The invention belongs to medical technical field, relate to a kind of clinical practice research of medicine novel form widely. In decades in the past, oxychloroquine in the antimalarial HCQ and chloroquine, the important drugs as therapy system property lupus erythematosus SLE and rheumatoid arthritis rheumatism such as RA is used to clinical always.
In recent ten years, owing to recognizing that the extensive effect of oxychloroquine in immunomodulating becomes a research focus, also makes the effect of oxychloroquine in rheumatism treatment more and more come into one's own. Current research shows, hydroxychloroquine sulfate is a kind of safe and effective and antirheumatic of effect slowly that toleration is fabulous.
The hydroxychloroquine sulfate of present clinical use has only the dosage form of conventional tablet, and its bioavailability is not high, and it is not too convenient to use, and hydroxychloroquine sulfate needs the patient to take for a long time. Deficiency to prior art; Under the prerequisite that guarantees medication effect and safety; We have proposed hydroxychloroquine sulfate capsule and two kinds of novel forms of hydroxychloroquine sulfate dispersible tablet; Can effectively improve the utilization rate of medicine, reduce side effects of pharmaceutical drugs, different dosage forms makes things convenient for different patients to use; Simultaneously; Carry out suitable technological transformation and can also reduce the production cost of medicine, thereby reduce drug price, alleviate patient's financial burden.
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A kind of hydroxychloroquine sulfate capsule comprises the composition of following weight portion in the hydroxychloroquine sulfate capsule of weight portions:. Be preferably: the composition that comprises following weight portion in the hydroxychloroquine sulfate capsule of weight portions:. Said hydroxychloroquine sulfate capsule is preferably capsule No. A kind of hydroxychloroquine sulfate dispersible tablet comprises the composition of following weight portion in the hydroxychloroquine sulfate dispersible tablet of weight portions:. Said disintegrating agent is a polyvinylpyrrolidone, and said fluidizer is micropowder silica gel, and said surfactant is a polyoxyethylene sorbitan monoleate;.
Said adjuvant is: starch, Pulvis Talci, mannitol, one or more in microcrystalline Cellulose and the sodium alginate. Preferably: the composition that comprises following weight portion in the hydroxychloroquine sulfate dispersible tablet of weight portions:. The application in the medicine of preparation treatment rheumatoid disease of hydroxychloroquine sulfate capsule of the present invention and hydroxychloroquine sulfate dispersible tablet.
Do further explanation and illustrate that the present invention develops two kinds of new dosage forms in the face of the present invention down:. Capsule has following characteristics: bad flavor, the raising medicine stability smelt that can cover medicine; In vivo rapid-action of medicine, its curative effect is higher than pill, tablets and other formulations generally speaking; Can delay release and positioning release medicine of medicine etc.
Several steps below the main branch of this research:. Separate and make by bone, the severe edema due to hypofunction of the spleen. Process by adjuvant for the gelatin of directly buying adds for the capsulae vacuus that the present invention tests employing. Select the specification of capsulae vacuus, the clinical consumption of bound drug, No. After medicine is filled in utricule, can the fit capsule cap. We use fore shaft formula capsule, and seal is good, needn't seal.
Why President Trump is at odds with his medical experts over using malaria drugs against Covid-19
The quality of capsule detects by the requirement to capsule in the pharmacopeia " rules of preparations ", and the result is following:. Content is dry, appropriate, the mix homogeneously of degree of tightness. Every loading amount is compared with average loading amount, exceeds no more than 2 of content uniformity limit, does not have one times of an overrun. Instrument: day island proper Tianjin high performance liquid chromatograph;. Get hydroxychloroquine sulfate reference substance 50mg, accurate claim surely, put in the 50mL measuring bottle, with the chromatograph dissolve with methanol and be diluted to graduation mark, shake up, promptly get.
Chromatographic condition: chromatographic column: shim-pack vp-ODS post; Mobile phase: 0. L -1 Potassium dihydrogen phosphate containing 1. L -1 The sodium heptanesulfonate methanol solution; Detect wavelength: nm; Flow velocity: 1.
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Sample treatment: get 50 of homemade hydroxychloroquine sulfate capsules, be dried to constant weight, porphyrize, precision takes by weighing 3 parts in an amount of sample being equivalent to hydroxychloroquine sulfate 50mg , puts respectively in the 50mL measuring bottle, with the chromatograph dissolve with methanol and be diluted to graduation mark, shakes up, and promptly gets.
Measure: get reference substance solution and 3 parts of need testing solutions carry out chromatography, calculate content by external standard method, the result shows that the content of 3 duplicate samples is respectively RSD relative standard deviation is respectively 0. Dispersible tablet means in water the homodisperse tablet of disintegrate rapidly.
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With respect to solid preparations such as conventional tablet, capsules, dispersible tablet have taking convenience, disintegrate rapidly, absorb characteristics such as fast and bioavailability height. It has simple, the taking convenience of preparation, can reduce medicine untoward reaction, improve advantage such as drug bioavailability. The prescription of these article designs as follows:.
