CN107789391A - A kind of Mulberry plant extract slow-release preparation and its preparation method and application - Google Patents

A kind of Mulberry plant extract slow-release preparation and its preparation method and application Download PDF

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CN107789391A
CN107789391A CN201610770262.5A CN201610770262A CN107789391A CN 107789391 A CN107789391 A CN 107789391A CN 201610770262 A CN201610770262 A CN 201610770262A CN 107789391 A CN107789391 A CN 107789391A
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plant extract
mulberry plant
slow
mulberry
montmorillonite
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邓超
周应军
徐瑾
陈正收
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CHANGSHA SANYOU MEDICINE SCIENCE & TECHNOLOGY Co Ltd
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/60Moraceae (Mulberry family), e.g. breadfruit or fig
    • A61K36/605Morus (mulberry)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0002Galenical forms characterised by the drug release technique; Application systems commanded by energy
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2009Inorganic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose

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  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
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  • Natural Medicines & Medicinal Plants (AREA)
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  • Alternative & Traditional Medicine (AREA)
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  • Inorganic Chemistry (AREA)
  • Medicines Containing Plant Substances (AREA)

Abstract

The invention discloses a kind of Mulberry plant extract slow-release preparation and its preparation method and application, the Mulberry plant extract slow-release agent is by montmorillonite, Mulberry plant extract, hydroxypropyl methyl cellulose by weight 1:(0.8~4):(0.5~2) form, type II diabetes medicine is treated available for preparing.

Description

A kind of Mulberry plant extract slow-release preparation and its preparation method and application
Technical field
The present invention relates to a kind of Mulberry plant extract slow-release preparation and its preparation method and application, especially in II type sugar Application in terms of urine disease treatment (mainly regulating and controlling to postprandial blood sugar).
Background technology
Modern pharmacological research proves that Mulberry plant has the function that suppressing blood glucose rises.And further investigations have shown that it drops Sugar effect be mainly derived from its alkaloid component, as fagomine, Isosorbide-5-Nitrae-dideoxy-1,4-imino-D-arabinitol, Zarzissine and 1-DNJ (1-deoxynojirimycin, DNJ) etc..Wherein fagomine by enhancing by Body strengthens insulin active so as to play a part of promoting glycometabolism, and 1-DNJ to the sensitiveness of insulin (DNJ) it is then a kind of chemical constitution polyhydroxylated alkaloid similar to glucose, is a kind of alpha-glucosidase inhibitor of high activity. DNJ suppresses hydrolysis of the alpha-glucosidase to disaccharide by being combined with the center site of the upper alpha-glucosidase of small intestine brush border cell Effect, so as to reduce the generation of internal glucose, the purpose for reducing blood glucose is reached with this.And Mulberry plant extract is because rich in upper State composition and there is good hypoglycemic effect.
Existing pharmacodynamic experiment shows only to need the DNJ of relatively low-dose can effectively suppress the upper of rat or people's postprandial blood sugar Rise.Using healthy rat in the research of administration object, compared with blank group, to give DNJ rat, equivalent sucrose is being given Afterwards, blood sugar level substantially drops;And in the diabetes rat model induced with streptozotocin, researcher has found to give DNJ reality Group is tested than control group, there is lower level of postprandial blood sugar, this shows that DNJ equally has hypoglycemic work to diabetes rat With.
In the further research taking human as experimental subjects, related data shows that the mulberry extract of the DNJ containing 6mg can be Healthy volunteer's level of postprandial blood sugar is significantly reduced in 2h, and the research to carbohydate metabolism system damage patient then shows to contain 3mg DNJ Mulberry plant extract can play certain hypoglycemic effect, and this effect is in dose dependent.For a long time simultaneously Take the regulation for being advantageous to the blood glucose system of diabetic.The above research and data show Mulberry plant extract Internal postprandial blood sugar can be effectively reduced in bion aspect.And Hye etc. research show with DNJ single phases ratio, containing identical Dosage DNJ Mulberry plant extract has more preferable hypoglycemic effect.
But experiment in vivo shows that the main sugar reducing substance DNJ enteron aisles in Mulberry plant extract eliminate half-life short, only about 15min.Therefore in order to maintain small intestine DNJ concentration, inhibition of the Mulberry plant extract to postprandial blood sugar is extended, it is necessary to prolong Residence time of the Changsang extract in enteron aisle.
