CN106214648B - Erythromycin Ethylsuccinate Tablets and preparation method thereof - Google Patents
Erythromycin Ethylsuccinate Tablets and preparation method thereof Download PDFInfo
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- CN106214648B CN106214648B CN201610697164.3A CN201610697164A CN106214648B CN 106214648 B CN106214648 B CN 106214648B CN 201610697164 A CN201610697164 A CN 201610697164A CN 106214648 B CN106214648 B CN 106214648B
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
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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
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/7042—Compounds having saccharide radicals and heterocyclic rings
- A61K31/7048—Compounds having saccharide radicals and heterocyclic rings having oxygen as a ring hetero atom, e.g. leucoglucosan, hesperidin, erythromycin, nystatin, digitoxin or digoxin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
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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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
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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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
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Abstract
The invention discloses a kind of Erythromycin Ethylsuccinate Tablets, it in terms of 1000, is made of the raw material of following weight: 100~150g of Erythromycin Ethylsuccinate, 100~150g of starch, 10~15g of sodium carboxymethyl starch, 1~10g of microcrystalline cellulose, 1~10g of hydroxypropyl cellulose, 1~10g of magnesium stearate.The present invention also provides the preparation method of the Erythromycin Ethylsuccinate Tablets, mixed using first preparing blank granules, then with Erythromycin Ethylsuccinate, then by the inclusion of auxiliary material, avoid Erythromycin Ethylsuccinate and occur the phenomenon that related substance raising in preparation process and storage.By low temperature drying in pelletization, avoiding drug from occurring, main ingredient is destroyed in adhesion and storing process, improves the stability of drug.By the meticulous screening of auxiliary material, made grain graininess is uniform, piece hardness, release, has in terms of piece sub-light cleanliness better than particle made of traditional handicraft.
Description
Technical field
The invention belongs to field of pharmaceutical preparations, and in particular to Erythromycin Ethylsuccinate Tablets and preparation method thereof.
Background technique
Erythromycin Ethylsuccinate, English name Erythromycin Ethylsuccinate, Chinese nickname: pediamycin, red
Mycin succinate, SAI NENG SHA, Abboticine, Western medicine drug.Common drug preparation have granule, tablet,
Capsule product etc..
Erythromycin Ethylsuccinate is New Generation Optical spectrality antibiosis anti-inflammatory drug, wide with powder, is suitable for various inflammation, such as hemolytic chain
Acute tonsillitis, acpuei pharyngitis, nasosinusitis caused by coccus, streptococcus pneumonia etc., légionaires' disease, mycoplasma pneumoniae pneumonia,
Chlamydia Pneumoniae, urogenital infections caused by chlamydiaceae, Mycoplasma, chlamydia trachomatis conjunctivitis, anaerobic bacteria
Caused mouth infection, campylobacter jejuni enteritis, pertussis, rheumatic fever recurrence, infectious endocarditis.
The Chinese patent literature of Publication No. CN1419913A discloses the Erythromycin Ethylsuccinate oral disnitegration tablet for the treatment of infection
And preparation method thereof, this method is suspended in main ingredient Erythromycin Ethylsuccinate in hydroxyethyl cellulose aqueous solution, formation solution A, then
Gelatin, fragrance, mannitol and sucrose mixed dissolution form solution B, and A and B is mixed, and add suitable water dilution, and sufficiently mixed
It is even, it is added to sharp freezing in mold, is put into freeze dryer and vacuumizes, ice sublimes up into material and is completely dried to obtain the final product.But the amber second
Erythromycin chewable tablets supplementary product kind and quantity are more, more and more researches show that the toxic side effect, excipient of excipient itself and master
Impurity in the incompatibility, accessory of medicine etc. can all have an impact the safety of drug.
The Chinese patent literature of 104434830 A of Publication No. CN discloses a kind of Erythromycin Ethylsuccinate Chewable Tablets in Healthy Volunteers and its system
Preparation Method, the chewable tablets include Erythromycin Ethylsuccinate, starch, sucrose, and this method first prepares gelatinization corn starch solution, then sucrose
It is soluble in water to obtain B solution, gelatinization corn starch solution and B solution are mixed to get gelatinization corn-sucrose system medical fluid, by main ingredient
Erythromycin Ethylsuccinate is added in gelatinization corn-sucrose system medical fluid, and is mixed well, and sharp freezing in mold is added to, and is used
Technique with two liters and two drops obtains final chewable tablets.The shortcomings that tablet overcomes common chewable tablets, reduces Erythromycin Ethylsuccinate
Supplementary product kind and dosage in chewable tablets, the pharmaceutical preparation function admirable, bioavilability is high, but the preparation process of the tablet is more multiple
Miscellaneous, product dissolution rate is poor.
