CN105380948A - Dihydroartemisinin piperaquine dry suspension agent and preparation process thereof - Google Patents
Dihydroartemisinin piperaquine dry suspension agent and preparation process thereof Download PDFInfo
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- CN105380948A CN105380948A CN201510846281.7A CN201510846281A CN105380948A CN 105380948 A CN105380948 A CN 105380948A CN 201510846281 A CN201510846281 A CN 201510846281A CN 105380948 A CN105380948 A CN 105380948A
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- Prior art keywords
- piperaquine
- dihydroarteannuin
- dry suspension
- dry
- phosphate
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
- A61K31/365—Lactones
- A61K31/366—Lactones having six-membered rings, e.g. delta-lactones
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
- A61K31/496—Non-condensed piperazines containing further heterocyclic rings, e.g. rifampin, thiothixene
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/02—Inorganic compounds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1629—Organic macromolecular compounds
- A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
Abstract
The invention belongs to the field of medical preparations and in particular provides a dihydroartemisinin piperaquine dry suspension agent. The dihydroartemisinin piperaquine dry suspension agent is prepared from dihydroartemisinin, piperaquine phosphate, sodium carbonate and pharmaceutically acceptable auxiliary materials, wherein the weight ratio of the dihydroartemisinin to the piperaquine phosphate to the sodium carbonate is (10 to 30) : (140 to 180) : (10 to 46). The technology can be used for remarkably improving the bitter taste of the piperaquine phosphate and improving the compliance of clinical medication for patients, and is more suitable for medication for children patients.
Description
Technical field
The present invention relates to pharmaceutical field, particularly relate to a kind of dihydroarteannuin piperaquine dry suspension and preparation technology thereof.
Background technology
Malaria is that by nationwide preventing and controlling, malaria disappeares substantially in China by a kind of malignant disease of mosquitoes spread, only has minority case to occur in indivedual areas in Hainan Province at present.But in underdeveloped tropical country, especially in the country of sub-Saharan Africa, malaria still serious threat health and the life of locals.According to World Health Organization (WHO) (WHO) report, malaria on average kills the child of less than 5 years old in every 30 seconds, about has 100-200 ten thousand people to die from malaria every year, and the malaria morbidity number in the annual whole world reaches 3-5 hundred million more than.
Dihydroarteannuin piperaquine dry suspension is the compound preparation of dihydroarteannuin and piperaquine phosphate composition.Dihydroarteannuin is the derivant of arteannuin, is the activity in vivo material of arteannuin, has stronger killing action to plasmodium phorozoon, can kill plasmodium rapidly, thus controls symptom.Piperaquine phosphate is 4-aminoquinolines antimalarial, Antimalarial and chloroquine similar, affect the ultrastructure of Blood-stage Plasmodium schizont.Mainly can make trophozoite food vacuolar membrane and mitochondrial swelling, cause the destruction of its physiological function, thus kill plasmodium.Dihydroarteannuin and piperaquine phosphate Papillary are without increasing toxic effect.Prove through clinical trial: dihydroarteannuin is rapid-action, the clinical symptoms of the rapid malaria control of energy, it can kill a large amount of plasmodium in a short period of time, piperaquine phosphate compared with long half-lift make blood drug level in patient body remain on a higher level in a long time, decrease the recrudescence rate of malaria.The compound recipe of dihydroarteannuin and piperaquine phosphate forms in 2009 by the recommended drug of WHO as antimalarial.Dihydroarteannuin piperaquine dry suspension is by dihydroarteannuin, the compound preparation of piperaquine phosphate composition, because piperaquine phosphate is a kind of medicine having remarkable bitterness, add essence, sweeting agents etc. can not effectively cover its bitterness, its bitterness can be effectively covered after adopting glyceric acid behenate enclose piperaquine phosphate, but glyceric acid behenate can produce Degradation to dihydroarteannuin, if make coated tablet, the stripping of principal agent composition can be affected again, therefore, at present in the urgent need to a kind of technology significantly improving piperaquine phosphate bitterness, improve the clinical application compliance of patient, and be more suitable for the medication of child patient.
Summary of the invention
Object of the present invention provides a kind of preparation technology of dihydroarteannuin piperaquine dry suspension.
A kind of dihydroarteannuin piperaquine dry suspension, described dry suspension is prepared from by dihydroarteannuin, piperaquine phosphate, sodium carbonate and pharmaceutically acceptable adjuvant, and the weight ratio of dihydroarteannuin, piperaquine phosphate and sodium carbonate is 10-30:140-180:10-46.
