CN101810581B - Method for enhancing content uniformity of clenbuterol hydrochloride and application thereof - Google Patents
Method for enhancing content uniformity of clenbuterol hydrochloride and application thereof Download PDFInfo
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- CN101810581B CN101810581B CN2010101270194A CN201010127019A CN101810581B CN 101810581 B CN101810581 B CN 101810581B CN 2010101270194 A CN2010101270194 A CN 2010101270194A CN 201010127019 A CN201010127019 A CN 201010127019A CN 101810581 B CN101810581 B CN 101810581B
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Abstract
The invention relates to a technological measure for enhancing the content uniformity of clenbuterol hydrochloride and application thereof. A technological method comprises the following steps: dissolving the clenbuterol hydrochloride and a pharmacologically-acceptable carrier in a solvent to prepare solution or suspension; and drying the solution or the suspension to form dry particles or powder.
Description
Technical field
The present invention relates to a kind of pharmaceutical formulation techniques, the particularly dispersion technology of medicine for respiratory system clenbuterol hydrochloride, the present invention is the clenbuterol hydrochloride homodisperse, thereby improves uniformity of dosage units.
Background technology
Clenbuterol hydrochloride (clenbuterol, CLB), a kind of medicine for respiratory system, chemistry 2-by name [(uncle's fourth is amino) methyl]-4-amino-3,5-dichlorbenzyl alcohol hydrochlorate, English name: Clenbuterol; Spiropent; Planipart; NAB365; 4-Amino-3,5-dichloro-alpha-((1,1-dimethylethyl) ami-no) methyl) benzenemethanol.Molecular formula is C
12H
19Cl
3N
2O, molecular weight are 313.5, and fusing point is 174～175.5 ℃, colourless micro-crystallization powder, and odorless, mildly bitter flavor, soluble in water, methanol, ethanol are slightly soluble in chloroform, are insoluble to benzene.Structural formula is following:
This medicine is synthesized in 1972 first, and records in two ones of Pharmacopoeias of People's Republic of China in 2000.Comprising that the approval of family's pharmaceutical producing enterprise is produced surplus Harbin Pharmaceutical Group, Changtian Pharmaceutical Co., Ltd., Hebei etc. 70, medicine " clenbuterol, salbutamol, Celenbuterol " by name etc. at present.
The chemical constitution of clenbuterol hydrochloride is similar with the adrenin medicine; Belong to adrenomimetic drug class medicine; Be beta-2-adrenoreceptor agonists, it combines with beta 2-receptor is to act on adenyl cyclase (AC) through SP (Gs), makes it activation; Activatory adenyl cyclase makes ATP (ATP) change cyclic adenosine monophosphate (cAMP) into; Cyclic adenosine monophosphate activated protein kinase K (PK) or itself are acted on and inactivation by phosphodiesterase (PDE), impel the phosphorylation of enzyme, thereby produce series effect.
Clenbuterol hydrochloride has higher selectivity agonism to the beta-2-adrenoreceptor of bronchus, uterus and vascular smooth muscle, can remove bronchospasm effectively.In addition, also have stronger antiallergic and obviously strengthen the effect of bronchus cilia activity, and act on lysosome, can promote mucolysis, help the discharge of sputum.Clenbuterol hydrochloride is mainly used in bronchial asthma and asthmatic bronchitis clinically, and effect is strong and lasting, is the main medicine that prevents bronchial asthma and bronchospasm.This drug use amount few (oral dose 20～40 μ g), and rapid-action after the medication, the length of holding time.
Clenbuterol hydrochloride is used increasingly extensive clinically, multiple dosage form listing such as existing tablet, suppository, aerosol, and can with the medicine combined effect of other respiratory tract disease such as ambroxol hydrochloride, process compound preparation, enhancing treatment effect.
Chinese Pharmacopoeia regulation tablet, capsule or injectable sterile powder, every (individual) labelled amount are not more than 10mg or drug content less than every (individual) weight, in other preparations each labelled amount less than 2mg or drug content less than each weight; And transdermal patch, all should check uniformity of dosage units.
