CN107456443A - A kind of Osthole self-emulsifiable preparation and preparation method thereof - Google Patents
A kind of Osthole self-emulsifiable preparation and preparation method thereof Download PDFInfo
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- CN107456443A CN107456443A CN201710598905.7A CN201710598905A CN107456443A CN 107456443 A CN107456443 A CN 107456443A CN 201710598905 A CN201710598905 A CN 201710598905A CN 107456443 A CN107456443 A CN 107456443A
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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
- A61K31/37—Coumarins, e.g. psoralen
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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
- A61K47/30—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
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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
Abstract
The invention discloses a kind of Osthole self-emulsifiable preparation and preparation method thereof, include the component of following parts by weight：The parts by weight of Osthole 1, the parts by weight of carbomer 0.1 0.5, the parts by weight of assistant for emulsifying agent 10 15, the parts by weight of emulsifying agent 15 25 and the parts by weight of oil phase solvent 1.0 2.5, Osthole, assistant for emulsifying agent, emulsifying agent and oil phase solvent are taken according to selected parts by weight, first Osthole is added in assistant for emulsifying agent, make its dissolving, emulsifying agent, oil phase solvent, after stirring, obtain self-emulsifiable liquid, clinically-acceptable formulation is made according still further to conventional method, produces.By the above-mentioned means, Osthole self-emulsifiable preparation of the present invention, stability is good, and the stimulation to intestines and stomach is smaller, and bioavilability is high, and solubility is good, and easily prepared, is easy to storage to transport.
Description
Technical field
The invention belongs to field of pharmaceutical preparations, and in particular to a kind of Osthole self-emulsifiable preparation and preparation method thereof.
Background technology
Osthole also known as osthole, it is the one kind extracted from the fruit of Umbelliferae frutus cnidii platymiscium cnidium monnieri
Coumarin kind compound.Pharmacological experiment study shows Osthole not only to cardiovascular system, central nervous system, immune system
Etc. having a major impact, and good therapeutic action is respectively provided with to some difficult diseases, such as fatty liver and cancer.But Osthole
Indissoluble, oral absorption are poor in water, bioavilability is low, individual difference is big, and this greatly limits its clinical practice.And snake
Machine tool element has acid, is unfavorable for being administered orally, and causes at present the oral formulations of the clinically composition to lack.
Self-emulsifying drug delivery system（Self-emulsifying drug delivery system, referred to as：SEDDS）
Refer to spontaneously form oil-in-water breast in intestines and stomach or in the case of environment temperature (being often referred to 37 DEG C of body temperature) and gentle agitation
The medicine of the isotropic of agent passs mode.Its usual very little of emulsion particle diameter formed, there is larger oil/water interface, can be with
The infiltration rate and degree of medicine are improved, improves the bioavilability of medicine.With the development of material and preparation technology, also occur
Solid self-emulsifying drug delivery system（Solidself-emulsifying drug delivery system, SSEDDS）'s
Correlative study.SSEDDS is the solid pharmaceutical preparation for being prepared by mixing into self-emulsifying component and suitable solid material, including self-emulsifying
Micropill, microballoon, tablet etc..Compared with traditional SEDDS, there is SSEDDS stability increase, longer storage duration, stomach to stimulate
The advantages that less, convenient to take, and can be by adding various solid adjuvant materials or slow controlled release easily being prepared using packaging technique
Preparation, there is preferable DEVELOPMENT PROSPECT.But when Osthole is made as into self-emulsifiable preparation, then face problems with：1）Due to
Osthole solubility property is poor, easy precipitation, is difficult to control in preparation process, in order to strengthen its stability, maintain its emulsion
State, it will usually add more surfactant（Emulsifying agent）, some prescription dosages are up to 70-80w%, and this is not only to stomach
Enteron aisle can play larger stimulation, and the absorption for medicine also produces certain influence；2）Osthole is being made as solid
During self-emulsifiable preparation, the solid absorbent of the compositions such as Osthole is adsorbed with easily because solid powder surfaces are adsorbed with oil
And be difficult to pelletize, not only conventional wet granulation can cause powder not infiltrate because profit mutually be dredged, and be not easy to during dry granulation
With reference to granulating, generally have to add substantial amounts of auxiliary material, and then cause the bioavilability of Osthole to substantially reduce.