Summary of the invention
The present invention provides a kind of Erythromycin Ethylsuccinate Tablets and preparation method thereof, and the Erythromycin Ethylsuccinate Tablets moisture content is low, collapse
It is short to solve the time limit, and quality is stablized.
A kind of Erythromycin Ethylsuccinate Tablets are made in terms of 1000 of the raw material of following weight:
100~150g of Erythromycin Ethylsuccinate 100~150g starch
1~10g of sodium carboxymethyl starch 10~15g microcrystalline cellulose
1~10g of hydroxypropyl cellulose 1~10g magnesium stearate.
The present invention has found through a large number of experiments, since hydroxy propyl cellulose is known as very big surface area and porosity, moisture absorption
Property and water absorption are preferable, and specific disintegrating agent hydroxypropyl cellulose is added in prescription, cooperates preparation process of the invention not only
The disintegration time limited of second erythromycin tablet can be effectively reduced, the moisture in tablet can also be greatly reduced.
Preferably, a kind of Erythromycin Ethylsuccinate Tablets are made in terms of 1000 of the raw material of following weight:
100~105g of Erythromycin Ethylsuccinate 100g starch
1~3g of sodium carboxymethyl starch 10~11g microcrystalline cellulose
1~3g of hydroxypropyl cellulose 1~4g magnesium stearate.
Alternatively, preferably, a kind of Erythromycin Ethylsuccinate Tablets are made in terms of 1000 of the raw material of following weight:
100~105g of Erythromycin Ethylsuccinate 125g starch
4~6g of sodium carboxymethyl starch 12~13g microcrystalline cellulose
5~6g of hydroxypropyl cellulose 5~6g magnesium stearate.
Alternatively, preferably, a kind of Erythromycin Ethylsuccinate Tablets are made in terms of 1000 of the raw material of following weight:
100~103g of Erythromycin Ethylsuccinate 125g starch
6~7g of sodium carboxymethyl starch 11~12g microcrystalline cellulose
6~7g of hydroxypropyl cellulose 6~7g magnesium stearate.
Alternatively, preferably, a kind of Erythromycin Ethylsuccinate Tablets are made in terms of 1000 of the raw material of following weight:
100~103g of Erythromycin Ethylsuccinate 125g starch
9~10g of sodium carboxymethyl starch 11~12g microcrystalline cellulose
9~10g of hydroxypropyl cellulose 9~10g magnesium stearate.
Alternatively, preferably, a kind of Erythromycin Ethylsuccinate Tablets are made in terms of 1000 of the raw material of following weight:
100~110g of Erythromycin Ethylsuccinate 150g starch
6~10g of sodium carboxymethyl starch 13~15g microcrystalline cellulose
6~10g of hydroxypropyl cellulose 6~10g magnesium stearate.
Alternatively, preferably, a kind of Erythromycin Ethylsuccinate Tablets are made in terms of 1000 of the raw material of following weight:
140~150g of Erythromycin Ethylsuccinate 150g starch
8~10g of sodium carboxymethyl starch 12~13g microcrystalline cellulose
9~10g of hydroxypropyl cellulose 9~10g magnesium stearate.
Obtained Erythromycin Ethylsuccinate Tablets are matched using these while there is lower moisture, preferable disintegration time limited and can press
Property.
