CN1370522A - Method of producing penetrating pump capsule as one new dosage form - Google Patents
Method of producing penetrating pump capsule as one new dosage form Download PDFInfo
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- CN1370522A CN1370522A CN 02109221 CN02109221A CN1370522A CN 1370522 A CN1370522 A CN 1370522A CN 02109221 CN02109221 CN 02109221 CN 02109221 A CN02109221 A CN 02109221A CN 1370522 A CN1370522 A CN 1370522A
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Abstract
The present invention is method of producing penetrating pump capsule as one new dosage form from common capsule. This kind of new dosage has the features of both common gastric coated capsule and enteric coated capsule and its medicine is controlled to release safely and in long action and absorbed in both stomach and intestines in certain propertion. With material similar those in common capsule, the medicine and active penetrating supplementary material are filled into capsule, and the capsule coating is coated with coating liquid in certain thickness before one or several holes are drilled.
Description
Technical field:
The present invention relates to medical technical field, exactly it is a method of conventional capsule being made the osmotic pump capsule novel form.
Background technology:
Capsule is a kind of dosage form that grows up from the improvement condition of taking medicine, world trends have been complied with in its development, various in style, as quick-release capsules (is that capsule capsule body and capsule medicated cap respectively have 10 apertures, the medicine of packing into can dissolve rapidly), two chambers capsule (is that separate layer is arranged in the capsule, in order to discharge the medicine that medicine or branch are equipped with incompatibility), slow releasing capsule, effervescent capsule, implant capsule, colon targeting drug administration capsule, magnetic capsule etc., become one of the most widely used peroral dosage form.By 1986, the production capacity of China's capsule reached 26,400,000,000, and development speed is apparently higher than other peroral dosage form.In recent years, except that traditional gelatine capsule, also has the capsulae vacuus made from methylcellulose, calcium alginate, polyvinyl alcohol, degeneration silica gel and other macromolecular material, to change its solubility property or to reach the purpose of enteric, but price is more expensive, and technology is more cumbersome than conventional capsule.
The conventional capsule agent has the bad smell of covering, exquisite appearance, swallows easily, and disintegrate is fast, release is rapid, bioavailability is high, improves medicine stability, prevents advantages such as oxidation of drug, photolysis.Easily dissolve but also exist, easy-weathering, easy deliquescence, the medicine that zest is strong should not be made capsule, and quality is stable inadequately in the storage process, particularly the easy moisture absorption of Chinese medicine hard capsule and shortcoming such as rotten.The temperature and humidity of air has a significant effect to the steady quality of Capsules when especially storing, the general water content 12%-15% of Capsules, when being higher than 38 ℃, can make the utricule distortion, the change of relative humidity can influence the water content of softgel shell, the moisture of softgel shell is lower than 10%, and easily embrittlement and shrinkage is higher than 16% and easily softens.For this reason, softgel shell should be left in 18 ℃-25 ℃ of temperature, in the special warehouse of relative humidity 30%-45%.Enteric coated capsule is suitable for avoiding stomach acids destroy and needs to keep the medicine of time of a specified duration with the prolongation effect in intestinal, and medicine arrives the enteral disintegrate by stomach and brings into play curative effect.The preparation of enteric coated capsule mainly contains the formaldehyde infusion process at present (because of technology is difficult for grasping, be prone to i.e. dissolving under one's belt or also undissolved phenomenon in intestinal, few with), gelatin spraying (adopt formaldehyde-acetone soln directly to be sprayed on capsule and make, effect is better) and wrap the casing method.Bag casing method is the capsulae vacuus made from gelatin or sodium alginate, coat enteric coat, fill medicine then, and seal with the enteric solubility glue and to make, enteric coat commonly used has cellulose acetate-phthalate, enteric acrylic resin II number and III number, methacrylic acid copolymer etc.The price of enteric coated capsule is more expensive.Also has a kind of novel form that is called as osmotic pump type, be because in capsule, added osmo active substance, contact with body fluid, dissolving also forms saturated solution, the osmotic pressure that produces permeates medicine and discharges from drug release hole, can both absorb under one's belt with in the intestinal, have the dark capsular advantage of common gastric-dissolved capsule and intestinal simultaneously, reach slow release, controlled release, safety, long lasting effect.
