CN103393543A - Method using 3D printing technology to prepare dropping pills - Google Patents
Method using 3D printing technology to prepare dropping pills Download PDFInfo
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- CN103393543A CN103393543A CN2013103401983A CN201310340198A CN103393543A CN 103393543 A CN103393543 A CN 103393543A CN 2013103401983 A CN2013103401983 A CN 2013103401983A CN 201310340198 A CN201310340198 A CN 201310340198A CN 103393543 A CN103393543 A CN 103393543A
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
- Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
- Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
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Abstract
The invention relates to a method using the 3D printing technology to prepare dropping pills. The method using the 3D printing technology to prepare the dropping pills comprises the steps of (1) using polyethylene glycol and the like as base materials, carrying out heating melting, (2) adding prescription drugs at the specified temperature, carrying out mixing, even stir and freeze drying to obtain solid powder, carrying out sieving on the solid powder, and (3) placing the solid powder into a powder box of a 3D printer, and preparing the dropping pills through electronic drafting, remote data transmission and laser scanning printing. According to the method using the 3D printing technology to prepare the dropping pills, due to the facts that through a series of technologies such as the electronic design technology, the remote data transmission technology, the laser scanning technology and the raw material and auxiliary material melting technology, the specific drug powder materials are melted, and electronic model graphs are changed into the real dropping pills according to designed indications, the advantages of the dropping method of preparing the dropping pills are kept, and the defects that due to the influence of the factors such as physical properties of liquid medicine, droppers and cooling liquid, pill weights are different, the roundness of pills is difficult to control, the percent of pass is low, and specially-shaped dropping pills cannot be easily prepared when the dropping method is used for preparation are overcome.
Description
Technical field
The invention belongs to the medical field, relate to a kind of method for preparing drop pill with the 3D printing technique, particularly relate to the preparation method of a kind of large specification drop pill and special-shaped drop pill.
Background technology
Drop pill refers to solid or liquid medicine and after suitably material (being commonly referred to as substrate) heat fused mixes, splashes in not miscible condensed fluid, and that drop is shrunk to is spherical due to capillary effect, cooled and solidified and the pill made.Main for orally using, also can be for external application and local pleasant, nose, eye, rectum, vagina use.
The main feature of drop pill has: dissolution rate is fast, and bioavailability is high, and untoward reaction is little; Liquid medicine can be made into the solid drop pill, is easy to carry and takes; Increase the stability of medicine.From drop pill, come out and have so far the history of nearly 70 years, its preparation technology, theory, equipment and kind all have very large development, from the above content of summarizing.Drop pill is a kind of good dosage form that continues to develop of waiting, believes that necessarily having more medicine can make drop pill, for clinical, provides service.
Though drop pill has above-mentioned advantage, but also having in process of production some problems, is to borrow medicinal liquid gravity naturally to be oozed by the water dropper mouth of pipe as the pill dripping machine cardinal principle, then enters in liquid coolant and is shrunk to pill.This technique is more to the influence factor of drop pill quality, except mainly by the thickness of dropper bore, being controlled, affected by quality, the temperature of medicinal liquid, in addition, the outward appearance of product, roundness are affected by the factors such as interfacial tension of kind, temperature, medicinal liquid and the liquid coolant of liquid coolant also, make drop pill in commercial production, have the different and uppity problem of pill roundness of the ball method of double differences, and product qualified rate is lower, production cost is higher, especially more than producing 100mg during large specification drop pill problem more outstanding.
At first the concept that the 3D printing-forming technical basis that is proposed by people such as the Sachs of the Massachusetts Institute of Technology " is successively printed, is layering " prepares the object with distinctive appearance or complex internal structure.This technology is take powder as material, and the course of processing is very flexible, and forming speed is fast, and operating cost is low and reliability is high, is to have one of new technique of vitality most in the quick shaping industry.The key equipment 3D printer of this technology generally is comprised of with binding agent feedway precision surface plate and mobile device terminal, powder-processed system, shower nozzle.
3D printing-forming technology has the height process flexibility of having no precedent on traditional manufacture; because position, number of times, the speed of spraying can arbitrarily be controlled; different materials can be by different shower nozzle sprayings; simultaneously owing to numerous conventional processes being combined on a machine to " printing " this process that constantly repeats; to the problem that does not have scale in the commercial production conversion process; can save plenty of time and fund, really embody the advantage of Rapid Prototyping technique.
The present invention is intended to utilize up-to-date technological means, opens up a kind of new drop pill and prepares approach, not only keeps the characteristics that current methods prepares drop pill, but also do not need dropper and liquid coolant, different and the roundness of the ball method of double differences is better controlled, greatly improved product qualified rate, reduced production cost; Simplify simultaneously production technology, dwindled the workshop floor space; More can produce easily various different sizes, difform drop pill.
Summary of the invention
For achieving the above object, the present invention adopts following method to prepare drop pill:
(1) by the drug matrices heating and melting of recipe quantity, and make temperature remain on certain limit, and keep temperature to make it to be in molten condition;
(2) 1 weight portion medicine is added in the substrate of 1-100 weight portion melting, stirs evenly, make uniform medicinal liquid, cooling standby;
(3) above-mentioned cooling medicine piece is sent into to freeze dryer and carried out lyophilization and become the pastille powder, then, through sieving, obtain the pastille powder standby;
(4) the pastille powder after above-mentioned lyophilization is placed in to 3D " printer " powder box, by electronic chart, transfer of data, laser scanning, prints and prepare drop pill; The drop pill of preparation directly enters packing shop and packs.
