CN102038700B - Bitter-taste-masking erythromycin-cydocarbonate-containing oral composition - Google Patents
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Abstract
The invention relates to the field of medicinal preparations, in particular to a bitter-taste-masking erythromycin-cydocarbonate-containing oral preparation and a preparation method thereof. The bitter-taste-masking erythromycin-cydocarbonate-containing oral preparation is characterized by mainly comprising 1 part of erythromycin cydocarbonate, 0.1 to 0.4 part of high-sweetness sugar, 1.0 to 1.5 parts of suspending agent, 5 to 15 parts of filling agent, 0.5 to 2.0 parts of absorbent and 0.1 to 0.2 part of surfactant. The bitter-taste-masking erythromycin-cydocarbonate-containing oral preparation has good mouthfeel, is taken after being mixed with water and improves the compliance of a patient.
Description
Technical field
The present invention relates to field of pharmaceutical preparations, be specifically related to a kind of cyclic ester erythromycin oral formulations of covering bitterness and preparation method thereof.
Background technology
Cyclic ester erythromycin is novel macrolide antibiotic.Similar erythromycin with tradition is compared: higher antibacterial activity is arranged, and the infection that various pathogens is caused has extremely strong antibacterial action; Be more conducive to intestinal absorption; Toxicity is low, and untoward reaction is few, and irritated incidence rate is low; Drug half-life is long, and patient's compliance is good.Cyclic ester erythromycin has carried out clinical Journal of Sex Research in each big well-known hospital of China; The result shows: the therapeutical effect that cyclic ester erythromycin not only infects the acute respiration system is remarkable and side effect is little, and can be widely used in all kinds of infection that caused by chlamydia, legionella, mycoplasma.To causing now the urogenital infections of concern day by day, cyclic ester erythromycin has more significant curative effect than common antibiotic.
Cyclic ester erythromycin is than the superiority of other macrolide antibiotics
1) clarithromycin and azithromycin are than the equal or more excellent external resisting gram-positive and the activity of negative bacterium are arranged.
2) biological half-life: than long 3 times of erythromycin, than long 2 times of carat mycin.
3) compare with the clarithromycin that fetal toxicity is arranged, high to fetal well-being property.
4) with up-to-date semi-synthetic macrolide antibiotics ratio, cost and price is lower, because synthetic reaction is uncomplicated, has only for three steps.
5) acid resistance is 2～3 times of erythromycin.
6) warp checking for many years, cyclic ester erythromycin are effective and good macrolide antibiotics of toleration, one day twice, and taking convenience.
At present; The cyclic ester erythromycin dosage form of list marketing has only tablet (film-coat) and capsule at home; Select these two kinds of dosage forms can cover this bitterness; But clinically, to oral solid formulation swallow inconvenience old man, pediatric patient and seriously ill, lie on the back, the patient of the inconvenience of taking medicine such as pharyngolaryngitis is swollen, these two kinds of dosage forms just have certain limitation.Cyclic ester erythromycin is insoluble drug in addition, selects suitable dosage form can increase the contact area of medicine and gastro-intestinal Fluid, improves absorbance, and dry suspension faces with preceding and becomes suspension just can address these problems well with mixing in water for oral taking.
Yet cyclic ester erythromycin raw material is very bitter, must be very bitter if process dry suspension according to ordinary skill, be difficult to swallow, and patient's compliance is very poor.Can limit diabetes patient's use to a certain extent if rectify flavor, nor be beneficial to child's health, also need consider growing of microorganism in the medicine storage process simultaneously with a large amount of sucrose.Therefore, limited the clinical practice of cyclic ester erythromycin.Thereby how can overcome effectively and cover bitterness and improve the dissolution of medicine, be the key issue of cyclic ester erythromycin dry suspension.
Summary of the invention
The object of the invention is to disclose a kind of facing with before taking after mixing it with water; Mouthfeel is cyclic ester erythromycin oral formulations preferably; Cover the bitterness of cyclic ester erythromycin through adding a certain proportion of high sweetness sugars and a certain proportion of adsorbent; Added a certain proportion of suspending agent again, making preparation is that suspendible is even taking after mixing it with water, and has increased patient's compliance.