Summary of the invention:
The present invention is material with the conventional capsule, with medicine (can be synthetic drug, the solid particle that Chinese medicine and composition thereof or proper method such as coated were handled, powder medicines etc.) being aided with active permeate substance (can be sodium chloride, potassium chloride, electrolyte such as potassium sulfate, lactose, fructose, glucose, saccharides such as sucrose, Pulvis Talci, dextrin, other solid matter such as starch or above-mentioned several mixture), be packed in the capsule, being equipped with coating solution then carries out coating (coating fluid prescription is a cellulose acetate, ethyl cellulose, the hydroxypropylmethylcellulose acetate methylcellulose, hydroxypropylmethylcellulose acetate methylcellulose succinate, cellulose acetate-phthalate, the O-phthalic acid methyl cellulose, the phthalic acid hydroxyethyl-cellulose, the phthalic acid hydroxyethylmethyl-cellulose, the hexahydrophthalic acid hydroxyethylmethyl-cellulose, carboxymethylethylcellulose, cellulose and derivant and their ethers such as tetrahydroxy cellulose acetate-phthalate, esters and above-mentioned salt, polyethylene, polypropylene, polystyrene, polrvinyl chloride, polyamide, polyimides, polylactic acid, polyglycolic acid, the polylactic acid-polyglycolic acid copolymer, poly-(diglycolic acid-ethylene glycol), poly-phthalic acid, poly-phthalic acid vinyl acetate, epoxy resin, polyester, acetal polymer, Merlon, polymer and derivant or their acids such as polyurethanes, amide-type and esters and above-mentioned several copolymers, acrylic resin, methacrylic resin, acrylic acid-methacrylic resin copolymer, polyacrylate, poly-(methacrylic acid-methyl methacrylate), methacrylic acid-methyl acrylate copolymer, methacrylic acid trimethylammonium ester-acrylate copolymer, acrylic resin or derivant and their copolymers thereof such as methacrylic acid trimethylammonium ester-methacrylate copolymer, chitin, polysaccharides such as chitosan, ethylene-vinyl acetate copolymer, maleic acid-phthalic acid derivatives copolymer, octadecanol, glycerol-stearate, nylon, glucosan, stomach slightly solubility materials such as polysiloxanes, sodium alginate, natural products such as Lac, and top described material adds that plasticizer (comprises sorbitol, mannitol, ethylene glycol, pure and mild polyalcohols such as glycerol, glycerol acetate, sebacate, stearate, esters such as phthalic acid ester, polyethylene glycols, polyalcohols such as polypropylene glycol, alkoxide, polyesters and dextrin, polyvinylpyrrolidone etc.) formulated, form certain thickness clothing film, and then on capsule, make a call to a hole or a plurality of hole with proper method.After body fluid penetrates into coating membrane inside gradually, make contained osmo active substance and medicine dissolution in the capsule, form saturated solution, and produce bigger osmotic pressure medicine constant release from drug release hole is come out, reach and keep lasting medicine, reduce toxic and side effects, reduce medicining times, the purpose of steady blood drug level is provided.The present invention is especially for Chinese medicine, and this will be good a kind of dosage form, and moisture infiltrated when coatings can be avoided high humidity, thus the easy moisture absorption of Chinese medicine when avoiding conventional capsule, easy deliquescence problem.For the photaesthesia medicine, also can be utilized after the white that should not select for use in the past or transparent conventional capsule are coated.And reasonable price, moderate, therefore, after this novel formulation puts goods on the market, will obtain huge economic benefit.
The present invention is through experiment repeatedly, favorable reproducibility, and steady quality has good feasibility, and outward appearance is level and smooth, bright clean, will be a kind of well slow controlled release osmotic pump capsule preparation.
The specific embodiment:
Embodiment 1:
Medicine is an amount of, and NaCl 15%, cellulose acetate 25.5g, Macrogol 4000 4.5g
It is an amount of to take by weighing medicine, adds the sodium chloride that accounts for drug weight 15%, and uniform mixing is in the capsule of certain model of packing into according to quantity.Take by weighing cellulose acetate 25.5g, after acetone 970ml dissolving, add the water 30ml that contains Macrogol 4000 4.5g again, stir, above-mentioned capsule is carried out coating as coating solution, punching, promptly.
Embodiment 2:
Medicine is an amount of, and KCl 20%, ethyl cellulose 20.5g, Macrogol 4000 4.5g
It is an amount of to take by weighing medicine, adds the potassium chloride that accounts for drug weight 20%, and uniform mixing is in the capsule of certain model of packing into according to quantity.Take by weighing ethyl cellulose 20.5g, after ethyl acetate 900ml dissolving, add the water 40ml that contains Macrogol 4000 5.0g again, stir, above-mentioned capsule is carried out coating as coating solution, punching, promptly.
Embodiment 3:
Medicine is an amount of, starch 5%, cellulose acetate-phthalate 27.5g, polyvinylpyrrolidone 5.0g
It is an amount of to take by weighing medicine, adds the starch that accounts for drug weight 5%, and uniform mixing is in the capsule of certain model of packing into according to quantity.Take by weighing cellulose acetate-phthalate 27.5g, after chloroform 980ml dissolving, add the methanol 20ml that contains polyvinylpyrrolidone 5.0g again, stir, above-mentioned capsule is carried out coating as coating solution, punching, promptly.