The content of the invention
First technical problem to be solved by this invention is Cnidiadin emulsion less stable of the prior art, and
Then need to add excessive surfactant, stimulating intestine and stomach when preparing self-emulsifiable preparation and absorb the problem of bad, and then provide a kind of
The Osthole self-emulsifying system that stability is good, emulsifying effectiveness is good, emulsifier is relatively low, absorption is preferable and bioavilability is high
Agent.
Second technical problem to be solved by this invention is to prepare Osthole solid self-emulsifying preparation in the prior art
Be difficult to pelletize, added in pelletization auxiliary material it is excessive and the problem of cause the bioavilability of Osthole relatively low, and then provide
It is a kind of be easy to pelletize, the preparation side for auxiliary material addition is relatively low, bioavilability the is high Osthole solid self-emulsifying preparation of pelletizing
Method.
To solve the above problems, the invention provides a kind of Osthole self-emulsifiable preparation, include the group of following parts by weight
Point：
The parts by weight of Osthole 1；
Carbomer 0.1-0.6 parts by weight；
Assistant for emulsifying agent 10-15 parts by weight；
Emulsifying agent 15-25 parts by weight；
Oil phase solvent 10-25 parts by weight.
Further, the Osthole self-emulsifiable preparation also includes the solid absorbent of 90-110 parts by weight.
Further, the solid absorbent is the one or more in PEG-4000, lactose, mannitol.
Further, the oil phase solvent is the fatty glyceride of middle long-chain.
Further, the oil phase solvent is that oleic acid, propylene ethyl glycol laurate, polyethylene glycol -6- glycerine are different hard
Resin acid ester, pungent certain herbaceous plants with big flowers acid glycerol three ester, ethyl oleate, one kind in glyceryl oleate -2- Wickenol 142s or
It is a variety of.
Further, the emulsifying agent is the one or more in PLURONICS F87, Tween-80.
One or more in the polyethylene glycol that the assistant for emulsifying agent is propane diols, polyglycereol, molecular weight are 200 ~ 700.
To solve the above problems, the invention provides a kind of preparation method of Osthole self-emulsifiable preparation, including it is following
Step：
（1）Osthole, carbomer, assistant for emulsifying agent, emulsifying agent, oil phase solvent are taken according to selected parts by weight, first by frutus cnidii
Element is added in assistant for emulsifying agent, is made its dissolving, is added carbomer, emulsifying agent, oil phase solvent, after stirring, obtains self-emulsifying
Liquid, the carbomer are Carbomer981 NF；
（2）By step 1）In the obtained self-emulsifiable liquid clinically-acceptable formulation is conventionally made, produce.
Further, the above method also includes mixing solid absorbent with water, pelletizes, then by obtained particle and institute
Self-emulsifiable liquid mixing is stated, it is adsorbed in particle, the step of obtaining self-emulsification solid.
Further, the above method specifically includes following steps：The solid absorbent is mixed with water, sieved, wet method
Granulation, re-dry, then by obtained particle and step 1）In obtain the self-emulsifiable liquid mixing, it is adsorbed in particle
In, obtain self-emulsification solid.
Preferably, when the solid absorbent is mixed with water, the content for making solid absorbent in water is 8w%-20w%.
Preferably, self-emulsifiable liquid described in the granular absorption with magnitude relation be every gram of granular absorption 0.6-0.8g from
Emulsifying liquid.
Capsule, tablet, granule, the oral liquid being prepared using the above method, the capsule include soft capsule,
Hard shell capsules.
It should be noted that the carbomer refers to the high score of acrylic acid bonding allyl sucrose or pentaerythrite allyl ether
Sub- polymer.
The above-mentioned technical proposal of the present invention, compared with prior art with advantages below：
（1）The addition of carbomer substantially increases the stability of Osthole self-emulsifiable preparation, meanwhile, coordinate 15-25 parts by weight
Emulsifying agent, the assistant for emulsifying agent of 10-15 parts by weight, so as to get Osthole self-emulsifiable preparation there is good emulsifying effectiveness,
And there is good stability after forming self-emulsifiable liquid, ensureing preferably in addition, the cooperation of above-mentioned each component also achieves
While stability and emulsifying effectiveness, reduce the dosage of emulsifying agent, the dosage of emulsifying agent is 30-50w%, to the thorn of intestines and stomach
Swash it is smaller, our experiments show that, using above-mentioned parts by weight component prepare Osthole self-emulsifiable preparation, its bioavilability compared with
Height, assimilation effect are ideal.
