CN103550289B - A kind of Duyiwei soft capsule and preparation method thereof - Google Patents
A kind of Duyiwei soft capsule and preparation method thereof Download PDFInfo
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Abstract
The present invention relates to a kind of Duyiwei soft capsule and preparation method thereof, belong to medical art, concrete belongs to technical field of medicine.This Duyiwei soft capsule is made up of content and soft softgel shell, and containing total flavones in every mg content take molecular formula as C
27h
30o
16rutin count 0.063-0.078mg.Duyiwei soft capsule of the present invention has the stable in properties that common soft capsule does not possess, and the storage time is long, and disintegration time is short, and stripping waits significance feature rapidly.
Description
Technical field
The present invention relates to a kind of soft capsule preparation and preparation method thereof, particularly relate to a kind of Duyiwei soft capsule and preparation method thereof, belong to medical art, concrete belongs to technical field of medicine.
Background technology
Radix Lamiophlomidis Rotatae, medical material, herbaceos perennial.Hardship, is slightly cold.Slightly poisonous.There is blood circulation promoting and blood stasis dispelling, effect of reducing swelling and alleviating pain, for traumatic injury, fracture, lumbar strain.Its chemical composition has luteolin (luteolin), luteolin-7-O-glycoside (luteolin-7-O-glucoside), Quercetin (quercetin), the Arabic glucoside (quercetin-3O-glucoside) of Quercetin-3-O-
quercetin(quercetin), the Arabic glucoside (quercetin-3-O-arabinoside) of Quercetin-3-O-, apigenin-7-O-new dried orange peel glycoside (api-genin-7-O-neohesperidoside).
The preparation that Duyiwei soft capsule system is made up of Radix Lamiophlomidis Rotatae processing of crude drugs, soft capsule becomes pharmaceutical industry with its exclusive advantage and pays close attention to more dosage form.Chinese invention patent 200710108359.0 discloses a kind of soft capsule containing Radix Lamiophlomidis Rotatae extract, the content of this soft capsule at least contains the Radix Lamiophlomidis Rotatae extract of 20% ~ 70%, other comprise substrate, liquid Paraffin and suspending agent, described substrate and the weight ratio of liquid Paraffin are 1: 0.05 ~ 5, this soft capsule significantly can strengthen the beneficial effect of Radix Lamiophlomidis Rotatae extract, has more significant stability and treatment advantage than current commercially available prod.But do not mention in this patent description while ensureing that Duyiwei soft capsule has remarkable stability, how to improve the technology contents of Radix Lamiophlomidis Rotatae extract active constituent content, become a matter of regret of this patent application.
The stability of pharmaceutical preparation and the content of effective ingredient are that this pharmaceutical preparation gives full play to the indispensable key factor of clinical practice, therefore, when developing drugs preparation, considering various factors, give full play to its effectiveness, is a kind of thinking of medicament research and development innovation.
Summary of the invention
Technical problem to be solved by this invention is that the defect overcoming prior art provides a kind of Duyiwei soft capsule, this Duyiwei soft capsule not only has excellent stability, disintegration properties, and there is the high feature of active constituent content, in addition, the present invention further provides the preparation method of this soft capsule, the method have the time short, do not use the features such as ethanol equal solvent environmental protection.
Technical problem of the present invention is realized by following technical scheme.
A kind of Duyiwei soft capsule, is made up of content and soft softgel shell, and containing total flavones in every mg content take molecular formula as C
27h
30o
16rutin count 0.063-0.078mg.
Above-mentioned Duyiwei soft capsule, in described content each component by weight unit count Radix Lamiophlomidis Rotatae extract fine powder 150-300, Oleum Vitis viniferae 200-500, mannitol 20-100; In described soft softgel shell each component by weight unit count gelatin 100-200, glycerol 50-100, purified water 150-300, PEG400 90-130, brilliant black 2-8 and xylitol 15-25.