Substrate of the present invention can be any substrate that drop pill is commonly used, comprises water-soluble base, for example Macrogol 2000～8000, polyoxyethylene monostearate, sodium stearate, glycerin gelatine, carbamide, poloxamer; Or water-insoluble substrate, such as stearic acid, glyceryl monostearate, insect wax, hydrogenated vegetable oil, stearyl alcohol, spermol etc.
Preferred substrate is Macrogol 2000～8000, and described substrate adjuvant heating and melting temperature is 60-80 ℃.
Medicine and substrate adjuvant mix and blend time are 5-100 minute, preferred 10-30 minute.
The ratio of medicine and substrate can be 1: 1-100 weight portion, preferred 1: 1-50 weight portion, more preferably 1: the 1-20 weight portion.
The specification of described drop pill is every ball 1-200mg, preferred 5-150mg, more preferably 10-100mg.
In one embodiment, the pastille powder laying described in printing is that each layer all spreads with identical pastille powder, so is repeated to processing drop pill spray formation and completes.
In one embodiment, use Polyethylene Glycol to do substrate printing drop pill and can not use binding agent.
Any medicine that is suitable for making drop pill can be printed and be prepared into drop pill by 3D, and they can be Chinese medicine, Chinese medicine extract and chemicals, can be liquid, thick paste, powder etc.described medicine can be acyclovir for example, azithromycin, oxaliplatin, Omeprazole Sodium, aztreonam, amifostine, amrinone, atracurium besilate, sodium ozagrel, sodium ferulate, ornidazole, tranexamic acid, aminomethylbenzoic acid, the azithromycin sodium dihydrogen phosphate, aminobutyric acid, sodium ampicillin, amipicloxacillin sodium, Aspirin-arginin, arfonad, amycin, aklavine, amrinone, oxiracetam, hyaluronidase, sodium phenobarbital, phenytoin Sodium, the Fructus Citri tangerinae propyl ester, white-browed snake venom blood coagulation enzyme, C14H25N4NaO11P2, alarelin, the C14H25N4NaO11P2 inosine, alanyl glutamine, bumetanide, betamethasone sodium phosphate, benzathine benzylpenicillin, bristopen, bleomycin, epirubicin, cloth Salmonella live vaccine, interleukin, Radix Isatidis, RhIL-2, recombined human granulocyte-macrophage stimulating factors, the recombinant human somatropin, hepatocyte growth-promoting factors, Andrographolide, recombinant mutant human tumor necrosis factor, vinpocetine, thyroliberin, octreotide acetate, Vinorelbine monotartrate, bulleyaconitine A, superoxide dismutase, vincaleucoblastine, Radix Et Caulis Acanthopanacis Senticosi, Rhizoma Dioscoreae Nipponicae, andrographolide, Radix Bupleuri, DANHONG, to Aminosalicylic sodium, isosorbide mononitrate, breviscapine, low molecular weight heparin sodium, Radix Salviae Miltiorrhizae, the monophosphate cytosine arabinoside, dacarbazine, docetaxel, salvianolate, doxofylline, dexamethasone sodium phosphate, scopolamine butylbromide, dacarbazine, pralidoxime iodide, dopamine, Pheretima, sodium tanshinone IIA sulfate, polyene phosphatidylcholine, Calcium Dibutyryladenosine Cyclophosph-ate, diprophylline, the diacetayl amide acetic ethylenediamine, dimercaptosuccinic acid, Oleum Curcumae, coenzyme A, the fluorine cytidine, actinomycin D, fleroxacin, famotidine, Venenum apis, Coenzyme Complex, compound three-vitamines B, sodium amidotrizoate, etamsylate, fluconazol, fluorouracil, compound monoammonium glycyrrhizinate S, floxuridine, sodium fusidate, fotemustine, voriconazole, compound diisopropylamine dichloroacetate, SNMC, furosemide, floxapenstaphylex, furbenicillin, compound quinine, Compound recipe Radix Isatidis, coenzyme Q10, the compound recipe methionine-vitamin B 1, Fructose Diphosphate sodium, gonadorelin, puerarin, CMNa, Carbamaid peroxide, mannatide, ganciclovir, bone peptide, norfloxacin glutamate, adenosine cyclophosphate, homoharringtonine, the glycyrrhizic acid diamidogen, fructose, bone-melon extract, Kaglutam, calciparine, bacitracin, glucagon, interferon, dactinomycin, mithramycin, glutathione, mannomustin, cyclophosphamide, reduced glutathion, ribonucleic acid, adenosine cyclophosphate, sulfomercaprine sodium, meglumine adenosine cycle phosphate, astragalus polysaccharides, Carthamus yellow, riboflavin sodium phosphate, kedacillin, nootkatin, ribostamycin, ancitabine, sulfatodiamino cyclohexane platinum, erythromycin, the Radix Astragali, Radix Illicii Lanceolati, methotrexate, the metronidazole sodium phosphate, the methoxy isonitrile, Urbason Solubile, phentolamine mesylate, pefloxacin mesilate, pentoxifylline, sodium citrate, collagenase, Gatifloxacin, Kitasamycin tartrate, inosine, spectinomycin hydrochloride, mecobalamin, Pazufloxacin Mesilate, sarcosine peptide aglycone, methionine vitamin B 1, gabexate mesilate, s-ropivacaine mesylate, phloroglucinol, thiamphenicol, kitasamycin tartrate, formyl hydrogen Calcium Folinate-SF, the influenza A vaccine, old tuberculin, dihydroergotoxine methanesulfonate, cimetidine, methyl prednisone sodium succinate, human normal plasma, refined tetanus antitoxin, refined diphtheria antitoxin, Antirobies Serum, Flos Trollii, clindamycin phosphate, carboplatin, Cobratide, bacillus calmette-guerin vaccine, anti-hepatitis B immune ribonucleic acid, kurarinone, matrine, captopril, carbazochrome sodium