CN103565902B - Slow releasing agent and its preparation method and application - Google Patents
Slow releasing agent and its preparation method and application Download PDFInfo
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- CN103565902B CN103565902B CN201310574687.5A CN201310574687A CN103565902B CN 103565902 B CN103565902 B CN 103565902B CN 201310574687 A CN201310574687 A CN 201310574687A CN 103565902 B CN103565902 B CN 103565902B
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Abstract
The preparation method of slow releasing agent provided by the invention and slow releasing agent, by Rhododendron oil, sodium alginate, surfactant and distilled water Homogeneous phase mixing, be prepared into emulsion; Emulsion is added in aqueous chloride solution the bead obtaining gelation; Bead is carried out dried, obtains coccoid medicine; With coccoid medicine for raw material prepares Rhododendron oil-alginate embedding slow releasing agent.Preparation method that the present invention adopts, first medicament dropping is made pharmaceutical pellet, pharmaceutical pellet is carried out multi-form encapsulation, and become final medicine, the defect of the pattern aspect such as circularity, microscopic bubble, hangover of such pharmaceutical pellet, do not affect the total quality of medicine, just improve the degree of controllability of product quality accordingly yet.Slow releasing agent drug release rate prepared by the present invention is stablized controlled, avoids the fluctuation of blood drug level, avoids the stimulation to digestive system, and framework material good biocompatibility used.
Description
[technical field]
The present invention relates to a kind of biomedicine technical field, particularly relate to a kind of slow releasing agent and its preparation method and application.
[background technology]
Rhododendron oil is the ethereal oil extracted from Hemerocallis citrina Baroni Cuculus polioephalus branch and leaf, and it has unique curative effect to chronic tracheitis, asthma etc., has heat-clearing and toxic substances removing, relieving cough and asthma, spasmolytic circulation of qi promoting, effect of stomach invigorating detumescence, and toxicity is little, few side effects.
The current preparation of Rhododendron mainly contains powder, tablet, pill, embedding medium, drop pill, emulsifying agent etc.The research carried out for Rhododendron oil formulation at present mainly embeds preparation and emulsifying agent for drop pill, beta-schardinger dextrin-.And as treating the Rhododendron oil formulation of the disease such as chronic tracheitis, asthma, dropping pill formulation is the preparation of comparative maturity, there are medicine enterprise and research institution also in the research carrying out beta-schardinger dextrin-embedding preparation, but it is not high also to there is carrying drug ratio at present, the problems such as Release Performance is undesirable, are also in conceptual phase.In actual production adopt dosage form to only have drop pill a kind of.
The technological process control of current production Rhododendron oil drop pill is: rhododendron oil extracts through the technique such as lixiviate, extraction in earlier stage by 1.Rhododendron oil mixes even with edible oil and gelatin by 2 according to a certain percentage.Mixed solution instills in condensed fluid by 3, forms dropping pill formulation.Although the preparation technology of drop pill is from view of theory, method is simple, equipment investment is also few, but actual from production, in preparation process, more to the influence factor of product quality, in the particularly dripping stage, the selection etc. of formula, dripping temperature, dripping speed, condensing agent, even drips distance, water dropper bore, condensation column height etc. all has influence on the quality of drop pill.In production practices prepared by Rhododendron oil drop pill, manufacturing enterprise is lower in drop pill preparation technology work-in-process qualification rate, is 30-50%, has a strong impact on production.4 drop pills are after patient takes, and after outside gel layer dissolves, release concentrated by medicine, stimulate comparatively large to people digest's system, cause have the hiccups, the discomfort such as Nausea and vomiting.5 drop pill medicines easily cause patient's height blood drug level, have certain toxicity after concentrating release.6 drop pills form peak, the paddy of blood drug level after taking in patient body, affect therapeutic effect.
These existing problems are all urgently to be resolved hurrily, and for this reason, relevant manufacturing enterprise has carried out the research work of beta-schardinger dextrin-investment novel form, but due to carrying drug ratio too low, drug release feature does not reach requirement etc., does not succeed.Meng Qing has just waited the volatile oil with beta-schardinger dextrin-embedding Cuculus polioephalus and Radix Angelicae Sinensis, and the carrying drug ratio of gained preparation is 54.64%; Hu Yongfang etc. are with beta-schardinger dextrin-embedding rhododendron oil, and carrying drug ratio is 57.12%.Above-mentioned research is that the research of novel form provides good approaches and methods, but carrying drug ratio is also not fully up to expectations.And these methods are also only carried out at present in laboratory, fail to obtain more ripe result.