The preparation method of the Erythromycin Ethylsuccinate Tablets, which comprises the following steps:
(1) it is sieved: Erythromycin Ethylsuccinate being crossed into 80 meshes, other auxiliary materials sieve with 100 mesh sieve；
(2) it pelletizes: starch, microcrystalline cellulose being taken to set in rotation pelletizer, the hydroxypropyl that spray mass fraction is 1~5% is fine
Plain aqueous solution is tieed up, the particle of 35~45 mesh is made in whole grain, dries 1~3 hour after drawing off in 60~75 DEG C, as hollow particle；It takes
Hollow particle is placed in the granulation chamber of rotation pelletizer, and the Erythromycin Ethylsuccinate medicinal powder that will separately crushed in advance is placed in the powder of pelletizer
In last loading hopper, the hydroxypropyl cellulose aqueous solution that spray mass fraction is 1~5%, whole grain, dry 1 under the conditions of 40~50 DEG C
~3h, obtains medicine-containing particle；Medicine-containing particle is taken to be placed in the granulation chamber of rotation pelletizer, separately by magnesium stearate, carboxymethyl starch
Sodium is placed in the powder hopper of pelletizer, the hydroxypropyl cellulose aqueous solution that spray mass fraction is 1~5%, whole grain, in 40~
Dry 1~3h, obtains Erythromycin ethylsuccinate under the conditions of 50 DEG C；
(3) tabletting: particulate matter obtained is placed in tabletting in tablet press machine, obtains the Erythromycin Ethylsuccinate Tablets.
The present invention carries out process optimization in production technology, since the temperature for drying needs after granulation is higher, main ingredient amber second
Erythromycin is easy unstable and decomposes, therefore uses and first prepare blank granules, then mix with Erythromycin Ethylsuccinate, then passes through auxiliary material
The technique of inclusion, avoid Erythromycin Ethylsuccinate preparation process it is unstable and storage in occur related substance raising the phenomenon that,
Be conducive to the reduction of tablet moisture simultaneously.By the screening that auxiliary material is meticulous, composition of medicine in good taste is not only obtained, it is ensured that
The stability of quality.
The present invention divides disintegrating agent hydroxypropyl cellulose uniformly by the way of repeatedly spraying hydroxypropyl cellulose aqueous solution
Cloth is in tablet, and it is fine-powdered that being conducive to, which is disintegrated tablet all, and disintegration rate is very fast.
Preferably, work as the Erythromycin Ethylsuccinate Tablets, in terms of 1000, when being made of the raw material of following weight:
100~103g of Erythromycin Ethylsuccinate 125g starch
6~7g of sodium carboxymethyl starch 11~12g microcrystalline cellulose
Hydroxypropyl cellulose 6~7g, 6~7g of magnesium stearate,
Simultaneously using following preparation method:
(1) it is sieved: Erythromycin Ethylsuccinate being crossed into 80 meshes, other auxiliary materials sieve with 100 mesh sieve；
(2) it pelletizes: starch, microcrystalline cellulose being taken to set in rotation pelletizer, the hydroxypropyl cellulose that spray mass fraction is 4%
The particle of 40~45 mesh is made in aqueous solution, whole grain, dries 2~3 hours after drawing off in 75 DEG C, as hollow particle；Hollow particle is taken to set
In the granulation chamber of rotation pelletizer, the Erythromycin Ethylsuccinate medicinal powder that will separately crushed in advance is placed in the powder hopper of pelletizer
Hydroxypropyl cellulose aqueous solution interior, that spray mass fraction is 4%, whole grain, dry 1~2h, is contained under the conditions of 40~45 DEG C
Medicine particle；It takes medicine-containing particle to be placed in the granulation chamber of rotation pelletizer, magnesium stearate, sodium carboxymethyl starch is separately placed in pelletizer
Powder hopper in, the hydroxypropyl cellulose aqueous solution that spray mass fraction is 4%, whole grain, dry 1 under the conditions of 40~45 DEG C
~2h, obtains Erythromycin ethylsuccinate；
(3) tabletting: particulate matter obtained is placed in tabletting in tablet press machine, obtains the Erythromycin Ethylsuccinate Tablets.
When using above-mentioned formula and specific preparation process, obtained Erythromycin Ethylsuccinate Tablets moisture content is minimum, when disintegration
It limits best.
Compared with prior art, the invention has the following advantages:
(1) it effectively avoids drug main ingredient in adhesion and storing process occur by low temperature drying in pelletization and is broken
It is bad, improve the stability of drug.
(2) it uses and first prepares blank granules, then mixed with Erythromycin Ethylsuccinate, then by the inclusion of auxiliary material, avoid amber second
There is the phenomenon that related substance raising in preparation process and storage in erythromycin.
(3) pass through the meticulous screening of auxiliary material, made grain graininess is uniform, piece hardness, release, piece sub-light cleanliness
Aspect has better than particle made of traditional handicraft.