sulfonate, card nitrogen is situated between, bekanamycin, antilymphocyte globulin, rabies vaccine, AT 581., BCG-polysaccharide nucleic acid, Netilmicin Sulfate, aspisol, kanamycin sulfate, amikacin sulfate, Vistamycin, phosphorus enzyme element sodium, sodium prasterone sulfate, Azithromycin Sulfate, vindesine sulfate, vincristine sulfate, tiopronin, sodium thiosulfate, kangdisu sulfas, amphotericin B, penthiobarbital, Etimicin sulfate., Hemarisin, capreomycin sulfate Capastat sulfate, aerosporin, chondroitin sulfate, AM Bison, terbutaline sulphate, ligustrazine phosphate, lecithin, Micronomicin Sulfate, foscarnet sodium, lornoxicam, rifampicin, etoposide phosphate, rifamicina, armillarisin A, fludarabine phosphate, cervus and cucumis polypeptide, Long Ruikelin, potassium chloride, cloxacillin sodium, streptomycin sulfate, amikacin sulfate, the sulphuric acid oleandomycin, many glutinosins of sulphuric acid E, the sulphuric acid AEROSPORIN, vinblastine sulfate, Clomipramine, fosfomycin sodium, meclofenoxane, aspisol, streptokinase, prodigiosin, streptomycin, ethacrynate sodium, malaridine, ribavirin, Roxithromycin, ropivacaine, asparaginase, maleic acid Archie enzyme element, meropenem, Chymotrypsin, the mezlocillin sulbactam sodium, motassium magnessium aspartate, aspartic acid ornithine, Mycophenolate Mofetil, asparaginase, thioctic acid, xylitol, Chymotrypsin, Trypsin-chymotrypsin, chymopapain, immune ribonucleic acid, nimustine, metadoxine, milrinone, Moxifloxacin, urokinase, brain heart health, nedaplatin, nicergoline, menotrophin, naproxen sodium, carbamide, Clistin-M Vial, Energy mixture, meningococcal polysaccharide vaccin, Cerebrolysin Vial, nimodipine, nizatidine, Protirelin, Pantoprazole Sodium, pamidronic acid acyl disodium, piracetam, sodium glucuronate, Enoxacin Gluconate, pemetrexed disodium, the Pamidronic Acid disodium, procaine benzylpenicillin, avocin, piperazine ketone sodium, Bleomycin A5, pirenzepine, dandelion, aescine, hydrocortisone sodium succinate, Alprostadil, dianhydrodulcitol, hydroxycamptothecin, mouse nerve growth factor, QINGKAILING, troxerutin, lappaconitine hydrobromide, Injectio natarii norcantharidatis, benzylpenicillin potassium, penicillin sodium, rolitetracycline, rolitetracycline nitrate, globoroseomycin, penicillin, the zinc hydroxide thyroliberin, gentamycin, penicillinase, dextromethorphan hydrobromide, erythromycin lactobionate, chorionic gonadotrophin, ethacridine lactate, reteplase, zidovudine, Norfloxacin Lactate, Rui Sixi butyl hydrogen sulphate salt, chorionic gonadotrophin, daunorubicin, sarcolycin, lactobionic acid azithromycin, lysozyme, the human albumin, blood albumin of human placenta, human γ-globulin, human fiber's proteinogen, adenosine triphosphate disodium salt, cisplatin, water soluble vitamins, ethylenedicysteine, SHUANGHUANLIAN, ethyl cysteinate dimer, sulbactam sodium, the adenosine triphosphate, coenzyme insulin, somatostatin, dipyridamole, oxytocin, the diclofenac sodium lignocaine, huperzine A, Cisatracurium besylate, hetacillin potassium, carboxylic benzyl sodium penem, licarcillin sodium, thiophene oxime sodium, dibekacin, streptokinase-streptodornase, Calcium Dibutyryladenosine Cyclophosph-ate, adenosine triphosphate, GTP (guanosine triphosphate), cytidine, harringtonine, sultopride, give birth to arteries and veins, arsenic trioxide, Moschus moschiferous perfume (or spice), hirudin, ftorafur, impersonate Lamine, cefonicid sodium, placental lipo-glucosaminoglycan, gastrodine, cefpiramide, cephalothin sodium, Elastase, cefaloridine, cefazolin sodium, cefradine, cefacetrile sodium.cephapirin sodium, cefathiamidine, cefuroxime, cefoxitin, cefotiam, ceftazidime, cefotaxime, cefmenoxime, cefsulodine sodium, cefmetazole, parotin, carboplatin, sodium bicarbonate, cefamandole nafate, torasemide, Ro 15-8074/001, Ketoprofen, salmon calcitonin see calcimar, ulinastatin, vitamin B6, vecuronium bromide, vitamin C, cytochrome C, thymosin, lentinan, neoarsphenamine, XUESAITONG, nitrocaphane, cobamamide, sodium nitroprusside, angiotensin, Thymopentin, cimetidine, neo-houttuyninum, asarone, calf blood protein-removed extraction, antostab, fibrinoclase, thymosin, ametycin, nitrocaphanum, sorbide nitrate, nifedipine, the energy fruit acid, scorpion venom, Herba Saussureae Involueratae, cidofovir, Amiodarone Hydrochloride, simvastatin, the human normal immunoglobulin, gemcitabine hydrochloride, tetracaine hydrochloride, spectinomycin hydrochloride, norvancomycin hydrochloride, ofloxacin, kallidinogenase, levofloxacin hydrochloride, mitoxantrone hydrochloride, Ondansetron Hydrochloride, calcium folinate, inferior stannum sodium phytate, methylenediphsphonate and stannous chloride, inferior stannum gluceptate sodium, inferior stannum pentetic acid, sodium pyrophosphate and stannous chloride, aprotinin, lomefloxacin hydrochloride, Buflomedil Hydrochloride, cefotiam hydrochloride is fixed, meclofenoxate hydrochloride, quadracycline, topotecan hydrochloride, inferior stannum sodium dimercaptosuccinate, inferior stannum dextran, inferior stannous gluconate acid calcium, isoniazid, cytarabine hydrochloride, Retilian Simplex, irinotecan hydrochloride, ketalar, andrographolide, Antiradon, hydrochloric acid is gentle pyrrole star how, ifosfamide, remifentanil