CN102302473A - Matrine magnetic slow-releasing capsule and preparation method - Google Patents
Matrine magnetic slow-releasing capsule and preparation method Download PDFInfo
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- CN102302473A CN102302473A CN201110212444A CN201110212444A CN102302473A CN 102302473 A CN102302473 A CN 102302473A CN 201110212444 A CN201110212444 A CN 201110212444A CN 201110212444 A CN201110212444 A CN 201110212444A CN 102302473 A CN102302473 A CN 102302473A
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Abstract
The invention discloses a matrine magnetic slow-releasing capsule for treating gastrointestinal tumors through oral administration, and a preparation method of the matrine magnetic slow-releasing capsule. The content of the matrine magnetic slow-releasing capsule is matrine magnetic slow-releasing particles; the matrine magnetic slow-releasing capsule comprises drug carried magnetic particles and a slow-releasing coating film; the drug carried magnetic particles of the content include matrine, magnetic substance (ferroferric oxide) nanoparticles, microcrystalline cellulose and chitosan in the slow-releasing coating film; and the mass ratio of the matrine, the magnetic substance (ferroferric oxide) nanoparticles, the microcrystalline cellulose and the chitosan is 1 : 0.5-2 : 1-8: 0.1-3 . Through oral administration and being guided by the magnetic field, the matrine magnetic slow-releasing capsule not only can target the gastrointestinal tumor cells, but also can delay the release speed of the main drug; the adverse effects, complications and adverse reactions of the drug can be expected to be reduced; the drug administration frequency is reduced; the compliance of the patients is increased; and the clinical treatment effect of the drug is enhanced.
Description
Technical field:
The present invention relates to a kind of pharmaceutical preparation, especially a kind of new matrine slow-release magnetic capsule and method for preparing of treating digestive tract tumor.
Background technology:
Matrine is a kind of alkaloid that extraction separation obtains from leguminous plant Radix Sophorae Flavescentis, Herba Sophorae alopecuroidis, root of subprostrate sophora; Belong to the Fourth Ring quinolizidine kind; Has notable antitumor activity, referring to " Jiang H, et al.Matrine upregulates the cell cycle protein E2F-1 and triggers apoptosis via the mitochondrial pathway in K562 cells.European Journal of Pharmacology; 2007,559:98. ".Research shows that the mechanism of action of its anti-tumor activity comprises: the cachexia of suppress tumor proliferation, induced tumor differentiation and apoptosis, inhibition is tumor-infiltrated and far-end shifts, ameliorate tumor brings out and inhibition drug resistance of tumor, inhibition telomerase activation etc.
In addition, matrine also has following pharmacologically active:
(1) anti-liver injury: hepatic injury is the result of various hepatic disease pathological changes, and the mechanism of hepatic injury can be divided into chemical and immunity.Matrine all has protective effect to the hepatic injury that these two kinds of mechanism cause, referring to " Xue Gui equality. the research of matrine on immune liver injury in rats effect. the time precious traditional Chinese medical science traditional Chinese medicines, 2007,8 (4): 242. ".
(2) anti-cardiovascular disease: matrine can strengthen the contractile function in isolated frog heart, Bufo siccus heart and isolated rabbit atrium; Coronary blood flow increasing; Decreased heart rate; Suppress diastole etc., referring to " Liu JY, et al.Effect of matrine on the expression of substance P receptor and inflammatory cytokines production in human skin keratinocytes and fibroblasts.International Immunopharmacology; 2007,7:816. ".
(3) antiviral: matrine can obviously suppress duplicating of HBV-DNA; Make hepatitis HBeAg negative conversion rate reach 51%; Anti-HBc-lgM negative conversion rate reaches 50%, referring to " Wan XY, et al.Hepatoprotective and anti-hepatocarcinogenic effects of glycyrrhizin and matrine.Chemico-Biological Interactions; 2009,181:15. ".
(4) fibrosis: matrine can have certain inhibitory action to the fibrosis of matter between liver, pancreas and renal tubules, referring to " appoint big waves etc. Mus pancreatic gland fibrosis effect of the matrine Chinese People's Anti-Japanese Military and Political College and Mechanism Study. pancreas is sick learns 2007,7 (2): 90. ".
Clinical treatment cancer, viral hepatitis, the leukopenia etc. of being mainly used in of matrine.