Described dihydroarteannuin piperaquine dry suspension, the weight ratio of dihydroarteannuin, piperaquine phosphate and sodium carbonate is 20:160:20.
Described dihydroarteannuin piperaquine dry suspension, pharmaceutically acceptable adjuvant comprises filler, suspending agent and lubricant, filler is carboxymethylstach sodium, one or more in pregelatinized Starch, sucrose, suspending agent is one or more in hypromellose, crosslinked carboxy sodium cellulosate, and lubricant is magnesium stearate.
Described dihydroarteannuin piperaquine dry suspension, preparation method comprises the steps: to get above-mentioned supplementary material, pulverizes, sieves, dry; Pour in mixer just mixed, carry out a dry granulation, sieve; To once granulating, gained material sieves, collect the dry granule A between 16 order-40 orders, secondary granulation is carried out with the following material of 40 order after the above crushing material of 16 order, gained pellet through sieves, the above crushing material granulate of 16 order, whole granule B after collecting secondary granulation, by mixed eventually for granule A, the B made, obtains dry suspension.
Taste masking dihydroarteannuin piperaquine dry suspension provided by the present invention, provides a kind of new approaches of new taste masking, and preparation method simply, is conveniently easy to operation.Inventor carefully studies through great many of experiments, by regulating the pH value of aqueous solution, thus cover its bitterness of piperaquine phosphate, do not affect again the preparation process of drug-eluting simultaneously, be a kind of dosage form for children exploitation, meet children taking, and good mouthfeel, steady quality, dihydroarteannuin and piperaquine phosphate dissolution high.
Detailed description of the invention
Form by the following examples, on of the present invention
State content to be described in further detail again, but this should be interpreted as that the scope of the above-mentioned theme of the present invention is only limitted to following example, all technology realized based on foregoing of the present invention all belong to scope of the present invention.
Embodiment 1
| Name of material | Weight (g) |
| Dihydroarteannuin | 10 |
| Piperaquine phosphate | 180 |
| Sodium carbonate | 20 |
| Starch | 250 |
| Carboxymethylstach sodium | 46 |
| Hypromellose | 2 |
| Sucralose | 2 |
| Sucrose | 500 |
| Crosslinked carboxy sodium cellulosate | 15 |
| Magnesium stearate | 5 |
Prepare according to following preparation technology: under the condition of temperature≤25 DEG C, relative humidity≤45%, operate as follows:
(1) get the supplementary material of above-mentioned recipe quantity, pulverize, for subsequent use after 60 orders sieve, 40 ± 5 DEG C of constant pressure and dries 5 hours;
(2) dried supplementary material is poured in mixer and just mix 60min;
(3) carry out a dry granulation to mixed material, 16 orders sieve; To once granulating, gained material sieves, and collects the dry granule A between 16 order ~ 40 orders.
Secondary granulation is carried out, gained pellet through sieves, the above crushing material granulate of 16 order with the following material of 40 order, whole granule B after collecting secondary granulation after the above crushing material of (4) 16 order.
(5), after granule A, B of making being mixed 30min eventually, dry suspension is obtained.
Embodiment 2
| Name of material | Weight (g) |
| Dihydroarteannuin | 20 |
| Piperaquine phosphate | 140 |
| Sodium carbonate | 10 |
| Dextrin | 100 |
| Carboxymethylstach sodium | 200 |
| Pregelatinized Starch | 300 |
| Hypromellose | 2 |
| Sucralose | 2 |
| Sucrose | 200 |
| Crosslinked carboxy sodium cellulosate | 20 |
| Magnesium stearate | 5 |
Preparation method is with embodiment 1.
Embodiment 3
| Name of material | Weight (g) |
| Dihydroarteannuin | 30 |
| Piperaquine phosphate | 160 |
| Sodium carbonate | 46 |
| Starch | 200 |
| Dextrin | 100 |
| Carboxymethylstach sodium | 15 |
| Pregelatinized Starch | 250 |
| Hypromellose | 2 |
| Sucralose | 2 |
| Sucrose | 300 |
| Crosslinked carboxy sodium cellulosate | 20 |
| Magnesium stearate | 5 |
Preparation method is with embodiment 1.
Comparative example 1
| Name of material | Weight (g) |
| Dihydroarteannuin | 20 |
| Piperaquine phosphate | 160 |
| Starch | 200 |
| Dextrin | 100 |
| Carboxymethylstach sodium | 15 |
| Pregelatinized Starch | 250 |
| Hypromellose | 2 |
| Sucralose | 2 |
| Sucrose | 300 |
| Crosslinked carboxy sodium cellulosate | 20 |
| Magnesium stearate | 5 |
Preparation method is with embodiment 1.
