CN102697753B - Roxithromycin soft capsule preparation thereof - Google Patents
Roxithromycin soft capsule preparation thereof Download PDFInfo
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- CN102697753B CN102697753B CN 201210189580 CN201210189580A CN102697753B CN 102697753 B CN102697753 B CN 102697753B CN 201210189580 CN201210189580 CN 201210189580 CN 201210189580 A CN201210189580 A CN 201210189580A CN 102697753 B CN102697753 B CN 102697753B
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Abstract
The invention relates to a roxithromycin compound preparation, in particular to a soft capsule preparation of a roxithromycin compound. A preparation method for soft roxithromycin capsules comprises the following steps of: adding 150 weight parts of roxithromycin and 100 to 150 weight parts of oily matrix into a solution preparation tank, mixing uniformly, and grinding with a colloid grinder; freezing the mixture of the roxithromycin and the oily matrix to the temperature of between 25 DEG C below zero and 40 DEG C below zero at the cooling rate of 2 to 15 DEG C per minute; vacuumizing, and heating to the temperature of between 15 and 25 DEG C in 2 to 6 hours; treating for 5 to 15 minutes in an ultrasonic emulsifier of which the frequency is 20 to 30KHz and the power is 20 to 500W; and preparing capsule wrappers of the soft roxithromycin capsules, injecting medicinal liquid, pelleting, sizing, wiping the capsules, and drying. The soft roxithromycin capsules are low in consumption of the oily matrix and high in stability.
Description
Technical field
The present invention relates to a kind of Roxithromycin compound formulation, specifically, relate to a kind of Roxithromycin chemical compound soft capsule preparation.
Background technology
Roxithromycin (Roxithromycin) has another name called Roxithromycin, its molecular structure is suc as formula shown in the I, be the fourteen-ring oral liquid macrolide antibiotics of early 1980s exploitation, this product was stable to gastric acid first in France's listing in 1988, absorbance is high, good effect, untoward reaction is little, and clinical effectiveness is remarkable, moderate cost, most countries and area are widely used in clinical in the world at present.
In order to adapt to patient's needs, developed a lot of dosage forms about Roxithromycin, comprise capsule, soft capsule, various tablet, granule etc.Because the heavy bitter taste of Roxithromycin, so the tablet of Roxithromycin, granule are difficult for being accepted by the patient; And the capsule of Roxithromycin and soft capsule then more can adapt to the needs of extensive patients.
Patent application 200410041018.2 discloses a kind of Roxithromycin soft capsule and preparation method thereof, contains Roxithromycin and the pharmaceutic adjuvant of effective dosage, and pharmaceutic adjuvant comprises diluent, antioxidant, solubilizing agent, cosolvent, pH adjusting agent etc.By the normal capsules grain, contain Roxithromycin 0.01～0.25 gram in every medicinal liquid.Roxithromycin soft capsule preparation method: with the water-soluble adding glycerol of gelatin, transfer to suitable color, be incubated set aside for use after the vacuumize degassing; Solubilizing agent, antioxidant, pH adjusting agent, dehydrated alcohol are added in the diluent, and Roxithromycin is dissolved in wherein, both mix homogeneously; 50-60 ℃ of reduction vaporization removed ethanol, gets settled solution; With the medicinal liquid for preparing pour in the pellet processing machine, typing, put drying, scrape and get final product.It is wide in variety to add adjuvant in the soft capsule of this patent disclosure, and stability is indefinite.
Patent ZL200710108360.3 discloses a kind of soft capsule that contains Roxithromycin, it is 1%～85% Roxithromycin that wherein said content contains percentage by weight, 7%～95% oleaginous base and suspending agent, this soft capsule can show the beneficial effect that strengthens Roxithromycin, has more aobvious the stability of improving and treatment advantage than present commercially available prod.This soft capsule is to reach solubilization by adding suspending agent.
Summary of the invention
Goal of the invention of the present invention is to propose a kind of preparation method of Roxithromycin soft capsule.