Specific embodiment:
Embodiment 1
Prescription: in terms of 1000
Erythromycin Ethylsuccinate 125g starch 100g
Sodium carboxymethyl starch 12g microcrystalline cellulose 6g
Hydroxypropyl cellulose 6g magnesium stearate 6g
Preparation method:
(1) it is sieved: Erythromycin Ethylsuccinate being crossed into 80 meshes, other auxiliary materials sieve with 100 mesh sieve；
(2) it pelletizes: starch, microcrystalline cellulose being taken to set in rotation pelletizer, the hydroxypropyl cellulose that spray mass fraction is 4%
The particle of 40 mesh is made in aqueous solution 50g, whole grain, dries 2 hours after drawing off in 75 DEG C, as hollow particle；It takes hollow particle to be placed in turn
In the granulation chamber of dynamic pelletizer, the Erythromycin Ethylsuccinate medicinal powder that will separately crushed in advance is placed in the powder hopper of pelletizer, spray
The hydroxypropyl cellulose aqueous solution 50g that mass fraction is 4%, whole grain, dry 2h, obtains medicine-containing particle under the conditions of 45 DEG C；It takes
Medicine-containing particle is placed in the granulation chamber of rotation pelletizer, separately adds the powder that magnesium stearate, sodium carboxymethyl starch are placed in pelletizer
In hopper, the hydroxypropyl cellulose aqueous solution 50g that spray mass fraction is 4%, whole grain, dry 2h, obtains amber second under the conditions of 45 DEG C
Erythromycin particle；
(3) tabletting: particulate matter obtained is placed in tabletting in tablet press machine, obtains the Erythromycin Ethylsuccinate Tablets.
Embodiment 2
Prescription: in terms of 1000
Erythromycin Ethylsuccinate 125g starch 100g
Sodium carboxymethyl starch 12g microcrystalline cellulose 10g
Hydroxypropyl cellulose 10g magnesium stearate 10g
Preparation method:
(1) it is sieved: Erythromycin Ethylsuccinate being crossed into 80 meshes, other auxiliary materials sieve with 100 mesh sieve；
(2) it pelletizes: starch, microcrystalline cellulose being taken to set in rotation pelletizer, the hydroxypropyl cellulose that spray mass fraction is 5%
The particle of 41 mesh is made in aqueous solution 100g, whole grain, dries 3 hours after drawing off in 60 DEG C, as hollow particle；Hollow particle is taken to be placed in
In the granulation chamber for rotating pelletizer, the Erythromycin Ethylsuccinate medicinal powder that will separately crushed in advance is placed in the powder hopper of pelletizer,
The hydroxypropyl cellulose aqueous solution 50g that mass fraction is 5% is sprayed, whole grain, dry 3h, obtains medicine-containing particle under the conditions of 40 DEG C；
It takes medicine-containing particle to be placed in the granulation chamber of rotation pelletizer, magnesium stearate, sodium carboxymethyl starch is separately placed in the powder of pelletizer
In loading hopper, the hydroxypropyl cellulose aqueous solution 50g that spray mass fraction is 5%, whole grain, dry 3h, obtains amber under the conditions of 40 DEG C
Second erythromycin particle；
(3) tabletting: particulate matter obtained is placed in tabletting in tablet press machine, obtains the Erythromycin Ethylsuccinate Tablets.
Embodiment 3
Prescription: in terms of 1000
Erythromycin Ethylsuccinate 100g starch 105g
Sodium carboxymethyl starch 10g microcrystalline cellulose 1g
Hydroxypropyl cellulose 2g magnesium stearate 3g
Preparation method:
(1) it is sieved: Erythromycin Ethylsuccinate being crossed into 80 meshes, other auxiliary materials sieve with 100 mesh sieve；
(2) it pelletizes: starch, microcrystalline cellulose being taken to set in rotation pelletizer, the hydroxypropyl cellulose that spray mass fraction is 2%
The particle of 40 mesh is made in aqueous solution 50g, whole grain, dries 3 hours after drawing off in 65 DEG C, as hollow particle；It takes hollow particle to be placed in turn
In the granulation chamber of dynamic pelletizer, the Erythromycin Ethylsuccinate medicinal powder that will separately crushed in advance is placed in the powder hopper of pelletizer, spray
The hydroxypropyl cellulose aqueous solution 50g that mass fraction is 1%, whole grain, dry 2h, obtains medicine-containing particle under the conditions of 40 DEG C；It takes
Medicine-containing particle is placed in the granulation chamber of rotation pelletizer, separately adds the powder that magnesium stearate, sodium carboxymethyl starch are placed in pelletizer
In hopper, the hydroxypropyl cellulose aqueous solution 50g that spray mass fraction is 1%, whole grain, dry 3h, obtains amber second under the conditions of 40 DEG C
Erythromycin particle；
(3) tabletting: particulate matter obtained is placed in tabletting in tablet press machine, obtains the Erythromycin Ethylsuccinate Tablets.