The sustained release research of the Mulberry plant extract on DNJ and containing DNJ is less at present, there is only the two of document report Kind of mode, a kind of is to prepare the micro-capsule containing DNJ by using the mode of gel parcel, another then made by using CMC-Na Delay DNJ rate of release for slow-release material.Although both serve certain slow release effect, using CMC-Na as slow When releasing material, although the C compared with giving DNJ merelymaxValue decreases, but AUC and is not apparent from increasing, and shows prepared slow Release formulation DNJ discharges not fully, while its action time also shorter only 2h.And DNJ micro-capsules prepared by gel are used in 3h Good slow-release capability is shown, but preparation process is complicated, it is higher to equipment requirement.In addition there is patent【Application number 201010557683.2 the A of application publication number CN 102166258】A kind of preparation method of slow-release micropill with mulberry leaf extract, by mulberry Genus plants extract is prepared into micropill to realize that it slowly discharges.
Montmorillonite (montmorillonite, MMT) be it is a kind of be mainly made up of montmorillonite 2:1 clay of laminar silicate, Existing many MMT are used for the research of sustained release preparation both at home and abroad at present.Montmorillonite, which removes, has specific surface area big and cation exchange Capacity (CEC) it is suitable the features such as outside, also there is good adsorption capacity to the moisture in environment, there are some researches show montmorillonite energy Adsorb the water of up to 3 times of own wt in environment.Therefore the MMT using montmorillonite as main ingredient composition can be effectively by flowing soaking paste Mulberry plant extract is converted into solid state.
In addition montmorillonite has high security, and be grown up the much 9g of odd-numbered day oral dose, and montmorillonite orally enters people After body, it is only necessary to which 1~2g can form protective cover layer on child's gastrointestinal mucosal, not only there is protection to make enteron aisle With, and action time of the medicine in enteron aisle can be extended.
The content of the invention
It is contemplated that overcome prior art insufficient, there is provided a kind of Mulberry plant extract slow-release agent and preparation method thereof and Using to reduce blood glucose rise caused by feed, and persistently suppressing in 3h the generation of enteron aisle monose.The Mulberry plant carries Thing sustained release preparation is taken to include two parts:Mulberry plant extract component of the immediate release section quick release using DNJ as representative, with confrontation The glycemic peaks quickly occurred after feed;Slow-released part slowly discharges the Mulberry plant extract component using DNJ as representative, with length Time plays the inhibitory action to enteron aisle alpha-glucosidase, so as to extend blood sugar reducing function.
To reach above-mentioned purpose, technical scheme provided by the invention is:
The Mulberry plant extract slow-release agent is by montmorillonite, Mulberry plant extract, hydroxypropyl methyl cellulose by weight Measure ratio 1:(0.8~4):(0.5~2) form.
Preferably, the Mulberry plant extract slow-release agent is by montmorillonite, Mulberry plant extract, hydroxypropyl methyl fiber Element is by weight 1:(0.8~2):(0.5~2) form.
Preferably, the Mulberry plant extract slow-release agent is by montmorillonite, Mulberry plant extract, hydroxypropyl methyl fiber Element is by weight 1:1:1.2 composition.
Preferably, in the Mulberry plant extract slow-release agent mixture of both montmorillonite and Mulberry plant extract with The weight ratio of hydroxypropyl methyl cellulose is 62.3:37.7.
Preferably, the montmorillonite is that calcium-base montmorillonite, sodium-based montmorillonite, sour modified montmorillonoid or Fe- pillared modifications cover De- soil.
Preferably, the hydroxypropyl methyl cellulose is hydroxypropyl methyl cellulose K45, hydroxypropyl methyl cellulose K4000 or hydroxypropyl methyl cellulose K15000.
It is above-mentioned state Mulberry plant extract slow-release agent preparation method be first by montmorillonite and Mulberry plant extract by than Example is well mixed, dries, 160 mesh sieves are crossed after crushing, produce montmorillonite and Mulberry plant extract mixtures powder;Take montmorillonite With Mulberry plant extract mixtures powder, hydroxypropyl methyl cellulose is added thereto in proportion, be well mixed, cross 160 mesh Sieve, produces Mulberry plant extract slow-release agent.Carried Mulberry plant is obtained after Mulberry plant extract slow-release agent direct powder compression Take thing sustained release tablets..The methods of drying is using vacuum drying, freeze-drying, film vacuum belt drying.The drying Temperature is preferably that 70 DEG C of crushing are to use the modes such as grinding, shearing crush, nanometer superfine powder is broken.
