CN101301276A - Preparation of microcrystallite medicament - Google Patents
Preparation of microcrystallite medicament Download PDFInfo
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- CN101301276A CN101301276A CNA2008101404740A CN200810140474A CN101301276A CN 101301276 A CN101301276 A CN 101301276A CN A2008101404740 A CNA2008101404740 A CN A2008101404740A CN 200810140474 A CN200810140474 A CN 200810140474A CN 101301276 A CN101301276 A CN 101301276A
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Abstract
The invention discloses a method for preparing a microgranular drug, which belongs to the organic drug microcrystallite manufacturing field and is suitable for preparing raw material drugs of eye drops, aerosol, and cutaneous permeable agents. The main technology is as follows: an organic raw material drug with a granularity between 10 and 300 mu m and dispersion liquid are plunged into a storage tank according to the weight ratio of 5-45:100, are mixed and stirred into suspension, and are crushed by an ultrasonic crusher special for drugs, and microcrystallites of the organic drug in the dispersion liquid are collected by a filtering apparatus and are gathered into a filter cake which is dried then. The method has the advantages that: the method overcomes the disadvantages in the prior preparation method, has no pollution during the crushing, extremely small loss of the raw material drug, simple crushing method and convenient equipment, and is suitable for large-scale industrialized production.
Description
One, technical field
The invention belongs to organic drug crystallite product and make the field.
Two, background technology
The countries in the world pharmacopeia: routine Chinese Pharmacopoeia 2005, American Pharmacopeia usp30, British Pharmacopoeia BP2007 and European Pharmacopoeia EP5 have all clearly set forth the prescription to the microcrystalline grain of organic drug, aspect crude drug and preparation variety, specified in more detail need the kind of control organic drug microcrystalline grain granularity and the span of control of granularity.It is indispensable unit operations part in the medical industry that medicine crystal is pulverized, and in the production of microcrystalline grain at modern medicines of machine medicine, being widely used in the eye drop, aerosol, cutaneous permeable agent of crude drug and preparation production all has application.The microcrystalline grain of organic drug can make human body that the absorption of relevant organic drug is improved relatively, be worth to increase drug utilization, improve the curative effect of medicine, the microcrystalline grain by the preparation organic drug reaches maximum raising and improves the bioavailability of organic drug to human body.Production technology in the past: in order to adapt to the needs of medical aspect, a lot of organic drugs need be adjusted to the microcrystalline grain that is fit to treatment to granularity, and preparation method has a variety of, are divided into mechanical type preparation and chemical formula preparation two big classes.The mechanical type preparation method has comminution by gas stream, colloid mill comminuting method, shearing method etc.Medicine crystal is pulverized by the knife cut of high speed rotating, or passes through the method for dry grinding or wet grinding, and medicine crystal is pulverized.Chemical method prepares microcrystalline grain and often adopts super critical gas generation method, the supersaturated solution sedimentation method, the less microcrystalline grain of antisolvent crystallisation method production granularity.More than the shortcoming of these breaking methods: their common weakness are exactly the granularity control in can not solving more among a small circle, and machinery equipment costs an arm and a leg, the cost height, the loss height, the operational approach complexity, production process can cause the pollution of environmental pollution and medicine itself.
Three, summary of the invention
Purpose of the present invention be exactly to invent a kind of granularity of pulverizing the Organic Ingredients medicine should be thin, production efficiency is high again, the former medicine of loss is few again, the production equipment price is also wanted the preparation method of cheap microcrystallite medicament.
The technical scheme that technical solution problem of the present invention is adopted is: with granularity in 10 μ m-300 mu m ranges Organic Ingredients medicine and dispersion liquid by 5-45: 100 weight ratio drops in the storage tank and is mixed into suspension, pulverize through the special-purpose ultrasonic grinding machine of medicine, collect the microcrystalline grain of the organic drug in the dispersion liquid with defecator, microcrystalline grain is gathered into filter cake, and filter cake is again through super-dry.
Beneficial effect of the present invention is: the present invention has overcome the shortcoming of original preparation method, and there is not pollution in crushing process, and the crude drug loss is few, and breaking method is simple, and equipment is cheap, is fit to big suitability for industrialized production.