Embodiment 4
Prescription: in terms of 1000
Erythromycin Ethylsuccinate 150g starch 150g
Sodium carboxymethyl starch 15g microcrystalline cellulose 10g
Hydroxypropyl cellulose 10g magnesium stearate 10g
Preparation method:
(1) it is sieved: Erythromycin Ethylsuccinate being crossed into 80 meshes, other auxiliary materials sieve with 100 mesh sieve；
(2) it pelletizes: starch, microcrystalline cellulose being taken to set in rotation pelletizer, the hydroxypropyl cellulose that spray mass fraction is 5%
The particle of 41 mesh is made in aqueous solution 100g, whole grain, dries 3 hours after drawing off in 70 DEG C, as hollow particle；Hollow particle is taken to be placed in
In the granulation chamber for rotating pelletizer, the Erythromycin Ethylsuccinate medicinal powder that will separately crushed in advance is placed in the powder hopper of pelletizer,
The hydroxypropyl cellulose aqueous solution 50g that mass fraction is 5% is sprayed, whole grain, dry 3h, obtains medicine-containing particle under the conditions of 45 DEG C；
It takes medicine-containing particle to be placed in the granulation chamber of rotation pelletizer, magnesium stearate, sodium carboxymethyl starch is separately placed in the powder of pelletizer
In loading hopper, the hydroxypropyl cellulose aqueous solution 50g that spray mass fraction is 5%, whole grain, dry 3h, obtains amber under the conditions of 40 DEG C
Second erythromycin particle；
(3) tabletting: particulate matter obtained is placed in tabletting in tablet press machine, obtains the Erythromycin Ethylsuccinate Tablets.
Comparative example 1
Prescription: in terms of 1000
Erythromycin Ethylsuccinate 125g starch 100g
Sodium carboxymethyl starch 12g microcrystalline cellulose 6g
Hydroxypropyl cellulose 4g magnesium stearate 6g
Preparation method:
(1) it is sieved: Erythromycin Ethylsuccinate being crossed into 80 meshes, other auxiliary materials sieve with 100 mesh sieve；
(2) it pelletizes: starch, microcrystalline cellulose, Erythromycin Ethylsuccinate medicinal powder being taken to set in rotation pelletizer, spray mass fraction is
The particle of 40 mesh is made in 4% hydroxypropyl cellulose aqueous solution 50g, whole grain, dries 2 hours after drawing off in 75 DEG C, separately will be stearic
Sour magnesium, sodium carboxymethyl starch are placed in the powder hopper of pelletizer, the hydroxypropyl cellulose aqueous solution that spray mass fraction is 4%
50g, whole grain, dry 2h, obtains Erythromycin ethylsuccinate under the conditions of 45 DEG C；
(3) tabletting: particulate matter obtained is placed in tabletting in tablet press machine, obtains the Erythromycin Ethylsuccinate Tablets.
Comparative example 2
Prescription: in terms of 1000
Erythromycin Ethylsuccinate 125g starch 100g
Sodium carboxymethyl starch 12g microcrystalline cellulose 6g
75% ethanol solution 150g magnesium stearate 6g
Preparation method:
(1) it is sieved: Erythromycin Ethylsuccinate being crossed into 80 meshes, other auxiliary materials sieve with 100 mesh sieve；
(2) it pelletizes: taking starch, microcrystalline cellulose to set in rotation pelletizer, spray 75% ethanol solution 50g, whole grain is made 40
Purpose particle is dried 2 hours after drawing off in 75 DEG C, as hollow particle；Hollow particle is taken to be placed in the granulation chamber of rotation pelletizer, separately
The Erythromycin Ethylsuccinate medicinal powder that will be crushed in advance, is placed in the powder hopper of pelletizer, 75% ethanol solution 50g of spray, whole grain,
Dry 2h, obtains medicine-containing particle under the conditions of 45 DEG C；Medicine-containing particle is taken to be placed in the granulation chamber of rotation pelletizer, separately by stearic acid
Magnesium, sodium carboxymethyl starch are placed in the powder hopper of pelletizer, spray 75% ethanol solution 50g, and whole grain is done under the conditions of 45 DEG C
Dry 2h, obtains Erythromycin ethylsuccinate；
(3) tabletting: particulate matter obtained is placed in tabletting in tablet press machine, obtains the Erythromycin Ethylsuccinate Tablets.