In order to finish purpose of the present invention, the technical scheme of employing is:
The present invention relates to a kind of preparation method of Roxithromycin soft capsule, may further comprise the steps:
1. with Roxithromycin 150 weight portions, oleaginous base 100～150 weight portions; Join by weight in the Agitation Tank, mix homogeneously is crossed colloid mill;
2. the mixture with Roxithromycin and oleaginous base is refrigerated to-25～-40 ℃, and cooling rate is 2～15 ℃/min; Evacuation was warming up to 15～25 ℃ in 2～6 hours;
3. then placing frequency is that 20～30KHz, power are 20～500W ultrasonic emulsification instrument effect 5～15 minutes;
4. the rubber of preparation Roxithromycin soft capsule injects medicinal liquid, pelleting, typing, wiping ball, drying.
The first optimal technical scheme of the present invention is, described oleaginous base is selected from least a in soybean oil, Semen Maydis oil, olive oil, the Oleum Arachidis hypogaeae semen and preferred soybean oil.
The second optimal technical scheme of the present invention is, in step (1), Roxithromycin is 150 weight portions, and oleaginous base is 120～150 weight portions, preferred 135～145 weight portions.
The 3rd optimal technical scheme of the present invention is in step (2), behind the evacuation, to be warming up to 18～22 ℃ in 4～5 hours.
The 4th optimal technical scheme of the present invention is in step (2), Roxithromycin and oleaginous base mixture to be refrigerated to-30～-40 ℃, preferred-30～-35 ℃; Cooling rate is 5～15 ℃/min, preferred 5～12 ℃/min.
The 5th optimal technical scheme of the present invention is that in step (3), the frequency of described ultrasonic emulsification instrument is that 20～28KHz, power are 30～300W; Optimized frequency is that 24～28KHz, power are 35～250W.
The 6th optimal technical scheme of the present invention is that in step (4), the prescription of described rubber is: gelatin 180～200 weight portions, glycerol 60～100 weight portions; Water 180～200 weight portions; Sorbitol 18～22 weight portions; Microcrystalline Cellulose 2～4 weight portions; Ethyl hydroxybenzoate 0.2～0.4 weight portion; Titanium dioxide 0.9～1.0 weight portion; Ethanol 120～150 weight portions.
The 7th optimal technical scheme of the present invention is that in step (4), the prescription of described rubber is: gelatin 200 weight portions; Glycerol 60～80 weight portions; Water 200 weight portions; Sorbitol 20 weight portions; Microcrystalline Cellulose 2～4 weight portions; Ethyl hydroxybenzoate 0.4 weight portion; Titanium dioxide 1.0 weight portions; Ethanol 150 weight portions.
The 8th optimal technical scheme of the present invention is that in step (4), the preparation technology of described rubber is:
(1) microcrystalline Cellulose adds suitable quantity of water and crosses colloid mill, and titanium dioxide adds suitable quantity of water and crosses colloid mill, and sorbitol is used an amount of hot water dissolving, and ethyl hydroxybenzoate is with 2 times of dissolve with ethanols, and is for subsequent use;
(2) with in G ﹠ W, microcrystalline Cellulose serosity, titanium dioxide slurries, sorbitol solution, the ethyl hydroxybenzoate solution addingization glue tank, heating;
(3) temperature adds gelatin after rising to 70 ℃ in tank, opens stirring system and stirs and make it melt and dissolved, and temperature is controlled at below 80 ℃, treats that gelatin dissolves when even entirely, opens the vacuum system evacuation, until glue is without bubble;
(4) glue of step (3) preparation is emitted, put 50 ℃～60 ℃ of gelatin bucket insulations and leave standstill use in 2～12 hours.
The 9th optimal technical scheme of the present invention is that in step (4), the thickness of described rubber is 0.7～0.9mm, preferred 0.75～0.8mm.
The below makes further explanation content of the present invention.