（2）The preparation method of the Osthole self-emulsifiable preparation of the present invention, first Osthole is added in assistant for emulsifying agent, by
Larger solubility is known as to frutus cnidii in assistant for emulsifying agent, therefore can ensure that Osthole will not analyse in subsequent steps
Go out, then add carbomer, emulsifying agent, oil phase solvent, form stable system.
（3）The preparation method of the Osthole self-emulsifiable preparation of the present invention, when preparing self-emulsification solid, first to solid absorption
Agent pelletize, then adsorbed again, avoid first adsorb pelletize again the problem of being difficult to form particle, it is ensured that drug dose
Homogeneity, because sheeting operation is the process that makes material and particulate plastic deformation, therefore, the oiliness thing of above-mentioned particle surface attachment
Matter does not interfere with tabletting, sheeting operation also can be easier carried out, suitable for various solid dosage forms.
The above method can obtain drying powdered self-emulsification solid, and be affected by temperature it is smaller, be easy to storage transport.
Our experiments show that, obtained self-emulsification solid can in water 1min internal emulsifications, drug solubility is good, and bioavilability is high, can be real
The effect of now preferable.
（4）The preparation method of the Osthole self-emulsifiable preparation of the present invention, when preparing self-emulsification solid, after wet granulation
Osthole self-emulsifiable liquid is adsorbed in drying again, due to that can make to leave more space inside particle after drying, this increases not only
The specific surface area of particle, while the hole on grain structure is accommodated Osthole self-emulsifiable liquid, significantly increase appearance
Receive the ability of oily matter, preferably ensure that the stability of obtained Osthole self-emulsification solid.
Brief description of the drawings
In order that present disclosure is more likely to be clearly understood, below in conjunction with the accompanying drawings, the present invention is made further detailed
Thin explanation, wherein,
Fig. 1 is the situation curve map of 1 group of embodiment and Osthole concentration changes with time in commercially available group of rat plasma.
Embodiment
Embodiment 1
In the present embodiment, the Osthole self-emulsifying soft capsule is composed of the following components：
Osthole 20g；
Carbomer981 NF 8g；
PEG-4000 200g；
PLURONICS F87 300g；
Ethyl oleate 200g.
The preparation method of above-mentioned Osthole self-emulsifying soft capsule, comprises the following steps：
（1）Osthole, carbomer, PEG-4000, PLURONICS F87, ethyl oleate are measured according to above-mentioned prescription, first will
Osthole is added in PEG-4000, and heating makes its dissolving, adds carbomer, PLURONICS F87, ethyl oleate, stirs
After mixing uniformly, self-emulsifiable liquid is obtained；
（2）By step 1）In the obtained self-emulsifiable liquid using gelatin, glycerine, water as capsule material（1:0.4~0.6:1, w/w）Dress
Enter 40 DEG C of encapsulating machine temperature control to be suppressed, obtain single 0.5ml soft capsule.
Embodiment 2
In the present embodiment, the Osthole self-emulsifiable oral liquid is composed of the following components：
Osthole 20g；
Carbomer981 NF 10g；
Propane diols 250g；
Tween-80 350g；
Propylene ethyl glycol laurate 500g.
The preparation method of above-mentioned Osthole self-emulsifiable oral liquid, comprises the following steps：
（1）Osthole, carbomer, propane diols, Tween-80, propylene ethyl glycol laurate are measured according to above-mentioned prescription
Ester, Osthole is first added into propane diols, ultrasound makes its dissolving, adds carbomer, Tween-80, propylene ethyl glycol
Laurate, after stirring, obtain self-emulsifiable liquid；
（2）By step 1）In the obtained self-emulsifiable liquid direct packaging, produce.
Above-mentioned Osthole self-emulsifiable oral liquid using when take out to be diluted with water in the desired amount and can obtain oil-in-water type
Emulsion, then take；Also directly taken after can taking out in the desired amount, water-in-oil type breast can be spontaneously formed after contact gastro-intestinal Fluid
Liquid.
Embodiment 3
In the present embodiment, the Osthole self-emulsifying granule is composed of the following components：
Osthole 20g；
Carbomer981 NF 12g；
PEG-4000 200g；
PLURONICS F87 300g；
Polyethylene glycol -6- iso stearic acid of glycerine ester 200g；
PEG-4000 2000g.
