CN106902097A - A kind of pharmaceutical composition for improving drug bioavailability - Google Patents
A kind of pharmaceutical composition for improving drug bioavailability Download PDFInfo
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- CN106902097A CN106902097A CN201510961582.4A CN201510961582A CN106902097A CN 106902097 A CN106902097 A CN 106902097A CN 201510961582 A CN201510961582 A CN 201510961582A CN 106902097 A CN106902097 A CN 106902097A
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- stomach
- soluble
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- enteric
- pharmaceutical composition
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- 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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5084—Mixtures of one or more drugs in different galenical forms, at least one of which being granules, microcapsules or (coated) microparticles according to A61K9/16 or A61K9/50, e.g. for obtaining a specific release pattern or for combining different drugs
-
- 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
- A61K31/16—Amides, e.g. hydroxamic acids
- A61K31/165—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
-
- 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
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
-
- 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
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
-
- 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
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/34—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
-
- 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
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K47/38—Cellulose; Derivatives thereof
Abstract
The present invention relates to a kind of pharmaceutical composition for improving drug bioavailability, belong to pharmaceutical technology field.The composition is made up of enteric complex composition I and the compounding of complex composition soluble in the stomach II；The enteric complex composition I is made up of enteric capsule core and enteric coating, described complex composition soluble in the stomach II is made up of capsule core soluble in the stomach and coating soluble in the stomach, the inventive method prepare pharmaceutical composition can make main ingredient reach it is quick-acting with it is long-acting, the effect of effective combination of sustained release and controlled release, the medicine bioavilability can be improved in the case of identical dosage compared with ordinary preparation, or can reach preferable therapeutic effect in the case of relatively small dosage, advantageously reduce toxic and side effect, slow down stimulation of the medicine to intestines and stomach, its preparation process is simple, it is quality controllable, without bitter taste, it is suitable for industrialized large-scaled production.
Description
Technical field
The invention belongs to field of pharmaceutical preparations, more particularly to a kind of pharmaceutical composition for improving drug bioavailability.
Background technology
Bioavilability (bioavailability, F) refers to that medicine is absorbed by organisms the relative quantity and speed for entering body circulation
Rate.The Bioavailability Determination of pharmaceutical preparation, is usually administered (such as oral administration, intramuscular injection etc.) with non-vascular approach
Area (AUC) under drug-time curve and the ratio after the medicine reference preparation such as intravenous (iv) or identical approach administration (po), to inhale
Percentage is received to represent.According to test reagent (t) and the similarities and differences of reference reagent (r) method of administration, absolute bioavailability can be divided into
And relative bioavailability.May be different in view of dosage, therefore its computation formula is as follows：
Absolute bioavailability：F=(AUCpoDiv)/(AUCivDpo) × 100%；
Relative bioavailability：F=(AUCtDr)/(AUCrDt) × 100%；
If medicine is in vivo mainly with original shape through RE, it is also possible to which urinary drug excretion total amount is estimated.
Bioavilability is closely related with curative effect of medication, and particularly therapeutic index is narrow, dosage is small, solubility is small and first aid is used
Medicine, the change of its bioavilability, the influence to clinical efficacy is particularly acute, when bioavilability is by low uprising, can lead
Cause poisoning, or even threat to life.Otherwise do not reach then and answer effective in cure and affect treatment adversely.Clinical analysis drug therapy is invalid, it is poor to imitate
Or during poisoning reason, it is considered as the influence of bioavilability.
Influence bioavilability factor it is more, including drug particles size, crystal formation, the tight ness rating of filler, excipient
Agent and production technology etc..According to influence solubility and the factors of rate of dissolution, typically there are micronizing approach, the precursor medicine of medicine
Thing approach and change approach etc. of drug molecular structure by solubilising, hydrotropy, into salt or part.
In the existing method for improving drug bioavailability, consider that the identical structure multiple homogeneity chemoattractant molecule of same medicine is whole more
Body effect.Similar medicine cluster absorbs, is distributed, being metabolized, draining with high consistency in animal body, causes medicine after administration
Thing blood concentration is very high or even near or above toxic dose in early stage, and not enough in later stage blood concentration, and not reaching minimum has
Effect treatment concentration, so as to effective blood drug concentration is held time greatly shorten, directly affects medication effect.
The content of the invention
The present invention in order to preferably solve the above problems, from entirety to local, macroscopical to microcosmic angle, more rationally
A kind of ground regulating drug blood concentration in vivo, there is provided pharmaceutical composition for improving drug bioavailability.