Because the use amount of these article is very little, the preparation process that progressively increases with traditional solid material equivalent can't make its abundant mixing, has the inhomogenous drawback of content of drug.Thereby the uniformity of dosage units that adopts simple method to improve clenbuterol hydrochloride in the preparation has great importance.
In disclosed patent, do not see and relate to the content that increases content uniformity of clenbuterol hydrochloride.
Summary of the invention
In order to overcome owing to the low excessively uniformity of dosage units that causes of clenbuterol hydrochloride content in the medicine does not reach the problem of requirement; The invention provides a kind of technological means that can improve content uniformity of clenbuterol hydrochloride, make the content uniformity of clenbuterol hydrochloride in the pharmaceutical preparation can reach requirement.
The present invention provides a kind of clenobuterol hydrochloride homodisperse method for this reason; This method may further comprise the steps: clenbuterol hydrochloride and medicine acceptable carrier are dissolved in process solution or suspension in the solvent, with above-mentioned solution or dry dried granules or the powder of forming of suspension.Wherein said medicine acceptable carrier is selected from: the mixture of one or more in mannitol, sucrose, lactose, glucose, fructose, the sodium carboxymethyl cellulose; Wherein said solvent is selected from: one or more in water, ethanol, methanol, the chloroform are with the mixed mixture of arbitrary proportion, and wherein clenbuterol hydrochloride and medicine acceptable carrier ratio are: 1: 10～100000.Wherein said drying is selected from: spray drying, lyophilization, film drying.
The present invention also provides a kind of method of utilizing method for preparing clenbuterol hydrochloride preparation; This method for preparing comprises; Clenbuterol hydrochloride and medicine acceptable carrier are dissolved in the solvent or process suspension; Make it dry dried granules or the powder of forming through dry technology again, further be prepared into pharmaceutical preparation again, for example tablet, granule, capsule, pill, suppository, membrane etc. through the galenic pharmacy routine techniques.
Method for preparing of the present invention, wherein said medicine acceptable carrier is selected from: the mixture of one or more in mannitol, sucrose, lactose, glucose, fructose, the sodium carboxymethyl cellulose, and other drug solid preparation adjuvant commonly used.
Method for preparing of the present invention, wherein said solvent is selected from: one or more in water, ethanol, methanol, the chloroform are with the mixed mixture of arbitrary proportion.
Method for preparing of the present invention, wherein clenbuterol hydrochloride and medicine acceptable carrier ratio are: 1: 10～100000.
The present invention also provides the homogeneous powder or the granule of the clenbuterol hydrochloride that contains useful the inventive method preparation; And the solid chemicals of this powder or preparation of granules, for example tablet, granule, capsule, pill, suppository, membrane etc.
Drying means of the present invention is selected from: methods such as spray drying, lyophilization, film drying.
Spray-diredly be characterised in that it is meant and adopt different aerosol apparatus, and between the hot-air heat transmission takes place and carry out exsiccant process solution or suspension atomisation.Finished product, is discharged from discharger in the bottom of hothouse with pulverulence or graininess depression continuously or discontinuously.Cryodesiccated to be characterised in that it is meant containing solution or suspension freezing to below freezing, makes water change ice into, under high vacuum, changes ice into steam then and the drying means removed.Film drying is characterised in that solution or suspension is formed falling liquid film that after distributing device is uniformly distributed with cylinder inboard wall (through the chuck heating) force into thin film through rotor segment, thin film is evaporated exsiccant method in moving downward process.
Preferably spray drying method of the present invention.
For example: get clenbuterol hydrochloride and adjuvant to scale, spray drying with dissolution with solvents or after processing suspension.Here said spray drying is meant and adopts different aerosol apparatus with solution or suspension atomisation, and between the hot-air heat transmission takes place and carry out exsiccant process.Finished product, is discharged from discharger in the bottom of hothouse with pulverulence or graininess depression continuously or discontinuously.The aerosol apparatus that is adopted comprises: three kinds of pressure-type spray days with fog, air-flowing type aerosol apparatus, centrifugal sprayer.For example use the spray dryer of LB6-5 type, parameter is provided with as follows:
Intake air temperature: 150～180 ℃; Air outlet temperature: 90～110 ℃; Delivery rate: 3ml/ branch; Nebulizer rotating speed: 500 rev/mins.