hydrochloride, Betahistine Hydrochloride, the different dried meat of inferior stannum methoxy, ligustrazine hydrochloride, the ethamine uride, diltiazem hydrochloride, verapamil hydrochloride, dopamine hydrochloride, divalvon-D, esmolol hydrochloride, idarubicin hydrochloride, nicotinic acid, nicotiamide, sodium etacrynate, aceglutamide, hydrochloric acid replaces fourth for the Buddhist nun, dimefline hydrochloride, nefopam hydrochloride, Boanmycin Hydrochloride, Nimustine, lysine hydrochloride, tramadol hydrochloride, inferior stannum etifenin, indole Pu is green, sotalol hydrochloride, the hydrochloric acid glucagon, Granisetron Hydrochloride, Bisolvon, Ramosetron HCl, arginine hydrochloride, Arterenol (Hoechst)., labetalol hydrochloride, Tiapride Hydrchloride, ambroxol hydrochloride, naloxone hydrochloride, papaverin hydrochloride, doxapram hydrochloride, Imipenem-cilastatin sodium, Propacetamol Hydrochloride, dexrazoxane, etoposide, Dextran 40, hydrochloric acid is for how non-class, Navoban (Soz), hydrochloric acid horse traction ground that, folic acid, abadox, minocycline hydrochloride, Lyphocin (Fujisawa), methylphenidate hydrochloride, procaine hydrochloride, clonidine hydrochloride, dobutamine hydrochloride, the hydrochloric acid vidarabine, edetate sodium, ciprofloxacin, insulin, trypsin, the hydrochloric acid Cys, Lumbrukinase, hydrochloric acid Ni Keli is fixed, Sodium Houttuyfonate, bilobalide, minocycline hydrochloride, Incadronate, mattress Cape jasmine Huang, leucovorin sodium, Herba Houttuyniae, itraconazole, Flos Chrysanthemi Indici, Radix Curcumae, the U.S. phenol of hydrochloric acid sodium, transfer factor, Paclitaxel liposome, propylene glycol alginate sodium sulfate, levocarnitine, zoledronic acid, fatsoluble vitamin, Nulomoline, phytohaemagglutinin, polyporusum bellatus, left-handed motassium magnessium aspartate, left cloth Buddhist nun caine etc.
Drop pill prepared by printing of the present invention has solid drop pill, hollow drop pill, drop pill with holes and special-shaped drop pill.
Method for preparing drop pills of the present invention and traditional dripping method prepare drop pill and relatively have following advantage:
The present invention has thoroughly changed the traditional processing technology of drop pill, takes the lead in laser fast shaping is manufactured (3D printing) this world-leading manufacturing technology and is applied to pharmaceutical field;
The present invention has simplified the drop pill production technology, has saved dripping and cooling link, has reduced the key factor that affects the drop pill quality, make the ball method of double differences of drop pill different be down to minimum, roundness is reached near 100% consistent, greatly improved product qualified rate, reduced production cost;
The present invention makes to produce drop pill and becomes more freely, only needs, by computer adjusted design scheme, just can produce the drop pill of all size and shape;
The present invention has dwindled man-hour, has reduced workman's operation link, has reduced the use of chemicals, not only is conducive to improve working environment, saves labor cost, and has avoided the murder by poisoning to operator;
The present invention does not use liquid coolant, has avoided the wasting of resources, is conducive to environmental conservation.
The 3D laser printer that the present invention relates to, comprise the model workbench and be placed in photosensitive drums, powder box and the chromacoder of described model workbench top, it is characterized in that: described photosensitive drums is one, and a described powder box and a chromacoder are arranged respectively; In powder box, be filled with the hot melt powder.
In the following embodiments, the 3D printer is commercially available Cube X3D printer, and the powder of medicine and substrate is added in its powder box.The 3D printer of other models is applicable to the present invention too.(if special printer needs more detailed description)
The present invention uses a kind of brand-new mode to manufacture drop pill, and 3D printing technique and pharmaceuticals industry technology are integrated, and compares existing drop pill manufacturing technology, can significantly improve the quality of products, reduce production costs, have good application and promotional value, for the drop pill internationalization is laid a good foundation.Product, through check, meets country's all requirements to drop pill, can be applied to safely and effectively clinical.
The specific embodiment
Below with way of example, to of the present invention, with the method that the 3D printing technique prepares drop pill, be described further:
Embodiment 1:
The Polyethylene Glycol substrate of 40g is heated to 80 ℃ of meltings, and be held between 70-80 ℃, 10g breviscapine powder is joined in described Polyethylene Glycol substrate, stir and made in 30 minutes evenly, after cooling, send in freeze dryer, lyophilization becomes pressed powder, sieves, and obtains the pastille powder, described powder is joined in 3D printer powder box again, by the computer installation drop pill, be shaped as circular solids, specification is every ball 30mg, prints and prepares drop pill.