Described composition is made up of enteric complex composition I and the compounding of complex composition soluble in the stomach II；
Described enteric complex composition I is made up of enteric capsule core and enteric coating, and the enteric capsule core is by main ingredient and medicine
Constituted with auxiliary material, the thickness of the enteric coating is 0.01~2mm.
Described complex composition soluble in the stomach II is made up of capsule core soluble in the stomach and coating soluble in the stomach, described capsule core soluble in the stomach by main ingredient and
Pharmaceutic adjuvant is constituted, and the thickness of described coating soluble in the stomach is 0.01~2mm.
Enteric complex composition I and the mass ratio of complex composition soluble in the stomach II are 5 in described composition:95~95:5.
The preparation method of described enteric complex composition I is：
(1) main ingredient and pharmaceutic adjuvant are crossed into 80 mesh sieves respectively, supplementary material is claimed by recipe quantity, it is standby.
(2) taking adhesive is prepared and obtains binder solution, adds main ingredient and other auxiliary materials, prepares enteric capsule core.
(3) take pharmaceutically acceptable coating material and prepare acquisition enteric coating liquid.
(4) take and be coated after the capsule core mixes with the enteric coating liquid, obtain final product enteric complex composition I.
The preparation method of described complex composition soluble in the stomach II is：
(1) main ingredient and pharmaceutic adjuvant are crossed into 80 mesh sieves respectively, supplementary material is claimed by recipe quantity, it is standby.
(2) taking adhesive is prepared and obtains binder solution, adds main ingredient and other auxiliary materials, prepares capsule core soluble in the stomach.
(3) take pharmaceutically acceptable coating material and prepare acquisition coating solution soluble in the stomach.
(4) take and be coated after the capsule core mixes with the coating solution soluble in the stomach, obtain final product enteric complex composition II.
Described composition is 5 with complex composition soluble in the stomach II by enteric complex composition I in mass ratio:95~95:5 simultaneously
Equal increments method is mixed and is obtained.Middle product examine is surveyed, inspection proterties, granularity, mobility, dissolution rate or release, loss on drying,
Relevant material, content etc., take inspection qualified products and are packed, and obtain final product a kind of drug regimen for improving drug bioavailability
Thing.Described solid composite medicament can be made into several formulations form, including granule, oral tablet, capsule, pre-mixing agent,
Dry suspensoid agent etc. or other forms preparation.The beneficial effects of the invention are as follows：
Its part soluble in the stomach of pharmaceutical composition that the present invention is provided can effectively quick release, quick acting；Its enteric part
Its release can effectively be delayed and absorbed, reach the effect of slow release long-acting；It is quick-acting and long that both effective combinations can reach main ingredient
Effect, sustained release and the effect of effective combination of controlled release, can improve the medicine compared with ordinary preparation in the case of identical dosage
Bioavilability, or can reach preferable therapeutic effect, acquired treatment in the case of relatively small dosage
Effect is better than the single preparations of ephedrine containing each medicine respectively.Toxic and side effect is advantageously reduced simultaneously, slows down stimulation of the medicine to intestines and stomach,
Without bitter taste.
Brief description of the drawings：
Accompanying drawing 1：The Drug-time curve of the embodiment of the present invention one and control drug
Numbered in figure and represented：Sample prepared by A, florfenicol powder B, the embodiment of the present invention one
Accompanying drawing 2：Structural representation of the invention.
Numbered in figure and represented：1st, coating soluble in the stomach, 2, main ingredient, 3, auxiliary material a, 4, auxiliary material b, 5, auxiliary material c, 6, auxiliary material d, 7, auxiliary material
E, 8, auxiliary material f, 9, other adjuvants, 10, enteric coating.
Specific embodiment
Now provide following examples to further explain invention, but be not meant to that embodiment does any to the present invention
The restriction of form, all technologies realized based on content of the present invention belong to the scope of the present invention.
Embodiment 1：A kind of pharmaceutical composition for improving Florfenicol and flunixin meglumine bioavilability.
Prescription：
The prescription of enteric complex composition I：
The preparation method of enteric complex composition I：
(1) by Florfenicol, flunixin meglumine, sodium carboxymethylcellulose, magnesium stearate, dextrin, microcrystalline cellulose sodium,
Malic acid, starch, sodium sulfite cross 80 mesh sieves respectively, and supplementary material is claimed by recipe quantity, standby.
(2) taking adhesive is prepared and obtains binder solution, adds Florfenicol, flunixin meglumine and other auxiliary materials, system
It is standby to obtain enteric capsule core.
(3) take pharmaceutically acceptable coating material and prepare acquisition coating solution.
(4) take and be coated after the enteric capsule core mixes with the enteric coating liquid, obtain final product enteric complex composition I.