Above-mentioned Duyiwei soft capsule, in described content each component by weight unit count Radix Lamiophlomidis Rotatae extract fine powder 230, Oleum Vitis viniferae 300, mannitol 70; In described soft softgel shell each component by weight unit count gelatin 150, glycerol 80, purified water 235, PEG400 115, brilliant black 5 and xylitol 20.
Above-mentioned Duyiwei soft capsule, in described content each component by weight unit count Radix Lamiophlomidis Rotatae extract fine powder 150, Oleum Vitis viniferae 230, mannitol 20; In described soft softgel shell each component by weight unit count gelatin 100, glycerol 55, purified water 160, PEG400 100, brilliant black 3 and xylitol 17.
Above-mentioned Duyiwei soft capsule, in described content each component by weight unit count Radix Lamiophlomidis Rotatae extract fine powder 300, Oleum Vitis viniferae 400, mannitol 100; In described soft softgel shell each component by weight unit count gelatin 200, glycerol 90, purified water 280, PEG400 128, brilliant black 7 and xylitol 23.
Prepare a method for above-mentioned Duyiwei soft capsule, comprise the steps:
(1) extraction of Radix Lamiophlomidis Rotatae extract fine powder: the Radix Lamiophlomidis Rotatae medical material getting pulverizing, mix with cellulase, D-AAO, phospholipase, the weight ratio of its cellulase, D-AAO, phospholipase is 5-10:10-12:1, the gross weight of three is 0.5-0.8 times of Radix Lamiophlomidis Rotatae medical material weight, decocts with water 25 minutes, filters, filtrate is condensed at 60 DEG C the extractum that relative density is 1.20, at 80 DEG C, drying under reduced pressure obtains Radix Lamiophlomidis Rotatae extract fine powder, for subsequent use
(2) preparation of content: by the Radix Lamiophlomidis Rotatae extract fine powder of step (1) gained and Oleum Vitis viniferae, mannitol at 50 DEG C, mix homogeneously, for subsequent use;
(3) preparation of glue: added by gelatin in purified water, is heated to temperature 35 DEG C, adds glycerol, PEG400, brilliant black and xylitol, stirs 15 minutes, obtains glue for subsequent use;
(4) preparation of finished product: pellet press put into by step (2) gained content and step (3) gained glue, i.e. obtained Duyiwei soft capsule of the present invention.
The above-mentioned method preparing Duyiwei soft capsule, the weight ratio of described cellulase, D-AAO, phospholipase is 8:11:1, and the gross weight of three is 0.7 times of Radix Lamiophlomidis Rotatae medical material weight.
The present invention is devoted to innovation research prepared by Chinese medicine extraction, in research and development process, carry out a large amount of tests, pay extremely hard and bitter effort, object is to develop the Chinese medicine extraction, the technology of preparing that make new advances, can improve the content of effective ingredient, can realize again good Clinical practice compliance, the method that the present invention studies is realize Chinese medicine extraction to provide new example, has very high exemplary role.
The present invention is in research process, and unexpected discovery Oleum Vitis viniferae and mannitol can realize good peptizaiton, and can realize again good suspending effect, effective ingredient is uniformly dispersed, not stratified, not muddy, and good fluidity.Owing to containing comparatively poly-glycerine in soft softgel shell, adsorption phenomena can be there is when the resting period is long or temperature is higher, the present invention is by a large amount of investigative tests, when finding the consumption of xylitol in softgel shell to control between 15-25 weight portion, can be good at solving soft capsule absorption problem, make the preservation condition of soft capsule be unlikely to harsh; The present invention solves absorption problem preferably.In addition, the present invention, in research process, finds that the water content of soft capsule shell can affect disintegration.Its reason is that the oxygen penetration capacity of flexible glue cyst membrane is direct and cyst membrane water content is proportional, therefore moisture can accelerate the oxidation of gelatin, makes the aging quickening of cyst wall, causes disintegration time to extend.Technical scheme of the present invention efficiently solves the aging problem of softgel shell.When being controlled between 15-25 weight portion by the consumption of xylitol in softgel shell, can effectively solve softgel shell problem of aging, the soft capsule holding time is increased.The present invention can not only control the absorption of soft capsule to moisture, reduce the increase of moisture in soft capsule, delay the oxidation of gelatin in soft capsule, and can also prevent soft capsule content and gelatin from reacting, thus the stable in properties making Duyiwei soft capsule of the present invention have common soft capsule not possess, storage time is long, and disintegration time is short, and stripping waits significance feature rapidly.