Embodiment 2:
The Polyethylene Glycol substrate of 100g is heated to 80 ℃ of meltings, and be held between 70-80 ℃, 5g compound Salviae Miltiorrhizae thick paste is joined in described Polyethylene Glycol substrate, stir and made in 20 minutes evenly, after cooling, send in freeze dryer, lyophilization becomes pressed powder, sieves, and obtains the pastille powder, described powder is joined in 3D printer powder box again, by the computer installation drop pill, be shaped as circular solids, specification is every ball 20mg, prints and prepares drop pill.
Embodiment 3:
The Polyethylene Glycol substrate of 60g is heated to 80 ℃ of meltings, and be held between 70-80 ℃, 10g simvastatin powder is joined in described Polyethylene Glycol substrate, stir and made in 30 minutes evenly, after cooling, send in freeze dryer, lyophilization becomes pressed powder, sieves, and obtains the pastille powder, described powder is joined in 3D printer powder box again, by the computer installation drop pill, be shaped as ellipse solid, specification is every ball 10mg, prints and prepares drop pill.
Embodiment 4:
The Polyethylene Glycol substrate of 100g is heated to 80 ℃ of meltings, and be held between 70-80 ℃, 20g nifedipine powder is joined in described Polyethylene Glycol substrate, stir and made in 30 minutes evenly, after cooling, send in freeze dryer, lyophilization becomes pressed powder, sieves, and obtains the pastille powder, described powder is joined in 3D printer powder box again, by the computer installation drop pill, be shaped as circular solids, specification is every ball 10mg, prints and prepares drop pill.
Embodiment 5:
Take the product of embodiment 1 as example, carry out the quality inspection of product:
Produce as described in Example 1 three batches of drop pill, and check respectively that its outward appearance, the ball method of double differences are different, dissolve scattered time limit and measure the content of lamp-dish flower acetic.The results are shown in Table 1:
Table 1:
| Lot number | Outward appearance | Average ball heavy (mg, n=100) | Average dissolve scattered time limit (second, n=6) |
| 1 | Circle, evenly, color and luster is consistent for size | 30.12 | 424 |
| 2 | Circle, evenly, color and luster is consistent for size | 29.94 | 418 |
| 3 | Circle, evenly, color and luster is consistent for size | 30.16 | 428 |
In table 1, weight differential: get 20 of drop pill, accurate its gross weight that claims, after trying to achieve average ball weight, distinguish again accurately weighed each ball weight, every ball weight and average ball heavy phase relatively, the limit test of weight variation scope front average ball heavy 10% between, the drop pill that exceeds limit test of weight variation is less than 2 balls, there is no one times of 1 ball overrun.All meet appendix regulation of Chinese Pharmacopoeia version in 2000.
Dissolve scattered time limit: according to Chinese Pharmacopoeia version in 2000 appendix, the method inspection under the disintegration item, the drop pill of surveying all at 10min with interior disintegrate and pass through screen cloth.
Drop pill Chinese medicine assay: press the content that assay method in the breviscapine drop pills draft standard is measured lamp-dish flower acetic in every batch sample, the results are shown in Table 2:
Table 2:
| Lot number | Lamp-dish flower acetic content (mg/ ball) |
| 1 | 6.24 |
| 2 | 6.36 |
| 3 | 6.31 |
Table 1 and 2 results show, preparation method of the present invention can accurately be controlled all technical of drop pill, and the requirements of products obtained therefrom all meets the breviscapine drop pills standard code.
Through mouse stomach approach acute toxicity test, mice gives breviscapine with gavage of dosage of 5g/kg according to the prepared breviscapine drop pills of the production method of breviscapine drop pills of the present invention, without the overt toxicity reaction, occurs; The maximum dosage-feeding of an oral Breviscapine of mice is 5g/kg, and this dosage calculates by kg body weight, approximately is equivalent to more than 1000 times of clinical full-time consumption.The breviscapine drop pills long term toxicity test, breviscapine, has no animal and occurs that outward appearance, body weight gain, hematology, blood biochemical are learned and the toxicity of 16 kinds of organs and tissues changes with 100mg/kg/d, 300mg/kg/d and the continuous gavage of 600mg/kg/d 90 days to rat; The drug withdrawal observation of 30 days and indices detect and also have no obvious delayed toxicity reaction.
Pharmacodynamics research according to the prepared breviscapine drop pills of the production method of breviscapine drop pills of the present invention:
The animal model close with human diseases adopted in this research, observes its anti-cardiac-cerebral ischemia and function of promoting blood circulation to disperse blood clots.Result of the test shows: described breviscapine drop pills with 20,40, the continuous gastric infusion of dosage of 80mg/kg/d, once a day, continuous 5 days, the electrocardiogram that can obviously improve the coronary artery ligation rat changes, dose dependent ground reduces the activity of Serum CK-MB and CK, dwindle myocardial infarct size, three dosage groups dwindle respectively 48.12%, 56.37%, 57.13%.With commercially available (production of Nanjing Hong Yi pharmaceutcal corporation, Ltd) breviscapine drop pills, carry out identical test, acquired results is respectively 46.13%, 54.65% and 56.13%.Result shows, the drop pill of embodiments of the invention 1 preparation has identical pharmacodynamics with the drop pill of prior art.
Medicine to embodiment 2-4 has carried out similar quality inspection and pharmacodynamics check, and selects corresponding commercially available prod to compare, and shows that product of the present invention meets the prescription of country to drop pill, has also kept the drug effect of medicine simultaneously.While using method of the present invention, owing to having reduced the key factor that affects the drop pill quality, make the ball method of double differences of drop pill different be down to minimum, roundness is reached and approach unanimously, greatly improve product qualified rate, also reduced simultaneously the use of chemical reagent, be conducive to operator's physical and mental health.