In the preparation method of Roxithromycin soft capsule of the present invention, at first adopt cryodesiccated technique, reduced the moisture in Roxithromycin and the oleaginous base.Because Roxithromycin is met water unstable, the present invention has removed moisture content in Roxithromycin and the oleaginous base by freeze-dry process, thereby has guaranteed the stability of Roxithromycin.Secondly, the present invention has also adopted the technique of ultrasonic emulsification, and the mixture after will processing through lyophilization mixes.Not only reduced the consumption of oleaginous base in the drop pill, can also medicine and oleaginous base mix more uniformly, form the form of oil bag solid, thereby further avoid Roxithromycin to be subject to the impact of extraneous factor and react, guarantee the stability of Roxithromycin.
The preparation method of Roxithromycin soft capsule of the present invention may further comprise the steps:
1. with Roxithromycin 150 weight portions, oleaginous base 100～150 weight portions, preferred 120～150 weight portions, further preferred 135～145 weight portions; Join by weight in the Agitation Tank, mix homogeneously is crossed colloid mill; Wherein, described oleaginous base is selected from least a in soybean oil, Semen Maydis oil, olive oil, the Oleum Arachidis hypogaeae semen, and preferred soybean oil; The consumption of oleaginous base reduces than the consumption of the actual use of prior art among the present invention, has reduced the patient burden, has avoided eating when taking medicine into a large amount of adjuvants, has reduced the picked-up to oils and fats;
2. the Roxithromycin soybean oil blend is refrigerated to-25～-40 ℃, preferred-30～-40 ℃, more preferably-30～-35 ℃; Cooling rate is 2～15 ℃/min, preferred 5～15 ℃/min, preferred 5～12 ℃/min; Evacuation was warming up to 15～25 ℃ in 2～6 hours;
3. then placing frequency is that 20～30KHz, power are 20～500W ultrasonic emulsification instrument effect 5～15 minutes, obtains Roxithromycin and oleaginous base mixture; The frequency of described ultrasonic emulsification instrument is that 20～28KHz, power are 30～300W; Optimized frequency is that 24～28KHz, power are 35～250W; And in ultrasonic emulsification instrument, be filled with nitrogen protected, and avoid oxidation Decomposition on the one hand, avoid on the other hand Roxithromycin and oleaginous base to reuptake airborne moisture, affect cryodesiccated effect; Wherein, the power of ultrasonic emulsification instrument determines that according to the volume of mixture adopt the reactor of 1 ~ 5L in the general operation process, its power is that 20～100W is advisable, and the routine that is chosen as those skilled in the art of this power is selected;
4. the rubber of preparation Roxithromycin soft capsule injects medicinal liquid, pelleting, typing, wiping ball, drying.
The prescription of described rubber is: gelatin 180～200 weight portions, glycerol 60～100 weight portions; Water 180～200 weight portions; Sorbitol 18～22 weight portions; Microcrystalline Cellulose 2～4 weight portions; Ethyl hydroxybenzoate 0.2～0.4 weight portion; Titanium dioxide 0.9～1.0 weight portion; Ethanol 120～150 weight portions.Be preferably: gelatin 200 weight portions; Glycerol 60～80 weight portions; Water 200 weight portions; Sorbitol 20 weight portions; Microcrystalline Cellulose 2～4 weight portions; Ethyl hydroxybenzoate 0.4 weight portion; Titanium dioxide 1.0 weight portions; Ethanol 150 weight portions.The thickness of rubber is 0.7～0.9mm, preferred 0.75～0.8mm.The inventor adopts the rubber character of prescription of the present invention and ratio more stable by screening test, but under the commercially available back condition normal temperature storage; And disintegration time is suitable, is conducive to the absorption of medicine, increases the bioavailability of medicine.
The specific embodiment of the present invention makes further explanation invention, summary of the invention is not construed as limiting.
The specific embodiment
Embodiment 1～8: preparation Roxithromycin soft capsule
It is as shown in table 1 to fill a prescription:
Table 1:
Preparation technology is:
(1) Roxithromycin and the oleaginous base with formula ratio joins in the Agitation Tank by weight, and mix homogeneously is crossed colloid mill;
(2) mixture with Roxithromycin and oleaginous base is divided in the 100ml wide-mouth vial, is refrigerated to-40 ℃; Cooling rate is 2～15 ℃/min; Evacuation was warming up to 15～25 ℃ in 2～6 hours;
(3) then placing volume is that 1L, frequency are that 30KHz, power are 50W ultrasonic emulsification instrument effect 15 minutes, obtains Roxithromycin and oleaginous base mixture, and be filled with nitrogen protected in ultrasonic emulsification instrument;
(4) rubber of preparation Roxithromycin soft capsule injects medicinal liquid, pelleting, typing, wiping ball, drying.
