CN107468650A - A kind of Irbesartan self-emulsifying soft capsule and preparation method thereof - Google Patents
A kind of Irbesartan self-emulsifying soft capsule and preparation method thereof Download PDFInfo
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- CN107468650A CN107468650A CN201710584352.XA CN201710584352A CN107468650A CN 107468650 A CN107468650 A CN 107468650A CN 201710584352 A CN201710584352 A CN 201710584352A CN 107468650 A CN107468650 A CN 107468650A
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- irbesartan
- emulsifying
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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
- A61K9/10—Dispersions; Emulsions
- A61K9/107—Emulsions ; Emulsion preconcentrates; Micelles
- A61K9/1075—Microemulsions or submicron emulsions; Preconcentrates or solids thereof; Micelles, e.g. made of phospholipids or block copolymers
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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
- A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
- A61K31/4164—1,3-Diazoles
- A61K31/4184—1,3-Diazoles condensed with carbocyclic rings, e.g. benzimidazoles
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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
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/12—Carboxylic acids; Salts or anhydrides 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
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
-
- 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
- A61K9/4816—Wall or shell material
- A61K9/4825—Proteins, e.g. gelatin
Abstract
The invention belongs to technical field of medicine, and in particular to a kind of Irbesartan self-emulsifying liquid, it is made up of the raw material of following weight percentage：Irbesartan 20%-40%, oil phase 25%-50%, emulsifying agent 10%-50%, assistant for emulsifying agent 5%-20%.The invention also discloses a kind of preparation method of Irbesartan self-emulsifying soft capsule, and a certain proportion of Irbesartan, emulsifying agent, assistant for emulsifying agent and oil phase are combined into Irbesartan self-emulsifying liquid by it, and self-emulsifying liquid then is made into soft capsule by equipment.Irbesartan self-emulsifying liquid and self-emulsifying soft capsule produced by the present invention, be by medicine be dissolved in oil phase it is oral after in vivo can self-emulsifying form micro emulsion of the particle diameter in 200nm or so, the dissolution in vitro and body absorption of Irbesartan are significantly improved, improves vivo biodistribution availability.Medicine can be swallowed with whole grain after soft capsule is made, and content can also be taken to be taken after being diluted with water, and improve the compliance of the elderly and dysphagia patients medication.
Description
Technical field
The invention belongs to technical field of medicine, and in particular to a kind of Irbesartan self-emulsifying liquid and self-emulsifying soft capsule
And preparation method thereof.
Background technology
Irbesartan（English name：Irbesartan）It is angiotensinⅡ（Angiotensin II, Ang II）Acceptor presses down
Preparation, Ang I can be suppressed and be converted into Ang II, can the specifically acceptor of antagonizing angiotensin converting Enzyme 1（AT1）, to the short of money of AT1
Anti- effect is substantially better than AT.By optionally blocking Ang II and AT1 acceptors combination, suppress vessel retraction and aldosterone
Release, produces powerful antihypertensive effect.Irbesartan is clinically mainly used in the treatment of hypertension, does not suppress while decompression
Angiotensin-Converting（ACE）, feritin, other hormone receptors, do not suppress the ion relevant with blood pressure control and sodium balance yet
Passage, therefore have the advantages that to be depressured steady, Small side effects, medicine better tolerance；And its absorption is not influenceed by food, egg
White Percentage bound is low.In recent years, European Union ratified the first anti-high blood that the medicine is used to prevent diabetes early stage and advanced renal disease
Pressing thing, therefore Irbesartan has good clinical anti-hypertension medication prospect.
Oneself lists Irbesartan in the U.S., European Union, China etc., for treating hypertension.The medicine is in existing report and makes
In, the medicine of its conventional tablet and capsule formulation is really referred to.Conventional tablet medicine when taking one be required for directly
Connect and swallow, for some such as the elderly, children and having the patient of dysphagia, compliance is with regard to poor.In addition, such tablet medicine
Thing poorly water-soluble., it is necessary to which dissolution after being first disintegrated, in general relative action is slow, slow up to peak, and soft for ordinary solid preparation
Medicine self-emulsifying systems are discharged after capsule preparations disintegration, oil-in-water breast are formed in the presence of gastric juice, when shortening insoluble drug release
Between, while the compatibility of medicine and gastrointestinal wall is stronger, is advantageous to the absorption of medicine, can significantly improve bioavilability.
