mg
Avicel(RC591) 10mg
Sucrose 15mg
Embodiment 3：
Ranitidine hydrochloride: 300mg
AmberliteIRP69: 350mg
PEG4000： 20mg
PEG400: 2.5mg
Dibutyl sebacate: 2.5mg
EC(45cps) 20mg
Tragcanth 7.5mg
HPMC(K4M) 7.5mg
Carbopol(934P) 5mg
Fragrant citrus essence 15mg
The vitro release experiment of 1 ranitidine hydrochloride controlled release dry suspensoid agent of experimental example
In vitro test is that screening prescription determines the important means of technique, and have important work to the quality control of preparation
With mainly being investigated by dissolution rate.The present invention uses the 900ml0.15mol/l Nacl of degassed processing to be situated between for release
Matter：Rotating speed 50r/min, 37 DEG C of temperature.Operated according to 2000 editions annex of Chinese Pharmacopoeia, Ⅹ C paddle method, respectively at 2,4,6,8,12,
18th, sample 5ml for 24 hours, filtered through 0.45 μm of miillpore filter, discard primary filtrate, take subsequent filtrate spare, add in time it is synthermal, together
Subsequent filtrate is measured absorbance by the respective media of volume at 307nm, and it is dense to calculate different time sample liquid according to standard curve
Degree investigates Cumulative release amount and the relationship of time of 12 hours.
Experimental result is as shown in fig. 1.The result shows that ranitidine hydrochloride controlled release prepared in embodiment 1 is dry-mixed outstanding
The vitro release 12 hours of agent is 75%-85%, it is thus possible to enter drug slow release internal.
The stability experiment of 2 ranitidine hydrochloride controlled release dry suspensoid agent of experimental example
High temperature, high humidity, illumination, exposure sky will have been carried out according to ranitidine hydrochloride controlled release dry suspensoid agent made of the present invention
Gas is tested, the results showed that for this product under conditions of high temperature, high humidity, illumination, exposure air, stability is preferable.
The interior medicine dynamics research of 3 ranitidine hydrochloride controlled release dry suspensoid agent of experimental example
Pharmacokinetics（pharmacokinetics）It is the principle and mathematical processing methods of applied dynamics, quantitatively retouches
Drug is stated by all means into the dynamic rule of the processes such as absorption, distribution, metabolism and the excretion in body, that is, is studied
Present site, concentration and the relationship between the time of internal drug, and the required relationship of these data that provides an explanation
Science.
Using high performance liquid chromatography as detection method, the beagle of ranitidine hydrochloride controlled release dry suspensoid agent has been carried out
Dog Internal pharmacokinetics are studied.The results are shown in Figure 2.The result shows that ranitidine hydrochloride controlled release dry suspensoid agent is released the drug in vivo than slow
It is more steady to release piece, duration of efficacy is longer.
As described above, the controlled release dry suspensoid agent comprising ranitidine hydrochloride of the present invention can realize improved controlled release effect
Fruit provides improved dissolution rate and stability, and effective blood concentration can be provided daily by being only administered once.
Although describing the present invention according to above-mentioned specific embodiment, it will be recognized that, those skilled in the art
Various modifications and transformation may be made to the present invention, and these modifications and transformation are also belonged to defined in the appended claims
In the scope of the present invention.
Claims (4)
1. ranitidine hydrochloride controlled release dry suspensoid agent, which is characterized in that said preparation is by as follows into being grouped as by weight percentage：
Ranitidine hydrochloride 10-90%；
Play the auxiliary material 10-90% of controlled-release function；
Other auxiliary material surpluses；
The auxiliary material of controlled-release function is wherein played as cation exchange resin and methylcellulose, ethyl cellulose, acrylic resin, hydroxyl
Third methylcellulose one or more therein；
The preparation method of the dry suspensoid agent includes the following steps：
1）Prepare the load medicated resin for being loaded with ranitidine hydrochloride；
2）Impregnate the load medicated resin；
3）It prepares and carries loblolly tree lipid microvesicle；
4）Dry suspensoid agent is prepared using above-mentioned load loblolly tree lipid microvesicle.
2. ranitidine hydrochloride controlled release dry suspensoid agent according to claim 1, it is characterised in that other auxiliary materials are selected from
It is one or more in retarding agent, impregnating agent, plasticizer and suspending agent.
3. ranitidine hydrochloride controlled release dry suspensoid agent according to claim 1 or 2, it is characterised in that the preparation is solid
Dry suspensoid agent.
4. the preparation method of the ranitidine hydrochloride controlled release dry suspensoid agent as described in claim 1-3 any claims, special
Sign is, the described method comprises the following steps：
1）Prepare the load medicated resin for being loaded with ranitidine hydrochloride；
2）Impregnate the load medicated resin；
3）It prepares and carries loblolly tree lipid microvesicle；
4）Dry suspensoid agent is prepared using above-mentioned load loblolly tree lipid microvesicle.
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| CN105496967B true CN105496967B (en) | 2018-07-03 |
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| CN106176670B (en) * | 2016-08-30 | 2019-02-01 | 江苏苏南药业实业有限公司 | A kind of famotidine medical resin micro-capsule |
| CN106176672B (en) * | 2016-08-30 | 2019-01-04 | 江苏苏南药业实业有限公司 | The preparation method of famotidine medical resin micro-capsule |
| CN110327295A (en) * | 2019-08-05 | 2019-10-15 | 五邑大学 | A kind of formula and preparation method thereof of ranitidine hydrochloride slow-release suspension |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101927002A (en) * | 2010-07-16 | 2010-12-29 | 钟术光 | Medicament and coating composition |
| CN101987081A (en) * | 2010-07-16 | 2011-03-23 | 钟术光 | Controlled release preparation |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| US20080248107A1 (en) * | 2005-08-24 | 2008-10-09 | Rubicon Research Pvt. Ltd. | Controlled Release Formulation |
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Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101927002A (en) * | 2010-07-16 | 2010-12-29 | 钟术光 | Medicament and coating composition |
| CN101987081A (en) * | 2010-07-16 | 2011-03-23 | 钟术光 | Controlled release preparation |
Non-Patent Citations (3)
| Title |
|---|
| 盐酸雷尼替丁控释微丸的制备和释药机理的研究;杨宏图等;《中国药师》;20031231;第6卷(第3期);第136-138页 * |
| 离子交换树脂在药物制剂中的研究进展;徐斌;《中南药学》;20150531;第13卷(第5期);第512-517页 * |
| 离子交换树脂控释混悬剂的研究进展;许真玉等;《沈阳药科大学学报》;20001130;第17卷(第6期);第461-464页 * |
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