The prescription of rubber is: gelatin 200 weight portions, glycerol 80 weight portions, water 200 weight portions, sorbitol 20 weight portions, microcrystalline Cellulose 2 weight portions, ethyl hydroxybenzoate 0.4 weight portion, titanium dioxide 1.0 weight portions, ethanol 150 weight portions.
The thickness of rubber is 0.75mm.
The preparation technology of rubber is:
(1) microcrystalline Cellulose adds suitable quantity of water and crosses colloid mill, and titanium dioxide adds suitable quantity of water and crosses colloid mill, and sorbitol is used an amount of hot water dissolving, and ethyl hydroxybenzoate is with 2 times of dissolve with ethanols, and is for subsequent use;
(2) with in G ﹠ W, microcrystalline Cellulose serosity, titanium dioxide slurries, sorbitol solution, the ethyl hydroxybenzoate solution addingization glue tank, heating;
(3) temperature adds gelatin after rising to 70 ℃ in tank, opens stirring system and stirs and make it melt and dissolved, and temperature is controlled at below 80 ℃, treats that gelatin dissolves when even entirely, opens the vacuum system evacuation, until glue is without bubble;
(4) glue of step (3) preparation is emitted, put 50 ℃～60 ℃ of gelatin bucket insulations and leave standstill use in 6 hours.
Embodiment 9～13: preparation Roxithromycin soft capsule
It is as shown in table 2 to fill a prescription:
Table 2:
Preparation technology is:
(5) Roxithromycin and the oleaginous base with formula ratio joins in the Agitation Tank by weight, and mix homogeneously is crossed colloid mill;
(6) mixture with Roxithromycin and oleaginous base is divided in the 100ml wide-mouth vial, is refrigerated to-35 ℃; Cooling rate is 12 ℃/min; Evacuation was warming up to 20 ℃ in 5 hours;
(7) then placing frequency is that volume is that 1L, 28KHz, power are 35W ultrasonic emulsification instrument effect 10 minutes, obtains Roxithromycin and oleaginous base mixture; And in ultrasonic emulsification instrument, being filled with nitrogen protected, the rubber of preparation Roxithromycin soft capsule injects medicinal liquid, pelleting, typing, wiping ball, drying.
The prescription of rubber is: gelatin 200 weight portions, glycerol 80 weight portions, water 200 weight portions, sorbitol 20 weight portions, microcrystalline Cellulose 2～4 weight portions, ethyl hydroxybenzoate 0.4 weight portion, titanium dioxide 1.0 weight portions, ethanol 150 weight portions.
The thickness of rubber is 0.8mm.
The preparation technology of rubber is with embodiment 1.
Embodiment 14～15: preparation Roxithromycin soft capsule
It is as shown in table 3 to fill a prescription:
Table 3:
Preparation technology is:
(8) Roxithromycin and the oleaginous base with formula ratio joins in the Agitation Tank by weight, and mix homogeneously is crossed colloid mill;
(9) mixture with Roxithromycin and oleaginous base is divided in the 100ml wide-mouth vial, is refrigerated to-30 ℃; Cooling rate is 5 ℃/min; Evacuation was warming up to 15 ℃ in 2 hours;
(10) then placing volume is that 5L, frequency are that 24KHz, power are 100W ultrasonic emulsification instrument effect 5～15 minutes, obtains Roxithromycin and oleaginous base mixture, and be filled with nitrogen protected in ultrasonic emulsification instrument;
5. the rubber of preparation Roxithromycin soft capsule injects medicinal liquid, pelleting, typing, wiping ball, drying.
The prescription of rubber, thickness and preparation method are with embodiment 1.