[summary of the invention]
It is wayward that the technical problem to be solved in the present invention is to overcome the quality existed in prior art, and carrying drug ratio is not high, and the defect that Release Performance is undesirable provides a kind of preparation method of slow releasing agent.
For solving the problems of the technologies described above, the present invention adopts following technical proposals:
By Rhododendron oil, sodium alginate, surfactant and distilled water Homogeneous phase mixing, be prepared into emulsion;
There is provided monochloride aqueous solution, described aqueous chloride solution is at least one in calcium chloride solution or strontium chloride solution;
Described emulsion is added into the bead obtaining gelation in described aqueous chloride solution;
Described bead is carried out dried, obtains coccoid medicine;
With described coccoid medicine for raw material prepares Rhododendron oil-alginate embedding slow releasing agent.
In embodiment provided by the invention, described is (23-68.8%) by the mass percent of Rhododendron oil, sodium alginate, surfactant and distilled water ratio: (0.8-8%), (0.4-4%): (30-65%).
In embodiment provided by the invention, described surfactant is Polyethylene Glycol or cyclodextrin surfactant or spans surfactant or Tweens surfactant.
In embodiment provided by the invention, the concentration of described aqueous chloride solution is 0.2 ~ 6.5molL-1.
In embodiment provided by the invention, described dried is heat drying or lyophilization.
In addition, present invention also offers a kind of slow releasing agent, described slow releasing agent is prepared by the preparation method by above-mentioned slow releasing agent.
In addition, present invention also offers the application of a kind of slow releasing agent in tracheitis or asthma.
Adopt technique scheme, beneficial effect of the present invention is:
The preparation method of the slow releasing agent that the above embodiment of the present invention provides and slow releasing agent, by Rhododendron oil, sodium alginate, surfactant and distilled water Homogeneous phase mixing, be prepared into emulsion; Described emulsion is added into the bead obtaining gelation in described aqueous chloride solution; Described bead is carried out dried, obtains coccoid medicine; With described coccoid medicine for raw material prepares Rhododendron oil-alginate embedding slow releasing agent.Preparation method that the present invention adopts, first medicament dropping is made pharmaceutical pellet, pharmaceutical pellet is carried out multi-form encapsulation, and become final medicine, the defect of the pattern aspect such as circularity, microscopic bubble, hangover of such pharmaceutical pellet, do not affect the total quality of medicine, just improve the degree of controllability of product quality accordingly yet; Adopt the slow releasing preparation that said method prepares, play carrying drug ratio and be much higher than beta-schardinger dextrin-preparation; Adopt the slow releasing preparation for preparing of said method, have good sustained release performance, make blood drug level uniform and stable, reduce drug toxicity, improve curative effect; The mass percent of various material when preparing by changing preparation, can carry out manual control in addition to drug release rate, technique is simple, can be applicable to suitability for industrialized production.
[accompanying drawing explanation]
The flow chart of steps of the preparation method of the slow releasing agent that Fig. 1 provides for the embodiment of the present invention;
[detailed description of the invention]
In order to make object of the present invention, technical scheme and advantage clearly understand, below in conjunction with drawings and the specific embodiments, the present invention is further elaborated.Should be appreciated that specific embodiment described herein only in order to explain the present invention, be not intended to limit the present invention.
Refer to Fig. 1, steps flow chart Figure 100 of the preparation method of the slow releasing agent that Fig. 1 provides for the embodiment of the present invention, as can be seen from Fig. 1, the preparation method of slow releasing agent comprises the steps:
Step S110: by Rhododendron oil, sodium alginate, surfactant and distilled water Homogeneous phase mixing, be prepared into emulsion;
Preferably, the mass percent of Rhododendron oil, sodium alginate, surfactant and distilled water is compared for (23-68.8%): (0.8-8%), (0.4-4%): (30-65%).
Preferably, surfactant is Polyethylene Glycol or cyclodextrin surfactant or spans surfactant or Tweens surfactant.
Slow releasing preparation prepared by the above embodiment of the present invention, have employed the alginate of good biocompatibility as embedded material, it has good biological health effect, in the drug release process of preparation after taking, framework material is also by good absorption and digestion, harmless.
Slow releasing agent prepared by the above embodiment of the present invention, adds the surfactant of good biocompatibility, improves the water solublity of rhododendron oil, contributes to improving drug effect.
Step S120: monochloride aqueous solution is provided, aqueous chloride solution is at least one in calcium chloride solution or strontium chloride solution;
Preferably, the concentration of aqueous chloride solution is 0.2 ~ 6.5molL-1.
Step S130: described emulsion is added in aqueous chloride solution the bead obtaining gelation;
Particularly, the emulsion obtained evenly slowly is added drop-wise to the aqueous chloride solution in step S120 in step S130, the bead of obtained gelation.
