CN102772384A - Minocycline hydrochloride sustained release tablet and preparation method thereof - Google Patents
Minocycline hydrochloride sustained release tablet and preparation method thereof Download PDFInfo
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Abstract
The invention discloses a minocycline hydrochloride sustained release tablet which is prepared from the following components in parts by weight: 40-90 parts of hydrochloride sustained release tablet, 80-120 parts of hydroxypropyl methylcellulose, 200-260 parts of lactose, 3-8 parts of silicon dioxide, 2-6 parts of magnesium stearate and 4-10 parts of coating materials. The invention also discloses a preparation method of the sustained release tablet. According to the minocycline hydrochloride sustained release tablet disclosed by the invention, the known unhealthy acute vestibule events caused by minocyline can be reduced, the tablet is released stably; and the preparation method has the advantages that the concept is ingenious, the flow is simple, the process is stable, the operation is simple and convenient, the production period is short, the product yield and the product stability are increased, and the production cost is lowered.
Description
Technical field
The invention belongs to technical field of pharmaceutical chemistry, relate to a kind of minocycline hydrochloride sustained release tablet and preparation method thereof.
Background technology
Acne vulgaris is a kind of chronic inflammatory disease dermatoses of sebaceous gland; The sickness rate of acne is up to 85% in the 12-24 year teenager, and the male is many in the morbidity of 14-19 year, and the women is many in the morbidity of 10-17 year; Most recoveries from illness before 25 years old, have only few part to can continue until 45 years old and after.Acne is not only a kind of physical disease, its at aspects such as social activity, psychology, emotions to patient's influence not second to diseases such as serious asthma, epilepsy, diabetes, lumbago and skelalgia, arthritis, therefore, acne is a kind of psychosomatic disease that can not be ignored.
Because the inflammatory reaction that dyskeratosis, the sebum secretion of the cutaneous inflammatory lesion of acne---pimple, pustule, tuberosity or cyst and pilosebaceous duct increase, propionibacterium acnes is bred in a large number and cause all has relation, so treatment should comprise anti-keratinization, degrease and infection.Generally, can adopt local anti-keratinization, degrease (the same) and local antibacterials (like benzoyl peroxide, erythromycin, clindamycin, Azelaic Acid etc.) for the cutaneous inflammatory lesion (a small amount of pimple/pustule only being arranged, no tuberosity cyst) of slight acne vulgaris.But, should notice that the local topical antibiotic is to cause one of drug-fast key factor of propionibacterium acnes, particularly skin lesion periphery drug level is starkly lower than skin lesion central authorities, is prone to inducible resistance.For in to the cutaneous inflammatory lesion of severe acne (is main with pimple/pustule, do not have or a small amount of tuberosity cyst arranged) need be main then with infection, anti-acne are auxilliary, can select for use oral antibiotic to add the external tretinoin.For being master's severe acne with tuberosity/cyst; Then need oral isotretinoin to add oral antibiotic or oral estrogen adds oral antibiotic; Can share a certain amount of corticosteroid hormone in case of necessity; Wherein, oral isotretinoin is the standard method of the serious acne of treatment, but can not use simultaneously with Tetracyclines; Oral estrogen is only applicable to female patient, and epidemiology shows that male's patients with acne is generally more than the women.Therefore; In the external clinical trial of minocycline hydrochloride sustained release tablet; Do not include in tuberosity/cyst is the acne vulgaris patient of main cutaneous inflammatory lesion; But included in pimple/pustule is the acne vulgaris patient of main cutaneous inflammatory lesion (tuberosity or cyst < 2), so the indication of minocycline hydrochloride sustained release tablet is defined as the cutaneous inflammatory lesion of treatment non-nodular moderate to severe acne, this meets the present situation of clinical practice basically.
At present clinically be used to treat the alternative oral antibiotic of acne vulgaris Tetracyclines, Macrolide, clindamycin, bactrim and quinolones are arranged.