Above-mentioned Mulberry plant extract slow-release agent can be used for preparing treatment type II diabetes medicine.
With reference to research and development experimental data, the invention will be further described:
The selection of diluent
Mulberry plant extract (DNJ contents are 25.1%) prepared by laboratory is in flowing soaking paste, therefore in order to accurate The ratio of Mulberry plant extract in prescription is measured, it is necessary to make Mulberry plant extract be converted into from liquid from suitable auxiliary material Solid-state.The diluent with reference to described in pharmacopoeia of each country, initial option microcrystalline cellulose, starch, mannitol, calcium carbonate, sulfuric acid can be pressed 9 kinds of materials such as calcium, superfine silica gel powder, calcium-base montmorillonite, kaolin and calcium-base montmorillonite are as the potential of Mulberry plant extract Diluent.
Simultaneously in order to ensure DNJ percentage compositions (being unlikely to too low) in gained powder, therefore temporarily limit diluent and mulberry The acceptable percentage of genus plants extract is not more than 1:1.If desired result can not be obtained under the premise of herein, then to usage ratio Suitably adjusted or found new diluent.
About 10.00g Mulberry plant extract is accurately weighed with mortar, and weighs the diluent of equivalent weight, will be diluted Agent is slowly uniformly sprinkling upon Mulberry plant extract surface, well mixed under grinding, and is dried at 70 DEG C, according to institute after drying process The external character pair difference diluent for obtaining sample is screened.Above-mentioned 9 kinds of diluents press 1 with Mulberry plant extract:After 1 mixes It the results are shown in Table 1.
Effect after 1 different diluent treatments of table
Only tri- kinds of microcrystalline cellulose (MCC), MMT, Na-MMT diluents can be 1 as seen from the results in Table 1:Under 1 ratio MLE is set to be converted into the solid that can be crushed.Found in the further experiment to above-mentioned 3 kinds of diluent abilities to cure, as MMT and Na-MMT presses 4:5 ratio mixes with MLE can make it that solid-like be presented after drying, in MCC:MLE=3:Also may be used under 4 ratio Reach identical purpose.But in both ratios, gained powder hygroscopicity is larger, therefore the ratio of MLE and diluent should be greater than 1:0.8.Simultaneously when MLE and above-mentioned three kinds of diluent ratios are more than 1:DNJ contents are less than 5% in gained mixture when 4, are unfavorable for The preparation of tablet.Therefore it is 1 by weight to select MLE and diluent:(0.8-4), is preferably in a proportion of 1:1.
The foundation and evaluation of reference model
The alpha-glucosidase inhibitor class medicine of clinic is had been used at present without corresponding sustained release preparation, is lacked in experiment with reference to mark Standard, therefore it is used as control by establishing ideally DNJ intestinal sustained releasings model, to be screened to different prescription conditions.
DNJ only plays its inhibitory action to alpha-glucosidase in enteron aisle, can not be played a role into blood part, if therefore Extend DNJ hypoglycemic effect, then need to extend DNJ in the residence time of enteron aisle, and maintain the stabilization of enteron aisle DNJ concentration Property.Meanwhile the carbohydrate such as starch after feed in food is comparatively fast decomposed, cause blood glucose peak occurs in the short period Value, thus require that prepared sustained release preparation can comparatively fast discharge DNJ in a period of time of beginning, with the blood that confrontation feed is caused Sugared quick rise;And remainder then needs slowly release to maintain enteron aisle DNJ certain content.Therefore prepared tablet should include Two parts:Immediate release section and slow-released part.Therefore on the one hand DNJ is supplemented at enteron aisle by tablet slow-released part, and together When answer intestinal absorption and reduce, therefore refer to one compartment model under drip-feed as DNJ enteron aisle release-absorbing model.Then DNJ should meet with drag in the content of enteron aisle:
Immediate release section
Slow-released part
And glycemic peaks are about 1.5~2.0 times on an empty stomach in vivo after rat and people's feed, therefore immediate release section needs DNJ enteron aisle content peak values are made to reach 1.5~2.0 times of steady state content or more.Calculated in above-mentioned model under different quick-release ratios DNJ enteron aisles peak value and steady-state value, each theoretical value is shown in Table 2 under each immediate release section proportion.
