CN108670959A - A kind of ranitidine hydrochloride capsules and preparation method thereof - Google Patents
A kind of ranitidine hydrochloride capsules and preparation method thereof Download PDFInfo
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- CN108670959A CN108670959A CN201810702537.0A CN201810702537A CN108670959A CN 108670959 A CN108670959 A CN 108670959A CN 201810702537 A CN201810702537 A CN 201810702537A CN 108670959 A CN108670959 A CN 108670959A
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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
- A61K9/4841—Filling excipients; Inactive ingredients
- A61K9/4866—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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4833—Encapsulating processes; Filling of capsules
-
- 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
- A61K9/485—Inorganic compounds
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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
- A61K9/4841—Filling excipients; Inactive ingredients
- A61K9/4858—Organic 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
Present invention relates particularly to a kind of ranitidine hydrochloride capsules and preparation method thereof.Ranitidine hydrochloride capsules are made of capsule filler particles and capsule shells, and capsule filler particles are made of following components in percentage by weight：Ranitidine hydrochloride：50~97%；Starch：0.5~20%；Carboxyrnethyl starch sodium：0.5~15%；Colloidal silicon dioxide：1~10%；Magnesium stearate：0.1~5%.The preparation method of ranitidine hydrochloride capsules includes the following steps：By ranitidine hydrochloride, carboxyrnethyl starch sodium and colloidal silicon dioxide mixing；The wet grain of starch slurry system is added；The progress of stiffened fatty acid magnesium is always blended to obtain capsule filler particles after drying；Capsule filler particles are filled into capsule shells up to ranitidine hydrochloride capsules.The capsule filler particles of preparation will not form agglomerate, and production is made to be smoothed out, and ensure that the quality of product, and the quality of gained ranitidine hydrochloride capsules is consistent through examining dissolution cumulant in four kinds of media and reference sample.
Description
Technical field
The invention belongs to technical field of pharmaceuticals, and in particular to a kind of ranitidine hydrochloride capsules and preparation method thereof.
Background technology
Ranitidine hydrochloride is off-white color or light yellow crystalline powder；There is foreign odor；Mildly bitter flavor band is puckery；It easily deliquesces, inhales
It darkens after tide.This product is readily soluble in water or methanol, slightly molten in ethanol, almost insoluble in acetone.Fusing point be 137~
143℃。
Ranitidine hydrochloride is the hydrochloride of antacids and Mucosta ranitidine, the same ranitidine of pharmacological action,
Suitable for ulcer after treatment stomach and operation on duodenum, reflux esophagitis, Zhuo-Chinese mugwort syndrome, and prevent stress ulcer
Hydrochloric acid in gastric juice etc. is sucked when caused hemorrhage of gastrointestinal tract, the recurring hemorrhage of bleeding peptic ulcer, general anesthesia.
In the filling link of ranitidine hydrochloride capsules manufacturing process, the pressure that the particle in hopper is easy compression rod is made
With agglomerate is formed, it is full of hopper, influences the filling uniformity of next step, causing to produce greatly cannot be smoothed out.
Invention content
The present invention in order to solve the above problem, is added to colloidal silicon dioxide when preparing wet grain, colloidal silicon dioxide is superfine
Particle and raw material combine after can barrier material, so that their binding force is declined, even if compression bar, which acts on, can not form agglomerate, shadow
Further filling is rung, production is made to be smoothed out.Utilize the molten of capsule made of the present invention and reference sample (i.e. control sample)
Go out curve to be consistent, ensure that the quality of product.
The technical solution that the present invention takes is：
A kind of ranitidine hydrochloride capsules are made of capsule filler particles and capsule shells, and the capsule filler particles are by following heavy
The component of amount percentage is made：
Ranitidine hydrochloride：50~97%；
Starch：0.5~20%；
Carboxyrnethyl starch sodium：0.5~15%；
Colloidal silicon dioxide：1~10%；
Magnesium stearate：0.1~5%.