Minocycline have absorb rapidly and be close to fully (more than 95% of dosage), long half time (15-25h), it is fat-soluble that higher (fat/water partition coefficient is 39.9; And tetracycline is 0.102, doxycycline is 0.63); And then more being prone to advantages such as absorption, convenient drug administration than other Tetracyclines during with clothes to rich lipid tissue permeability and distributivity better (more likely infiltrating through the micropowder thorn) and with food, an outstanding person can yet be regarded as in second filial generation tetracycline medication.But, though minocycline is the choice drug of treating acne at present, confirmed highly effective, the especially acute vestibule adverse events of its adverse events (as feel sick, vomiting, dizzy, dizzy or tinnitus) incidence rate seriously limited the use of this medicine.The clinical observation prompting of the normal release formulation of the minocycline acute vestibule adverse events relevant with minocycline more often occurred among the less patient of the bodily form (average body surface area).And some clinician advises using low predose to reduce the acute vestibule adverse events of minocycline.These important observations are pointed out maybe be useful according to body weight calculating dosage, and rapid absorption and high blood drug level possibly be the reasons that causes clinical acute vestibule adverse events during the treatment beginning.
The research and development of minocycline slow releasing tablet are in order to reduce the acute vestibule adverse events that known minocycline causes.More slowly reaching blood peak concentration of drug and lower blood peak concentration of drug can see through speed and the dose that blood brain barrier gets into the central nervous system by corresponding minimizing minocycline, thereby allows vestibular apparatus to adapt to the existence of minocycline, reduces the incidence rate of vestibule adverse events.
Summary of the invention
The objective of the invention is to provides a kind of hydrochloric acid minot ring slow releasing tablet to the deficiency that exists in the prior art.This slow releasing tablet has reduced the acute vestibule adverse events that known minocycline causes, drug release is stable.
Another object of the present invention provides the method for preparing of above-mentioned hydrochloric acid minot ring slow releasing tablet.This method for preparing process stabilizing, easy and simple to handle, with short production cycle, improved product yield and product stability, reduced production cost.
For realizing above-mentioned purpose, the technical solution adopted for the present invention to solve the technical problems is:
A kind of minocycline hydrochloride sustained release tablet is made up of following components in weight percentage:
Minocycline hydrochloride 40-90 part
Hypromellose 80-120 part
Lactose 200-260 part
Silicon dioxide 3-8 part
Magnesium stearate 2-6 part
Coating material 4-10 part.
As optimal way, constitute by following components in weight percentage:
Minocycline hydrochloride 45-80 part
Hypromellose 95-115 part
230 parts of lactose
5 parts of silicon dioxide
3.5 parts of magnesium stearate
7.8 parts of coating materials.
Further preferred, said coating material is stomach dissolved film coating pre-mix dose, purified water.
A kind of method for preparing of minocycline hydrochloride sustained release tablet may further comprise the steps:
A, minocycline hydrochloride is crossed the 100-120 mesh sieve, adjuvant is crossed the 80-100 mesh sieve, and is subsequent use;
B, get recipe quantity minocycline hydrochloride, hypromellose, lactose, mix homogeneously adopts the dry-pressing of dry granulation machine to granulate, and sieve is got 16 orders-30 order granule;
C, the granule that the sieve among the step B is got add silicon dioxide, the magnesium stearate mix homogeneously of recipe quantity, press plain sheet;
D, take by weighing the stomach dissolved film coating pre-mix dose of recipe quantity, be mixed with 10% coating solution with purified water;
E, get the plain sheet among the step C, sieve removes fine powder, puts in the coating pan, when slowly being warming up to 35-40 ℃ of sheet bed tempertaure, plain sheet is carried out coating, makes minocycline hydrochloride sustained release tablet.
As optimal way, among the step B, the extrusion speed of said granulator is 20-25r/min, and pressure is 2.5-3.0Mpa.
As optimal way, among the step B, the fine powder circulation of sifting out adds granulates.
As optimal way, in the step e, tablet increased weight about 2% o'clock, stopped coating, continued to blow 45-50 ℃ of hot blast 10 minutes, took out coated tablet.
Minocycline slow releasing tablet drug release of the present invention is stable; More slowly reach blood peak concentration of drug and lower blood peak concentration of drug and can see through speed and the dose that blood brain barrier gets into the central nervous system by corresponding minimizing minocycline; Thereby allow the existence of vestibular apparatus adaptation minocycline, reduce the incidence rate of vestibule adverse events.