Claims (5)
1, conventional capsule is made the method for osmotic pump capsule novel form, be it is characterized in that: be material with the conventional capsule, medicine and osmo active substance with the softgel shell coating, are made a call to a hole or a plurality of hole to capsule after packing in the capsule again.
2, according to claim 1 conventional capsule is made the method for osmotic pump capsule novel form, it is characterized in that: described dosage form is the osmotic pumps formula capsule of the coated of interior powder charge thing and osmo active substance and punching.
3, the method of conventional capsule being made the osmotic pump capsule novel form according to claim 1, it is characterized in that: the used coating fluid prescription of osmotic pump capsule is a cellulose acetate, ethyl cellulose, the hydroxypropylmethylcellulose acetate methylcellulose, hydroxypropylmethylcellulose acetate methylcellulose succinate, cellulose acetate-phthalate, the O-phthalic acid methyl cellulose, the phthalic acid hydroxyethyl-cellulose, the phthalic acid hydroxyethylmethyl-cellulose, the hexahydrophthalic acid hydroxyethylmethyl-cellulose, carboxymethylethylcellulose, cellulose and derivant and their ethers such as tetrahydroxy cellulose acetate-phthalate, esters and above-mentioned salt, polyethylene, polypropylene, polystyrene, polrvinyl chloride, polyamide, polyimides, polylactic acid, polyglycolic acid, the polylactic acid-polyglycolic acid copolymer, poly-(diglycolic acid-ethylene glycol), poly-phthalic acid, poly-phthalic acid vinyl acetate, epoxy resin, polyester, acetal polymer, Merlon, polymer and derivant or their acids such as polyurethanes, amide-type and esters and above-mentioned several copolymers, acrylic resin, methacrylic resin, acrylic acid-methacrylic resin copolymer, polyacrylate, poly-(methacrylic acid-methyl methacrylate), methacrylic acid-methyl acrylate copolymer, methacrylic acid trimethylammonium ester-acrylate copolymer, acrylic resin or derivant and their copolymers thereof such as methacrylic acid trimethylammonium ester-methacrylate copolymer, chitin, polysaccharides such as chitosan, ethylene-vinyl acetate copolymer, maleic acid-phthalic acid derivatives copolymer, octadecanol, glycerol-stearate, nylon, glucosan, stomach slightly solubility materials such as polysiloxanes, sodium alginate, natural products such as Lac, and top described material adds that plasticizer (comprises sorbitol, mannitol, ethylene glycol, pure and mild polyalcohols such as glycerol, glycerol acetate, sebacate, stearate, esters such as phthalic acid ester, polyethylene glycols, polyalcohols such as polypropylene glycol, alkoxide, polyesters and dextrin, polyvinylpyrrolidones etc.) formulated, each becomes the ratio of component not limit.
4, the method for conventional capsule being made the osmotic pump capsule novel form according to claim 1, it is characterized in that: institute's powder charge thing does not limit in the osmotic pump capsule, added osmo active substance is electrolyte such as sodium chloride, potassium chloride, potassium sulfate, saccharides such as lactose, fructose, glucose, sucrose, other solid matter or above-mentioned several mixture such as Pulvis Talci, dextrin, starch, each becomes the ratio of component not limit.
5, the method for conventional capsule being made the osmotic pump capsule novel form according to claim 1, it is characterized in that: solvent used in the preparation process is for dissolving the solvent of each material in the coating fluid prescription (plasticizer-containing), and the amount and the kind of solvent for use do not limit.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 02109221 CN1370522A (en) | 2002-03-01 | 2002-03-01 | Method of producing penetrating pump capsule as one new dosage form |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 02109221 CN1370522A (en) | 2002-03-01 | 2002-03-01 | Method of producing penetrating pump capsule as one new dosage form |
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| Publication Number | Publication Date |
|---|---|
| CN1370522A true CN1370522A (en) | 2002-09-25 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 02109221 Pending CN1370522A (en) | 2002-03-01 | 2002-03-01 | Method of producing penetrating pump capsule as one new dosage form |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN109394732A (en) * | 2017-08-16 | 2019-03-01 | 安徽中医药大学 | Sinomenine enteric positions osmotic pump controlled release capsule and preparation method thereof |
-
2002
- 2002-03-01 CN CN 02109221 patent/CN1370522A/en active Pending
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN109394732A (en) * | 2017-08-16 | 2019-03-01 | 安徽中医药大学 | Sinomenine enteric positions osmotic pump controlled release capsule and preparation method thereof |
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