Technical scheme of the present invention is following:
Cyclic ester erythromycin Orally administered composition of the present invention is characterized in that containing following component and weight ratio:
Cyclic ester erythromycin: 1
High sweetness sugars: 0.3～0.4
Suspending agent: 1.0～1.5
Filler: 5～15
Adsorbent: 0.5～1.5
Surfactant: 0.1～0.2
Wherein: high sweetness sugars is selected from acesulfame potassium, steviosin, cyclamate, saccharin sodium, sucralose, aspartame.
Suspending agent is selected from hyprolose, microcrystalline Cellulose, sodium carboxymethyl cellulose.
Filler is selected from microcrystalline Cellulose, sucrose, lactose, mannitol, starch.
Adsorbent is selected from alkaline earth oxide and alkaline earth metal hydroxide.
Surfactant is selected from sodium lauryl sulphate, tween 80, Arlacel-80.
Orally administered composition of the present invention also contains essence.
Orally administered composition of the present invention, the preferred dry suspension of dosage form.
When dosage form was dry suspension, preferred ingredients and weight ratio were:
Its preparation method is:
1) principal agent and adjuvant pulverize separately are crossed 80 mesh sieves, and be subsequent use.
2) take by weighing principal agent and adjuvant by recipe quantity, mix, and in blender, be mixed to evenly by the equivalent incremental method.
3) it is an amount of to get purified water, and the sodium lauryl sulphate that adds recipe quantity is processed binding agent, and the system soft material is crossed 20 mesh sieves and granulated, wet granular.
4) wet granular 60C dry to moisture less than 1.2%, cross 40 mesh sieve granulate.
5) packing after the assay was approved.
Characteristics of the present invention are to face with the preceding mixing in water for oral taking of using, and mouthfeel is better, can cover the bitterness of cyclic ester erythromycin itself well.
Prescription of the present invention obtains through screening, and screening process is following:
1, the foundation of dosage form selection
Dry suspension be applicable to oral solid formulation swallow inconvenience old man, pediatric patient and seriously ill, lie on the back, the patient of the inconvenience of taking medicine such as pharyngolaryngitis is swollen.Cyclic ester erythromycin is insoluble drug, selects dry suspension, faces with preceding with the suspension administration, can increase the contact area of medicine and gastro-intestinal Fluid, the raising absorption; Add correctives in the dosage form, improve mouthfeel, be convenient to take.
2, the selection of solubilizing agent
Because the prerequisite that medicine absorbs in gastrointestinal tract is to be dissolved in gastro-intestinal Fluid.When drug solubility less than 0.3% the time, dissolution rate becomes the restrictive factor of whole absorption process.Therefore dissolution rate also is the principal element of its absorption of decision.Cyclic ester erythromycin belongs to insoluble drug, is the rate-limiting factor that influences principal agent absorption and even bioavailability at the gastrointestinal process in leaching, and in prescription, adding solubilizing agent (sodium lauryl sulphate) is a kind of effectively short suction means.
According to bibliographical information, the solubilizing agent of various dose is different to the solubilizing effect of cyclic ester erythromycin in hydrochloric acid solution (1 → 1000).So existing preparation prescription I, II, III and IV, solubilizing agent (sodium lauryl sulphate) consumption is respectively 0.05%, 0.1%, 0.15%, 0.2% of total recipe quantity, and other supplementary product kind and consumption are constant.By making sample under the dry suspension preparation technology item, the dissolution of in hydrochloric acid solution (1 → 1000), measuring in 90 minutes with these article serves as to investigate index, and solubilizing agent (sodium lauryl sulphate) consumption in these article prescription is screened, and the result sees table 1.
The dissolution of the cyclic ester erythromycin granule prescription of the different solubilizing agent consumptions of table 1
Through overtesting, with the increase of solubilizing agent consumption, the dissolution of cyclic ester erythromycin significantly increases, and compares without solubilizing agent that there were significant differences.The solubilizing agent consumption is conceived to safety and practicality, owing to can not infinitely strengthen.The while bibliographical information, with the increase of dosage of surfactant, flocculation situation and CHARGE DISTRIBUTION in the suspension can exert an influence to the stability of suspension.Therefore, the preferred optimum amount 0.15～0.2 of sodium lauryl sulphate (pressing cyclic ester erythromycin weight ratio 1 calculates).