Because it is minocycline hydrochloride to damp and hot instability, adopts wet granulation and other prepared relative substance obviously to increase, particularly poor obvious to the minocycline increase; Drug quality is wayward, and the present invention adopts dry granulation technology, one-step palletizing; Wet granulation and drying process have been reduced; Avoided dry run and damp and hot influence to product quality, improved the quality of finished product, drug release is stable.Improve product yield and increased the stability of product.Process stabilizing, easy and simple to handle, with short production cycle, reduce the joint production cost.
Beneficial effect of the present invention is: hydrochloric acid minot ring slow releasing tablet of the present invention has reduced the acute vestibule adverse events that known minocycline causes, drug release is stable; Method for preparing is skillfully constructed, flow process is simple, and process stabilizing is easy and simple to handle, with short production cycle, has improved product yield and product stability, has reduced production cost.
The specific embodiment
Disclosed all characteristics in this description, or the step in disclosed all methods or the process except mutually exclusive characteristic and/or the step, all can make up by any way.
Comparative Examples: a kind of minocycline hydrochloride sustained release tablet, it is write out a prescription as follows:
Minocycline hydrochloride 45.0g (by minocycline)
Hypromellose (E50LV) 95.0g
Lactose 230.0g
Silicon dioxide 5.0g
Magnesium stearate 3.5g
The coating prescription:
Stomach dissolved film coating pre-mix dose 7.8g
Purified water 70.2ml
Method for preparing:
(1) minocycline hydrochloride is crossed 100 mesh sieves, adjuvant is crossed 80 mesh sieves, and is subsequent use.
(2) take by weighing minocycline hydrochloride, hypromellose (E50LV), the lactose of recipe quantity, mix homogeneously adds purified water and prepares soft material, crosses 20 mesh sieves and granulates, and 50 ℃ of dryings are crossed 20 mesh sieve granulate.
(3) silicon dioxide, the magnesium stearate mix homogeneously of adding recipe quantity are pressed plain sheet.
(4) take by weighing the stomach dissolved film coating pre-mix dose of recipe quantity, be mixed with 10% coating solution with purified water, subsequent use.
(5) get plain sheet, sieve removes fine powder, puts in the coating pan, slowly during about 35 ℃ of blowing hot-air to sheet bed tempertaure, plain sheet is carried out coating, treats that tablet increased weight at about 2% o'clock, stops coating, continues blowing hot-air 10 minutes, takes out coated tablet.
Embodiment 1: a kind of minocycline hydrochloride sustained release tablet, and it is write out a prescription as follows:
Minocycline hydrochloride 45.0g (by minocycline)
Hypromellose (E50LV) 95.0g
Lactose 230.0g
Silicon dioxide 5.0g
Magnesium stearate 3.5g
The coating prescription:
Stomach dissolved film coating pre-mix dose 7.8g
Purified water 70.2ml
Preparation technology:
(1) minocycline hydrochloride is crossed 100 mesh sieves, adjuvant is crossed 80 mesh sieves, and is subsequent use.
(2) take by weighing minocycline hydrochloride, hypromellose (E50LV), the lactose of recipe quantity, mix homogeneously is with the dry granulation machine dry-pressing (extrusion speed: 20r/min of granulating; Pressure: 3.0MPa), sieve is got 16 orders-30 order granule, and the fine powder that sifts out circulation adds granulates.
(3) silicon dioxide, the magnesium stearate mix homogeneously of adding recipe quantity are pressed plain sheet.
(4) take by weighing the stomach dissolved film coating pre-mix dose of recipe quantity, be mixed with 10% coating solution with purified water, subsequent use.
(5) get plain sheet, sieve removes fine powder, puts in the coating pan, slowly during about 35 ℃ of blowing hot-air to sheet bed tempertaure, plain sheet is carried out coating, treats that tablet increased weight at about 2% o'clock, stops coating, continues blowing hot-air 10 minutes, takes out coated tablet.