Carry out spray drying according to the above-mentioned parameter setting.
Preparation according to the invention is selected from the preparation of any other form except that liquid preparation.Can be the preparation that clenbuterol hydrochloride and adjuvant are formed, also can be the compound preparation that contains clenobuterol hydrochloride.
Method provided by the invention is applied in the preparation process, with the equivalent incremental method, clenbuterol hydrochloride is dissolved in the medium method of adhesive compares, can significantly improve the uniformity of dosage units of clenbuterol hydrochloride.
Use the contrast test of the inventive method and other mixed methods, concrete scheme is following:
Method one, get clenbuterol hydrochloride raw material 0.2g, mannitol 1000g mixes with equivalent incremental method method.Randomization is 10 parts behind the mixing, measures the uniformity of dosage units of clenbuterol hydrochloride wherein.Uniformity of dosage units A+1.8S is 17.9 as a result.
Method two, get clenbuterol hydrochloride raw material 0.2g, be dissolved in the 100ml 10%PvP solution, then this liquid is added in the mannitol of 1000g, granulate behind the mixing, oven dry.10 parts of randomizations, the uniformity of dosage units of mensuration clenbuterol hydrochloride.Uniformity of dosage units A+1.8S is 15.3 as a result.
Method three, get clenbuterol hydrochloride 0.2g and mannitol 1000g, be used for 2000ml water, spray drying.10 parts of randomizations are measured uniformity of dosage units.Uniformity of dosage units A+1.8S is 4.2 as a result.
The method of a kind of preferred raising content uniformity of clenbuterol hydrochloride provided by the invention, its operating process is following:
Press clenbuterol hydrochloride 0.2g and mannitol 1000g, be dissolved in 3000ml water, subsequent use.
Above aqueous solution is spray dried to powder, promptly gets.
Above-mentioned mannitol also can be the mixture of other adjuvants or several kinds of adjuvants.
The ratio of above-mentioned clenbuterol hydrochloride and mannitol can be the arbitrary proportion between 1: 10～100000.
Above-mentioned water can be the mixture of other solvents or other solvents.
The above-mentioned process that is dissolved in solvent according to circumstances also can be not dissolve or not exclusively dissolve the suspension of processing.
Preferred manufacturing procedure of the present invention obtains through screening, and effect is better.
The specific embodiment
Following embodiment can further specify technical scheme of the present invention, but and unrestricted range of application of the present invention.In technical scheme of the present invention, the preferred mannitol of adjuvant, solvent preferred water.
Embodiment 1
The special sieve dispersible tablet prescription of ammonia bromine, technology
Prescription
Ambroxol hydrochloride 30Kg
Clenbuterol hydrochloride 0.02Kg
Lactose 50Kg
Mannitol 50Kg
Hyprolose 130Kg
Microcrystalline Cellulose 30Kg
Sodium carboxymethyl cellulose 20Kg
Sodium lauryl sulphate 3Kg
10% 30 POVIDONE K 30 BP/USP, 3070% alcoholic solution is an amount of
Process 1,000,000
Technology
1 former, adjuvant was pulverized 100 mesh sieves, took by weighing 30 POVIDONE K 30 BP/USP 30 and was made into 10% solution as binding agent with 70% ethanol in right amount, and was subsequent use.
2 take by weighing the clenbuterol hydrochloride and the mannitol of recipe quantity, are dissolved in jointly in the 150L water, are spray dried to fine powder, are material 1.
3 progressively increase material 1 behind the dilution method mixing in mixer with equivalent together with recipe quantity ambroxol hydrochloride, lactose, hyprolose, and stirred 5 minutes and under agitation slowly add binding agent, the system soft material, 24 mesh sieves are granulated.Wet granular in 60 ℃ of air dry ovens dry 2 hours, treat that particle drying fully after, cross 20 mesh sieve granulate.