Comparative example 2: the preparation of coated tablet.
Batching: prepare raw material by following weight parts:
| Name of material | Weight (g) |
| Dihydroarteannuin | 40 |
| Piperaquine phosphate | 320 |
| Starch | 75 |
| Dextrin | 20 |
| Hypromellose | 5 |
| Carboxymethylstach sodium | 24 |
| Magnesium stearate | 2.7 |
| Opadry | 15 |
Operate as follows:
(1) get the supplementary material of above-mentioned recipe quantity, pulverize, dihydroarteannuin and piperaquine phosphate powder cross 100 mesh sieves, starch, dextrin, hypromellose, magnesium stearate and carboxymethyl starch sodium cross 60 orders sieve after for subsequent use;
(2) hypromellose binding agent is prepared: hypromellose being dissolved in weight percent concentration is in the alcoholic solution of 55%, is stirred to dissolving and makes binding agent;
(3) mixing granulation: the piperaquine phosphate after above-mentioned sieving, dihydroarteannuin, starch, dextrin, carboxymethylstach sodium are added in wet granulator, add the hypromellose binding agent soft material that step (2) obtains, cross 14 mesh sieves, obtain wet granular;
(4) dry: the wet granular that step (3) obtains is placed in explosion-proof boiling drier dry, temperature of charge controls, at 45 DEG C, to obtain dry granule;
(5) mixed pressuring plate: dry granule step (4) obtained, magnesium stearate carry out tabletting after fully mixing;
(6) coating: adopt mass percent concentration be 15% Opadry aqueous solution carry out coating, be prepared into coated tablet.
Embodiment 4: taste masking contrast test
Sample preparation: by above-described embodiment 1-3, comparative example 1 method prepares sample.
Test method: taste appraisal is the important step of taste masking technology, the mouthfeel evaluation of current medicine is still based on people's trial test.The applicant gives 30 healthy volunteers respectively to dihydroarteannuin piperaquine dry suspension mixture obtained in above-described embodiment 1-3 and comparative example 1, after it is taken, record experimenter mouthfeel, and mark according to following standard, result sees table: the standard evaluating bitterness: 0: do not have bitterness; 1: almost without bitterness, need carefully sensation just to have bitterness; 2: bitterness is very light; 3: have bitterness, but be not very bitter; 4: very bitter.
The result evaluated
| Embodiment 1 | Embodiment 2 | Embodiment 3 | Comparative example 1 | |
| Bitterness | 2 | 2 | 2 | 4 |
Conclusion (of pressure testing): dihydroarteannuin piperaquine dry suspension compositions of the present invention compares with comparative example 1 and can show person and improve bitterness, improves the compliance of patient clinical medication.
Embodiment 5: the dissolution determination experimentation of dihydroarteannuin dry suspension
(1) dihydroarteannuin dissolution determination: get this product (by above-described embodiment 1-3, comparative example 1, the preparation of comparative example 2 method), according to dissolution method (Chinese Pharmacopoeia version in 2010 two annex Ⅹ C second methods), with hydrochloric acid solution (9 → 1000) 500ml for dissolution medium, rotating speed is 75 turns per minute, operate in accordance with the law, through 45 minutes time, get solution and filter, get subsequent filtrate for subsequent use.Get above-mentioned subsequent filtrate as need testing solution.Separately get dihydroarteannuin reference substance appropriate, accurately weighed, add dissolve with ethanol and dilute the solution made about containing 0.4mg in every 1ml, shaking up, precision measures 2ml, puts in 10ml measuring bottle, is diluted to scale with dissolution medium, in 37 DEG C of insulations 45 minutes, let cool, in contrast product solution.Test according to high performance liquid chromatography (Chinese Pharmacopoeia version in 2010 two annex V D).Be filler with octadecylsilane chemically bonded silica; With 0.02mol/L disodium phosphate soln (by phosphoric acid adjust ph to 2.4)-acetonitrile (65:35) for mobile phase; Determined wavelength is 237nm.Number of theoretical plate calculates by dihydroarteannuin peak and is not less than 3000, and the separating degree at dihydroarteannuin two peak should be greater than 2.0.Precision measures need testing solution and each 5ml of reference substance solution respectively, puts in 25ml measuring bottle, is diluted to scale with 3.6% sodium hydroxide solution, shake up, put in 60 DEG C of water-baths and react 30 minutes, taking-up lets cool, and precision adds phosphoric acid 0.7ml, shake up, filter with 0.45 μm of filter membrane, in 2 hours, precision measures 20 μ l, injection liquid chromatography, record chromatogram, the stripping quantity often wrapped with calculated by peak area by external standard method.Limit is 65% of labelled amount, should conform with the regulations.The results are shown in Table 1.