3, the selection of high sweetness sugars
For the solid preparation of directly taking after mixing it with water, the quality of mouthfeel has determined directly whether the patient can accept to take this medicine.General sucrose or other nutrition sugar can not be covered the bitterness of cyclic ester erythromycin in conventional amount used, so need the high sweetness sugars of adding overcome this defective.If but the amount that high sweetness sugars adds too much can cause having abnormal flavour, if the very few bitterness that can not cover cyclic ester erythromycin again, therefore, the consumption that screens high sweetness sugars is the key of dealing with problems.For confirming the consumption of high sweetness sugars, adjust the ratio of high sweetness sugars, make an experiment, the result sees table 2.
The suspending effect screening of table 3 suspending agent different amounts
Through overtesting; The weight of discovery cyclic ester erythromycin and high sweetness sugars can be covered bitterness at 1: 0.3～0.4 o'clock, and along with the increase of acesulfame potassium consumption, mouthfeel is not significantly improved; And because of the acesulfame potassium consumption excessive; Itself also has bitterness, and simultaneously from security consideration, selecting the optimum amount scope is 1: 0.3～0.4.Acesulfame potassium, steviosin, cyclamate, saccharin sodium, sucralose, aspartame all are fit in this scope.
4, the selection of suspending agent
The consumption of suspending agent also has certain influence to the mouthfeel of these article, and the suspending agent consumption is too big, has tangible lamination; And the back viscosity of taking after mixing it with water is bigger, is unfavorable for the stripping of cyclic ester erythromycin, influences bioavailability; But the suspending agent consumption can not play the suspendible effect of uniform again very little, for confirming the consumption of suspending agent, the ratio of adjustment suspending agent; Make an experiment, the result sees table 3.
The suspending effect screening of table 3 suspending agent different amounts
According to result of the test, the amount ratio of cyclic ester erythromycin and suspending agent 1: 1.0～1.5 o'clock, suspending best results.
For the quality that proves product of the present invention is a stable and controllable, carry out following a series of test, concrete grammar is following:
1. influence factor's test
Sample thief removes unlap, under strong illumination, high temperature, super-humid conditions, the projects such as character, settling volume ratio, loss on drying and content of sample is investigated respectively.
1.1. strong illumination test
Instrument: JD-3 type illumination meter
Experimental condition: 4500lx
Sample thief removes unlap, puts in the lighting box (self-control), regulates irradiation distance, and making intensity of illumination is 4500lx, and Continuous irradiation 10 days in the 5th day and sampling in the 10th day, is investigated the inspection of project, and the result sees table 4.
Table semi-finals rayed result of the test
1.2. hot test
Instrument: 101-type Constant Temp. Oven, water isolation type electro-heating standing-temperature cultivator
Experimental condition: 40 ℃, 60 ℃
2 parts of sample thiefs remove unlap, and portion is put in the Constant Temp. Oven, adjusts the temperature to 60 ℃; Another part put in the water isolation type electro-heating standing-temperature cultivator, adjusts the temperature to 40 ℃.Above-mentioned sample was placed 10 days continuously, in the 5th day and sampling in the 10th day, investigated the inspection of project, and the result sees table 5.
Table 5 hot test result
1.3. high wet test
Instrument: biochemical incubator
Experimental condition: relative humidity 75% (saturated NaCl solution), 92.5% (saturated KNO
3Solution)
2 parts of sample thiefs remove unlap, are placed on respectively in the exsiccator, and one of them exsiccator bottom is put into saturated NaCl solution (relative humidity 75%), and saturated KNO is put in another exsiccator bottom
3Solution (relative humidity 92.5%), and then exsiccator is placed in the biochemical incubator, adjust the temperature to 25 ℃.Above-mentioned sample was placed 10 days continuously, in the 5th day and sampling in the 10th day, investigated the inspection of project, and the result sees table 6.
Table 6 hot test result
Brief summary: influence factor's result of the test shows, places under these conditions 10 days, and these article are all more stable under high light and hot conditions.But under super-humid conditions, loss on drying obviously increases, the equal overshoot scope at the 10th day.Therefore, with reference to two pertinent regulations of Chinese Pharmacopoeia version in 2005, confirm that tentatively these article holding conditions is " sealing is preserved at the drying place ".