Comparative example 3
Prescription: in terms of 1000
Erythromycin Ethylsuccinate 125g starch 100g
Sodium carboxymethyl starch 12g microcrystalline cellulose 6g
Hydroxypropyl cellulose 6g magnesium stearate 6g
Preparation method:
(1) it is sieved: Erythromycin Ethylsuccinate being crossed into 80 meshes, other auxiliary materials sieve with 100 mesh sieve；
(2) it pelletizes: starch, microcrystalline cellulose being taken to set in rotation pelletizer, the hydroxypropyl cellulose that spray mass fraction is 4%
The particle of 40 mesh is made in aqueous solution 50g, whole grain, dries 2 hours after drawing off in 70 DEG C, as hollow particle；It takes hollow particle to be placed in turn
In the granulation chamber of dynamic pelletizer, the Erythromycin Ethylsuccinate medicinal powder that will separately crushed in advance is placed in the powder hopper of pelletizer, spray
The hydroxypropyl cellulose aqueous solution 50g that mass fraction is 4%, whole grain, dry 2h, obtains medicine-containing particle under the conditions of 70 DEG C；It takes
Medicine-containing particle is placed in the granulation chamber of rotation pelletizer, separately adds the powder that magnesium stearate, sodium carboxymethyl starch are placed in pelletizer
In hopper, the hydroxypropyl cellulose aqueous solution 50g that spray mass fraction is 4%, whole grain, dry 2h, obtains amber second under the conditions of 70 DEG C
Erythromycin particle；
(3) tabletting: particulate matter obtained is placed in tabletting in tablet press machine, obtains the Erythromycin Ethylsuccinate Tablets.
Examples 1 to 4 and comparative example 1~3 are tested (2005 editions two annex of Chinese Pharmacopoeia), as a result such as table 1.
The related check data of 1 Erythromycin Ethylsuccinate Tablets of table
It is learnt by above data, the dissolution rate of Erythromycin Ethylsuccinate Tablets of Examples 1 to 4 preparation, moisture and disintegration time limited are equal
Better than comparative example 1~3.As it can be seen that the present invention be superior to by the Erythromycin Ethylsuccinate Tablets that optimization of C/C composites and preparation process obtain it is existing
Technology.Show not prepare hollow particle compared with comparative example 1, the moisture of gained Erythromycin Ethylsuccinate Tablets can be increased significantly；With comparative example
2 compared to showing after changing disintegrating agent hydroxypropyl cellulose aqueous solution into ethyl alcohol, even if using identical operating method, gained
The moisture of Erythromycin Ethylsuccinate Tablets and disintegration time limited all significantly increase.It can be seen that selecting specific disintegrating agent and technique to tablet
Performance be affected.
Claims (8)
1. a kind of Erythromycin Ethylsuccinate Tablets, which is characterized in that in terms of 1000, be made of the raw material of following weight:
100~150g of Erythromycin Ethylsuccinate 100~150g starch
1~10g of sodium carboxymethyl starch 10~15g microcrystalline cellulose
1~10g of hydroxypropyl cellulose 1~10g magnesium stearate；
The preparation method of the Erythromycin Ethylsuccinate Tablets, comprising the following steps:
(1) it is sieved: Erythromycin Ethylsuccinate being crossed into 80 meshes, other auxiliary materials sieve with 100 mesh sieve；
(2) it pelletizes: starch, microcrystalline cellulose being taken to set in rotation pelletizer, the hydroxypropyl cellulose that spray mass fraction is 1~5%
The particle of 35~45 mesh is made in aqueous solution, whole grain, dries 1~3 hour after drawing off in 60~75 DEG C, as hollow particle；Take empty
Grain is placed in the granulation chamber of rotation pelletizer, and the Erythromycin Ethylsuccinate medicinal powder that will separately crushed in advance, the powder for being placed in pelletizer adds
In hopper, the hydroxypropyl cellulose aqueous solution that spray mass fraction is 1~5%, whole grain, dry 1~3h under the conditions of 40~50 DEG C,
Obtain medicine-containing particle；It takes medicine-containing particle to be placed in the granulation chamber of rotation pelletizer, is separately placed in magnesium stearate, sodium carboxymethyl starch
In the powder hopper of pelletizer, the hydroxypropyl cellulose aqueous solution that spray mass fraction is 1~5%, whole grain, in 40~50 DEG C of items
Dry 1~3h, obtains Erythromycin ethylsuccinate under part；
(3) tabletting: particulate matter obtained is placed in tabletting in tablet press machine, obtains the Erythromycin Ethylsuccinate Tablets.