The content of the invention
For the deficiency of existing preparation, it is an object of the invention to provide a kind of self-emulsifying soft capsule of Irbesartan and its
Preparation method, solve the stability difference of existing Irbesartan oral tablet and the low technical problem of bioavilability.In addition, this hair
It is bright that also there is the characteristics of simple production process, be convenient for carrying and store.
To achieve the above object, the present invention adopts the following technical scheme that：
A kind of Irbesartan self-emulsifying liquid, its by medicine Irbesartan, oil phase, emulsifying agent and assistant for emulsifying agent form it is homogeneous,
Transparent self-emulsifying liquid, is specifically made up of the raw material of following weight percentage：
Irbesartan 20%-40%,
Oil phase 25%-50%,
Emulsifying agent 10%-50%,
The %-20% of assistant for emulsifying agent 5.
Specifically, described oil phase is selected from glyceryl monooleate, Masine 35-1, medium chain triglyceride, nutmeg
It is more than one or both of isopropyl propionate, ethyl oleate and oleic acid；It is preferred that Masine 35-1 or medium chain triglyceride；Most
It is preferred that medium chain triglyceride；
Described emulsifying agent is selected from Labraso, Gelucire 44/14, polyoxyethylene caster
It is more than one or both of oil, Crodaret, tween emulsifier type and polyethylene glycol mono stearate；It is preferred that
Crodaret；
Described assistant for emulsifying agent is selected from propane diols, ethylene glycol monomethyl ether, PEG（Polyethylene glycol）300、PEG 400、PEG 500
With it is more than one or both of PEG 600；It is preferred that PEG600.
It is further preferred that each raw material weight percentage of above-mentioned Irbesartan self-emulsifying liquid is listed below table：
The preparation method of above-mentioned Irbesartan self-emulsifying liquid, it is specially：Emulsifying agent and assistant for emulsifying agent are weighed in proportion, and mixing is equal
It is even, oil phase and Irbesartan are then added, ultrasound produces to whole dissolvings.
The method for preparing Irbesartan self-emulsifying soft capsule using above-mentioned self-emulsifying liquid, it is by medicine Irbesartan, oil
Homogeneous, the transparent self-emulsifying liquid of phase, emulsifying agent and assistant for emulsifying agent composition, then prepares soft capsule system using pressing
Agent.Specifically comprise the following steps：
1）Prepare self-emulsifying liquid：Emulsifying agent and assistant for emulsifying agent are weighed in proportion, is well mixed, and then add oil phase and E Beisha
Smooth, ultrasound is derived from emulsion to whole dissolvings；
2）Prepare soft capsule glue：In parts by weight, by 30-40 parts glycerine and 90-100 part water additionization glue tanks, heat
To 40-70 degrees Celsius, put into 100 parts of gelatin and be heated to 70-90 degrees Celsius, stir 30-40 minutes, stand 30-50 points
Clock, sieving filtration, screen cloth specification 120-140 mesh, glue 55 degrees Celsius of insulations in fluid reservoir are standby；
3）Prepare soft capsule：By step 1）Obtained self-emulsifying liquid and step 2）Gained glue input rolling molding type encapsulating machine,
Prepare capsule-type preparation；
4）By step 3）Obtained capsule-type preparation is transferred to rotating cage Setting drying box and sizing, drying temperature 20-25 is dried
Degree Celsius, relative humidity 5%-40%, hour drying time 3-4；
5）By step 4）The capsule-type preparation that dryness finalization is crossed is transferred in drying box, in 20-25 degrees Celsius of temperature, relatively wet
Continue to dry 10-15 hours under conditions of degree 5%-40%, produce.
Specifically, step 1）In the advance mesh sieve of mistake 120 of Irbesartan used.
Self-emulsified drug delivery system（Self-Emulsifying Drug Delivery System, SEDDS）：Be by oil phase,
The solid or liquid preparation of nonionic emulsifier and assistant for emulsifying agent composition, its essential characteristic is can be in intestines and stomach or environment temperature
Suitably（It is often referred to 37 DEG C of body temperature）And under conditions of gentle agitation, spontaneous emulsification forms emulsion of the particle diameter in 100-500nm or so.