Four, the specific embodiment
With granularity in 10 μ m-300 mu m ranges Organic Ingredients medicine and dispersion liquid by 5-45: 100 weight ratio drops in the storage tank and is mixed into suspension, pulverize through the special-purpose ultrasonic grinding machine of medicine, collect the microcrystalline grain of the organic drug in the dispersion liquid with defecator, microcrystalline grain is gathered into filter cake, and filter cake is again through super-dry.The special-purpose ultrasonic grinding machine of medicine is exactly a utility model patent, the patent No.: ZL200720089573.1, notification number: 201001843.The granularity of pulverizing the organic drug microcrystalline grain that obtains through the special-purpose ultrasonic grinding machine of medicine is 0.5 μ m-7 μ m, and maximum particle diameter is less than 10 μ m.The organic drug microcrystalline grain refine to the absorbent effect of skin, and the degree that bioavailability of medicament is improved greatly is just with the medicine grain refinement, thin more good more.With the blended dispersion liquid of crude drug be pure water, acetone, methanol, ethanol, tetrahydrochysene furan south.Dispersion liquid can not dissolve crude drug, and dispersibility liquid preferably.Filter cake is with exsiccant method drying, and exsiccant method is: lyophilization drying, boulton process drying.Some ways are in specific operation process: the Organic Ingredients medicine of one kilogram of granularity of ultrasonic grinding in 10 μ m-300 mu m ranges need be through sampling Detection after 0.5-3 hour the pulverizing, detect qualified after, for guaranteeing product quality, pulverize through 15 minutes ultrasonic grinding machine again, guarantee product quality.
Embodiment:
(1) according to customer requirement prepared sizes＜7 μ m, purity 〉=99% hydrocortisone
Hydrocortisone crude drug 5kg is put in the drug reservoir in the special-purpose ultrasonic grinding machine of the medicine system, add the airtight stirring of dispersion liquid 50kg, make into suspension, open the special-purpose ultrasonic grinding machine of medicine blood circulation, begin super powder, super powder was surveyed sample the granularity of hydrocortisone microcrystalline grain after 5 hours, and microcrystalline grain meets the requirements of the standard fully.After the hydrocortisone microcrystalline grain passed examination, continue super powder 1.25 hours, stop super powder.Through behind the system filtration, filter cake is through the lyophilization drying with the dispersion soln that contains hydrocortisone that obtains, obtains the microcrystalline grain product of the hydrocortisone that 4.98kg meets the requirements of the customers.
(2) prepared sizes＜5 μ m, purity 〉=99% prednisone
Prednisone crude drug 5kg is put in the drug reservoir in the special-purpose ultrasonic grinding machine of the medicine system, add dispersion liquid 50kg, airtight stirring, make into suspension, open the special-purpose ultrasonic grinding machine of medicine blood circulation, begin super powder, super powder is after 5 hours, the granularity of sampling check prednisone microcrystalline grain, microcrystalline grain meets the requirements of the standard fully.After the prednisone microcrystalline grain passed examination, continue super powder 1.25 hours, stop super powder.After obtaining containing the dispersion soln process system filtration of prednisone, filter cake obtains the microcrystalline grain product of 4.99kg prednisone through the lyophilization drying.
(3) prepared sizes＜5 μ m, purity 〉=99% hydrocortisone acetate
Hydrocortisone acetate crude drug 5kg is put in the drug reservoir in the special-purpose ultrasonic grinding machine of the medicine system, add dispersion liquid 50kg, airtight stirring, make into suspension, open the special-purpose ultrasonic grinding machine of medicine blood circulation, begin super powder, super powder is after 5 hours, the granularity of sampling check hydrocortisone acetate microcrystalline grain, microcrystalline grain meets the requirements of the standard fully.After the hydrocortisone acetate microcrystalline grain passed examination, continue super powder 1.25 hours, stop super powder.Behind the dispersion soln process system filtration that contains hydrocortisone acetate that obtains, filter cake obtains the microcrystalline grain product of 4.99kg hydrocortisone acetate through the lyophilization drying.
(4) prepared sizes＜5 μ m, purity 〉=95% prednisolone
Prednisolone crude drug 5kg is put in the drug reservoir in the special-purpose ultrasonic grinding machine of the medicine system, add dispersion liquid 50kg, airtight stirring, make into suspension, open the special-purpose ultrasonic grinding machine of medicine blood circulation, begin super powder, super powder is after 5 hours, the granularity of sampling check prednisolone microcrystalline grain, microcrystalline grain meets the requirements of the standard fully.After the prednisolone microcrystalline grain passed examination, continue super powder 1.25 hours, stop super powder.Behind the dispersion soln process system filtration that contains prednisolone that obtains, filter cake obtains the microcrystalline grain product of 4.497kg prednisolone through the lyophilization drying.
(5) prepared sizes＜5 μ m, purity 〉=99% cortisone acetate
Cortisone acetate crude drug 5kg is put in the special-purpose ultrasonic grinding machine of the medicine system Chinese medicine storage tank, add dispersion liquid 50kg, airtight stirring, make into suspension, open the special-purpose ultrasonic grinding machine of medicine blood circulation, begin super powder, super powder is after 5 hours, the granularity of sampling check cortisone acetate microcrystalline grain, microcrystalline grain meets the requirements of the standard fully.After the cortisone acetate microcrystalline grain passed examination, continue super powder 1.25 hours, stop super powder.Behind the dispersion soln process system filtration that contains cortisone acetate that obtains, filter cake obtains the microcrystalline grain product of 4.497kg cortisone acetate through the lyophilization drying.