Granule adds recipe quantity microcrystalline Cellulose, surplus hyprolose, sodium carboxymethyl cellulose, sodium lauryl sulphate and in mixer, mixed 10 minutes behind 4 granulate, powder body after the assay was approved, tabletting.Semi-finished product are packing after full inspection.
Embodiment 2
Clenbuterol hydrochloride tablet recipe, technology
Prescription:
Clenbuterol hydrochloride 0.04Kg
Mannitol 30Kg
Microcrystalline Cellulose 70Kg
Magnesium stearate 3Kg
10% 30 POVIDONE K 30 BP/USP, 3070% alcoholic solution is an amount of
Process 1,000,000
Technology
1. former, adjuvant was pulverized 100 mesh sieves, took by weighing 30 POVIDONE K 30 BP/USP 30 and was made into 10% solution as binding agent with 70% ethanol in right amount, and was subsequent use.
2. take by weighing the clenbuterol hydrochloride and the mannitol of recipe quantity, be dissolved in jointly in the 90L water, be spray dried to powder, be material 1.
3. get the microcrystalline Cellulose of material 1 and recipe quantity, mixing., granulate as adhesive with 10% 30 POVIDONE K 30 BP/USP, 30 70% alcoholic solution with 24 mesh sieves.Wet granular in 60 ℃ of air dry ovens dry 2 hours, treat that particle drying fully after, cross 20 mesh sieve granulate.
4. get top dried particles, add the magnesium stearate of recipe quantity, tabletting promptly gets.
Embodiment 3
Clenbuterol hydrochloride chewable tablet prescription, technology
Prescription:
Clenbuterol hydrochloride 0.04Kg
Mannitol 100Kg
Icing Sugar 400Kg
Magnesium stearate 9Kg
10% 30 POVIDONE K 30 BP/USP, 3070% alcoholic solution is an amount of
Make 1,000,000 altogether
Technology
1. former, adjuvant was pulverized 100 mesh sieves, took by weighing 30 POVIDONE K 30 BP/USP 30 and was made into 10% solution as binding agent with 70% ethanol in right amount, and was subsequent use.
2. take by weighing the clenbuterol hydrochloride and the mannitol of recipe quantity, be dissolved in jointly in the 300L water, be spray dried to powder, be material 1.
3. get the Icing Sugar of material 1 and recipe quantity, mixing., granulate as adhesive with 10% 30 POVIDONE K 30 BP/USP, 3070% alcoholic solution with 24 mesh sieves.Wet granular in 60 ℃ of air dry ovens dry 2 hours, treat that particle drying fully after, cross 20 mesh sieve granulate.
4. get top dried particles, add the magnesium stearate of recipe quantity, tabletting promptly gets.
Embodiment 4
Clenbuterol hydrochloride capsule prescription, technology
Clenbuterol hydrochloride 0.04Kg
Starch 100Kg
Mannitol 100Kg
Magnesium stearate 9Kg
10% 30 POVIDONE K 30 BP/USP, 3070% alcoholic solution is an amount of
Make 1,000,000 altogether
1. former, adjuvant was pulverized 100 mesh sieves, took by weighing 30 POVIDONE K 30 BP/USP 30 and was made into 10% solution as binding agent with 70% ethanol in right amount, and was subsequent use.
2. take by weighing the clenbuterol hydrochloride and the mannitol of recipe quantity, be dissolved in jointly in the 300L water, be spray dried to powder, be material 1.
3. get the starch of material 1 and recipe quantity, mixing., granulate as adhesive with 10% 30 POVIDONE K 30 BP/USP, 30 70% alcoholic solution with 24 mesh sieves.Wet granular in 60 ℃ of air dry ovens dry 2 hours, treat that particle drying fully after, cross 20 mesh sieve granulate.
4. get top dried particles, incapsulate shell, promptly get.