(2) piperaquine phosphate dissolution determination: according to dissolution method (Chinese Pharmacopoeia version in 2010 two annex Ⅹ C second methods), with hydrochloric acid solution (9 → 1000) 500ml for dissolution medium, rotating speed is 75 turns per minute, operate in accordance with the law, through 45 minutes time, get solution to filter, get subsequent filtrate for subsequent use.Get above-mentioned subsequent filtrate as need testing solution.
Precision measures above-mentioned subsequent filtrate 2ml, puts in 100ml measuring bottle, is diluted to scale with 0.1mol/L hydrochloric acid solution.Shake up, as need testing solution.Precision takes piperaquine phosphate reference substance 70mg (being about equivalent to piperaquine phosphate 64mg), puts in 100ml measuring bottle, adds the hydrochloric acid solution 50ml of 0.1mol/L, and supersound process 15 minutes, lets cool, and the hydrochloric acid adding 0.1mol/L, to scale, shakes up.Precision measures this solution 2ml, puts in 100ml measuring bottle, is diluted to scale, shakes up with 0.1mol/L hydrochloric acid solution, in contrast product solution.According to ultraviolet visible spectrophotometry, measure the trap of reference substance solution and need testing solution respectively at the wavelength place of 345nm.Calculate the stripping quantity of piperaquine phosphate in often wrapping.The results are shown in Table 2.
Table 1 dihydroarteannuin stripping curve (dissolution unit is %)
Table 2 piperaquine phosphate stripping curve (dissolution unit is %)
Embodiment 1-3 compares with comparative example 1 and 2, can improve the dissolution of dihydroarteannuin and piperaquine phosphate, and illustrate that the present invention is on the basis of good mouthfeel, steady quality, dissolution is high.
Claims (4)
1. a dihydroarteannuin piperaquine dry suspension, it is characterized in that: described dry suspension is prepared from by dihydroarteannuin, piperaquine phosphate, sodium carbonate and pharmaceutically acceptable adjuvant, the weight ratio of dihydroarteannuin, piperaquine phosphate and sodium carbonate is 10-30:140-180:10-46.
2. dihydroarteannuin piperaquine dry suspension according to claim 1, is characterized in that: the weight ratio of dihydroarteannuin, piperaquine phosphate and sodium carbonate is 20:160:20.
3. dihydroarteannuin piperaquine dry suspension according to claim 1, it is characterized in that: pharmaceutically acceptable adjuvant comprises filler, suspending agent and lubricant, filler is dextrin, starch, carboxymethylstach sodium, one or more in pregelatinized Starch, sucrose, hypromellose, sucralose, suspending agent is one or more in hypromellose, crosslinked carboxy sodium cellulosate, and lubricant is magnesium stearate.
4. dihydroarteannuin piperaquine dry suspension according to claim 1, is characterized in that: preparation method comprises the steps: to get above-mentioned supplementary material, pulverizes, sieves, dry; Pour in mixer just mixed, carry out a dry granulation, sieve; To once granulating, gained material sieves, collect the dry granule A between 16 order-40 orders, secondary granulation is carried out with the following material of 40 order after the above crushing material of 16 order, gained pellet through sieves, the above crushing material granulate of 16 order, whole granule B after collecting secondary granulation, by mixed eventually for granule A, the B made, obtains dry suspension.
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN105902501A (en) * | 2016-05-11 | 2016-08-31 | 四川援健药业有限公司 | Cefprozil dry mixed suspension and preparation method as well as application thereof |
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2015
- 2015-11-27 CN CN201510846281.7A patent/CN105380948A/en active Pending
Patent Citations (5)
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| CN100998594A (en) * | 2006-12-26 | 2007-07-18 | 重庆医药工业研究院有限责任公司 | Oral medicine composition contg. amodiaquine solid |
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| CN102210657A (en) * | 2010-04-01 | 2011-10-12 | 南京长澳医药科技有限公司 | Prulifloxacin tablets and preparation process thereof |
| CN102485226A (en) * | 2010-12-03 | 2012-06-06 | 昆明制药集团股份有限公司 | Compound artemisinin piperaquine pellet and preparation method thereof |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN105902501A (en) * | 2016-05-11 | 2016-08-31 | 四川援健药业有限公司 | Cefprozil dry mixed suspension and preparation method as well as application thereof |
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