Theoretical peak and steady-state value under the different quick-release ratios of table 2
As known from Table 2, when immediate release section proportion is less than 30%, the ratio of enteron aisle maximum level and steady state content is small In 2.0;And when immediate release section proportion is more than 35%, the ratio has been closer to 3.0.Although ratio is excessive to postprandial blood The inhibitory action of sugared peak value can be more preferable, but the DNJ required for slow-released part then accordingly increases, therefore shared by comprehensive selection immediate release section Ratio is 30% relatively reasonable.
Thus, it is supposed that DNJ total contents are m in preparation, then tablet is 0.3m in the preceding 15min DNJ discharged, rate of releaseRemainder (0.7m) is discharged in 0.25~3h by zero-order, rate of releaseTo know DNJ intestines Road absorption rate Ka=2.63/h then enteron aisle DNJ contents during stable state under the model
0.25th, 0.5,1.0,2.0,3.0h each point enteron aisle DNJ contents are:0.220m、0.161m、0.114m、0.098m、 0.097m.DNJ enteron aisle time-histories is shown in Fig. 1.
I.e. under the model, immediate release section can be such that enteron aisle DNJ concentration quickly raises in 15min, gradual in about 1h or so Reach Css, and maintain enteron aisle DNJ concentration to be basically unchanged at subsequent two hours.Under the model 0.25,0.5,1, 2nd, 3h each points Cumulative release amount is respectively:0.3m、0.363m、0.49m、0.746m、1.0m.
The screening and prediction of best prescription
Therefore using model as evaluation criterion, the Semblance (f that is recommended with FDA2> 50 represents the release of two groups of preparations Spend essentially identical) similarity degree of the different prescriptions of evaluation and model, investigated in experiment main ingredient, hydroxypropyl methyl cellulose species and The factor of dosage etc. three, totally 45 groups of difference prescriptions, each factor and level are shown in Table 3.
The respective level of 3 different factors of table
Find to do the tablet of main ingredient and putting down for model with microcrystalline cellulose to owning the progress statistical analysis of (45 groups × 3) data Equal similarity was 35.7 (being less than 50), and using calcium-base montmorillonite, sodium-based montmorillonite as its average phase with model of the tablet of main ingredient It is respectively 58.0 and 54.0 like degree, and difference has statistical significance (P=0.000 α=0.05) between three groups of data.Show in institute Microcrystalline cellulose under the species and dosage of hydroxypropyl methyl cellulose is selected to be not suitable for the system of Mulberry plant extract slow-release piece It is standby, and calcium-base montmorillonite then can be used for the preparation of Mulberry plant extract slow-release preparation with sodium-based montmorillonite.Simultaneously to calcium Base montmorillonite and sodium-based montmorillonite as the Morus sustained release tablets prepared by main ingredient using the usage amount of hydroxypropyl methyl cellulose as Independent variable, as dependent variable, Function Fitting is carried out to it, to find variant hydroxypropyl methyl cellulose with distortion Each optimal usage amount, the fit solution of variety classes hydroxypropyl methyl cellulose are shown in Fig. 2.
Function according to being fitted seeks the optimum quantum of utilization for calculating respective hydroxypropyl methyl cellulose, the fitting function of each group and Maximum is shown in Table 4.
The hydroxypropyl methyl cellulose dosage of table 4 and fitting of the similarity to function
Composition Fitting formula Degree of fitting Optimum value Theoretical f2 Actual f2
Ca-MMT K4000 Y=-1028.57X2+688X-52.06 R=0.918 33.4% 62 60
Ca-MMT K15000 Y=-1371.43X2+936X-96.34 R=0.997 34.1% 63 60
Ca-MMT K45 Y=-1000X2+762X-80.60 R=0.940 38.1% 65 59
Na-MMT K4000 Y=-628.57X2+336X+13.14 R=0.767 26.7% 58 62
Na-MMTK15000 Y=-542.86X2+314X+11.91 R=0.671 28.9% 57 61
Na-MMT K45 Y=-914.29X2+692X-67.03 R=0.994 37.7% 64 71
As known from Table 4 when being pressed using the mixture prepared by sodium-based montmorillonite as main ingredient with hydroxypropyl methyl cellulose K45 When weight is than 62.3: 37.7 collocation, prepared tablet has maximum similarity 71 with model, therefore selects this condition as the best of it Side.