At present, dosage forms such as existing matrine injection, tablet and capsule are applied to clinical studies and treatment.Yet; With regard to existing common oral preparation,, mostly exist duration of efficacy shorter owing to self dosage form design deficiency or mechanisms for drug release defective; Need frequent drug administration; And blood concentration fluctuation is bigger, and toxic and side effects and complication increase, and the patient is prone to produce degradation problem under drug resistance, adverse effect and the compliance.Injection agent medicine is evenly distributed in the systemic circulation, and medicine will pass through steps such as same protein binding, metabolism, drainage before arriving tumor focus, finally has only small amount of drug to arrive tumor focus.Above-mentioned matrine pharmaceutical preparation is because itself design defect and deficiency; When clinical use; The doctor strengthens drug dose to improve drug level for obtaining good clinical therapeutic efficacy, then can cause the toxic and side effects of medicine and untoward reaction to increase, and patient's compliance is relatively poor; Drug bioavailability is low, does not reach the therapeutic purposes of expection.In order to overcome above shortcoming; Chinese invention patent application 03100896.8 and Chinese invention patent application 03100897.6 disclose the slow releasing preparation of matrine, and the disclosed slow releasing preparation of above-mentioned patent documentation is soft gelatin capsule and enteric coatel tablets, though these two kinds of preparations can prolong the drug action time; But do not have the target administration characteristic; Still can not effectively reduce poisonous side effect of medicine and adverse effect, effectively improve drug bioavailability, strengthen clinical therapeutic efficacy.Chinese invention patent application 200610019300.X discloses a kind of matrine magnetic micro-ball, and this microsphere is gathered the preparation that forms with magnetic target and the dual release mechanism of slow release, yet said preparation is through the form administration of intravenous drip; Not only administrated method is complicated, and very inconvenient concerning the patient, compliance is poor; And there are many fatal problems to overcome; As remain in magnetic fluid in the blood vessel (because such material self can not be degraded, metabolism) and how to eliminate or remove, how to solve it and adhere to, gather at blood vessel, cause granulation tissue hyperplasia; And artery-clogging causes the blood flow minimizing, problems such as infringement bodily tissue organ.
Summary of the invention:
The object of the present invention is to provide a kind of prior art deficiency that overcomes, can through the digestive tract oral administration the matrine-loaded magnetic slow releasing capsule and preparation method thereof of anti-digestive system carcinoma.
Matrine-loaded magnetic slow releasing capsule content of the present invention is the matrine-loaded magnetic slow-releasing granules, comprises drug loaded magnetic granule and slow release coatings.Wherein the drug loaded magnetic granule comprises matrine, ferriferrous oxide nano grain (20nm), (content of cellulose is 97.0%～102% to microcrystalline Cellulose; Concentration can reach 3000～5000mPas) and chitosan at 3% o'clock colloid viscosity; Press mass ratio, matrine: ferriferrous oxide nano grain: microcrystalline Cellulose: chitosan is 1: 0.5～2: 1～8: 0.1～3.Magnetisable material is the ferriferrous oxide nano grain, and the used material of sustained release coating layer is chitosan.
The technology implementation scheme is: get matrine, ferriferrous oxide nano grain, microcrystalline Cellulose mixing by prescription, add in the chitosan-acetic acid solution, stir, the system soft material.Cross 65 mesh sieves and granulate, 50 ℃ of freeze-day with constant temperature, 65 mesh sieves sieve, granulate, promptly get the drug loaded magnetic granule.The chitosan-acetic acid solution repeated multiple times is sprayed or is wrapped in the drug loaded magnetic particle surface, and 50 mesh sieves sieve, granulate, and 50 ℃ of freeze-day with constant temperature obtain the magnetic slow-releasing granules.Above-mentioned magnetic slow-releasing granules is filled in No. 1 Capsules, promptly gets the matrine-loaded magnetic slow releasing capsule, every dress 0.3g ± 10% contains the about 25.2mg of matrine.
Concrete method for preparing of the present invention is following:
(1) matrine drug loaded magnetic preparation of granules
1) chitosan is dissolved in the aqueous acetic acid of volume ratio 0.2%～1%, chitosan concentration in aqueous acetic acid is 0.005～0.04g/mL, obtains chitosan-acetic acid solution.
2) with behind 0.05～0.15g matrine, 0.08～0.15g ferriferrous oxide nano grain, the 0.2～0.8g microcrystalline Cellulose mixing, add above-mentioned chitosan-acetic acid solution 2～5mL, stir, get soft material.