2. accelerated test
Instrument: water isolation type electro-heating standing-temperature cultivator
Condition: 40 ℃ of relative humiditys 75% of temperature (NaCl saturated solution)
Packing: composite membrane bellows pocket packing
Sample is placed the exsiccator (RH 75%) that is placed with saturated NaCl solution, and it is 40 ℃ incubator that exsiccator is placed temperature, places 3 months.Respectively at test 1,2,3, sampling in June, investigate item inspection, the result sees table 7.
Table 7 accelerated test result
Brief summary: show that through stable accelerated test result these article are at 40 ℃, relative humidity 75% condition held six months, each item index has no significant change.
3. keep sample for a long time and investigate test
Condition: 25 ℃ ± 2 ℃ of temperature, relative humidity 60% ± 10%
Packing: composite membrane bellows pocket packing
Above-mentioned three lot sample article are put under the room temperature natural conditions for a long time place, respectively at 3 months, 6 months, 9 months, 12 months, 18 months, 24 months, detected by the investigation project in 36 months, the result sees table 8.
The table 8 investigation result of the test that keeps sample for a long time
Brief summary: show that through stable long-term test results these article are 25 ℃ ± 2 ℃ of temperature, relative humidity 60% ± 10% condition held 36 months, each item index has no significant change.
Conclusion: above result of the test shows that the quality of product of the present invention is a stable and controllable.
The specific embodiment
Embodiment 1
Cyclic ester erythromycin dry suspension
Prescription:
Cyclic ester erythromycin 150g
Hyprolose 195g
Sucrose 1380g
Lactose 185g
Mannitol 150g
Sodium lauryl sulphate 25g
Magnesium oxide 150g
Acesulfame potassium 50g
Vanillin 15g
Process 1000 bags
Preparation technology:
1) principal agent and adjuvant pulverize separately are crossed 80 mesh sieves, and be subsequent use.
2) take by weighing cyclic ester erythromycin, hyprolose, sucrose, lactose, mannitol, magnesium oxide, acesulfame potassium, vanillin by recipe quantity, mix, and in blender, be mixed to evenly by the equivalent incremental method.
3) it is an amount of to get purified water, adds the recipe quantity sodium lauryl sulphate and processes binding agent, and the system soft material is crossed 20 mesh sieves and granulated, wet granular.
4) 60 ℃ of wet granulars dry to moisture less than 1.2%, cross 40 mesh sieve granulate.
5) after the assay was approved, be sub-packed in the compound membrane bag, promptly get cyclic ester erythromycin dry suspension.
The present invention uses conventional equipment, and preparation technology is simple, and mouthfeel effect is good, steady quality.Compare with ordinary preparation, this medicine is rapid-action, features good taste, be specially adapted to children's with, have the good tolerability characteristics, so therapeutic scheme will be easy.For patient, provide a kind of new treatment to select, so the dry suspension of development cyclic ester erythromycin has a crucial meaning to clinical.
Although the present invention describes with reference to specific embodiment, this description does not also mean that the present invention is constituted restriction.With reference to description of the invention, other distortion of the disclosed embodiments all can be expected to those skilled in the art.Therefore, such distortion can not break away from affiliated scope thereof and spirit.
Claims (8)
1. cyclic ester erythromycin Orally administered composition is characterized in that containing following component level weight ratio:
Cyclic ester erythromycin: 1
High sweetness sugars: 0.3～0.4
Suspending agent: 1.0～1.5
Filler: 5～15
Adsorbent: 0.5～1.5
Surfactant: 0.1～0.2
Wherein: high sweetness sugars is selected from acesulfame potassium, steviosin, cyclamate, saccharin sodium, sucralose, aspartame;
Suspending agent is selected from hyprolose, microcrystalline Cellulose, sodium carboxymethyl cellulose;
Filler is selected from microcrystalline Cellulose, sucrose, lactose, mannitol, starch;
Adsorbent is selected from alkaline earth oxide and alkaline earth metal hydroxide;
Surfactant is selected from sodium lauryl sulphate, tween 80, Arlacel-80.
2. the Orally administered composition of claim 1 is characterized in that containing following component level weight ratio:
Cyclic ester erythromycin: 1
High sweetness sugars: 0.3～0.4
Suspending agent: 1.0～1.5
Filler: 10～15
Adsorbent: 0.8～1.2
Surfactant: 0.15～0.2
Wherein: high sweetness sugars is selected from acesulfame potassium, steviosin, cyclamate, saccharin sodium, sucralose, aspartame;
Suspending agent is selected from hyprolose, microcrystalline Cellulose, sodium carboxymethyl cellulose;
Filler is selected from microcrystalline Cellulose, sucrose, lactose, mannitol, starch;
Adsorbent is selected from alkaline earth oxide and alkaline earth metal hydroxide;
Surfactant is selected from sodium lauryl sulphate, tween 80, Arlacel-80.