After having read foregoing of the present invention, those skilled in the art can make various changes or modification to the present invention, and these equivalent form of values fall within the application's appended claims institute limited range equally.
Claims (10)
1. method of utilizing the 3D printing technique to prepare drop pill is characterized in that: by 3D printing-forming technology, " successively print, be layering " and prepare, comprise the steps:
(1) by the drug matrices heating and melting of recipe quantity, and make temperature remain on certain limit, and keep temperature to make it to be in molten condition;
(2) 1 weight portion medicine is added in the substrate of 1-100 weight portion melting, stirs evenly, make uniform medicinal liquid, cooling standby;
(3) above-mentioned cooling medicine piece is sent into to freeze dryer and carried out lyophilization and become the pastille powder, then, through sieving, obtain the pastille powder standby;
(4) the pastille powder after above-mentioned lyophilization is placed in to 3D " printer " powder box, by electronic chart, transfer of data, laser scanning, prints and prepare drop pill; The drop pill of preparation directly enters packing shop and packs.
2. method claimed in claim 1, is characterized in that, substrate used comprises water-soluble base, for example Macrogol 2000～8000, polyoxyethylene monostearate, sodium stearate, glycerin gelatine, carbamide, poloxamer; Or water-insoluble substrate, such as stearic acid, glyceryl monostearate, insect wax, hydrogenated vegetable oil, stearyl alcohol, spermol etc., preferably Macrogol 2000～8000.
3. the described method of claim 1 or 2, is characterized in that, substrate is Macrogol 2000～8000, and described substrate adjuvant heating and melting temperature is 60-80 ℃.
4. the arbitrary described method of claim 1-3, is characterized in that, medicine and substrate adjuvant mix and blend time are 5-100 minute, preferred 10-30 minute.
5. the arbitrary described method of claim 1-4, is characterized in that, the ratio of medicine and substrate is 1: 1-100 weight portion, preferred 1: 1-50 weight portion, more preferably 1: the 1-20 weight portion.
6. the arbitrary described method of claim 1-5, is characterized in that, the specification of described drop pill is every ball 1-200mg, preferred 5-150mg, more preferably 10-100mg.
7. the arbitrary described method of claim 1-6, is characterized in that, described medicine can be liquid, thick paste, powder etc.
8. the arbitrary described method of claim 1-7, is characterized in that, the pastille powder laying described in printing is that each layer all spreads with identical pastille powder, so is repeated to processing drop pill spray formation and completes.
9. the arbitrary described method of claim 1-8, is characterized in that, the drop pill that described 3D prints preparation comprises solid drop pill, hollow drop pill, drop pill with holes or special-shaped drop pill.
10. the arbitrary described method of claim 1-9, it is characterized in that, described medicine is Chinese medicine, Chinese medicine extract and chemicals, it can be acyclovir for example, azithromycin, oxaliplatin, Omeprazole Sodium, aztreonam, amifostine, amrinone, atracurium besilate, sodium ozagrel, sodium ferulate, ornidazole, tranexamic acid, aminomethylbenzoic acid, the azithromycin sodium dihydrogen phosphate, aminobutyric acid, sodium ampicillin, amipicloxacillin sodium, Aspirin-arginin, arfonad, amycin, aklavine, amrinone, oxiracetam, hyaluronidase, sodium phenobarbital, phenytoin Sodium, the Fructus Citri tangerinae propyl ester, white-browed snake venom blood coagulation enzyme, C14H25N4NaO11P2, alarelin, the C14H25N4NaO11P2 inosine, alanyl glutamine, bumetanide, betamethasone sodium phosphate, benzathine benzylpenicillin, bristopen, bleomycin, epirubicin, cloth Salmonella live vaccine, interleukin, Radix Isatidis, RhIL-2, recombined human granulocyte-macrophage stimulating factors, the recombinant human somatropin, hepatocyte growth-promoting factors, Andrographolide, recombinant mutant human tumor necrosis factor, vinpocetine, thyroliberin, octreotide acetate, Vinorelbine monotartrate, bulleyaconitine A, superoxide dismutase, vincaleucoblastine, Radix Et Caulis Acanthopanacis Senticosi, Rhizoma Dioscoreae Nipponicae, andrographolide, Radix Bupleuri, DANHONG, to Aminosalicylic sodium, isosorbide mononitrate, breviscapine, low molecular weight heparin sodium, Radix Salviae Miltiorrhizae, the monophosphate cytosine arabinoside, dacarbazine, docetaxel, salvianolate, doxofylline, dexamethasone sodium phosphate, scopolamine butylbromide, dacarbazine, pralidoxime iodide, dopamine, Pheretima, sodium tanshinone IIA sulfate, polyene phosphatidylcholine, Calcium Dibutyryladenosine Cyclophosph-ate, diprophylline, the diacetayl amide acetic ethylenediamine, dimercaptosuccinic acid, Oleum Curcumae, coenzyme A, the fluorine cytidine, actinomycin D, fleroxacin, famotidine, Venenum apis, Coenzyme Complex, compound three-vitamines B, sodium