The preparation method of the ranitidine hydrochloride capsules, includes the following steps：
Step 1：By ranitidine hydrochloride, carboxyrnethyl starch sodium and colloidal silicon dioxide mixing；
Step 2：The wet grain of starch slurry system is added；The preparation method of the starch slurry is：Boiling pure water, 60 DEG C of guarantors are added in starch
Temperature；
Step 3：The progress of stiffened fatty acid magnesium is always blended to obtain capsule filler particles after wet grain is dried；
Step 4：Capsule filler particles are filled into capsule shells up to ranitidine hydrochloride capsules.
Further, in step 1, before ranitidine hydrochloride, carboxyrnethyl starch sodium and colloidal silicon dioxide mixing, 80 are crossed respectively
~120 mesh sieve.
Further, in step 2, the mass percent of starch is 1~20% in the starch slurry.
Further, in step 2, rotating speed when prepared by the wet grain is 50~250 revs/min, lateral incision 1000~2500
Rev/min, it pelletizes 1~15 minute；Wet grain crosses 10~30 mesh nylon screens after the completion of preparing.
Further, drying described in step 3 includes the following steps：
Wet grain is added in fluidized bed granulation seed-coating machine, wind turbine frequency is 5~50Hz, and inlet air temperature is 40~80 DEG C, drying
After particle crossed into 0.5~2.0mm sieve whole grains.
Further, it is always mixed in mixing machine and carries out described in step 3, it is 5~40 minutes always to do time.
Further, in step 4, filling speed when capsule filler particles are filled into capsule shells is 500~2000/point
Clock.
The positive beneficial effect of the present invention：
1, the ranitidine hydrochloride capsules prepared according to the present invention have carried out the comparison of stripping curve with reference sample, as a result show
Its dissolved corrosion is consistent.
2, ranitidine hydrochloride capsules prepared by the present invention reach " quality is equal " with reference sample in vitro, can determine whether this
The ranitidine hydrochloride capsules interior quality of invention is close with reference sample, in view of dissolution in vitro and vivo biodistribution availability
Correlation can determine whether that the consistent probability of the two vivo biodistribution availability is high, and then have identical clinical efficacy.
3, in produce reality, ranitidine hydrochloride capsules have clustering phenomena, agglomerate to concentrate the shadow in hopper when filling
The accuracy for ringing material metering, prevents filling from uniformly continuous, seriously affects production.The particle of the method according to the invention production
Agglomerate is not formed in the filling process, is not influenced further to fill, production can be made to be smoothed out.
Specific implementation mode：
The present invention is further explained with reference to embodiments, but is not intended to limit present disclosure.
Embodiment 1
Indicated with weight g, 1000 ranitidine hydrochloride capsules filler particles by raw material ranitidine hydrochloride 168g (94.1%),
Cornstarch 1.62g (0.9%), carboxyrnethyl starch sodium 1.8g (1.0%), colloidal silicon dioxide 6.3g (3.5%) and magnesium stearate
0.9g (0.5%) is formed.
The preparation of ranitidine hydrochloride capsules filler particles includes the following steps：
Slurrying：5% starch slurry makes：Cornstarch 1.62g is weighed, pure water 30.78g is added thereto, stirs evenly, boils.
60 DEG C of heat preservations are spare.
Mixing：Weigh the ranitidine hydrochloride 168g after sieving with 100 mesh sieve respectively, carboxyrnethyl starch sodium 1.8g and colloidal silica
Silicon 6.3g is added in wet mixing pelletizer, is uniformly mixed, obtains mixture.
Make wet grain：Into mixture plus starch slurry 32.4g, 200 revs/min of setting speed, 2000 revs/min of lateral incision are made
Grain 5 minutes crosses 20 mesh nylon screens, obtains wet grain.
Drying：Wet grain is added in fluidized bed granulation seed-coating machine, wind turbine is opened, wind turbine frequency 15Hz sets inlet air temperature
50 DEG C of drying, cross 1mm sieve whole grains, obtain dry granular.
It is total mixed：The stiffened fatty acid magnesium 0.9g into dry granular mixes 10 minutes in mixing machine, obtains capsule filler particles.
Filling：Capsule filler particles are filled into capsule shells up to ranitidine hydrochloride capsules, filling speed 1000
Grain/minute.