The preparation method of above-mentioned Osthole self-emulsifying granule, comprises the following steps：
（1）It is sweet that Osthole, carbomer, PEG-4000, PLURONICS F87, polyethylene glycol -6- are measured according to above-mentioned prescription
Oily isostearate, PEG-4000, first Osthole is added in PEG-4000, ultrasound makes its dissolving, adds
Carbomer, PLURONICS F87, polyethylene glycol -6- iso stearic acid of glycerine ester, keeping temperature is 50 DEG C, after being incubated 30 minutes, stirring
Uniformly, self-emulsifiable liquid is obtained；
（2）The PEG-4000 is mixed with water, the content of PEG-4000 described in water is 8w%, crosses 40 mesh sieves,
Wet granulation, then dried at 60 DEG C, cross 60 mesh sieves, whole grain, then by obtained particle and step 1）In obtain it is described from
Emulsifying liquid mixes, and it is adsorbed in particle, obtains self-emulsification solid；
（3）By step 2）The obtained self-emulsification solid is dried, and is produced.
Embodiment 4
In the present embodiment, the Osthole self-emulsifying hard shell capsules are composed of the following components：
Osthole 20g；
Carbomer 8g；
The 300g of polyethylene glycol -200；
PLURONICS F87 500g；
Polyethylene glycol -6- iso stearic acid of glycerine ester 200g；
Lactose 1800g.
The preparation method of above-mentioned Osthole self-emulsifying hard shell capsules, comprises the following steps：
（1）It is sweet that Osthole, carbomer, polyethylene glycol -200, PLURONICS F87, polyethylene glycol -6- are measured according to above-mentioned prescription
Oily isostearate, first Osthole is added in polyethylene glycol -200, makes its dissolving, adds carbomer, poloxamer
188th, polyethylene glycol -6- iso stearic acid of glycerine ester, keeping temperature are 50 DEG C, after being incubated 30 minutes, stir, obtain self-emulsifying
Liquid；
（2）The lactose is mixed with water, the content of lactose described in water is 14w%, excessively 40 mesh sieves, wet granulation, then at 60 DEG C
Lower drying, cross 60 mesh sieves, whole grain, then by obtained particle and step 1）In obtain the self-emulsifiable liquid mixing, make it
It is adsorbed in particle, obtains self-emulsification solid；
（3）By step 2）The 60 DEG C of dryings of the obtained self-emulsification solid, then by after dry complete particle addition magnesium stearate
Hard shell capsules are distributed into, are produced.
Embodiment 5
In the present embodiment, the Osthole self-emulsifying tablet is composed of the following components：
Osthole 20g；
Carbomer 6g；
Polyglycereol 200g；
PLURONICS F87 400g；
Pungent certain herbaceous plants with big flowers acid glycerol three ester 350g；
Mannitol 2200g.
The preparation method of above-mentioned Osthole self-emulsifying film agent, comprises the following steps：
（1）Osthole, carbomer, polyglycereol, PLURONICS F87, pungent certain herbaceous plants with big flowers acid glycerol three ester are measured according to above-mentioned prescription, first will
Osthole is added in polyglycereol, makes its dissolving, adds carbomer, PLURONICS F87, pungent certain herbaceous plants with big flowers acid glycerol three ester, keeps temperature
Spend for 45 DEG C, after being incubated 30 minutes, stir, obtain self-emulsifiable liquid；
（2）The mannitol is mixed with water, the content of mannitol described in water is 8w%, excessively 40 mesh sieves, wet granulation, then
Dried at 60 DEG C, cross 60 mesh sieves, whole grain, then by obtained particle and step 1）In obtain the self-emulsifiable liquid mixing,
It is adsorbed in particle, obtain self-emulsification solid；
（3）By step 2）The obtained self-emulsification solid is dried, and the complete granulation of drying produces.
Embodiment 6
In the present embodiment, the Osthole self-emulsifying tablet is composed of the following components：
Osthole 20g；
Carbomer 6g；
The 100g of polyethylene glycol -700；
Polyglycereol 100g；
PLURONICS F87 350g；
Tween-80 50g；
Glyceryl oleate -2- Wickenol 142s 250g；
Oleic acid 100g；
Mannitol 1200g；
Lactose 1000g.