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Experiment serves as to investigate kind and the best proportioning that index adopts uniform Design method screening disintegrating agent with disintegration time, suspension ability or uniformity, the stripping etc. Because it is relatively large that its capillary activity of polyvinylpyrrolidone PVPP is high, hydratability reaches specific surface area by force, can rapidly water be inhaled in people's sheet, makes the instantaneous disintegrate of tablet, finally confirms with polyvinylpyrrolidone PVPP as disintegrating agent.
The starch water absorption and swelling makes disintegration of tablet, does not dissolve after the swelling to form to be uniform aqueous suspension, as suspending agent. It is bigger to adopt polyvinylpyrrolidone to do the particle surface hydrophilic that binding agent makes. The easy label that infiltrates of moisture makes its quick disintegrate stripping behind the tabletting. In certain concentration range, the alcoholic solution concentration of polyvinylpyrrolidone is big more, can make the hydrophobic particle surface hydrophilicity increase, accelerate disintegrate.
It not only can improve powder, particulate flowability, can also significantly improve the dissolution rate of insoluble drug.
Lubricant adopts hydrophilic Pulvis Talci. Get hydroxychloroquine sulfate reference substance 50mg, accurate claim surely, put in the 50ml measuring bottle, with the chromatograph dissolve with methanol and be diluted to graduation mark, shake up, promptly get. Sample treatment: get 50 of homemade hydroxychloroquine sulfate dispersible tablets, be dried to constant weight, porphyrize, precision takes by weighing 3 parts in an amount of sample being equivalent to hydroxychloroquine sulfate 50mg , puts respectively in the 50ml measuring bottle, with the chromatograph dissolve with methanol and be diluted to graduation mark, shakes up, and promptly gets.
When 1, treating rheumatism, the effective ways that reduce adverse effect are to manage to improve focus kind drug concentrations, reduce the drug level of blood and liver, kidney. The present invention adopts two kinds of new dosage forms, helps improving the bioavailability of hydroxychloroquine sulfate, reduces side effects of pharmaceutical drugs, and it is convenient that the patient is taken.
Simultaneously, to patient's individual variation situation, can select different dosage forms. Below in conjunction with concrete embodiment to the present invention to further explanation and explanation. With No. The quality of capsule detects by the requirement to capsule in the pharmacopeia " rules of preparations ": content assaying method wherein adopts HPLC to measure; Detect wavelength nm; With ODS is immobile phase, and mobile phase is potassium dihydrogen phosphate containing 1. The content that records hydroxychloroquine sulfate in the sample is Adjuvant is: starch, Pulvis Talci, mannitol, microcrystalline Cellulose, sodium alginate.
Preparation technology: with medicine and adjuvant mix homogeneously, micronization processes makes its particle diameter below orders, and direct powder compression is processed the specification of 0. O ne of the most wrenching questions in medicine has been playing out to garish effect in White House press conferences.
The question is this: In an emergency, like the exploding pandemic of the coronavirus that causes Covid, how much data should doctors require before they use a medicine? President Donald Trump has made clear that he thinks two old malaria drugs, hydroxychloroquine and chloroquine, should be deployed quickly against the coronavirus, SARS-CoV But his own lieutenants, the heads of the Food and Drug Administration and the National Institute of Allergy and Infectious Diseases, have been hesitant. Cases of Covid are exploding, with more than 24, reported nationally and more than 10, in New York State alone.
Actual numbers may be far higher. Reports say that New York hospitals are full with patients on ventilators who need treatment now. Hope has emerged around two anti-malaria drugs: chloroquine, discovered in , and a derivative of it called hydroxychloroquine that is thought to have less severe side effects. And a small and preliminary clinical trial of hydroxychloroquine in France circulated widely and stirred excitement on social media including from the president — though its findings were hardly definitive about whether the drug would benefit coronavirus patients.
Doctors can already prescribe them off-label. I feel good about it. Just a feeling. Several other small studies of other antiviral drugs have also shown glimmers of hope. So what should doctors do? How likely is it that the possible benefits shown in a small study will turn out to be a mirage?
One way of understanding this is to look at what happens with medicines in clinical trials. Experimental drugs are usually studied in three stages of progressively larger studies. The first, called Phase 1 trials, are small studies used to get an early read on efficacy and rule out obvious safety issues. The study referenced by Trump , and other studies done so far of potential treatments for Covid, are small and hastily designed even by the standards of Phase 1 studies. So how often do infectious-disease drugs that enter Phase 2 studies reach the market?
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An analysis by the Biotechnology Industry Organization says they worked out only That means that three-quarters of the time, medicines against infectious disease that looked promising in small studies either were ineffective or had side effects that made them unusable. It goes to one of the big truths about how doctors, eager to see a new drug succeed, can subconsciously lie to themselves with clinical studies: To be trustworthy, these studies often need to be randomized.
The use of randomization as the standard way to design a medical study goes back to another deadly infectious disease: tuberculosis.