The repeatability investigation of best prescription
3 batches of sustained release tablets are prepared by best prescription, to investigate the release in vitro situation of different batches tablet under the prescription, specifically As a result Fig. 3 is seen, sustained release tablets prepared under different batches show preferably to repeat in release test in vitro as seen from the figure Property, and average accumulated release has preferable correlation (table 5) from different models fittings, wherein having with Higuchi models Best correlation.
The best prescription of table 5 and each models fitting
As shown in Table 5 in this place under the conditions of side, prepared tablet not only has higher similarity (f with model2= 71), and slow-released part and Higuchi equation models are good (r=0.996).
Release conditions of the prescription condition bottom sheet agent in acid solution (0.1mol/L aqueous hydrochloric acid solutions) have been investigated simultaneously, Test result indicates that tablet also can smoothly discharge in acid condition, specific release conditions are shown in Fig. 4.
Fig. 3 and Fig. 4 shows that prepared tablet can play corresponding slow release effect in intestinal juice and Gastric pH environment.Together When under conditions of the species and dosage of hydroxypropyl methyl cellulose is not changed, experiment show it is pillared with sour modified montmorillonoid, Fe- Mulberry plant extract slow-release piece prepared by modified montmorillonoid, the equal > 50 of similarity with model.Show calcium-base montmorillonite, Sodium-based montmorillonite, sour modified montmorillonoid are used equally for the preparation of Morus alkaloid sustained release tablets with Fe- pillared montmorillonites.
Compared with prior art, the present invention has advantages below to the Morus alkaloid sustained release tablets:
(1) the Sang Yesheng alkaloids sustained release tablets prepared by include immediate release section and slow-released part, and immediate release section makes enteron aisle DNJ dense The rapid rise of degree, so as to resist the caused Postprandial peak glucose of feed, reduce maximum blood sugar concentration and reduce injury;Slow-released part Gently release DNJ, holding enteron aisle DNJ contents are stablized relatively in 3 hours, and one can extend hypoglycemic effect until most of sugar By small intestine, two blood sugar concentrations that can avoid shining by enteron aisle DNJ changes of contents fluctuate class.
(2) montmorillonite used in the present invention is safe, can be adsorbed in enteron aisle, enteron aisle can not only be protected to play one Fixed positioning releasing effect.
(3) environmental protection and saving of the present invention, energy consumption are low, substantially pollution-free, relatively low to equipment requirement and reproducible, controllability By force, it is suitable for industrial big production.
In a word, sustained release agent of the present invention can slowly discharge the Mulberry plant extract of 1-DNJ in 3h and delay Release the preparation method of piece.This method is changed into what can be crushed using montmorillonite as diluent, by Mulberry plant extract by liquid Solid forms, Mulberry plant extract-montmorillonite mixture of gained are not easy the moisture absorption, and compressibility is good, is easy to preserve.It is mixed with this Compound is used as the obtained Mulberry plant that can be slowly discharged in 3h of framework material as main ingredient by adding the HPMC of appropriate ratio Extract slow-release piece.The characteristics of quickly being raised for postprandial blood sugar, the sustained release tablets include two parts:Immediate release section and sustained release portion Point.Immediate release section there are about accounting for the DNJ quick releases of total amount 30% in preceding 15min, quickly to improve enteron aisle DNJ within a short period of time Concentration reduces Postprandial peak glucose;Slow-released part accounts for the 70% of total amount with Higuchi equation models good (r=0.996), should Part is slowly discharged to extend DNJ enteron aisle action times in 2.75h.And the tablet Gastric pH (0.1mol/L HCl) with It can reach slow release effect in intestinal juice pH (potassium phosphate buffer).
Brief description of the drawings
Fig. 1 is DNJ enteron aisle contents after being administered under model;
Fig. 2 is the fit solution under different condition;
Fig. 3 is the release conditions (n=6) under best prescription different batches;
Fig. 4 is the release conditions (n=6) of best prescription in an acidic solution;
Fig. 5 is the vitro release of embodiment 1;
Fig. 6 is the vitro release of embodiment 2;
Fig. 7 is the vitro release of embodiment 3.