2. Erythromycin Ethylsuccinate Tablets according to claim 1, which is characterized in that in terms of 1000, by the raw material of following weight
It is made:
100~105g of Erythromycin Ethylsuccinate 100g starch
1~3g of sodium carboxymethyl starch 10~11g microcrystalline cellulose
1~3g of hydroxypropyl cellulose 1~4g magnesium stearate.
3. Erythromycin Ethylsuccinate Tablets according to claim 1, which is characterized in that in terms of 1000, by the raw material of following weight
It is made:
100~105g of Erythromycin Ethylsuccinate 125g starch
4~6g of sodium carboxymethyl starch 12~13g microcrystalline cellulose
5~6g of hydroxypropyl cellulose 5~6g magnesium stearate.
4. Erythromycin Ethylsuccinate Tablets according to claim 1, which is characterized in that in terms of 1000, by the raw material of following weight
It is made:
100~103g of Erythromycin Ethylsuccinate 125g starch
6~7g of sodium carboxymethyl starch 11~12g microcrystalline cellulose
6~7g of hydroxypropyl cellulose 6~7g magnesium stearate.
5. Erythromycin Ethylsuccinate Tablets according to claim 1, which is characterized in that in terms of 1000, by the raw material of following weight
It is made:
100~103g of Erythromycin Ethylsuccinate 125g starch
9~10g of sodium carboxymethyl starch 11~12g microcrystalline cellulose
9~10g of hydroxypropyl cellulose 9~10g magnesium stearate.
6. Erythromycin Ethylsuccinate Tablets according to claim 1, which is characterized in that in terms of 1000, by the raw material of following weight
It is made:
100~110g of Erythromycin Ethylsuccinate 150g starch
6~10g of sodium carboxymethyl starch 13~15g microcrystalline cellulose
6~10g of hydroxypropyl cellulose 6~10g magnesium stearate.
7. Erythromycin Ethylsuccinate Tablets according to claim 1, which is characterized in that in terms of 1000, by the raw material of following weight
It is made:
140~150g of Erythromycin Ethylsuccinate 150g starch
8~10g of sodium carboxymethyl starch 12~13g microcrystalline cellulose
9~10g of hydroxypropyl cellulose 9~10g magnesium stearate.
8. the preparation method of described in any item Erythromycin Ethylsuccinate Tablets according to claim 1~7, which is characterized in that including following
Step:
(1) it is sieved: Erythromycin Ethylsuccinate being crossed into 80 meshes, other auxiliary materials sieve with 100 mesh sieve；
(2) it pelletizes: starch, microcrystalline cellulose being taken to set in rotation pelletizer, the hydroxypropyl cellulose that spray mass fraction is 1~5%
The particle of 35~45 mesh is made in aqueous solution, whole grain, dries 1~3 hour after drawing off in 60~75 DEG C, as hollow particle；Take empty
Grain is placed in the granulation chamber of rotation pelletizer, and the Erythromycin Ethylsuccinate medicinal powder that will separately crushed in advance, the powder for being placed in pelletizer adds
In hopper, the hydroxypropyl cellulose aqueous solution that spray mass fraction is 1~5%, whole grain, dry 1~3h under the conditions of 40~50 DEG C,
Obtain medicine-containing particle；It takes medicine-containing particle to be placed in the granulation chamber of rotation pelletizer, is separately placed in magnesium stearate, sodium carboxymethyl starch
In the powder hopper of pelletizer, the hydroxypropyl cellulose aqueous solution that spray mass fraction is 1~5%, whole grain, in 40~50 DEG C of items
Dry 1~3h, obtains Erythromycin ethylsuccinate under part；
(3) tabletting: particulate matter obtained is placed in tabletting in tablet press machine, obtains the Erythromycin Ethylsuccinate Tablets.
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