Self-emulsifying drug delivery system has following characteristics：(1) medicine is dissolved in oil, then forms emulsion droplet, improve medicine dissolving
Degree；（2）Medicine improves the dissolution rate and bioavilability of insoluble drug by the huge surface area of fine oil droplets, while can be with
Avoid the pessimal stimulation of the hydrolysis and medicine of water-insoluble drug to intestines and stomach；(3) after self-emulsifiable preparation is oral, in intestines and stomach
Rapid emulsification, medicine are directly entered small bowel lymphatics, rear to reach the transhipment of thymic lymphoma pipe, rather than into vena portae hepatica.Therefore, it is micro-
Through lymphatic transport after breast absorption, avoid or reduce the first pass effect through liver, the bioavilability of medicine can be improved；(4) medicine
It is dissolved in oil phase, orally forms emulsion, avoids the lamination problem during traditional emulsion storage, be advantageous to drug storage and fortune
Defeated preparation technology is simple, and property is stable, convenient to take.
Effectively can be prepared above-mentioned single liquid preparation using suitable soft capsule technology of preparing turns into suitable
Solid pharmaceutical preparation.This new solid self-emulsifying preparation can not only retain liquid self-emulsifiable preparation high-dissolvability and high biology profit
The advantages of expenditure, also with many advantages, such as stability is high, conveniently administration and patient's compliance are high.Soft capsule is put into water
After can be disintegrated rapidly, form finely dispersed suspension emulsion, there is easy to use, the characteristics of bioavilability is high.Soft capsule
Preparation method, working condition and simple production process, instructions of taking is convenient, can swallow, can also squeeze as conventional tablet
Go out content to use to wet suit.In consideration of it, Irbesartan is designed to self-emulsifying soft capsule by the present invention, i.e., by a certain proportion of medicine
Thing, oil phase, emulsifying agent and assistant for emulsifying agent first form self-emulsifying liquid, then prepare Irbesartan self-emulsifying soft capsule using pressing.
Irbesartan self-emulsifying soft capsule produced by the present invention, be by medicine be dissolved in oil phase it is oral after in vivo can self-emulsifying formed
Micro emulsion of the particle diameter in 200nm or so.The present invention has carried out the research of Validation in vitro and internal pharmacokinetics to it.As a result table
Bright, the self-emulsifying soft capsule preparation significantly improves the external molten of Irbesartan while meeting that In Vitro Dissolution reaches requirement
Out-degree and internal intestinal absorption, improve vivo biodistribution availability.Medicine can be swallowed with whole grain after soft capsule is made, and can also take interior
It is tolerant be diluted with water after take, improve the elderly and dysphagia patients medication compliance.
According to the ordinary skill in the art, Irbesartan self-emulsifying liquid of the invention can be made outside soft capsule, may be used also
So that the various suitable solid dosage forms such as micropill, hard shell capsules, granule or other kinds of tablet are made.
Brief description of the drawings
Fig. 1 is influence of the extension rate to Irbesartan self-emulsifying liquid particle diameter
The influence that the Irbesartan self-emulsifying liquid particle diameter of Fig. 2 difference extension rates changes over time；
The commercially available Irbesartan Tablets of Fig. 3, the Irbesartan self-emulsifying liquid of embodiment 1 and the blood concentration-time of self-emulsifying soft capsule
Curve ratio compared with.
Embodiment
Technical scheme is further discussed in detail with reference to embodiments, but protection scope of the present invention
It is not limited thereto.