Experimental example 1 Study on influencing factors
Roxithromycin soft capsule with the embodiment preparation, simulation listing packing, put in the clean seal container, respectively at high temperature (40 ℃), high temperature (60 ℃), high humidity (relative humidity 90% ± 5%), high light (4500lx ± 500lx) placed 10 days under the condition, in the 5th day and the 10th day sampling and measuring.Measure its outward appearance, content shape, disintegration time, related substance, content, experimental result is as shown in table 4:
Table 4: influence factor's experimental result
By influence factor's experiment as can be known, the soft capsule of embodiment 1 preparation among the present invention, its disintegration time, dissolution, content and related substance have no significant change, and soft capsule of the present invention steady quality under high temperature, high humidity, high light is described.
Soft capsule to the other embodiments of the invention preparation carries out influence factor's experiment, obtains identical experimental result.
Embodiment 2 accelerated tests
Three batches 101201,101202,101203 simulation listing packings to the soft capsule of the embodiment of the invention 2 preparation, put in the clean seal container, be that 40 ℃, relative humidity are to place 6 months under 90% the condition in temperature, respectively at 0,1,2,3, June the Observe and measure of taking a sample, its accelerated test data are as shown in table 5.
Table 5: accelerate experimental result
By the accelerator experiment as can be known, the soft capsule of embodiment 2 preparations among the present invention, its disintegration, dissolution, content and related substance have no significant change, and illustrate that soft capsule quality of the present invention is stable.
Soft capsule to the other embodiments of the invention preparation accelerates experiment, obtains identical experimental result.
Embodiment 3: long-term experiment
Three batches 101101,101102,101103 simulation listing packings to the soft capsule of the embodiment of the invention 2 preparation, put in the clean seal container, be that 25 ℃, relative humidity are to place 24 months under 75% the condition in temperature, respectively at 0,3,6,9,12,18,24 month sampling Observe and measure, its long term test data were as shown in table 6.
Table 6: long-term experiment result
By the accelerator experiment as can be known, the soft capsule of embodiment 3 preparations among the present invention, its disintegration time, dissolution, content and related substance have no significant change, and illustrate that soft capsule quality of the present invention is stable.
Soft capsule to the other embodiments of the invention preparation carries out long-term experiment, obtains identical experimental result.
Experimental example 4 contrast tests
Comparative Examples 1: adopt prescription and the preparation method of embodiment 1, difference is not do in the preparation method step frozen dried;
Comparative Examples 2: adopt prescription and the preparation method of embodiment 1, difference is not do in the preparation method step ultrasonic emulsification and processes;
Comparative Examples 3: the product that adopts patent 20071011083603 methods.
Other gets the product of embodiment 1, and simulation listing packing is carried out accelerated test according to the condition of test example 2.Experimental result is as shown in table 7:
Table 7:
By contrast test as can be known, the technical scheme of the preparation method that the present invention adopts obtains soft capsule and all is better than prior art in disintegration time, dissolution, aspect stable, and be better than Comparative Examples 1 and Comparative Examples 2, illustrate that the present invention adopts the combination of ultrasonic emulsification and two techniques of lyophilizing, can prepare the Roxithromycin soft capsule that various aspects of performance all is improved.
Claims (16)
1. the preparation method of a Roxithromycin soft capsule is characterized in that, described preparation method may further comprise the steps:
(1) with Roxithromycin 150 weight portions, oleaginous base 100～150 weight portions; Join by weight in the Agitation Tank, mix homogeneously is crossed colloid mill;
(2) mixture with Roxithromycin and oleaginous base is refrigerated to-25～-40 ℃, and cooling rate is 2～15 ℃/min; Evacuation was warming up to 15～25 ℃ in 2～6 hours;
(3) then placing frequency is that 20～30KHz, power are 20～500W ultrasonic emulsification instrument effect 5～15 minutes;
(4) rubber of preparation Roxithromycin soft capsule injects medicinal liquid, pelleting, typing, wiping ball, drying.