The present invention is in the process of the preparation method of research Duyiwei soft capsule, find to use cellulase, D-AAO, phospholipase mixed weight than being 5-10:10-12:1, when the gross weight of three is the 0.5-0.8 times of Radix Lamiophlomidis Rotatae medical material weight, can be good at the extraction realizing effective ingredient, make Duyiwei soft capsule content of the present invention in 600mg containing total flavones with rutin (C
27h
30o
16) count up to 46.8mg, and not relating to any organic solvent in producing, the production cycle significantly shortens simultaneously, production technology environmental protection, and energy consumption and cost significantly reduce, and is applicable to large-scale industrial production.
Detailed description of the invention
In order to understand the present invention further, below in conjunction with embodiment, the present invention is described in detail, but these embodiments do not form any restriction to the present invention.
The preparation (1000) of embodiment 1 Duyiwei soft capsule of the present invention
Preparation method:
(1) extraction of Radix Lamiophlomidis Rotatae extract fine powder: the Radix Lamiophlomidis Rotatae medical material getting pulverizing, mix with cellulase, D-AAO, phospholipase, the weight ratio of its cellulase, D-AAO, phospholipase is 5:10:1, the gross weight of three is 0.5 times of Radix Lamiophlomidis Rotatae medical material weight, decocts with water 25 minutes, filters, filtrate is condensed at 60 DEG C the extractum that relative density is 1.20, at 80 DEG C, drying under reduced pressure obtains Radix Lamiophlomidis Rotatae extract fine powder, for subsequent use
(2) preparation of content: by the Radix Lamiophlomidis Rotatae extract fine powder of step (1) gained and Oleum Vitis viniferae, mannitol at 50 DEG C, mix homogeneously, for subsequent use;
(3) preparation of glue: added by gelatin in purified water, is heated to temperature 35 DEG C, adds glycerol, PEG400, brilliant black and xylitol, stirs 15 minutes, obtains glue for subsequent use;
(4) preparation of finished product: pellet press put into by step (2) gained content and step (3) gained glue, i.e. obtained Duyiwei soft capsule of the present invention.
The preparation (1000) of embodiment 2 Duyiwei soft capsule of the present invention
Preparation method:
(1) extraction of Radix Lamiophlomidis Rotatae extract fine powder: the Radix Lamiophlomidis Rotatae medical material getting pulverizing, mix with cellulase, D-AAO, phospholipase, the weight ratio of its cellulase, D-AAO, phospholipase is 10:12:1, the gross weight of three is 0.8 times of Radix Lamiophlomidis Rotatae medical material weight, decocts with water 25 minutes, filters, filtrate is condensed at 60 DEG C the extractum that relative density is 1.20, at 80 DEG C, drying under reduced pressure obtains Radix Lamiophlomidis Rotatae extract fine powder, for subsequent use
(2) preparation of content: by the Radix Lamiophlomidis Rotatae extract fine powder of step (1) gained and Oleum Vitis viniferae, mannitol at 50 DEG C, mix homogeneously, for subsequent use;
(3) preparation of glue: added by gelatin in purified water, is heated to temperature 35 DEG C, adds glycerol, PEG400, brilliant black and xylitol, stirs 15 minutes, obtains glue for subsequent use;
(4) preparation of finished product: pellet press put into by step (2) gained content and step (3) gained glue, i.e. obtained Duyiwei soft capsule of the present invention.