3) above-mentioned soft material is crossed 65 mesh sieves and granulate, 50 ℃ of freeze-day with constant temperature, 65 mesh sieves sieve, granulate, get matrine drug loaded magnetic granule.
(2) matrine-loaded magnetic slow-releasing granules preparation
1) gets chitosan-acetic acid solution according to last legal system.
2) matrine drug loaded magnetic granule, chitosan-acetic acid solution are 1: 10～20 by mass volume ratio; The chitosan-acetic acid solution repeated multiple times is sprayed or is wrapped in the drug loaded magnetic particle surface; 50 mesh sieves sieve, granulate, and 50 ℃ of freeze-day with constant temperature get the matrine-loaded magnetic slow-releasing granules.
(3) matrine-loaded magnetic slow releasing capsule preparation
Above-mentioned matrine-loaded magnetic slow-releasing granules is filled in No. 1 Capsules, makes the matrine-loaded magnetic slow releasing capsule.
Preparation medicine of the present invention discharges lasting, constant, under the guiding of externally-applied magnetic field, has the targeting location feature, can improve drug bioavailability.
Chitosan among the present invention has good biocompatibility, nontoxic, non-stimulated, no anaphylaxis, and adhesion, biological degradability, film property are good, environmentally friendly, free from environmental pollution.Prepare in the matrine-loaded magnetic slow releasing capsule and both can be used as adhesive in the process, can be used as slow-release material again, thereby reduced the kind of adjuvant in the prescription, help reducing its toxic and side effects.In drug loaded magnetic preparation of granules process, chitosan not only helps said preparation and prepares molding at first as adhesive, can play slow releasing function again, the release time of prolong drug.Prepare in the process at the slow release magnetic-particle, chitosan through spraying or the parcel operation, forms release membranes at the drug loaded magnetic particle surface once more as the sustained release coating material, has further strengthened its slow releasing function.
Ferriferrous oxide nano grain among the present invention is as magnetisable material; Have toxicity low, be easy to get, characteristics such as saturation magnetization height; Help matrine-loaded magnetic slow releasing capsule content and adding under the induced by magnetic field, the targeting location in digestive tract is after drug release finishes; Residue can excrete with feces, can not cause accumulate poisoning in vivo or influence body function.
The matrine-loaded magnetic slow releasing capsule of the present invention's preparation is carried, taking convenience, is easy to store.After the oral administration administration, the sustained release coating layer delays the rate of release of its content in digestive tract.Because this capsule 's content is a magnetic-particle, help it and adding under the induced by magnetic field, but targeting is positioned the tumor focus position.Thereby make said preparation have release continue, constant, bioavailability is high, the medication number of times is low, patient's compliance is good, poisonous side effect of medicine and untoward reaction are few, the characteristic of enhancing clinical prevention digestive system carcinoma effect.
Description of drawings:
The B-H loop of the matrine-loaded magnetic slow releasing capsule content of Fig. 1 ferroso-ferric oxide and embodiment 1 gained; The matrine-loaded magnetic slow releasing capsule content of Fig. 2 embodiment 1 gained is at the directed movement sketch map that adds under the introduction by magnetic field; The release in vitro curve of the matrine-loaded magnetic slow releasing capsule of Fig. 3 embodiment gained 1.
The specific embodiment
Be embodiments of the invention below, but the present invention is not limited only to embodiment.
Embodiment 1:
(1) chitosan is dissolved in the aqueous acetic acid of volume ratio 0.2%～1%, chitosan concentration in aqueous acetic acid is 0.005～0.04g/mL, obtains chitosan-acetic acid solution.Preparation of Chitosan method among other embodiment of the present invention is identical therewith.
(2) the particulate preparation of matrine drug loaded magnetic: take by weighing microcrystalline Cellulose (content of cellulose is 97.0%～102%, and concentration can reach 3000～5000mPas at 3% o'clock colloid viscosity, below used each microcrystalline Cellulose of each embodiment all identical) 0.4g, Fe with it
3O
4Magnetic nano particle (20nm, below the used magnetic nano particle granularity of each embodiment identical with it) 0.12g and matrine 0.1g behind the mixing, add among the 1% acetum 2mL of 0.02g/mL chitosan, stir the system soft material.Cross 65 mesh sieves and granulate, 50 ℃ of freeze-day with constant temperature, 65 mesh sieves sieve, granulate, promptly get matrine drug loaded magnetic granule.