Step S140: described bead is carried out dried, obtains coccoid medicine;
Preferably, adopt direct drying, or described bead is processed by lyophilization, obtains coccoid medicine.
Step S150: with described coccoid medicine for raw material prepares Rhododendron oil-alginate embedding slow releasing agent.
Particularly, prepare Rhododendron oil-alginate embedding slow releasing agent with coccoid medicine for raw material, following method can be adopted to obtain:
Using coccoid medicine directly as Rhododendron oil-alginate embedding sustained-release granular formulation; Coccoid medicine is filled into obtained Rhododendron oil in capsule-alginate embedding slow releasing capsule; With coccoid medicine for raw material, existing common processes is adopted to be prepared into Rhododendron oil-alginate embedding slow releasing pill; With coccoid medicine for raw material, existing common processes is adopted to be prepared into Rhododendron oil-alginate embedding slow release tablet.
In addition, present invention also offers a kind of adopt the preparation method of above-mentioned slow releasing agent to prepare slow releasing agent and application in tracheitis or asthma.
Slow releasing agent provided by the invention, have in vivo evenly, stable, the drug release feature that continues, controllably discharge medicine, can at the uniform velocity release, avoid crest and the trough of blood drug level, blood drug level is made to maintain a metastable numerical value, avoid the toxicity that high blood drug level causes, avoid the stimulation to patient, the mode of this continual and steady administration is simultaneously more conducive to improve curative effect, particularly Rhododendron oil is as the medicine for the treatment of asthma and bronchopathy, and continual and steady administration is particularly important to raising curative effect; In addition, this slow releasing agent after being taken by patient, medicine in stomach and intestines with relative speed stably, discharge constantly, constantly digested and assimilated while release, avoid the stimulation to people digest road, avoid patient to have the hiccups, Nausea and vomiting, improve the wish of patient on medication.
The preparation method of the slow releasing agent that the above embodiment of the present invention provides and slow releasing agent, by Rhododendron oil, sodium alginate, surfactant and distilled water Homogeneous phase mixing, be prepared into emulsion; Described emulsion is added into the bead obtaining gelation in described aqueous chloride solution; Described bead is carried out dried, obtains coccoid medicine; With described coccoid medicine for raw material prepares Rhododendron oil-alginate embedding slow releasing agent.Preparation method that the present invention adopts, first medicament dropping is made pharmaceutical pellet, pharmaceutical pellet is carried out multi-form encapsulation, and become final medicine, the defect of the pattern aspect such as circularity, microscopic bubble, hangover of such pharmaceutical pellet, do not affect the total quality of medicine, just improve the degree of controllability of product quality accordingly yet; In addition, adopt the slow releasing preparation that said method prepares, play carrying drug ratio and be much higher than beta-schardinger dextrin-preparation; Adopt the slow releasing preparation for preparing of said method, have good sustained release performance, make blood drug level uniform and stable, reduce drug toxicity, improve curative effect; The mass percent of various material when preparing by changing preparation, can carry out manual control in addition to drug release rate, technique is simple, can be applicable to suitability for industrialized production.
Set forth the present invention further by the following examples, these embodiments are only presented for purposes of illustration, do not limit the scope of the invention.Except the actual conditions indicated, the test method in embodiment all conveniently condition is carried out.
embodiment 1:
By Rhododendron oil, sodium alginate, Polyethylene Glycol and appropriate water in mass ratio for 68.8%:0.8%:0.4%:30% mix homogeneously obtains even emulsion; In above-mentioned emulsion, be added into concentration is the bead that the calcium chloride solution of 0.2molL-1 obtains gelation; The bead of above-mentioned gelation is stirred gently, then leaves standstill, formed bead is taken out, with distilled water wash, obtain moisture coccoid medicine and dried pellet shape medicine is obtained to the direct drying of aqueous drug bead; Using coccoid medicine directly as Rhododendron oil-alginate embedding sustained-release granular formulation.
embodiment 2:
By Rhododendron oil, sodium alginate, cyclodextrin and appropriate water in mass ratio for 45%:4%:2%:45% mix homogeneously obtains even emulsion; In above-mentioned emulsion, be added into concentration is the bead that the strontium chloride solution of 3molL-1 obtains gelation; The bead of above-mentioned gelation is stirred gently, then leaves standstill, formed bead is taken out, with distilled water wash, obtain moisture coccoid medicine and dried pellet shape medicine is obtained to the direct drying of aqueous drug bead; Coccoid medicine is filled into obtained Rhododendron oil in capsule-alginate embedding slow releasing capsule.