The preparation (1000) of embodiment 3 Duyiwei soft capsule of the present invention
Preparation method:
(1) extraction of Radix Lamiophlomidis Rotatae extract fine powder: the Radix Lamiophlomidis Rotatae medical material getting pulverizing, mix with cellulase, D-AAO, phospholipase, the weight ratio of its cellulase, D-AAO, phospholipase is 8:11:1, the gross weight of three is 0.7 times of Radix Lamiophlomidis Rotatae medical material weight, decocts with water 25 minutes, filters, filtrate is condensed at 60 DEG C the extractum that relative density is 1.20, at 80 DEG C, drying under reduced pressure obtains Radix Lamiophlomidis Rotatae extract fine powder, for subsequent use
(2) preparation of content: by the Radix Lamiophlomidis Rotatae extract fine powder of step (1) gained and Oleum Vitis viniferae, mannitol at 50 DEG C, mix homogeneously, for subsequent use;
(3) preparation of glue: added by gelatin in purified water, is heated to temperature 35 DEG C, adds glycerol, PEG400, brilliant black and xylitol, stirs 15 minutes, obtains glue for subsequent use;
(4) preparation of finished product: pellet press put into by step (2) gained content and step (3) gained glue, i.e. obtained Duyiwei soft capsule of the present invention.
The preparation (1000) of embodiment 4 Duyiwei soft capsule of the present invention
Preparation method:
(1) extraction of Radix Lamiophlomidis Rotatae extract fine powder: the Radix Lamiophlomidis Rotatae medical material getting pulverizing, mix with cellulase, D-AAO, phospholipase, the weight ratio of its cellulase, D-AAO, phospholipase is 8:11:1, the gross weight of three is 0.6 times of Radix Lamiophlomidis Rotatae medical material weight, decocts with water 25 minutes, filters, filtrate is condensed at 60 DEG C the extractum that relative density is 1.20, at 80 DEG C, drying under reduced pressure obtains Radix Lamiophlomidis Rotatae extract fine powder, for subsequent use
(2) preparation of content: by the Radix Lamiophlomidis Rotatae extract fine powder of step (1) gained and Oleum Vitis viniferae, mannitol at 50 DEG C, mix homogeneously, for subsequent use;
(3) preparation of glue: added by gelatin in purified water, is heated to temperature 35 DEG C, adds glycerol, PEG400, brilliant black and xylitol, stirs 15 minutes, obtains glue for subsequent use;
(4) preparation of finished product: pellet press put into by step (2) gained content and step (3) gained glue, i.e. obtained Duyiwei soft capsule of the present invention.
The preparation (1000) of embodiment 5 Duyiwei soft capsule of the present invention
Preparation method:
(1) extraction of Radix Lamiophlomidis Rotatae extract fine powder: the Radix Lamiophlomidis Rotatae medical material getting pulverizing, mix with cellulase, D-AAO, phospholipase, the weight ratio of its cellulase, D-AAO, phospholipase is 8:11:1, the gross weight of three is 0.7 times of Radix Lamiophlomidis Rotatae medical material weight, decocts with water 25 minutes, filters, filtrate is condensed at 60 DEG C the extractum that relative density is 1.20, at 80 DEG C, drying under reduced pressure obtains Radix Lamiophlomidis Rotatae extract fine powder, for subsequent use
(2) preparation of content: by the Radix Lamiophlomidis Rotatae extract fine powder of step (1) gained and Oleum Vitis viniferae, mannitol at 50 DEG C, mix homogeneously, for subsequent use;
(3) preparation of glue: added by gelatin in purified water, is heated to temperature 35 DEG C, adds glycerol, PEG400, brilliant black and xylitol, stirs 15 minutes, obtains glue for subsequent use;
(4) preparation of finished product: pellet press put into by step (2) gained content and step (3) gained glue, i.e. obtained Duyiwei soft capsule of the present invention.
The assay of embodiment 6 Duyiwei soft capsule of the present invention
(1) the preparation precision of reference substance solution to take at 120 DEG C of drying under reduced pressure to the control substance of Rutin 200mg of constant weight, puts in 100ml measuring bottle, adds 70% ethanol 70ml, put in 50 DEG C of water-baths and make dissolving, let cool, add 70% ethanol to scale, shake up.Precision measures 10ml, puts in 100ml measuring bottle, adds water to scale, shake up, and obtains (containing anhydrous rutin 0.2mg in every 1ml).