2. the preparation method of Roxithromycin soft capsule according to claim 1 is characterized in that, in step (1), described oleaginous base is selected from least a in soybean oil, Semen Maydis oil, olive oil, the Oleum Arachidis hypogaeae semen.
3. the preparation method of Roxithromycin soft capsule according to claim 2 is characterized in that, in step (1), described oleaginous base is selected from soybean oil.
4. the preparation method of Roxithromycin soft capsule according to claim 1 is characterized in that, in step (1), Roxithromycin is 150 weight portions, and oleaginous base is 120～150 weight portions.
5. the preparation method of Roxithromycin soft capsule according to claim 4 is characterized in that, in step (1), oleaginous base is 135～145 weight portions.
6. the preparation method of Roxithromycin soft capsule according to claim 1 is characterized in that, in step (2), behind the evacuation, is warming up to 18～22 ℃ in 4～5 hours.
7. the preparation method of Roxithromycin soft capsule according to claim 1 is characterized in that, in step (2), Roxithromycin and oleaginous base mixture is refrigerated to-30～-40 ℃; Cooling rate is 5～15 ℃/min.
8. the preparation method of Roxithromycin soft capsule according to claim 7 is characterized in that, in step (2), Roxithromycin and oleaginous base mixture is refrigerated to-30～-35 ℃.
9. the preparation method of Roxithromycin soft capsule according to claim 7 is characterized in that, in step (2), cooling rate is 5～12 ℃/min.
10. the preparation method of Roxithromycin soft capsule according to claim 1 is characterized in that, in step (3), the frequency of described ultrasonic emulsification instrument is that 20～28KHz, power are 30～300W.
11. the preparation method of Roxithromycin soft capsule according to claim 10 is characterized in that, in step (3), the frequency of described ultrasonic emulsification instrument is that 24～28KHz, power are 35～250W.
12. the preparation method of Roxithromycin soft capsule according to claim 1 is characterized in that, in step (4), the prescription of described rubber is: gelatin 180～200 weight portions, glycerol 60～100 weight portions; Water 180～200 weight portions; Sorbitol 18～22 weight portions; Microcrystalline Cellulose 2～4 weight portions; Ethyl hydroxybenzoate 0.2～0.4 weight portion; Titanium dioxide 0.9～1.0 weight portion; Ethanol 120～150 weight portions.
13. the preparation method of Roxithromycin soft capsule according to claim 12 is characterized in that, in step (4), the prescription of described rubber is: gelatin 200 weight portions; Glycerol 60～80 weight portions; Water 200 weight portions; Sorbitol 20 weight portions; Microcrystalline Cellulose 2～4 weight portions; Ethyl hydroxybenzoate 0.4 weight portion; Titanium dioxide 1.0 weight portions; Ethanol 150 weight portions.
14. the preparation method of Roxithromycin soft capsule according to claim 12 is characterized in that, in step (4), the preparation technology of described rubber is:
(1) microcrystalline Cellulose adds suitable quantity of water and crosses colloid mill, and titanium dioxide adds suitable quantity of water and crosses colloid mill, and sorbitol is used an amount of hot water dissolving, and ethyl hydroxybenzoate is with 2 times of dissolve with ethanols, and is for subsequent use;
(2) with in G ﹠ W, microcrystalline Cellulose serosity, titanium dioxide slurries, sorbitol solution, the ethyl hydroxybenzoate solution addingization glue tank, heating;
(3) temperature adds gelatin after rising to 70 ℃ in tank, opens stirring system and stirs and make it melt and dissolved, and temperature is controlled at below 80 ℃, treats that gelatin dissolves when even entirely, opens the vacuum system evacuation, until glue is without bubble;
(4) glue of step (3) preparation is emitted, put 50 ℃～60 ℃ of gelatin bucket insulations and leave standstill use in 2～12 hours.
15. the preparation method of Roxithromycin soft capsule according to claim 1 is characterized in that, in step (4), the thickness of described rubber is 0.7～0.9mm.
16. the preparation method of Roxithromycin soft capsule according to claim 15 is characterized in that, in step (4), the thickness of described rubber is 0.75～0.8mm.
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