The prescription of complex composition soluble in the stomach II：
The preparation method of complex composition soluble in the stomach II is：
(1) by Florfenicol, flunixin meglumine, sodium carboxymethylcellulose, maltitol, microcrystalline cellulose sodium, apple
Acid, lactose, sodium citrate cross 80 mesh sieves respectively, and supplementary material is claimed by recipe quantity, standby.
(2) taking adhesive is prepared and obtains binder solution, adds Florfenicol, flunixin meglumine and other auxiliary materials, system
It is standby to obtain capsule core soluble in the stomach.
(3) take pharmaceutically acceptable coating material and prepare acquisition coating solution soluble in the stomach.
(4) take and be coated after the capsule core soluble in the stomach mixes with the coating solution soluble in the stomach, obtain final product complex composition soluble in the stomach II.
In mass ratio it is 50 by enteric complex composition I and complex composition soluble in the stomach II：50 equal increments methods are mixed and are obtained.
Middle product examine is surveyed, inspection proterties, granularity, mobility, dissolution rate or release, loss on drying, relevant material, content etc. take
Inspection qualified products are packed, and obtain final product a kind of solid composite medicament containing Florfenicol and flunixin meglumine.
Embodiment 2：A kind of pharmaceutical composition for improving Florfenicol and flunixin meglumine bioavilability
The composition that Example 1 is prepared, is 5 by enteric complex composition I and complex composition soluble in the stomach II in mass ratio：
95 equal increments methods are mixed and are obtained.
Embodiment 3：A kind of pharmaceutical composition for improving Florfenicol and flunixin meglumine bioavilability
The composition that Example 1 is prepared, be in mass ratio with complex composition soluble in the stomach II by enteric complex composition I
95：5 equal increments methods are mixed and are obtained.
Embodiment 4：Pharmacokinetic trial
Healthy new zealand white rabbit 12, is randomly divided into two groups of A, B, and A group single doses gavage florfenicol powder, B group single doses
Gavage the medicine of prescription one in above-described embodiment 1, each group dosage is 20mg/kg (in terms of Florfenicol).Use efficient liquid
Phase chromatography determines the drug concentration in blood plasma, Winnonlin pharmacokinetic program software processing blood concentration-time numbers
According to.Result see the table below 1- tables 2, Fig. 1.
Table 1 different time points mean blood plasma concentration (μ g/ml) n=6
The pharmacokinetic parameter of table 2
Result of the test shows, gavages prescription one and compare with florfenicol powder, eliminates Increased Plasma Half-life 0.86h, peak time
1.7h is delayed, bioavilability is the 108% of common pulvis.
Claims (8)
1. a kind of pharmaceutical composition for improving drug bioavailability, it is characterised in that：Described pharmaceutical composition is answered by enteric
Polymeric composition I and the compounding composition of complex composition soluble in the stomach II.
2. a kind of pharmaceutical composition for improving drug bioavailability according to claim 1, it is characterized in that the intestines
Molten complex composition I is made up of enteric capsule core and enteric coating (10).Described enteric capsule core is by main ingredient (2) and pharmaceutic adjuvant
(3-8) is constituted, and the thickness of described enteric coating (10) is 0.01~2mm.
3. a kind of pharmaceutical composition for improving drug bioavailability according to claim 1, wherein described is soluble in the stomach
Complex composition I is made up of capsule core soluble in the stomach and coating soluble in the stomach (1), and described capsule core soluble in the stomach is by main ingredient (2) and pharmaceutic adjuvant (3-8)
Composition, the thickness of described coating soluble in the stomach (1) is 0.01~2mm.
4. a kind of pharmaceutical composition for improving drug bioavailability according to claim 1, wherein described combination
Enteric complex composition I and the mass ratio of complex composition soluble in the stomach II are 5 in thing:95~95:5.
5. a kind of pharmaceutical composition for improving drug bioavailability according to claims 1 to 4, it is characterised in that institute
The preparation method of the enteric complex composition I stated is：
(1) main ingredient (2) and pharmaceutic adjuvant (3-8) are crossed into 80 mesh sieves respectively, supplementary material is claimed by recipe quantity, it is standby；
(2) taking adhesive is prepared and obtains binder solution, adds main ingredient and other auxiliary materials, prepares capsule core；
(3) take coating material and prepare acquisition coating solution；
(4) take after the capsule core that step (2) obtained mixes with the coating solution and be coated, obtain final product enteric complex composition I.