(3) preparation of matrine-loaded magnetic slow-releasing granules: the aqueous acetic acid 10.5mL of preparation 1%; Add the 0.21g chitosan; Make its natural peptization, above-mentioned chitosan-acetic acid solution is sprayed or be wrapped in matrine drug loaded magnetic particle surface 13 times repeatedly, 50 mesh sieves sieve, granulate; 50 ℃ of freeze-day with constant temperature promptly get the matrine-loaded magnetic slow-releasing granules.
(4) preparation of matrine-loaded magnetic slow releasing capsule: above-mentioned matrine-loaded magnetic slow-releasing granules is filled in No. 1 Capsules, makes the matrine-loaded magnetic slow releasing capsule.
Embodiment 2:
(1) the particulate preparation of matrine drug loaded magnetic: take by weighing microcrystalline Cellulose 0.4g, Fe
3O
4Magnetic nano particle 0.1g and matrine 0.1g behind the mixing, add among the 1% acetum 3mL of 0.02g/mL chitosan, stir the system soft material.Cross 65 mesh sieves and granulate, 50 ℃ of freeze-day with constant temperature, 65 mesh sieves sieve, granulate, promptly get matrine drug loaded magnetic granule.
(2) preparation of matrine-loaded magnetic slow-releasing granules: the aqueous acetic acid 12mL of preparation 1%; Add the 0.24g chitosan; Make its natural peptization, above-mentioned chitosan-acetic acid solution is sprayed or be wrapped in matrine drug loaded magnetic particle surface 13 times repeatedly, 50 mesh sieves sieve, granulate; 50 ℃ of freeze-day with constant temperature promptly get the matrine-loaded magnetic slow-releasing granules.
(3) preparation of matrine-loaded magnetic slow releasing capsule: above-mentioned matrine-loaded magnetic slow-releasing granules is filled in No. 1 Capsules, makes the matrine-loaded magnetic slow releasing capsule.
Embodiment 3:
(1) the particulate preparation of matrine drug loaded magnetic: take by weighing microcrystalline Cellulose 0.4g, Fe
3O
4Magnetic nano particle 0.12g and matrine 0.1g behind the mixing, add among the 1% acetum 2mL of 0.025g/mL chitosan, stir the system soft material.Cross 65 mesh sieves and granulate, 50 ℃ of freeze-day with constant temperature, 65 mesh sieves sieve, granulate, promptly get matrine drug loaded magnetic granule.
(2) preparation of matrine-loaded magnetic slow-releasing granules: the aqueous acetic acid 6mL of preparation 1%; Add the 0.15g chitosan; Make its natural peptization, above-mentioned chitosan-acetic acid solution is sprayed or be wrapped in matrine drug loaded magnetic particle surface 13 times repeatedly, 50 mesh sieves sieve, granulate; 50 ℃ of freeze-day with constant temperature promptly get the matrine-loaded magnetic slow-releasing granules.
(3) preparation of matrine-loaded magnetic slow releasing capsule: above-mentioned matrine-loaded magnetic slow-releasing granules is filled in No. 1 Capsules, makes the matrine-loaded magnetic slow releasing capsule.
The B-H loop of matrine-loaded magnetic slow releasing capsule content is measured:
Under room temperature condition, measure ferriferrous oxide nano grain and matrine-loaded magnetic slow releasing capsule content with vibrating specimen magnetometer, the result is as shown in Figure 2.The result shows, with pure Fe
3O
4The saturation magnetization 58.57emu/g of nanoparticle compares, and the saturation magnetization of content is about 15.13emu/g; Coercivity is zero, shows typical superparamagnetism, can not produce gathering when using in vivo.
Matrine-loaded magnetic slow releasing capsule content is tested in the directed movement that adds under the introduction by magnetic field:
Matrine-loaded magnetic slow releasing capsule content is placed the PBS of pH6.8, observe it and move in the orientation that adds under the action of a magnetic field, the result is as shown in Figure 3.The result shows that content can be done directed movement along magnetic direction in the 30s, gathers on the bottle wall of Magnet one side, explains that this content has good magnetic response performance, can add under the introduction by magnetic field targeting in lesions position.