The preparation method of above-mentioned Osthole self-emulsifying film agent, comprises the following steps：
（1）Osthole, carbomer, polyethylene glycol -700, polyglycereol, PLURONICS F87, poly- sorb are measured according to above-mentioned prescription
Ester -80, glyceryl oleate -2- Wickenol 142s, oleic acid, first by Osthole add polyethylene glycol -700 with
In the mixed liquor of polyglycereol, make its dissolving, add carbomer, PLURONICS F87, Tween-80, glyceryl oleate -2-
Wickenol 142, oleic acid, stir, and obtain self-emulsifiable liquid；
（2）The mannitol, lactose are mixed with water, wet granulation, whole grain, then by obtained particle and step 1）In obtain
The self-emulsifiable liquid mixing, it is adsorbed in particle, obtain self-emulsification solid；
（3）By step 2）The obtained self-emulsification solid is dried, and the complete granulation of drying produces.
Comparative example 1
Osthole self-emulsifying soft capsule in this comparative example, without carbomer, remaining component is in the same manner as in Example 1, and adopts
It is prepared with the method in embodiment 1.
Comparative example 2
Osthole self-emulsifying particle in this comparative example, without carbomer, remaining component is in the same manner as in Example 3, and uses
Method in embodiment 3 is prepared.
Comparative example 3
Osthole self-emulsifying particle in this comparative example, the dosage of carbomer is 10g, the dosage of emulsifying agent PLURONICS F87
Dosage for 200g, assistant for emulsifying agent PEG-4000 is 400g, and remaining component is in the same manner as in Example 1, and uses embodiment 1
In method be prepared.
Comparative example 4
Osthole self-emulsifying particle in this comparative example, the dosage of carbomer is 10g, the dosage of emulsifying agent PLURONICS F87
For 400g, remaining component is in the same manner as in Example 3, and is prepared using the method in embodiment 3.
Effect experimental examples
Technique effect to illustrate the invention, to the Osthole self-emulsifying system being prepared in embodiment 1-6 and comparative example 1-4
Agent, do following detection：
1st, stability experiment
First, distinguish in Example 1-2 and comparative example 1, step（1）Obtained self-emulsifiable liquid, and embodiment 3-6 with
And in comparative example 2-4, step（2）Obtained self-emulsification solid, puts 30 DEG C, in the stability test case of relative humidity 65%, regularly takes
Sample determines Content of Osthole.
Assay method is：Precision measures testing sample 50ml（Self-emulsifiable liquid）、300g（Self-emulsification solid）, according to《In
State's pharmacopeia 2010 editions》Determination of volatile oil method in one D of annex Ⅹ is measured, and is 0.897 calculating frutus cnidii by relative density
Element content, using prepare complete when Content of Osthole as 100%, respectively detection 3 months after, after 6 months, after 9 months, 12
The changes of contents situation of Osthole, its test result are as shown in table 1 after individual month.
The Osthole relative amount of the embodiment 1-6 of table 1 and comparative example 1-4 self-emulsifiable preparation
From the above results, Osthole self-emulsifiable preparation 1-6 of the invention is more excellent compared to comparative example 1-4 stability, this
The Osthole self-emulsifiable preparation of invention, the content of Osthole has almost no change after placing 12 months, illustrates what it was formed
Self-emulsifiable liquid and self-emulsification solid have good stability.
Comparative example 1, comparative example 2 do not add carbomer, and its stability substantially reduces, especially Osthole self-emulsifiable liquid
Preparation, the content of Osthole is only 7.4% after 12 months.Although comparative example 3 adds more carbomer, the use of emulsifying agent
Amount is less than the scope of the present invention, and emulsification is very low, and emulsion stability is still poor.Comparative example 4 adds carbomer, and emulsifies
The dosage of agent is higher than the scope of the present invention, but its stability is still not ideal enough.
2nd, blood concentration is tested after rat administration
Using Self-control method, take 110 rats, be randomly divided into 11 groups, every group 10, respectively numbering be embodiment 1-6 groups, it is right
Ratio 1-4 groups.Respectively correspond to give 250mg/kg Osthole preparation after, determine rat plasma in Osthole concentration at any time
Between situation about changing.Snake in 100min, 200min, 300min, 400min, 600min blood plasma after recording respectively to rat administration
Machine tool element concentration, its result are as shown in table 2.By Osthole concentration average in embodiment group and comparative example group measure rat plasma
Situation about changing over time is plotted as curve map, as shown in Figure 1.