3. the Orally administered composition of claim 1 is characterized in that containing following component level weight ratio:
Cyclic ester erythromycin: 1
High sweetness sugars: 0.33
Suspending agent: 1.3
Filler: 11.4
Adsorbent: 1.0
Surfactant: 0.17
Wherein: high sweetness sugars is selected from acesulfame potassium, steviosin, cyclamate, saccharin sodium, sucralose, aspartame;
Suspending agent is selected from hyprolose, microcrystalline Cellulose, sodium carboxymethyl cellulose;
Filler is selected from microcrystalline Cellulose, sucrose, lactose, mannitol, starch;
Adsorbent is selected from alkaline earth oxide and alkaline earth metal hydroxide;
Surfactant is selected from sodium lauryl sulphate, tween 80, Arlacel-80.
Any one Orally administered composition of claim 1 to claim 3, it is characterized in that the preferred acesulfame potassium of wherein high sweetness sugars; The preferred hyprolose of suspending agent; Filler is sucrose, lactose and mannitol; The preferred magnesium oxide of adsorbent; The surfactant preferably sodium dodecyl sulfate.
5. each Orally administered composition in claim 1 to the claim 3, its dosage form is a dry suspension.
6. any one Orally administered composition of claim 1 to claim 3 also contains essence.
7. the Orally administered composition of claim 6 when dosage form is dry suspension, is characterized in that prescription consists of:
8. the method for preparing of the Orally administered composition of claim 1 to claim 7 is characterized in that, method is following:
1) principal agent and adjuvant pulverize separately are crossed 80 mesh sieves, and be subsequent use;
2) take by weighing principal agent and adjuvant by recipe quantity, mix, and in blender, be mixed to evenly by the equivalent incremental method;
3) it is an amount of to get purified water, and the sodium lauryl sulphate that adds recipe quantity is processed binding agent, and the system soft material is crossed 20 mesh sieves and granulated, wet granular;
4) 60 ℃ of wet granulars dry to moisture less than 1.2%, cross 40 mesh sieve granulate;
5) packing after the assay was approved.
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| CN200910206556A CN102038700B (en) | 2009-10-14 | 2009-10-14 | Bitter-taste-masking erythromycin-cydocarbonate-containing oral composition |
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| CN103099807A (en) * | 2011-11-15 | 2013-05-15 | 海南澳美华制药有限公司 | Compound zinc gluconate and ibuprofen oral-administration composition for covering bitter taste and improving ibuprofen dissolution |
| CN104688757A (en) * | 2013-12-09 | 2015-06-10 | 海南澳美华制药有限公司 | Dissolution rate increased erythromycin cydocarbonate oral composition |
| WO2018124284A1 (en) * | 2016-12-28 | 2018-07-05 | 富山化学工業株式会社 | Pharmaceutical composition |
| CN113679685B (en) * | 2021-08-27 | 2022-10-14 | 澳美制药(苏州)有限公司 | Preparation method of erythromycin cydocarbonate tablet |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1631371A (en) * | 2004-12-20 | 2005-06-29 | 李�杰 | Oral administered bitter free powder of macrolide antibiotic, its prescription and preparation process |
| CN1660872A (en) * | 2005-01-02 | 2005-08-31 | 李�杰 | Antibiotic 2-hydroxy ester in new type macrolide group, preparation and preparing method |
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Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1631371A (en) * | 2004-12-20 | 2005-06-29 | 李�杰 | Oral administered bitter free powder of macrolide antibiotic, its prescription and preparation process |
| CN1660872A (en) * | 2005-01-02 | 2005-08-31 | 李�杰 | Antibiotic 2-hydroxy ester in new type macrolide group, preparation and preparing method |
Non-Patent Citations (1)
| Title |
|---|
| 王妤.环酯红霉素干混悬剂微生物限度检查方法的建立.《广东药学院学报》.2007,第23卷(第6期),p.665- 666. * |
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