The extracorporeal releasing test of matrine-loaded magnetic slow releasing capsule:
Get 6 of matrine-loaded magnetic slow releasing capsule, fixed its weight of accurate title is according to two drug release determination methods of Chinese Pharmacopoeia version in 2010 (the appendix X D first method method 1); Adopting dissolution method (appendix X C) first subtraction unit, is that 6.8 PBS 900mL is a release medium with pH value, and rotating speed is that per minute 100 changes; Temperature is 37 ± 0.5 ℃, measures, in 0.5,1,2,4,8,12,18,24 hour in accordance with the law; The precision of fixing a point is respectively measured releasing solution 10mL, and replenishes the blank release medium of uniform temp, equal volume simultaneously, filters with 0.22 μ m microporous filter membrane; Precision is measured subsequent filtrate 10 μ L; Inject high performance liquid chromatograph (Agilent 1200 types, the U.S.) and measure, the result sees table 1.And draw release profiles according to measuring the result, see Fig. 3.The result shows that matrine-loaded magnetic slow releasing capsule accumulative total release rate in 24 hours is 96.25%.
Chromatographic condition
Mobile phase: 70: 30 (phosphoric acid solution of methanol/0.1)
Detect wavelength: 220nm.
Flow velocity: 1mL/min.
Column temperature: 30 ℃.
Table 1
| Time (h) | 0.5 | 1 | 2 | 4 | 8 | 12 | 18 | 24 |
| Accumulative total degree of release (%) | 20.87 | 27.21 | 45.28 | 52.31 | 73.05 | 83.43 | 92.55 | 96.25 |
Claims (3)
1. a matrine-loaded magnetic slow releasing capsule is characterized in that content is the matrine-loaded magnetic slow-releasing granules, comprises drug loaded magnetic granule and slow release coatings.
2. matrine-loaded magnetic slow releasing capsule according to claim 1; It is characterized in that the drug loaded magnetic granule in the content comprises matrine, magnetisable material ferriferrous oxide nano grain, microcrystalline Cellulose and slow release coatings chitosan, and matrine: ferriferrous oxide nano grain: microcrystalline Cellulose: the mass ratio of chitosan is 1: 0.5～2: 1～8: 0.1～3.
3. the method for preparing of matrine-loaded magnetic slow releasing capsule according to claim 1 and 2 is characterized in that may further comprise the steps:
1) chitosan being dissolved in volume ratio is that chitosan concentration in aqueous acetic acid is 0.005～0.04g/mL, obtains chitosan-acetic acid solution in 0.2%～1% the aqueous acetic acid;
2) with behind 0.05～0.15g matrine, 0.08～0.15g ferriferrous oxide nano grain, the 0.2～0.8g microcrystalline Cellulose mixing, add chitosan-acetic acid solution 2～5mL, stir, get soft material;
3) above-mentioned soft material crossed carried out dried after 65 mesh sieves are granulated, again through 65 mesh sieves sieve, granulate, matrine drug loaded magnetic granule;
4) the chitosan-acetic acid solution repeated multiple times is sprayed or be wrapped in the drug loaded magnetic particle surface, matrine drug loaded magnetic granule is 1: 15～25 than the mass volume ratio of chitosan-acetic acid solution, again through sieve, granulate, dried gets the matrine-loaded magnetic slow-releasing granules;
5) will be filled in the Capsules by the matrine-loaded magnetic slow-releasing granules that step 4) makes, make the matrine-loaded magnetic slow releasing capsule.
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102669192A (en) * | 2012-05-14 | 2012-09-19 | 沈阳东大迪克化工药业有限公司 | Matrine microcapsule suspension agent and preparation method thereof |
| CN107607665A (en) * | 2017-09-29 | 2018-01-19 | 贵州师范大学 | One seedling medicine subprostrate sophora and its Chinese medicine preparation method of quality control |
| CN112439063A (en) * | 2019-08-12 | 2021-03-05 | 湖南早晨纳米机器人有限公司 | Preparation method of far infrared magnetic therapy body nano robot |
-
2011
- 2011-07-23 CN CN201110212444A patent/CN102302473A/en active Pending
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102669192A (en) * | 2012-05-14 | 2012-09-19 | 沈阳东大迪克化工药业有限公司 | Matrine microcapsule suspension agent and preparation method thereof |
| CN107607665A (en) * | 2017-09-29 | 2018-01-19 | 贵州师范大学 | One seedling medicine subprostrate sophora and its Chinese medicine preparation method of quality control |
| CN112439063A (en) * | 2019-08-12 | 2021-03-05 | 湖南早晨纳米机器人有限公司 | Preparation method of far infrared magnetic therapy body nano robot |
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Application publication date: 20120104 |