Embodiment 2: a kind of minocycline hydrochloride sustained release tablet, and it is write out a prescription as follows:
Minocycline hydrochloride 45.0g (by minocycline)
Hypromellose (E50LV) 95.0g
Mannitol 230.0g
Silicon dioxide 5.0g
Magnesium stearate 3.5g
The coating prescription:
Stomach dissolved film coating pre-mix dose 7.8g
Purified water 70.2ml
Preparation technology:
(1) minocycline hydrochloride is crossed 100 mesh sieves, adjuvant is crossed 80 mesh sieves, and is subsequent use.
(2) take by weighing minocycline hydrochloride, hypromellose (E50LV), the mannitol of recipe quantity, mix homogeneously is with the dry granulation machine dry-pressing (extrusion speed: 20r/min of granulating; Pressure: 3.0MPa), sieve is got 16 orders-30 order granule, and the fine powder that sifts out circulation adds granulates.
(3) silicon dioxide, the magnesium stearate mix homogeneously of adding recipe quantity are pressed plain sheet.
(4) take by weighing the stomach dissolved film coating pre-mix dose of recipe quantity, be mixed with 10% coating solution with purified water, subsequent use.
(5) get plain sheet, sieve removes fine powder, puts in the coating pan, slowly during about 35 ℃ of blowing hot-air to sheet bed tempertaure, plain sheet is carried out coating, treats that tablet increased weight at about 2% o'clock, stops coating, continues blowing hot-air 10 minutes, takes out coated tablet.
Embodiment 3: a kind of minocycline hydrochloride sustained release tablet, and it is write out a prescription as follows:
Minocycline hydrochloride 45.0g (by minocycline)
Hypromellose (E50LV) 95.0g
Lactose 230.0g
Silicon dioxide 5.0g
Magnesium stearate 3.5g
The coating prescription:
Stomach dissolved film coating pre-mix dose 7.8g
Purified water 70.2ml
Preparation technology:
(1) minocycline hydrochloride is crossed 100 mesh sieves, adjuvant is crossed 80 mesh sieves, and is subsequent use.
(2) take by weighing minocycline hydrochloride, hypromellose (E50LV), the lactose of recipe quantity, mix homogeneously is with the dry granulation machine dry-pressing (extrusion speed: 20r/min of granulating; Pressure: 2.5MPa), sieve is got 16 orders-30 order granule, and the fine powder that sifts out circulation adds granulates.
(3) silicon dioxide, the magnesium stearate mix homogeneously of adding recipe quantity are pressed plain sheet.
(4) take by weighing the stomach dissolved film coating pre-mix dose of recipe quantity, be mixed with 10% coating solution with purified water, subsequent use.
(5) get plain sheet, sieve removes fine powder, puts in the coating pan, slowly during about 35 ℃ of blowing hot-air to sheet bed tempertaure, plain sheet is carried out coating, treats that tablet increased weight at about 2% o'clock, stops coating, continues blowing hot-air 10 minutes, takes out coated tablet.
Embodiment 4: a kind of minocycline hydrochloride sustained release tablet, and it is write out a prescription as follows:
Minocycline hydrochloride 55.0g (by minocycline)
Hypromellose (E50LV) 100.0g
Lactose 230.0g
Silicon dioxide 5.0g
Magnesium stearate 3.5g
The coating prescription:
Stomach dissolved film coating pre-mix dose 7.8g
Purified water 70.2ml
Preparation technology:
(1) minocycline hydrochloride is crossed 100 mesh sieves, adjuvant is crossed 80 mesh sieves, and is subsequent use.
(2) take by weighing minocycline hydrochloride, hypromellose (E50LV), the lactose of recipe quantity, mix homogeneously is with the dry granulation machine dry-pressing (extrusion speed: 20r/min of granulating; Pressure: 2.5MPa), sieve is got 16 orders-30 order granule, and the fine powder that sifts out circulation adds granulates.
(3) silicon dioxide, the magnesium stearate mix homogeneously of adding recipe quantity are pressed plain sheet.
(4) take by weighing the stomach dissolved film coating pre-mix dose of recipe quantity, be mixed with 10% coating solution with purified water, subsequent use.