embodiment 3:
By Rhododendron oil, sodium alginate, cyclodextrin and appropriate water in mass ratio for 23%:8%:4%:65% mix homogeneously obtains even emulsion; The bead that calcium chloride solution that concentration is 6.5molL-1 and strontium chloride solution mixed solution obtain gelation is added in above-mentioned emulsion; The bead of above-mentioned gelation is stirred gently, then leaves standstill, formed bead is taken out, with distilled water wash, obtain moisture coccoid medicine and dried pellet shape medicine is obtained to the direct drying of aqueous drug bead; With coccoid medicine for raw material, existing common processes is adopted to be prepared into Rhododendron oil-alginate embedding slow releasing pill.
The above, it is only preferred embodiment of the present invention, not any pro forma restriction is done to the present invention, although the present invention discloses as above with preferred embodiment, but and be not used to limit the present invention, any those skilled in the art, do not departing within the scope of technical solution of the present invention, make a little change when the technology contents of above-mentioned announcement can be utilized or be modified to the Equivalent embodiments of equivalent variations, in every case be do not depart from technical solution of the present invention content, according to any simple modification that technical spirit of the present invention is done above embodiment, equivalent variations and modification, all still belong in the scope of technical solution of the present invention.
Claims (4)
1. a preparation method for slow releasing agent, is characterized in that, comprises the steps:
By Rhododendron oil, sodium alginate, surfactant and distilled water Homogeneous phase mixing, be prepared into emulsion;
There is provided monochloride aqueous solution, described aqueous chloride solution is at least one in calcium chloride solution or strontium chloride solution;
Described emulsion is added into the bead obtaining gelation in described aqueous chloride solution;
Described bead is carried out dried, obtains coccoid medicine;
With described coccoid medicine for raw material prepares Rhododendron oil-alginate embedding slow releasing agent;
Described surfactant is Polyethylene Glycol or cyclodextrin surfactant or spans surfactant or Tweens surfactant; The mass percent of described Rhododendron oil, sodium alginate, surfactant and distilled water is than being (23-68.8%): (0.8-8%): (0.4-4%): (30-65%).
2. the preparation method of slow releasing agent according to claim 1, is characterized in that, the concentration of described aqueous chloride solution is 0.2 ~ 6.5molL-1.
3. the preparation method of slow releasing agent according to claim 1, is characterized in that, described dried is heat drying or lyophilization.
4. a slow releasing agent, is characterized in that, slow releasing agent prepared by the preparation method comprising the slow releasing agent described in any one of claims 1 to 3.
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Citations (5)
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| CN1593504A (en) * | 2004-07-15 | 2005-03-16 | 天津大学 | Microencapsulation method of Chinese traditional medicine |
| CN1872028A (en) * | 2006-04-28 | 2006-12-06 | 深圳市人民医院 | Immune magnetic Nano microsphere, preparation method, and application |
| CN101401975A (en) * | 2008-11-07 | 2009-04-08 | 中国人民解放军第三军医大学第三附属医院 | Tissue engineering bone carrying sustained-release antimicrobial peptide and preparation method thereof |
| CN101947212A (en) * | 2010-09-08 | 2011-01-19 | 华侨大学 | Micro-embedded medicament carrier and preparation method thereof |
| CN101972038A (en) * | 2010-10-28 | 2011-02-16 | 上海理工大学 | Slowly-released filter stick essence microcapsule and preparation method thereof |
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2013
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Patent Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1593504A (en) * | 2004-07-15 | 2005-03-16 | 天津大学 | Microencapsulation method of Chinese traditional medicine |
| CN1872028A (en) * | 2006-04-28 | 2006-12-06 | 深圳市人民医院 | Immune magnetic Nano microsphere, preparation method, and application |
| CN101401975A (en) * | 2008-11-07 | 2009-04-08 | 中国人民解放军第三军医大学第三附属医院 | Tissue engineering bone carrying sustained-release antimicrobial peptide and preparation method thereof |
| CN101947212A (en) * | 2010-09-08 | 2011-01-19 | 华侨大学 | Micro-embedded medicament carrier and preparation method thereof |
| CN101972038A (en) * | 2010-10-28 | 2011-02-16 | 上海理工大学 | Slowly-released filter stick essence microcapsule and preparation method thereof |
Non-Patent Citations (2)
| Title |
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| 正交实验研制烈香杜鹃油-β-环糊精包合物;胡永芳等;《中成药》;20021025;第24卷(第10期);第746-747页 * |
| 黄芪多糖海藻酸钠微胶囊的制备及释放性能研究;樊英等;《饲料研究》;20111130(第11期);全文 * |
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