amidotrizoate, etamsylate, fluconazol, fluorouracil, compound monoammonium glycyrrhizinate S, floxuridine, sodium fusidate, fotemustine, voriconazole, compound diisopropylamine dichloroacetate, SNMC, furosemide, floxapenstaphylex, furbenicillin, compound quinine, Compound recipe Radix Isatidis, coenzyme Q10, the compound recipe methionine-vitamin B 1, Fructose Diphosphate sodium, gonadorelin, puerarin, CMNa, Carbamaid peroxide, mannatide, ganciclovir, bone peptide, norfloxacin glutamate, adenosine cyclophosphate, homoharringtonine, the glycyrrhizic acid diamidogen, fructose, bone-melon extract, Kaglutam, calciparine, bacitracin, glucagon, interferon, dactinomycin, mithramycin, glutathione, mannomustin, cyclophosphamide, reduced glutathion, ribonucleic acid, adenosine cyclophosphate, sulfomercaprine sodium, meglumine adenosine cycle phosphate, astragalus polysaccharides, Carthamus yellow, riboflavin sodium phosphate, kedacillin, nootkatin, ribostamycin, ancitabine, sulfatodiamino cyclohexane platinum, erythromycin, the Radix Astragali, Radix Illicii Lanceolati, methotrexate, the metronidazole sodium phosphate, the methoxy isonitrile, Urbason Solubile, phentolamine mesylate, pefloxacin mesilate, pentoxifylline, sodium citrate, collagenase, Gatifloxacin, Kitasamycin tartrate, inosine, spectinomycin hydrochloride, mecobalamin, Pazufloxacin Mesilate, sarcosine peptide aglycone, methionine vitamin B 1, gabexate mesilate, s-ropivacaine mesylate, phloroglucinol, thiamphenicol, kitasamycin tartrate, formyl hydrogen Calcium Folinate-SF, the influenza A vaccine, old tuberculin, dihydroergotoxine methanesulfonate, cimetidine, methyl prednisone sodium succinate, human normal plasma, refined tetanus antitoxin, refined diphtheria antitoxin, Antirobies Serum, Flos Trollii, clindamycin phosphate, carboplatin, Cobratide, bacillus calmette-guerin vaccine, anti-hepatitis B immune ribonucleic acid, kurarinone, matrine, captopril, carbazochrome sodium sulfonate, card nitrogen is situated between, bekanamycin, antilymphocyte globulin, rabies vaccine, AT 581., BCG-polysaccharide nucleic acid, Netilmicin Sulfate, aspisol, kanamycin sulfate, amikacin sulfate, Vistamycin, phosphorus enzyme element sodium, sodium prasterone sulfate, Azithromycin Sulfate, vindesine sulfate, vincristine sulfate, tiopronin, sodium thiosulfate, kangdisu sulfas, amphotericin B, penthiobarbital, Etimicin sulfate., Hemarisin, capreomycin sulfate Capastat sulfate, aerosporin, chondroitin sulfate, AM Bison, terbutaline sulphate, ligustrazine phosphate, lecithin, Micronomicin Sulfate, foscarnet sodium, lornoxicam, rifampicin, etoposide phosphate, rifamicina, armillarisin A, fludarabine phosphate, cervus and cucumis polypeptide, Long Ruikelin, potassium chloride, cloxacillin sodium, streptomycin sulfate, amikacin sulfate, the sulphuric acid oleandomycin, many glutinosins of sulphuric acid E, the sulphuric acid AEROSPORIN, vinblastine sulfate, Clomipramine, fosfomycin sodium, meclofenoxane, aspisol, streptokinase, prodigiosin, streptomycin, ethacrynate sodium, malaridine, ribavirin, Roxithromycin, ropivacaine, asparaginase, maleic acid Archie enzyme element, meropenem, Chymotrypsin, the mezlocillin sulbactam sodium, motassium magnessium aspartate, aspartic acid ornithine, Mycophenolate Mofetil, asparaginase, thioctic acid, xylitol, Chymotrypsin, Trypsin-chymotrypsin, chymopapain, immune ribonucleic acid, nimustine, metadoxine, milrinone, Moxifloxacin, urokinase, brain heart health, nedaplatin, nicergoline, menotrophin, naproxen sodium, carbamide, Clistin-M Vial, Energy mixture, meningococcal polysaccharide vaccin, Cerebrolysin Vial, nimodipine, nizatidine, Protirelin, Pantoprazole Sodium, pamidronic acid acyl disodium, piracetam, sodium glucuronate, Enoxacin Gluconate, pemetrexed disodium, the Pamidronic Acid disodium, procaine benzylpenicillin, avocin, piperazine ketone sodium, Bleomycin A5, pirenzepine, dandelion, aescine, hydrocortisone sodium succinate, Alprostadil, dianhydrodulcitol, hydroxycamptothecin, mouse nerve growth factor, QINGKAILING, troxerutin, lappaconitine hydrobromide, Injectio natarii norcantharidatis, benzylpenicillin potassium, penicillin sodium, rolitetracycline, rolitetracycline nitrate, globoroseomycin, penicillin, the zinc hydroxide thyroliberin, gentamycin, penicillinase, dextromethorphan hydrobromide, erythromycin lactobionate, chorionic gonadotrophin, ethacridine lactate, reteplase, zidovudine, Norfloxacin Lactate, Rui Sixi butyl hydrogen sulphate salt, chorionic gonadotrophin, daunorubicin, sarcolycin, lactobionic acid azithromycin, lysozyme, the human albumin, blood albumin of human placenta, human γ-globulin, human fiber's proteinogen, adenosine triphosphate disodium salt, cisplatin, water soluble vitamins, ethylenedicysteine, SHUANGHUANLIAN, ethyl cysteinate dimer, sulbactam sodium, the adenosine triphosphate, coenzyme insulin, somatostatin, dipyridamole, oxytocin, the diclofenac sodium lignocaine, huperzine A, Cisatracurium besylate, hetacillin potassium, carboxylic benzyl sodium penem, licarcillin sodium, thiophene oxime