Embodiment 2
Indicated with weight g, 1000 ranitidine hydrochloride capsules filler particles by raw material ranitidine hydrochloride 336g (96.7%),
Cornstarch 2.5g (0.72%), carboxyrnethyl starch sodium 1.8g (0.52%), colloidal silicon dioxide 6.3g (1.8%) and magnesium stearate
0.9g (0.26%) is formed.
The preparation of ranitidine hydrochloride capsules filler particles includes the following steps：
5% starch slurry makes：Cornstarch 2.5g is weighed, pure water 47.5g is added thereto, stirs evenly, boils.60 DEG C of heat preservations
It is spare.
Mixing：Weigh the ranitidine hydrochloride 336g after sieving with 100 mesh sieve respectively, carboxyrnethyl starch sodium 1.8g and colloidal silica
Silicon 6.3g is added in wet mixing pelletizer, is uniformly mixed, obtains mixture.
Make wet grain：Into mixture plus starch slurry 50g, 100 revs/min of setting speed, 1500 revs/min of lateral incision are pelletized
10 minutes, 30 mesh nylon screens are crossed, wet grain is obtained.
Drying：Wet grain is added in fluidized bed granulation seed-coating machine, wind turbine is opened, wind turbine frequency 15Hz sets inlet air temperature
40 DEG C of drying, cross 2mm sieve whole grains, obtain dry granular.
It is total mixed：The stiffened fatty acid magnesium 0.9g into dry granular mixes 30 minutes in mixing machine, obtains capsule filler particles.
Filling：Capsule filler particles are filled into capsule shells up to ranitidine hydrochloride capsules, the filling speed of setting
For 2000/minute.
Embodiment 3
Indicated with weight g, 1000 ranitidine hydrochloride capsules filler particles by raw material ranitidine hydrochloride 337g (97.0%),
Cornstarch 1.8g (0.5%), carboxyrnethyl starch sodium 1.8g (0.5%), colloidal silicon dioxide 3.5g (1%) and magnesium stearate 3.5g
(1%) it forms.
The preparation of ranitidine hydrochloride capsules filler particles includes the following steps：
1% starch slurry makes：Cornstarch 1.8g is weighed, pure water 178.2g is added thereto, stirs evenly, boils.60 DEG C of guarantors
Warm standby is used.
Mixing：Weigh the ranitidine hydrochloride 337g after sieving with 100 mesh sieve respectively, carboxyrnethyl starch sodium 1.8g and colloidal silica
Silicon 3.5g is added in wet mixing pelletizer, is uniformly mixed, obtains mixture.
Make wet grain：Into mixture plus starch slurry 180g, 250 revs/min of setting speed, 2500 revs/min of lateral incision are pelletized
15 minutes, 10 mesh nylon screens are crossed, wet grain is obtained.
Drying：Wet grain is added in fluidized bed granulation seed-coating machine, wind turbine is opened, wind turbine frequency 50Hz sets inlet air temperature
80 DEG C of drying, cross 2mm sieve whole grains, obtain dry granular.
It is total mixed：The stiffened fatty acid magnesium 3.5g into dry granular mixes 40 minutes in mixing machine, obtains capsule filler particles.
Filling：Capsule filler particles are filled into capsule shells up to ranitidine hydrochloride capsules, the filling speed of setting
For 500/minute.
Embodiment 4
Indicated with weight g, 1000 ranitidine hydrochloride capsules filler particles by raw material ranitidine hydrochloride 168g (94.1%),
Cornstarch 1.62g (0.9%), carboxyrnethyl starch sodium 2.7g (1.5%), colloidal silicon dioxide 5.4g (3.0%) and magnesium stearate
0.9g (0.5%) is formed.
The preparation of ranitidine hydrochloride capsules filler particles includes the following steps：
5% starch slurry makes：Cornstarch 1.62g is weighed, pure water 30.78g is added thereto, stirs evenly, boils.60 DEG C of guarantors
Warm standby is used.