(2) the preparation precision of standard curve measures reference substance solution 1.0ml, 2.0ml, 3.0ml, 4.0ml, 5.0ml, 6.0ml, put in 25ml measuring bottle respectively, add water to 6ml, add 5% sodium nitrite solution 1ml, mixing, place 6 minutes, add 10% aluminum nitrate solution 1ml, shake up, place 6 minutes, hydro-oxidation sodium test solution 10ml, add water to scale again, shake up, place 15 minutes, with corresponding solution for blank, according to spectrophotography (Chinese Pharmacopoeia version in 2000 annex V B), trap is measured at 500nm wavelength place, take trap as vertical coordinate, concentration is abscissa, drawing standard curve.
(3) Duyiwei soft capsule obtained by algoscopy embodiment 1 to 5, the Duyiwei soft capsule prepared according to Chinese patent 200710108359.0 support methods and commercially available Duyiwei soft capsule operate respectively by the following method
Get the content of this product 20, mixing, get 2.0g, accurately weighed, put in 100ml ground triangular flask, heating water 25ml, stir and supersound process 20 minutes, let cool, extract once with petroleum ether (60-90 DEG C) 15ml, water layer is quantitatively transferred in 100ml measuring bottle, precision adds dehydrated alcohol 70ml again, supersound process 10 minutes again, let cool, add water to scale, shake up, centrifugal (3000r/ppm) 5 minutes, precision measures supernatant 1ml, put in 25ml measuring bottle, method under the preparation of sighting target directrix curve, from " adding water to 6ml ", measure trap in accordance with the law, the weight of rutin in need testing solution is read from standard curve, calculate, obtain.
(4) measurement result is in table 1.
Table 1
As can be seen here, contained by the every mg content of Duyiwei soft capsule of the present invention, total flavones is with rutin (C
27h
30o
16) count up to 0.078mg.Calculate with content 600mg, Duyiwei soft capsule every of the present invention contains total flavones with rutin (C
27h
30o
16) count 46.8mg, the Duyiwei soft capsule every obtained by patent 200710108359.0 contains total flavones with rutin (C
27h
30o
16) count 20.4mg, commercially available Duyiwei soft capsule every contains total flavones with rutin (C
27h
30o
16) count 21.6mg, Duyiwei soft capsule every of the present invention contains total flavones with rutin (C
27h
30o
16) meter exceeds 129.4%, 116.7% respectively than Duyiwei soft capsule obtained by patent 200710108359.0 and commercially available Duyiwei soft capsule, significantly improve the content of effective ingredient, improve service efficiency.
Embodiment 7 Duyiwei soft capsule safety testing of the present invention
The content mixing of the Duyiwei soft capsule obtained by Example 1 20, numbering 1, such as the method for the Duyiwei soft capsule obtained by embodiment 2-5 operates, numbering 2-5;
Mice divides a, b, c, d, e group often to organize 10, by numbering 1 gavage mice a group, numbering 2 gavage mice b group, by that analogy, dosage gives 0.3g (being equivalent to more than 10 times of ordinary people's single oral dose) according to every kg, observes the defecation situation of mice.Five groups of mice defecations are all normal.Illustrate that Duyiwei soft capsule of the present invention is while active constituent content improves, the safety of clinical practice is also secure.
Embodiment 8 Duyiwei soft capsule slaking test of the present invention
(1) accelerated test:
Experimental condition: by the Duyiwei soft capsule prepared by embodiment 1 to 5, is placed on temperature 37 DEG C, in the climatic chamber of relative humidity 70%, in the sampling of different time periods, measures disintegration time (minute).In table 2.
Table 2
(2) room temperature test:
Experimental condition: by the Duyiwei soft capsule prepared by embodiment 1 to 5, be placed on indoor, temperature and relative humidity, with extraneous consistent, in the sampling of different time periods, measure disintegration time (minute).In table 3, table 4.