Embodiment l
A kind of Irbesartan self-emulsifying soft capsule, specification 1000, each raw material proportioning is as shown in the table：
Specific preparation method is as follows：
1) content is prepared：After precision weighs Crodaret by weight ratio, PEG600 is well mixed, add extremely
In the medium chain triglyceride of recipe quantity, vortex mixed is uniform, adds Irbesartan, and ultrasound is derived from breast to complete drug dissolution
Change liquid；
2）Prepare soft capsule glue：In parts by weight, by 35 parts of glycerine and 95 parts of water additionization glue tanks, it is heated to 40-70 and takes the photograph
Family name's degree, put into 100 parts of gelatin and be heated to 70-90 degrees Celsius, stir 30-40 minutes, stand 30-50 minutes, cross sieving
Cross, screen cloth specification 120-140 mesh, glue 55 degrees Celsius of insulations in fluid reservoir are standby；
3）Prepare soft capsule：By step 1）Obtained self-emulsifying liquid and step 2）Gained glue input rolling molding type encapsulating machine,
Prepare capsule-type preparation；
4）By step 3）Obtained capsule-type preparation is transferred to rotating cage Setting drying box and sizing, drying temperature 20-25 is dried
Degree Celsius, relative humidity 5%-40%, hour drying time 3-4；
5）By step 4）The capsule-type preparation that dryness finalization is crossed is transferred in drying box, in 20-25 degrees Celsius of temperature, relatively wet
Continue to dry 10-15 hours under conditions of degree 5%-40%, produce.
Embodiment 2
A kind of Irbesartan self-emulsifying soft capsule, specification 1000, each raw material proportioning is as shown in the table：
Preparation method：With preparation method in embodiment 1.
Embodiment 3
A kind of Irbesartan self-emulsifying soft capsule, specification 1000, each raw material proportioning is as shown in the table：
Preparation method：With preparation method in embodiment 1.
Embodiment 4-6
Irbesartan self-emulsifying soft capsule, specification 1000, each raw material weight proportioning of soup processed is as shown in the table：
Preparation method：With preparation method in embodiment 1.
Embodiment 7-9
Irbesartan self-emulsifying soft capsule, specification 1000, each raw material weight proportioning of soup processed is as shown in the table：
Preparation method：With preparation method in embodiment 1.
Dilution stability is tested
Irbesartan self-emulsifying liquid 0.5g in Example l, embodiment 2, embodiment 3, at 37 DEG C, add 37 DEG C 100,
200th, 300,500 and 1000 times of simulated gastric fluid, slight wobble, the micro emulsion of different multiples is diluted to, with Zeta potential analyzer
Determine emulsion droplet size；Accompanying drawing l is shown in influence of the extension rate to particle diameter.Figure l result shows：When diluting 100~1000 times, E Bei
Particle diameter after being emulsified outside husky smooth self-emulsifiable liquid is between 200~320nm.
By the Irbesartan self-emulsifying liquid of 0.5g embodiments 1 dilute 100 times and dilution 1000 times dilution place 0.5h,
The change of particle diameter is detected after 1h, 2h.Accompanying drawing 2 is shown in the influence that particle diameter changes over time.Fig. 2 result shows：Extension rate is to grain
The influence in footpath is little.Experiment in vitro shows medicine after emulsion is formed, stable in 2h, disclosure satisfy that the side of different crowd medication
Formula.
The test of Irbesartan self-emulsifying soft capsule
Result of the test is found：Irbesartan self-emulsifying soft capsule prepared by above-described embodiment is neither too hard, nor too soft, any surface finish, during disintegration
Limit meets《Chinese Pharmacopoeia》2015 editions requirements.
The pharmacokinetic trial of Irbesartan self-emulsifying soft capsule
9 healthy adult 6.5~7.8kg of beasle dog are taken, random point three groups, every group 3.Fasting 12h before administration, free water.
Oral administration is taken, it is a piece of to give commercially available Irbesartan Tablets respectively（Dosage 150mg）, the E Bei for preparing in embodiment 1
Husky smooth self-emulsifying liquid（Dosage 150mg）The Irbesartan self-emulsifying soft capsule one prepared with embodiment 1（Every contains main ingredient
150mg）.0.25h, 0.50h, 0.75h, 1.0h, 1.5h, 2.0h, 2.5h, 3h, 4h, 6 h, 8 h, 10h are in than lattice after administration
Dog foreleg vein takes blood about 5mL, is placed in the centrifuge tube of test tube of hepari, after processing, HPLC sample detection blood concentrations.As a result show
Show, the bioavilability of Irbesartan self-emulsifying liquid of the invention and self-emulsifying soft capsule is apparently higher than marketed tablet（Accompanying drawing 3）.
Claims (6)
1. a kind of Irbesartan self-emulsifying liquid, it is characterised in that be made up of the raw material of following weight percentage：
Irbesartan 20%-40%,
Oil phase 25%-50%,
Emulsifying agent 10%-50%,
The %-20% of assistant for emulsifying agent 5.