(5) get plain sheet, sieve removes fine powder, puts in the coating pan, slowly during about 35 ℃ of blowing hot-air to sheet bed tempertaure, plain sheet is carried out coating, treats that tablet increased weight at about 2% o'clock, stops coating, continues blowing hot-air 10 minutes, takes out coated tablet.
Embodiment 5: a kind of minocycline hydrochloride sustained release tablet, and it is write out a prescription as follows:
Minocycline hydrochloride 65.0g (by minocycline)
Hypromellose (E50LV) 105.0g
Lactose 230.0g
Silicon dioxide 5.0g
Magnesium stearate 3.5g
The coating prescription:
Stomach dissolved film coating pre-mix dose 7.8g
Purified water 70.2ml
Preparation technology:
(1) minocycline hydrochloride is crossed 100 mesh sieves, adjuvant is crossed 80 mesh sieves, and is subsequent use.
(2) take by weighing minocycline hydrochloride, hypromellose (E50LV), the lactose of recipe quantity, mix homogeneously is with the dry granulation machine dry-pressing (extrusion speed: 20r/min of granulating; Pressure: 2.5MPa), sieve is got 16 orders-30 order granule, and the fine powder that sifts out circulation adds granulates.
(3) silicon dioxide, the magnesium stearate mix homogeneously of adding recipe quantity are pressed plain sheet.
(4) take by weighing the stomach dissolved film coating pre-mix dose of recipe quantity, be mixed with 10% coating solution with purified water, subsequent use.
(5) get plain sheet, sieve removes fine powder, puts in the coating pan, slowly during about 35 ℃ of blowing hot-air to sheet bed tempertaure, plain sheet is carried out coating, treats that tablet increased weight at about 2% o'clock, stops coating, continues blowing hot-air 10 minutes, takes out coated tablet.
Embodiment 6: a kind of minocycline hydrochloride sustained release tablet, and it is write out a prescription as follows:
Minocycline hydrochloride 80.0g (by minocycline)
Hypromellose (E50LV) 115.0g
Lactose 230.0g
Silicon dioxide 5.0g
Magnesium stearate 3.5g
The coating prescription:
Stomach dissolved film coating pre-mix dose 7.8g
Purified water 70.2ml
Preparation technology:
(1) minocycline hydrochloride is crossed 100 mesh sieves, adjuvant is crossed 80 mesh sieves, and is subsequent use.
(2) take by weighing minocycline hydrochloride, hypromellose (E50LV), the lactose of recipe quantity, mix homogeneously is with the dry granulation machine dry-pressing (extrusion speed: 20r/min of granulating; Pressure: 2.5MPa), sieve is got 16 orders-30 order granule, and the fine powder that sifts out circulation adds granulates.
(3) silicon dioxide, the magnesium stearate mix homogeneously of adding recipe quantity are pressed plain sheet.
(4) take by weighing the stomach dissolved film coating pre-mix dose of recipe quantity, be mixed with 10% coating solution with purified water, subsequent use.
(5) get plain sheet, sieve removes fine powder, puts in the coating pan, slowly during about 35 ℃ of blowing hot-air to sheet bed tempertaure, plain sheet is carried out coating, treats that tablet increased weight at about 2% o'clock, stops coating, continues blowing hot-air 10 minutes, takes out coated tablet.
1, determination of related substances (lucifuge operation).
These article of getting fine powder is an amount of, adds water and processes the solution that contains minocycline 0.5mg among every 1ml, filters, and gets subsequent filtrate as need testing solution; Precision is measured in right amount, and thin up is processed the solution that contains minocycline 5 μ g among every 1ml, as contrast solution.According to the chromatographic condition under the assay item, get contrast solution 10 μ l and inject chromatograph of liquid, regulate detection sensitivity, make the peak height of main constituent chromatographic peak be about 20%～25% of full scale; Precision is measured each 10 μ l of need testing solution and contrast solution again, injects chromatograph of liquid respectively, 2.6 times of record chromatogram to main constituent peak retention time.In the test sample chromatogram if any impurity peaks; Difference must not be greater than 1.2 times (1.2%) of contrast solution main peak area to the minocycline peak area; Other single impurity peak area must not be greater than 1.2 times (1.2%) of contrast solution main peak area, other each impurity peak area with must not be greater than 2 times (2.0%) (can ignore in any peak less than 0.05 times of contrast solution main peak area of need testing solution) of contrast solution main peak area.