Table 3
Table 4
(3) low-temperature test:
Experimental condition: by the Duyiwei soft capsule prepared by embodiment 1 to 5, is placed in low temperature chamber, and temperature, throughout the year lower than 20 DEG C, in the sampling of different time periods, measures disintegration time (minute).In table 5 and table 6.
Table 5
Table 6
As seen from the experiment, no matter at acceleration environment, room temperature condition, still under cryogenic, Duyiwei soft capsule character of the present invention is still stablized, disintegration meets the requirements, and still can play good effectiveness from storing, using this soft capsule under various circumstances, ensure therapeutic effect.
The explanation of above embodiment just understands the present invention for helping; professional and technical personnel in the field are realized or uses the present invention; not in order to limit the present invention; within the spirit and principles in the present invention all; any amendment of doing, equivalent replacement, improvement etc., all should be included within protection scope of the present invention.
Claims (5)
1. a Duyiwei soft capsule, is made up of content and soft softgel shell, it is characterized in that, containing total flavones in every mg content take molecular formula as C
27h
30o
16rutin count 0.063-0.078mg; In described content each component by weight unit count Radix Lamiophlomidis Rotatae extract fine powder 150-300, Oleum Vitis viniferae 200-500, mannitol 20-100; In described soft softgel shell each component by weight unit count gelatin 100-200, glycerol 50-100, purified water 150-300, PEG400 90-130, brilliant black 2-8 and xylitol 15-25; Further, this soft capsule is prepared by following methods:
(1) extraction of Radix Lamiophlomidis Rotatae extract fine powder: the Radix Lamiophlomidis Rotatae medical material getting pulverizing, mix with cellulase, D-AAO, phospholipase, the weight ratio of its cellulase, D-AAO, phospholipase is 5-10:10-12:1, the gross weight of three is 0.5-0.8 times of Radix Lamiophlomidis Rotatae medical material weight, decoct with water 25 minutes, filter, filtrate is condensed at 60 DEG C the extractum that relative density is 1.20, at 80 DEG C, drying under reduced pressure obtains Radix Lamiophlomidis Rotatae extract fine powder, for subsequent use;
(2) preparation of content: by the Radix Lamiophlomidis Rotatae extract fine powder of step (1) gained and Oleum Vitis viniferae, mannitol at 50 DEG C, mix homogeneously, for subsequent use;
(3) preparation of glue: added by gelatin in purified water, is heated to temperature 35 DEG C, adds glycerol, PEG400, brilliant black and xylitol, stirs 15 minutes, obtains glue for subsequent use;
(4) preparation of finished product: pellet press put into by step (2) gained content and step (3) gained glue, i.e. obtained described Duyiwei soft capsule.
2. Duyiwei soft capsule according to claim 1, is characterized in that, in described content each component by weight unit count Radix Lamiophlomidis Rotatae extract fine powder 230, Oleum Vitis viniferae 300, mannitol 70; In described soft softgel shell each component by weight unit count gelatin 150, glycerol 80, purified water 235, PEG400 115, brilliant black 5 and xylitol 20.
3. Duyiwei soft capsule according to claim 2, is characterized in that, in described content each component by weight unit count Radix Lamiophlomidis Rotatae extract fine powder 150, Oleum Vitis viniferae 230, mannitol 20; In described soft softgel shell each component by weight unit count gelatin 100, glycerol 55, purified water 160, PEG400 100, brilliant black 3 and xylitol 17.
4. Duyiwei soft capsule according to claim 3, is characterized in that, in described content each component by weight unit count Radix Lamiophlomidis Rotatae extract fine powder 300, Oleum Vitis viniferae 400, mannitol 100; In described soft softgel shell each component by weight unit count gelatin 200, glycerol 90, purified water 280, PEG400 128, brilliant black 7 and xylitol 23.
5. Duyiwei soft capsule according to claim 1, is characterized in that, the weight ratio of described cellulase, D-AAO, phospholipase is 8:11:1, and the gross weight of three is 0.7 times of Radix Lamiophlomidis Rotatae medical material weight.
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