(6) prepared sizes＜5 μ m, purity 〉=99% Wo Shi thing
Wo Shi raw material medicine 3kg is put in the special-purpose ultrasonic grinding machine of the medicine system Chinese medicine storage tank, add dispersion liquid 50kg, airtight stirring, make into suspension, open the special-purpose ultrasonic grinding machine of medicine blood circulation, begin super powder, super powder is after 5 hours, the granularity of sampling check Wo Shi thing microcrystalline grain, microcrystalline grain meets the requirements of the standard fully.After the Wo Shi thing microcrystalline grain passed examination, continue super powder 1.25 hours, stop super powder.Behind the dispersion soln process system filtration that contains the Wo Shi thing that obtains, filter cake obtains the microcrystalline grain product of 2.497kg Wo Shi thing through the lyophilization drying.
(7) prepared sizes＜5 μ m, purity 〉=99% flumetasone dragon
Flumetasone dragon crude drug 5kg is put in the special-purpose ultrasonic grinding machine of the medicine system Chinese medicine storage tank, add dispersion liquid 50kg, airtight stirring, make into suspension, open the special-purpose ultrasonic grinding machine of medicine blood circulation, begin super powder, super powder is after 4 hours, the granularity of sampling check flumetasone dragon microcrystalline grain, microcrystalline grain meets the requirements of the standard fully.After the flumetasone dragon microcrystalline grain passed examination, continue super powder 1 hour, stop super powder.Behind the dispersion soln process system filtration that contains the flumetasone dragon that obtains, filter cake obtains the microcrystalline grain product of 4.497kg flumetasone dragon through the lyophilization drying.
Claims (5)
1. the preparation method of a microcrystallite medicament, it is characterized in that: with granularity in 10 μ m-300 mu m ranges Organic Ingredients medicine and dispersion liquid by 5-45: 100 weight ratio drops in the storage tank and is mixed into suspension, pulverize through the special-purpose ultrasonic grinding machine of medicine, collect the microcrystalline grain of the organic drug in the dispersion liquid with defecator, crystallite is gathered into filter cake, and filter cake is again through super-dry.
2. the preparation method of a kind of microcrystallite medicament according to claim 1 is characterized in that: the granularity of pulverizing the organic drug microcrystalline grain that obtains through the special-purpose ultrasonic grinding machine of medicine is 0.5 μ m-7 μ m, and maximum particle diameter is less than 10 μ m.
3. the preparation method of a kind of microcrystallite medicament according to claim 1, it is characterized in that: dispersion liquid is pure water, acetone, methanol, ethanol, tetrahydrochysene furan south.
4. the preparation method of a kind of microcrystallite medicament according to claim 1, it is characterized in that: exsiccant method is: lyophilization drying, boulton process drying.
5. the preparation method of a kind of microcrystallite medicament according to claim 1, it is characterized in that: the Organic Ingredients medicine of one kilogram of granularity of ultrasonic grinding in 10 μ m-300 mu m ranges need be through sampling Detection after 0.5-3 hour the pulverizing, detect qualified after, for guaranteeing product quality, pulverize through 15 minutes ultrasonic grinding machine again.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA2008101404740A CN101301276A (en) | 2008-06-25 | 2008-06-25 | Preparation of microcrystallite medicament |
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| CNA2008101404740A CN101301276A (en) | 2008-06-25 | 2008-06-25 | Preparation of microcrystallite medicament |
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| CN101301276A true CN101301276A (en) | 2008-11-12 |
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| CNA2008101404740A Pending CN101301276A (en) | 2008-06-25 | 2008-06-25 | Preparation of microcrystallite medicament |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102552283A (en) * | 2010-11-23 | 2012-07-11 | 天津金耀集团有限公司 | Transdermal absorption drug for skin prepared from hydrocortisone butyrate containing adjuvant and water containing adjuvant |
| CN114213495A (en) * | 2021-12-09 | 2022-03-22 | 河南利华制药有限公司 | Method for refining fluorometholone |
-
2008
- 2008-06-25 CN CNA2008101404740A patent/CN101301276A/en active Pending
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102552283A (en) * | 2010-11-23 | 2012-07-11 | 天津金耀集团有限公司 | Transdermal absorption drug for skin prepared from hydrocortisone butyrate containing adjuvant and water containing adjuvant |
| CN102552283B (en) * | 2010-11-23 | 2015-03-18 | 天津金耀集团有限公司 | Transdermal absorption drug for skin prepared from hydrocortisone butyrate containing adjuvant and water containing adjuvant |
| CN114213495A (en) * | 2021-12-09 | 2022-03-22 | 河南利华制药有限公司 | Method for refining fluorometholone |
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Open date: 20081112 |