2, drug release determination
These article of getting according to drug release determination method (two appendix X of Chinese Pharmacopoeia version in 2010 D, first method), adopt dissolution method (two appendix X of Chinese Pharmacopoeia version in 2010 C, first method) device; With 0.01mol/L hydrochloric acid solution 900ml is release medium, and rotating speed is that per minute 100 changes, operation in accordance with the law; When 1 hour, 2 hours and 4 hours; Get solution 10ml respectively, filter, and replenish the release medium 10ml of uniform temp immediately; Precision is measured subsequent filtrate 3ml, puts in the 10ml measuring bottle, adds the 0.01mol/L hydrochloric acid solution and is diluted to scale, shakes up, and according to ultraviolet visible spectrophotometry (two appendix IV of Chinese Pharmacopoeia version in 2005 A), measures absorbance in the wavelength of 352nm; It is an amount of that other gets the minocycline hydrochloride reference substance, and accurate the title decides, and processes the solution that contains minocycline 15 μ g among every 1ml approximately with release medium, measures with method, calculates every burst size at different time.Every of these article burst size when 1 hour, 2 hours and 4 hours is respectively more than 30%～52%, 53%～85% and 85% of labelled amount, all should be up to specification.
3, assay is measured according to HPLC (two appendix V of Chinese Pharmacopoeia version in 2010 D).
Chromatographic condition and system suitability test:
Use octyl silane group silica gel to be filler; With 0.2mol/L ammonium acetate-N, dinethylformamide-oxolane (600:398:2 includes the 0.01mol/L Calcium Disodium Versenate) is a mobile phase; The detection wavelength is 280nm.Get the about 10mg of minocycline hydrochloride reference substance, put in the 25ml measuring bottle, after adding water 5ml and making dissolving, put in the boiling water bath heating 60 minutes, cooling, thin up shakes up to scale, gets 10 μ l and injects chromatograph of liquid, the record chromatogram.The tailing factor at minocycline peak should be between 0.9～1.35, and the minocycline peak should be not less than 2.5 with the separating degree of difference to minocycline peak (RRT is about 0.8), and number of theoretical plate calculates by the minocycline peak should be not less than 3000.
Algoscopy: get 20 of these article, the accurate title, decide, porphyrize, and precision takes by weighing in right amount (being equivalent to minocycline 50mg approximately); Put in the 100ml measuring bottle, add ethanol 10ml, after jolting makes sample dispersion evenly rapidly, add water 70ml; The jolting of ultrasonic limit, limit was handled 10 minutes, and thin up shakes up to scale, filtered; Get 5 times of the accurate dilutions of subsequent filtrate water, as need testing solution, precision is measured 10 μ l and is injected chromatograph of liquid, the record chromatogram; It is an amount of that other gets the minocycline hydrochloride reference substance, accurate claims surely, add ethanol 10ml and water and dissolve in right amount, and dilute with water processes the solution that contains minocycline 0.1mg among every 1ml approximately, measures with method,, promptly gets with calculated by peak area by external standard method.
Table 1 is seen in the minocycline hydrochloride sustained release tablet quality contrast of Comparative Examples and embodiment:
Table 1 minocycline hydrochloride sustained release tablet quality contrast table
Visible from above-mentioned experimental data, mass parameters such as minocycline hydrochloride sustained release tablet release degree of the present invention, impurity content obviously are better than existing technology, and drug release is stable; Technology is easy; Easy and simple to handle, reduced the particle drying operation, with short production cycle; Improve product yield and product stability, reduced production cost.
The present invention is not limited to the aforesaid specific embodiment.The present invention expands to any new feature or any new combination that discloses in this manual, and the arbitrary new method that discloses or step or any new combination of process.
Claims (7)
1. a minocycline hydrochloride sustained release tablet is characterized in that, is made up of following components in weight percentage:
Minocycline hydrochloride 40-90 part
Hypromellose 80-120 part
Lactose 200-260 part
Silicon dioxide 3-8 part
Magnesium stearate 2-6 part
Coating material 4-10 part.