sodium, dibekacin, streptokinase-streptodornase, Calcium Dibutyryladenosine Cyclophosph-ate, adenosine triphosphate, GTP (guanosine triphosphate), cytidine, harringtonine, sultopride, give birth to arteries and veins, arsenic trioxide, Moschus moschiferous perfume (or spice), hirudin, ftorafur, impersonate Lamine, cefonicid sodium, placental lipo-glucosaminoglycan, gastrodine, cefpiramide, cephalothin sodium, Elastase, cefaloridine, cefazolin sodium, cefradine, cefacetrile sodium.cephapirin sodium, cefathiamidine, cefuroxime, cefoxitin, cefotiam, ceftazidime, cefotaxime, cefmenoxime, cefsulodine sodium, cefmetazole, parotin, carboplatin, sodium bicarbonate, cefamandole nafate, torasemide, Ro 15-8074/001, Ketoprofen, salmon calcitonin see calcimar, ulinastatin, vitamin B6, vecuronium bromide, vitamin C, cytochrome C, thymosin, lentinan, neoarsphenamine, XUESAITONG, nitrocaphane, cobamamide, sodium nitroprusside, angiotensin, Thymopentin, cimetidine, neo-houttuyninum, asarone, calf blood protein-removed extraction, antostab, fibrinoclase, thymosin, ametycin, nitrocaphanum, sorbide nitrate, nifedipine, the energy fruit acid, scorpion venom, Herba Saussureae Involueratae, cidofovir, Amiodarone Hydrochloride, simvastatin, the human normal immunoglobulin, gemcitabine hydrochloride, tetracaine hydrochloride, spectinomycin hydrochloride, norvancomycin hydrochloride, ofloxacin, kallidinogenase, levofloxacin hydrochloride, mitoxantrone hydrochloride, Ondansetron Hydrochloride, calcium folinate, inferior stannum sodium phytate, methylenediphsphonate and stannous chloride, inferior stannum gluceptate sodium, inferior stannum pentetic acid, sodium pyrophosphate and stannous chloride, aprotinin, lomefloxacin hydrochloride, Buflomedil Hydrochloride, cefotiam hydrochloride is fixed, meclofenoxate hydrochloride, quadracycline, topotecan hydrochloride, inferior stannum sodium dimercaptosuccinate, inferior stannum dextran, inferior stannous gluconate acid calcium, isoniazid, cytarabine hydrochloride, Retilian Simplex, irinotecan hydrochloride, ketalar, andrographolide, Antiradon, hydrochloric acid is gentle pyrrole star how, ifosfamide, remifentanil hydrochloride, Betahistine Hydrochloride, the different dried meat of inferior stannum methoxy, ligustrazine hydrochloride, the ethamine uride, diltiazem hydrochloride, verapamil hydrochloride, dopamine hydrochloride, divalvon-D, esmolol hydrochloride, idarubicin hydrochloride, nicotinic acid, nicotiamide, sodium etacrynate, aceglutamide, hydrochloric acid replaces fourth for the Buddhist nun, dimefline hydrochloride, nefopam hydrochloride, Boanmycin Hydrochloride, Nimustine, lysine hydrochloride, tramadol hydrochloride, inferior stannum etifenin, indole Pu is green, sotalol hydrochloride, the hydrochloric acid glucagon, Granisetron Hydrochloride, Bisolvon, Ramosetron HCl, arginine hydrochloride, Arterenol (Hoechst)., labetalol hydrochloride, Tiapride Hydrchloride, ambroxol hydrochloride, naloxone hydrochloride, papaverin hydrochloride, doxapram hydrochloride, Imipenem-cilastatin sodium, Propacetamol Hydrochloride, dexrazoxane, etoposide, Dextran 40, hydrochloric acid is for how non-class, Navoban (Soz), hydrochloric acid horse traction ground that, folic acid, abadox, minocycline hydrochloride, Lyphocin (Fujisawa), methylphenidate hydrochloride, procaine hydrochloride, clonidine hydrochloride, dobutamine hydrochloride, the hydrochloric acid vidarabine, edetate sodium, ciprofloxacin, insulin, trypsin, the hydrochloric acid Cys, Lumbrukinase, hydrochloric acid Ni Keli is fixed, Sodium Houttuyfonate, bilobalide, minocycline hydrochloride, Incadronate, mattress Cape jasmine Huang, leucovorin sodium, Herba Houttuyniae, itraconazole, Flos Chrysanthemi Indici, Radix Curcumae, the U.S. phenol of hydrochloric acid sodium, transfer factor, Paclitaxel liposome, propylene glycol alginate sodium sulfate, levocarnitine, zoledronic acid, fatsoluble vitamin, Nulomoline, phytohaemagglutinin, polyporusum bellatus, left-handed motassium magnessium aspartate, left cloth Buddhist nun caine etc.
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| CN106511285B (en) * | 2016-09-20 | 2019-06-21 | 南方医科大学 | A kind of 3D printing Breviscapinun oral disintegrating tablet and preparation method thereof |
| CN106511285A (en) * | 2016-09-20 | 2017-03-22 | 南方医科大学 | 3D printing breviscapine orally disintegrating tablet and preparation method thereof |
| CN107669648A (en) * | 2017-11-07 | 2018-02-09 | 互竑实业(上海)有限公司 | A kind of 3D printing doxofylline oral disintegrating tablet and preparation method thereof |
| CN107669648B (en) * | 2017-11-07 | 2021-02-09 | 江苏互竑生物医学有限公司 | 3D-printed doxofylline orally disintegrating tablet and preparation method thereof |
| CN108676769A (en) * | 2018-04-24 | 2018-10-19 | 武汉仝干医疗科技股份有限公司 | A kind of Non-woven scaffold material and preparation method thereof promoting hepatic cell growth |
| CN110151712A (en) * | 2019-05-14 | 2019-08-23 | 扬子江药业集团江苏紫龙药业有限公司 | A kind of lavo-ofloxacin hydrochloride dripping pill and preparation method thereof |
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