6. a kind of pharmaceutical composition for improving drug bioavailability according to claims 1 to 4, it is characterised in that institute
The preparation method of the complex composition soluble in the stomach II stated is：
(1) main ingredient (2) and pharmaceutic adjuvant (3-8) are crossed into 80 mesh sieves respectively, supplementary material is claimed by recipe quantity, it is standby；
(2) taking adhesive is prepared and obtains binder solution, adds main ingredient and other auxiliary materials, prepares capsule core soluble in the stomach；
(3) take coating material and prepare acquisition coating solution soluble in the stomach；
(4) take and be coated after the capsule core mixes with the coating solution soluble in the stomach, obtain final product enteric complex composition II.
7., according to a kind of any described pharmaceutical composition for improving drug bioavailability of claim 1~6, its feature exists
In described composition be in mass ratio 5 by enteric complex composition I and complex composition soluble in the stomach II:95~95:5, and equivalent
Incremental method is mixed and is obtained.
8. a kind of pharmaceutical composition for improving drug bioavailability according to claim 7, it is characterised in that described
Pharmaceutical composition is made granule, oral tablet, capsule, pre-mixing agent, dry suspensoid agent, for Clinical practice.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201510961582.4A CN106902097B (en) | 2015-12-21 | 2015-12-21 | A pharmaceutical composition for improving bioavailability of medicine |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201510961582.4A CN106902097B (en) | 2015-12-21 | 2015-12-21 | A pharmaceutical composition for improving bioavailability of medicine |
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| CN106902097A true CN106902097A (en) | 2017-06-30 |
| CN106902097B CN106902097B (en) | 2020-01-07 |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN109106694A (en) * | 2018-08-27 | 2019-01-01 | 佛山市正典生物技术有限公司 | A kind of flunixin meglumine microcapsule formulation and preparation method thereof |
| CN113288876A (en) * | 2021-03-25 | 2021-08-24 | 华南农业大学 | Quality evaluation and control method of florfenicol sustained-release particles |
Citations (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1969834A (en) * | 2005-11-25 | 2007-05-30 | 天津市润拓生物技术有限公司 | Method for preparing colon targeted pill of florfenicol used for poultry and livestock |
| CN101011395A (en) * | 2007-02-02 | 2007-08-08 | 东南大学 | Sustained release preparation of licardipine hydrochloride and its preparing process |
| CN201426855Y (en) * | 2009-07-13 | 2010-03-24 | 上海恒丰强动物药业有限公司 | Florfenicol enteric coated granule |
| CN101693012A (en) * | 2009-08-21 | 2010-04-14 | 天津生机集团股份有限公司 | Preparation and application of florfenicol slowly-releasing micropill for treating animal digestive canal infection |
| CN101909600A (en) * | 2007-11-09 | 2010-12-08 | 英特维特国际股份有限公司 | Fast release solid formulation, preparation and use thereof |
| CN104257614A (en) * | 2014-09-26 | 2015-01-07 | 郑州福源动物药业有限公司 | Flunixin meglumine coated granule and preparation method thereof |
-
2015
- 2015-12-21 CN CN201510961582.4A patent/CN106902097B/en active Active
Patent Citations (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1969834A (en) * | 2005-11-25 | 2007-05-30 | 天津市润拓生物技术有限公司 | Method for preparing colon targeted pill of florfenicol used for poultry and livestock |
| CN101011395A (en) * | 2007-02-02 | 2007-08-08 | 东南大学 | Sustained release preparation of licardipine hydrochloride and its preparing process |
| CN101909600A (en) * | 2007-11-09 | 2010-12-08 | 英特维特国际股份有限公司 | Fast release solid formulation, preparation and use thereof |
| CN201426855Y (en) * | 2009-07-13 | 2010-03-24 | 上海恒丰强动物药业有限公司 | Florfenicol enteric coated granule |
| CN101693012A (en) * | 2009-08-21 | 2010-04-14 | 天津生机集团股份有限公司 | Preparation and application of florfenicol slowly-releasing micropill for treating animal digestive canal infection |
| CN104257614A (en) * | 2014-09-26 | 2015-01-07 | 郑州福源动物药业有限公司 | Flunixin meglumine coated granule and preparation method thereof |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN109106694A (en) * | 2018-08-27 | 2019-01-01 | 佛山市正典生物技术有限公司 | A kind of flunixin meglumine microcapsule formulation and preparation method thereof |
| CN113288876A (en) * | 2021-03-25 | 2021-08-24 | 华南农业大学 | Quality evaluation and control method of florfenicol sustained-release particles |
| CN113288876B (en) * | 2021-03-25 | 2022-09-27 | 华南农业大学 | Quality evaluation and control method of florfenicol sustained-release particles |
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| CN106902097B (en) | 2020-01-07 |
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