Mixing：Weigh the ranitidine hydrochloride 168g after sieving with 100 mesh sieve respectively, carboxyrnethyl starch sodium 2.7g and colloidal silica
Silicon 5.4g is added in wet mixing pelletizer, is uniformly mixed, obtains mixture.
Make wet grain：Add starch slurry 32.4g, 200 revs/min of setting speed, 2000 revs/min of lateral incision into above-mentioned mixture
Clock is pelletized 5 minutes, is crossed 20 mesh nylon screens, is obtained wet grain.
Drying：Wet grain is added in fluidized bed granulation seed-coating machine, wind turbine is opened, wind turbine frequency 15Hz sets inlet air temperature
50 DEG C of drying, cross 1mm sieve whole grains, obtain dry granular.
It is total mixed：The stiffened fatty acid magnesium 0.9g into dry granular mixes 10 minutes in mixing machine, obtains capsule filler particles.
Filling：Capsule filler particles are filled into capsule shells up to ranitidine hydrochloride capsules, the filling speed of setting
For 1000/minute.
Embodiment 5
Indicated with weight g, 1000 ranitidine hydrochloride capsules filler particles by raw material ranitidine hydrochloride 224g (89.6%),
Cornstarch 9.75g (3.9%), carboxyrnethyl starch sodium 7.5g (3.0%), colloidal silicon dioxide 7.5g (3.0%) and magnesium stearate
1.25g (0.5%) is formed.
The preparation of ranitidine hydrochloride capsules filler particles includes the following steps：
10% starch slurry makes：Cornstarch 9.75g is weighed, pure water 87.75g is added thereto, stirs evenly, boils.60℃
It keeps the temperature spare.
Mixing：Weigh the ranitidine hydrochloride 224g after sieving with 100 mesh sieve respectively, carboxyrnethyl starch sodium 7.5g and colloidal silica
Silicon 7.5g is added in wet mixing pelletizer, is uniformly mixed, obtains mixture.
Make wet grain：Into mixture plus starch slurry 97.5g, 200 revs/min of setting speed, 2000 revs/min of lateral incision are made
Grain 5 minutes crosses 20 mesh nylon screens, obtains wet grain.
Drying：Wet grain is added in fluidized bed granulation seed-coating machine, wind turbine is opened, wind turbine frequency 15Hz sets inlet air temperature
50 DEG C of drying, cross 1mm sieve whole grains, obtain dry granular.
It is total mixed：The stiffened fatty acid magnesium 1.25g into dry granular mixes 10 minutes in mixing machine, obtains capsule filler particles.
Filling：Capsule filler particles are filled into capsule shells up to ranitidine hydrochloride capsules, the filling speed of setting
For 1000/minute.
Embodiment 6
Indicated with weight g, 1000 ranitidine hydrochloride capsules filler particles by raw material ranitidine hydrochloride 224g (89.6%),
Cornstarch 7.25g (2.9%), carboxyrnethyl starch sodium 6.25g (2.5%), colloidal silicon dioxide 10g (4.0%) and magnesium stearate
2.5g (1.0%) is formed.
The preparation of ranitidine hydrochloride capsules filler particles includes the following steps：
10% starch slurry makes：Cornstarch 7.25g is weighed, pure water 65.25g is added thereto, stirs evenly, boils.60℃
It keeps the temperature spare.
Mixing：Weigh the ranitidine hydrochloride 224g after sieving with 100 mesh sieve respectively, carboxyrnethyl starch sodium 6.25g and colloid dioxy
SiClx 10g is added in wet mixing pelletizer, is uniformly mixed, obtains mixture.
Make wet grain：Into mixture plus starch slurry 72.5g, 200 revs/min of setting speed, 2000 revs/min of lateral incision are made
Grain 5 minutes crosses 20 mesh nylon screens, obtains wet grain.
Drying：Wet grain is added in fluidized bed granulation seed-coating machine, wind turbine is opened, wind turbine frequency 15Hz sets inlet air temperature
50 DEG C of drying, cross 1mm sieve whole grains, obtain dry granular.
It is total mixed：The stiffened fatty acid magnesium 2.5g into dry granular mixes 10 minutes in mixing machine, obtains capsule filler particles.