2. Irbesartan self-emulsifying liquid as claimed in claim 1, it is characterised in that described oil phase is selected from single oleic
One or both of ester, Masine 35-1, medium chain triglyceride, isopropyl myristate, ethyl oleate and oleic acid with
On；Described emulsifying agent is selected from Labraso, Gelucire 44/14, polyoxyethylene caster
It is more than one or both of oil, Crodaret, tween emulsifier type and polyethylene glycol mono stearate；It is described
One kind in propane diols, ethylene glycol monomethyl ether, PEG 300, PEG 400, PEG 500 and PEG 600 of assistant for emulsifying agent
It is or two or more.
3. Irbesartan self-emulsifying liquid as claimed in claim 2, it is characterised in that by the raw material group of following weight percentage
Into：
Irbesartan 25%-35%,
Medium chain triglyceride 35%-50%,
Crodaret 20%-30%,
The %-10% of PEG 600 5.
4. the preparation method of any Irbesartan self-emulsifying liquid of claims 1 to 3, it is characterised in that weigh breast in proportion
Agent and assistant for emulsifying agent, it is well mixed, then adds oil phase and Irbesartan, ultrasound produces to whole dissolvings.
5. the method for preparing Irbesartan self-emulsifying soft capsule using any self-emulsifying liquid of claims 1 to 33, its feature exist
In comprising the following steps：
1）Prepare self-emulsifying liquid：Emulsifying agent and assistant for emulsifying agent are weighed in proportion, is well mixed, and then add oil phase and E Beisha
Smooth, ultrasound is derived from emulsion to whole dissolvings；
2）Prepare soft capsule glue：In parts by weight, by 30-40 parts glycerine and 90-100 part water additionization glue tanks, heat
To 40-70 degrees Celsius, put into 100 parts of gelatin and be heated to 70-90 degrees Celsius, stir 30-40 minutes, stand 30-50 points
Clock, sieving filtration, screen cloth specification 120-140 mesh, glue 55 degrees Celsius of insulations in fluid reservoir are standby；
3）Prepare soft capsule：By step 1）Obtained self-emulsifying liquid and step 2）Gained glue input rolling molding type encapsulating machine,
Prepare capsule-type preparation；
4）By step 3）Obtained capsule-type preparation is transferred to rotating cage Setting drying box and sizing, drying temperature 20-25 is dried
Degree Celsius, relative humidity 5%-40%, hour drying time 3-4；
5）By step 4）The capsule-type preparation that dryness finalization is crossed is transferred in drying box, in 20-25 degrees Celsius of temperature, relatively wet
Continue to dry 10-15 hours under conditions of degree 5%-40%, produce.
6. the method for preparing Irbesartan self-emulsifying soft capsule as claimed in claim 5, it is characterised in that step 1）In strategic point used
The advance mesh sieves of mistake 120 of Bei Shatan.
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| CN201610880119 | 2016-10-09 |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110025591A (en) * | 2019-04-29 | 2019-07-19 | 郑州泰丰制药有限公司 | A kind of Austria's shellfish cholic acid self-emulsifiable preparation and its soft capsule |
| WO2021057042A1 (en) * | 2019-09-26 | 2021-04-01 | 湖南慧泽生物医药科技有限公司 | Drug composition containing abiraterone acetate, and preparation method therefor and application thereof |
| US11806313B2 (en) | 2021-12-15 | 2023-11-07 | Hunan Huize Biopharma S&T Co., Ltd. | Abiraterone acetate containing composition and application thereof |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110025591A (en) * | 2019-04-29 | 2019-07-19 | 郑州泰丰制药有限公司 | A kind of Austria's shellfish cholic acid self-emulsifiable preparation and its soft capsule |
| WO2021057042A1 (en) * | 2019-09-26 | 2021-04-01 | 湖南慧泽生物医药科技有限公司 | Drug composition containing abiraterone acetate, and preparation method therefor and application thereof |
| US11806313B2 (en) | 2021-12-15 | 2023-11-07 | Hunan Huize Biopharma S&T Co., Ltd. | Abiraterone acetate containing composition and application thereof |
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Application publication date: 20171215 |