Embodiment
Embodiment 1
20.00g calcium-base montmorillonites are well mixed with 20.00g Mulberry plant extracts, mistake after dry, pulverize at 70 DEG C 160 mesh sieves, produce Mulberry plant extract-montmorillonite mix powder;Take Mulberry plant extract-montmorillonite mix powder 14.00g, 6.00g hydroxypropyl methyl cellulose K4000 are added thereto, be well mixed, cross 160 mesh sieves, tabletting, produce Morus Plant extracts sustained release tablets.Vitro release is shown in Fig. 5 (n=6) under the prescription.
Embodiment 2
20.00g sodium-based montmorillonites are well mixed with 20.00g Mulberry plant extracts, mistake after dry, pulverize at 70 DEG C 160 mesh sieves, produce Mulberry plant extract-montmorillonite mix powder;Take Mulberry plant extract-montmorillonite mix powder 13.00g, 7.00g hydroxypropyl methyl cellulose K15000 are added thereto, be well mixed, cross 160 mesh sieves, tabletting, produce Morus Plant extracts sustained release tablets.Vitro release is shown in Fig. 6 (n=6) under the prescription.
Embodiment 3
20.00g Fe- pillared montmorillonites are well mixed with 20.00g Mulberry plant extracts, dry, pulverize at 70 DEG C 160 mesh sieves are crossed afterwards, produce Mulberry plant extract-montmorillonite mix powder;Take Mulberry plant extract-montmorillonite mixture Powder 12.00g, 8.00g hydroxypropyl methyl cellulose K45 are added thereto, be well mixed, cross 160 mesh sieves, tabletting, produce mulberry Genus plants extract sustained release tablets.Vitro release is shown in Fig. 7 (n=6) under the prescription.

Claims (9)

1. a kind of Mulberry plant extract slow-release agent, it is characterised in that the Mulberry plant extract slow-release agent is by montmorillonite, mulberry Genus plants extract, hydroxypropyl methyl cellulose are by weight 1:(0.8~4):(0.5~2) form.
2. Mulberry plant extract slow-release agent as claimed in claim 1, it is characterised in that the Mulberry plant extract slow-release Agent is by montmorillonite, Mulberry plant extract, hydroxypropyl methyl cellulose by weight 1:(0.8~2):(0.5~2) form.
3. Mulberry plant extract slow-release agent as claimed in claim 2, it is characterised in that the Mulberry plant extract slow-release Agent is by montmorillonite, Mulberry plant extract, hydroxypropyl methyl cellulose by weight 1:1:1.2 composition.
4. Mulberry plant extract slow-release agent as claimed in claim 1, it is characterised in that the Mulberry plant extract slow-release The mixture of both montmorillonite and Mulberry plant extract and the weight ratio 62.3 of hydroxypropyl methyl cellulose in agent:37.7.
5. Mulberry plant extract slow-release agent as claimed in claim 1, it is characterised in that the montmorillonite is calcium Ji Mengtuo Soil, sodium-based montmorillonite, sour modified montmorillonoid or Fe- pillared modification montmorillonites.
6. Mulberry plant extract slow-release agent as claimed in claim 1, it is characterised in that the hydroxypropyl methyl cellulose is Hydroxypropyl methyl cellulose K45, hydroxypropyl methyl cellulose K4000 or hydroxypropyl methyl cellulose K15000.
7. the preparation method of Mulberry plant extract slow-release agent as described in any one of claim 1 to 6, it is characterised in that described Method is first to mix in proportion montmorillonite and Mulberry plant extract, dries, 160 mesh sieves are crossed after crushing, it is de- to produce illiteracy Soil and Mulberry plant extract mixtures powder;Montmorillonite and Mulberry plant extract mixtures powder are taken, in proportion thereto Hydroxypropyl methyl cellulose is added, is well mixed, 160 mesh sieves is crossed, produces Mulberry plant extract slow-release agent.
8. method as claimed in claim 7, it is characterised in that will be obtained after Mulberry plant extract slow-release agent direct powder compression Mulberry plant extract slow-release piece.
9. the Mulberry plant extract slow-release agent as described in any one of claim 1 to 6 is preparing treatment type II diabetes medicine In application.
CN201610770262.5A 2016-08-30 2016-08-30 A kind of Mulberry plant extract slow-release preparation and its preparation method and application Pending CN107789391A (en)

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Application publication date: 20180313