Filling：Capsule filler particles are filled into capsule shells up to ranitidine hydrochloride capsules, the filling speed of setting
For 1000/minute.
Embodiment 7
Indicated with weight g, 1000 ranitidine hydrochloride capsules filler particles by raw material ranitidine hydrochloride 224g (89.6%),
Cornstarch 6g (2.4%), carboxyrnethyl starch sodium 3.75g (1.5%), colloidal silicon dioxide 12.5g (5.0%) and magnesium stearate
3.75g (1.5%) is formed.
The preparation of ranitidine hydrochloride capsules filler particles includes the following steps：
10% starch slurry makes：Cornstarch 6g is weighed, pure water 54g is added thereto, stirs evenly, boils.60 DEG C of heat preservations are standby
With.
Mixing：Weigh the ranitidine hydrochloride 224g after sieving with 100 mesh sieve respectively, carboxyrnethyl starch sodium 3.75g and colloid dioxy
SiClx 12.5g is added in wet mixing pelletizer, is uniformly mixed, obtains mixture.
Make wet grain：Add starch slurry 60g, 200 revs/min of setting speed, 2000 revs/min of lateral incision, granulation 5 into mixture
Minute, 20 mesh nylon screens are crossed, wet grain is obtained.
Drying：Wet grain is added in fluidized bed granulation seed-coating machine, wind turbine is opened, wind turbine frequency 15Hz sets inlet air temperature
50 DEG C of drying, cross 1mm sieve whole grains, obtain dry granular.
It is total mixed：The stiffened fatty acid magnesium 3.75g into dry granular mixes 10 minutes in mixing machine, obtains capsule filler particles.
Filling：Capsule filler particles are filled into capsule shells up to ranitidine hydrochloride capsules, set filling speed as
1000/minute.
8 ranitidine hydrochloride capsules quality testing of embodiment
1, leaching condition：
Medium：Water, pH1.2 hydrochloric acid solutions, pH4.5 Acetate Solutions, pH6.8 phosphate solutions；
Medium volume：900mL；
Medium temperature：37℃；
Method：Slurry processes (add sedimentation blue)；
Rotating speed：50 revs/min；
Sample point：5min, 10min, 15min, 20min, 30min, 45min；
Sampling amount：10mL (supplement solvent)；
After sampling, filtering takes subsequent filtrate as the test solution of each moment point after filtering off 5mL.
2, HPLC determination conditions：
Chromatographic column：Waters XTERRA MS C18Chromatographic column (100*4.6mm, 3.5 μm)；
Mobile phase A:PH7.1 phosphate solutions：Acetonitrile=98:2；
Mobile phase B:PH7.1 phosphate solutions：Acetonitrile=78:22；
The preparation of pH7.1 phosphate solutions：It weighs after potassium dihydrogen phosphate 6.8g dissolves in 900mL water, adds NaOH solution tune pH
Value adds water to 7.1 and is diluted to 1000mL.
Eluent gradient is arranged：
| Time (min) | Mobile phase A (%) | Mobile phase B (%) |
| 0 | 100 | 0 |
| 10 | 0 | 100 |
| 15 | 0 | 100 |
| 16 | 100 | 0 |
| 20 | 100 | 0 |
Detection wavelength：230nm；
Column temperature：35℃；
Sample size：10μL；
Flow velocity：1.5mL/min.
The preparation of reference substance solution：Ranitidine hydrochloride reference sample 15mg is taken, it is accurately weighed, add each medium to dissolve and dilute
It releases to 100mL, as a contrast product solution.
Stripping quantity computational methods：The single-point stripping quantity of each moment point is calculated with external standard method, specific formula for calculation is as follows：
Single-point stripping quantity=(each moment point test sample peak area * F average values)/0.1667；
F average values are the average value of (reference substance concentration/reference substance peak area), reference substance concentration unit mg/mL.
Accumulate stripping quantity calculation formula：Single-point stripping quantity+(the sum of single-point stripping quantity of all the points * 10/900).