After the administration of 2 each preparation of table in different time blood plasma Osthole concentration
As can be seen here, Osthole self-emulsifiable preparation of the invention has good dissolution rate, has after administration in rat plasma
It is significantly higher to imitate the concentration of composition Osthole, ensure that its higher bioavilability, shows the Osthole of the present invention certainly
Emulsification preparation can be realized in vivo faster and preferably to be absorbed.
Obviously, above-described embodiment is only intended to clearly illustrate example, and is not the restriction to embodiment.It is right
For those of ordinary skill in the art, can also make on the basis of the above description it is other it is various forms of change or
Change.There is no necessity and possibility to exhaust all the enbodiments.And the obvious change thus extended out or
Among changing still in the protection domain of the invention.
Claims (10)
1. a kind of Osthole self-emulsifiable preparation, it is characterised in that include the component of following parts by weight：
The parts by weight of Osthole 1；
Carbomer 0.1-0.6 parts by weight；
Assistant for emulsifying agent 10-15 parts by weight；
Emulsifying agent 15-25 parts by weight；
Oil phase solvent 10-25 parts by weight.
2. Osthole self-emulsifiable preparation according to claim 1, it is characterised in that the Osthole self-emulsifiable preparation
Also include the solid absorbent of 90-110 parts by weight.
3. Osthole self-emulsifiable preparation according to claim 2, it is characterised in that the solid absorbent is poly- second two
One or more in alcohol -6000, lactose, mannitol.
4. Osthole self-emulsifiable preparation according to claim 1, it is characterised in that the oil phase solvent is middle long-chain
Fatty glyceride.
5. Osthole self-emulsifiable preparation according to claim 4, it is characterised in that the oil phase solvent is oleic acid, third
Alkenyl ethylene glycol laurate, polyethylene glycol -6- iso stearic acid of glycerine ester, pungent certain herbaceous plants with big flowers acid glycerol three ester, ethyl oleate, glycerine oleic acid
One or more in ester -2- Wickenol 142s.
6. Osthole self-emulsifiable preparation according to claim 1, it is characterised in that the emulsifying agent is poloxamer
188th, the one or more in Tween-80；The assistant for emulsifying agent is propane diols, polyglycereol, molecular weight be 200 ~ 700 it is poly-
One or more in ethylene glycol.
A kind of 7. method for preparing any Osthole self-emulsifiable preparation in claim 1-6, it is characterised in that including with
Lower step：
（1）Osthole, carbomer, assistant for emulsifying agent, emulsifying agent, oil phase solvent are taken according to selected parts by weight, first by frutus cnidii
Element is added in assistant for emulsifying agent, makes its dissolving, then adds carbomer, emulsifying agent, oil phase solvent, after stirring, is obtained from breast
Change liquid；
（2）By step 1）In the obtained self-emulsifiable liquid clinically-acceptable formulation is conventionally made, produce.
8. the method according to claim 7 for preparing Osthole self-emulsifiable preparation, it is characterised in that also include solid
Adsorbent mixes with water, granulation, then obtained particle is mixed with the self-emulsifiable liquid, it is adsorbed in particle, obtains
The step of to self-emulsification solid.
9. the method according to claim 8 for preparing Osthole self-emulsifiable preparation, it is characterised in that the granulation is wet
Method is pelletized, and the solid absorbent is mixed with water, is sieved, re-dry after wet granulation.
A kind of 10. glue being prepared according to any described methods for preparing Osthole self-emulsifiable preparation of claim 7-9
Wafer, tablet, granule or oral liquid.
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108553417A (en) * | 2018-03-30 | 2018-09-21 | 陕西中医药大学 | A kind of Osthole self-emulsifying drug delivery system and preparation method thereof and purposes |
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2017
- 2017-07-21 CN CN201710598905.7A patent/CN107456443A/en not_active Withdrawn
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108553417A (en) * | 2018-03-30 | 2018-09-21 | 陕西中医药大学 | A kind of Osthole self-emulsifying drug delivery system and preparation method thereof and purposes |
| CN108553417B (en) * | 2018-03-30 | 2022-06-21 | 陕西中医药大学 | Osthole self-emulsifying drug release system and preparation method and application thereof |
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Application publication date: 20171212 |