Embodiment 5
Clenbuterol hydrochloride effervescent tablet prescription, technology
Prescription
Clenbuterol hydrochloride 0.04Kg
Mannitol 100Kg
Sucrose 460Kg
Citric acid 320Kg
Sodium bicarbonate 460Kg
Aspartame 20Kg
Strawberry essence 8Kg
Carmine 0.2Kg
Magnesium stearate 20Kg
10% 30 POVIDONE K 30 BP/USP, 30 ethanol solutions are an amount of
Process 1000
Technology:
1. former, adjuvant was pulverized 100 mesh sieves, took by weighing 30 POVIDONE K 30 BP/USP 30 and was made into 10% solution as binding agent with 70% ethanol in right amount, and was subsequent use.
2. take by weighing clenbuterol hydrochloride and mannitol, the carmine of recipe quantity, be dissolved in jointly in the 300L water, be spray dried to powder, be material 1.
3. get Icing Sugar, citric acid, sodium bicarbonate, Aspartane, the strawberry essence of material 1 and recipe quantity, mixing., granulate as adhesive with 10% 30 POVIDONE K 30 BP/USP, 30 ethanol solutions with 24 mesh sieves.Wet granular in 60 ℃ of air dry ovens dry 2 hours, treat that particle drying fully after, cross 20 mesh sieve granulate.
4. get top dried particles, sneak into magnesium stearate, mixing, tabletting promptly gets.
Embodiment 6,
Clenbuterol hydrochloride 0.04Kg, mannitol 100Kg is dissolved in the 300L water jointly, uses the spray dryer of LB6-5 type, and parameter is provided with as follows:
Intake air temperature: 150～180 ℃; Air outlet temperature: 90～110 ℃; Delivery rate: 3ml/ branch; Nebulizer rotating speed: 500 rev/mins.
Carry out spray drying according to the above-mentioned parameter setting.Be spray dried to fine powder.
Embodiment 7,
Clenbuterol hydrochloride 0.04Kg, lactose 100Kg is dissolved in the 300L water jointly, uses the spray dryer of LB6-5 type, and parameter is provided with as follows:
Intake air temperature: 150～180 ℃; Air outlet temperature: 90～110 ℃; Delivery rate: 3ml/ branch; Nebulizer rotating speed: 500 rev/mins.
Carry out spray drying according to the above-mentioned parameter setting.Be spray dried to fine powder.
Embodiment 8,
Clenbuterol hydrochloride 0.04Kg, sucrose l00Kg is dissolved in the 300L ethanol jointly, obtains suspension, uses the spray dryer of LB6-5 type, and parameter is provided with as follows:
Intake air temperature: 150～180 ℃; Air outlet temperature: 90～110 ℃; Delivery rate: 3ml/ branch; Nebulizer rotating speed: 500 rev/mins.
Carry out spray drying according to the above-mentioned parameter setting.Be spray dried to fine powder.
Embodiment 9,
Clenbuterol hydrochloride 0.04Kg, glucose 100Kg is dissolved in the 300L water jointly, uses the spray dryer of LB6-5 type, and parameter is provided with as follows:
Intake air temperature: 150～180 ℃; Air outlet temperature: 90～110 ℃; Delivery rate: 3ml/ branch; Nebulizer rotating speed: 500 rev/mins.
Carry out spray drying according to the above-mentioned parameter setting.Be spray dried to fine powder.
Embodiment 10,
Clenbuterol hydrochloride 0.04Kg, fructose 100Kg is dissolved in the 300L water jointly, uses the spray dryer of LB6-5 type, and parameter is provided with as follows:
Intake air temperature: 150～180 ℃; Air outlet temperature: 90～110 ℃; Delivery rate: 3ml/ branch; Nebulizer rotating speed: 500 rev/mins.
Carry out spray drying according to the above-mentioned parameter setting.Be spray dried to fine powder.