The reference sample is that the ranitidine hydrochloride original of lot number FW3143 and FY6474 grind product.
Examples 1 to 7 products obtained therefrom ranitidine hydrochloride capsules and the quality testing comparing result of reference sample are shown：
In water, pH1.2 hydrochloric acid solutions, pH4.5 Acetate Solutions and pH6.8 phosphate solutions these four media, side according to the invention
Ranitidine hydrochloride capsules prepared by method are consistent with the dissolved corrosion of reference sample.Refer to table 1~4.
1 Examples 1 to 7 products obtained therefrom of table and the accumulative stripping quantity of reference sample in water
2 Examples 1 to 7 products obtained therefrom of table and accumulative stripping quantity of the reference sample in pH1.2 hydrochloric acid solutions
3 Examples 1 to 7 products obtained therefrom of table and accumulative stripping quantity of the reference sample in pH4.5 Acetate Solutions
4 Examples 1 to 7 products obtained therefrom of table and accumulative stripping quantity of the reference sample in pH6.8 phosphate solutions
The foregoing is only a preferred embodiment of the present invention, but scope of protection of the present invention is not limited thereto,
Any one skilled in the art in the technical scope disclosed by the present invention, according to the technique and scheme of the present invention and its
Inventive concept is subject to equivalent substitution or change, should be covered by the protection scope of the present invention.
Claims (8)
1. a kind of ranitidine hydrochloride capsules are made of capsule filler particles and capsule shells, which is characterized in that the capsule filling
Particle is made of following components in percentage by weight：
Ranitidine hydrochloride：50~97%；
Starch：0.5~20%；
Carboxyrnethyl starch sodium：0.5~15%；
Colloidal silicon dioxide：1~10%；
Magnesium stearate：0.1~5%.
2. the preparation method based on ranitidine hydrochloride capsules described in claim 1, which is characterized in that include the following steps：
Step 1：By ranitidine hydrochloride, carboxyrnethyl starch sodium and colloidal silicon dioxide mixing；
Step 2：The wet grain of starch slurry system is added；The preparation method of the starch slurry is：Boiling pure water, 60 DEG C of guarantors are added in starch
Temperature；
Step 3：The progress of stiffened fatty acid magnesium is always blended to obtain capsule filler particles after wet grain is dried；
Step 4：Capsule filler particles are filled into capsule shells up to ranitidine hydrochloride capsules.
3. the preparation method of ranitidine hydrochloride capsules according to claim 2, which is characterized in that in step 1, hydrochloric acid thunder
Before Buddhist nun replaces fourth, carboxyrnethyl starch sodium and colloidal silicon dioxide mixing, 80~120 mesh sieve is crossed respectively.
4. the preparation method of ranitidine hydrochloride capsules according to claim 2, which is characterized in that in step 2, the shallow lake
The mass percent of starch is 0.1~10% in slurry.
5. the preparation method of ranitidine hydrochloride capsules according to claim 2, which is characterized in that described wet in step 2
Rotating speed is 50~250 revs/min when prepared by grain, and 1000~2500 revs/min of lateral incision is pelletized 1~15 minute；Prepared by wet grain completes
10~30 mesh nylon screens are crossed afterwards.
6. the preparation method of ranitidine hydrochloride capsules according to claim 2, which is characterized in that dried described in step 3
It is dry to include the following steps：
Wet grain is added in fluidized bed granulation seed-coating machine, wind turbine frequency is 5~50Hz, and inlet air temperature is 40~80 DEG C, drying
After particle crossed into 0.5~2.0mm sieve whole grains.
7. the preparation method of ranitidine hydrochloride capsules according to claim 2, which is characterized in that total described in step 3
It is mixed in mixing machine and carries out, it is 5~40 minutes always to do time.
8. the preparation method of ranitidine hydrochloride capsules according to claim 2, which is characterized in that in step 4, capsule is filled out
Fill it is particles filled to capsule shells when filling speed be 500~2000/minute.
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN111202718A (en) * | 2020-02-25 | 2020-05-29 | 北京鑫开元医药科技有限公司 | Ranitidine hydrochloride capsule and preparation method thereof |
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