2. a kind of minocycline hydrochloride sustained release tablet according to claim 1 is characterized in that, is made up of following components in weight percentage:
Minocycline hydrochloride 45-80 part
Hypromellose 95-115 part
230 parts of lactose
5 parts of silicon dioxide
3.5 parts of magnesium stearate
7.8 parts of coating materials.
3. a kind of minocycline hydrochloride sustained release tablet according to claim 1 and 2 is characterized in that: said coating material is stomach dissolved film coating pre-mix dose, purified water.
4. the method for preparing of a minocycline hydrochloride sustained release tablet according to claim 1 and 2 is characterized in that, may further comprise the steps:
A, minocycline hydrochloride is crossed the 100-120 mesh sieve, adjuvant is crossed the 80-100 mesh sieve, and is subsequent use;
B, get recipe quantity minocycline hydrochloride, hypromellose, lactose, mix homogeneously adopts the dry-pressing of dry granulation machine to granulate, and sieve is got 16 orders-30 order granule;
C, the granule that the sieve among the step B is got add silicon dioxide, the magnesium stearate mix homogeneously of recipe quantity, press plain sheet;
D, take by weighing the stomach dissolved film coating pre-mix dose of recipe quantity, be mixed with 10% coating solution with purified water;
E, get the plain sheet among the step C, sieve removes fine powder, puts in the coating pan, when slowly being warming up to 35-40 ℃ of sheet bed tempertaure, plain sheet is carried out coating, makes minocycline hydrochloride sustained release tablet.
5. the method for preparing of a kind of minocycline hydrochloride sustained release tablet according to claim 4, it is characterized in that: among the step B, the extrusion speed of said granulator is 20-25r/min, and pressure is 2.5-3.0Mpa.
6. the method for preparing of a kind of minocycline hydrochloride sustained release tablet according to claim 4 is characterized in that: among the step B, the fine powder circulation of sifting out adds granulates.
7. the method for preparing of a kind of minocycline hydrochloride sustained release tablet according to claim 4, it is characterized in that: in the step e, tablet increased weight about 2% o'clock, stopped coating, continued to blow 45-50 ℃ of hot blast 10 minutes, took out coated tablet.
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| CN105534941A (en) * | 2016-01-04 | 2016-05-04 | 浙江美华鼎昌医药科技有限公司 | Minocycline hydrochloride sustained release tablets and preparation method |
| CN108414466A (en) * | 2018-03-09 | 2018-08-17 | 浙江美华鼎昌医药科技有限公司 | A kind of minocycline hydrochloride sustained release tablet In Vitro Dissolution assay method |
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| US11331320B2 (en) | 2005-12-13 | 2022-05-17 | Incyte Holdings Corporation | Heteroaryl substituted pyrrolo[2,3-b]pyridines and pyrrolo[2,3-b]pyrimidines as Janus kinase inhibitors |
| US11285140B2 (en) | 2010-03-10 | 2022-03-29 | Incyte Corporation | Piperidin-4-yl azetidine derivatives as JAK1 inhibitors |
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| CN105353062A (en) * | 2015-11-25 | 2016-02-24 | 北京化工大学 | HPLC analysis method for measuring minocycline and related substances thereof |
| CN105534941A (en) * | 2016-01-04 | 2016-05-04 | 浙江美华鼎昌医药科技有限公司 | Minocycline hydrochloride sustained release tablets and preparation method |
| CN108414466A (en) * | 2018-03-09 | 2018-08-17 | 浙江美华鼎昌医药科技有限公司 | A kind of minocycline hydrochloride sustained release tablet In Vitro Dissolution assay method |
| US11833155B2 (en) | 2020-06-03 | 2023-12-05 | Incyte Corporation | Combination therapy for treatment of myeloproliferative neoplasms |
| CN115128185A (en) * | 2022-06-24 | 2022-09-30 | 海口市制药厂有限公司 | Method for detecting impurities in minocycline hydrochloride capsule and product |
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Application publication date: 20121114 |