Embodiment 11,
Clenbuterol hydrochloride 0.04Kg, sodium carboxymethyl cellulose 100Kg is dissolved in the 300L chloroform jointly, obtains suspension, uses the spray dryer of LB6-5 type, and parameter is provided with as follows:
Intake air temperature: 150～180 ℃; Air outlet temperature: 90～110 ℃; Delivery rate: 3ml/ branch; Nebulizer rotating speed: 500 rev/mins.
Carry out spray drying according to the above-mentioned parameter setting.Be spray dried to fine powder.
Embodiment 12,
Clenbuterol hydrochloride 0.04Kg, mannitol 1000Kg is dissolved in the 500L methanol jointly, obtains suspension, uses the spray dryer of LB6-5 type, and parameter is provided with as follows:
Intake air temperature: 150～180 ℃; Air outlet temperature: 90～110 ℃; Delivery rate: 3ml/ branch; Nebulizer rotating speed: 500 rev/mins.
Carry out spray drying according to the above-mentioned parameter setting.Be spray dried to fine powder.
Claims (5)
1. homodisperse method of clenbuterol hydrochloride; It is characterized in that; This method may further comprise the steps: clenbuterol hydrochloride and medicine acceptable carrier are dissolved in process solution or suspension in the solvent; With above-mentioned solution or dry dried granules or the powder of forming of suspension, wherein said medicine acceptable carrier is selected from: the mixture of one or more in mannitol, sucrose, lactose, glucose, fructose, the sodium carboxymethyl cellulose, wherein said solvent are water; Wherein clenbuterol hydrochloride and medicine acceptable carrier ratio are: 1: 10-100000, wherein said is spray drying with above-mentioned solution or suspension drying.
2. the method for preparing of a homodisperse clenbuterol hydrochloride preparation; It is characterized in that; Comprising that the method for using claim 1 is dissolved in clenbuterol hydrochloride and medicine acceptable carrier processes solution or suspension in the solvent; With above-mentioned solution or dry dried granules or the powder of forming of suspension, be prepared into pharmaceutical preparation through the galenic pharmacy routine techniques again.
3. according to the method for preparing of claim 2, it is characterized in that wherein said preparation is selected from the preparation of any other form except that liquid preparation.
4. according to the method for claim 1, it is characterized in that this method comprises the following steps: to take by weighing clenbuterol hydrochloride and carrier; Solubilizer makes dissolving or evenly is suspended in the solvent; Subsequent use, use spray dryer that above-mentioned solution or suspension are dried to powder, granule or other forms, solvent for use is a water; Course of dissolution can heat, and also can not heat.
5. according to the method for claim 1, it is characterized in that this method comprises the following steps: clenbuterol hydrochloride 0.04kg, mannitol 100kg is dissolved in the 300L water jointly, uses the spray dryer of LB6-5 type, wherein, and intake air temperature: 150-180 ℃; Air outlet temperature: 90-110 ℃; Delivery rate: 3ml/ branch; The nebulizer rotating speed: 500 rev/mins, carry out spray drying according to the above-mentioned parameter setting, be spray dried to fine powder.
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| CN104188941B (en) * | 2014-09-02 | 2016-11-16 | 重庆和平制药有限公司 | A kind of method preparing clenbuterol hydrochloride inhaling powder mist agent |
| CN104958338B (en) * | 2015-07-15 | 2018-06-08 | 江苏中兴药业有限公司 | A kind of method for improving the medicament contg uniformity |
| CN109674756B (en) * | 2019-02-19 | 2021-03-16 | 河北君临药业有限公司 | Clenbuterol hydrochloride tablet and preparation method thereof |
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| CN100438914C (en) * | 2003-10-15 | 2008-12-03 | 富士化学工业株式会社 | Tablet quickly disintegrating in oral cavity |
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Effective date of registration: 20200330 Address after: 050035 Tianshan Science Park 6-501, No.319 Xiangjiang Road, hi tech Zone, Shijiazhuang City, Hebei Province Patentee after: HEBEI FEINISI BIOTECHNOLOGY Co.,Ltd. Address before: 050035 No. 319, Xiangjiang Road, Shijiazhuang, Hebei Patentee before: Liu Chao |