CN1969933A - Drop pills of Dahurian rhododendron leaf oil for stopping cough and resolving phlegm and preparation process thereof - Google Patents
Drop pills of Dahurian rhododendron leaf oil for stopping cough and resolving phlegm and preparation process thereof Download PDFInfo
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- CN1969933A CN1969933A CN 200610165793 CN200610165793A CN1969933A CN 1969933 A CN1969933 A CN 1969933A CN 200610165793 CN200610165793 CN 200610165793 CN 200610165793 A CN200610165793 A CN 200610165793A CN 1969933 A CN1969933 A CN 1969933A
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- rhododendri daurici
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Abstract
The invention discloses a pharmaceutical composition for treating chronic trachitis with cough-relieving and phlegm reducing functions, the purpose of the invention is to overcome the drawbacks of the conventional preparations and provide a composition with the advantages of high biological availability, quick-speed medicine release, quick-speed effect, less toxic and side effects, higher medicinal content, smaller amount of administration, accurate administration dosage, easy administering, and low cost. The pharmaceutical composition can be made into dose form of dripping pills. The dripping pills comprise extract oil of dahurian rhododendron leaf as the effective constituent and medicinal carrying agent as the base material.
Description
Technical field
The present invention relates to a kind of Oleum Rhododendri Daurici drop pill of eliminating phlegm and stopping cough, the invention still further relates to the preparation method of this drop pill.
Background technology
The Folium Rhododendri Daurici soft gelatin capsule records in one one of Chinese Pharmacopoeia (2005 editions), be a kind of have eliminate the phlegm, antitussive action, be used for the treatment of the oral formulations of acute/chronic bronchitis, be clinical and family is used for the treatment of the oral drug preparation commonly used of chronic bronchitis.The envelop materials of preparation soft gelatin capsule uses gelatin more, owing to reasons such as the characteristic of gelatin and technologies of preparing, usually soft gelatin capsule is in storing process, it is aging that the capsule crust takes place easily, thereby can produce certain insoluble matter in human body, this insoluble matter remains in brings certain influence can in the human body health of human body, therefore, international, domestic all have many medical workers in the research that deepens continuously, to seek the improvement to this phenomenon.Drop pill but enjoys great popularity as a kind of new pharmaceutical dosage form, and drop pill is that solid dispersion method is made, and it has dissolving rapidly, rapid release, and produce effects fast, taking convenience, advantage such as cheap has been avoided the above-mentioned shortcoming of soft gelatin capsule.Still do not have the Oleum Rhododendri Daurici drop pill at present, do not have the relevant report of Oleum Rhododendri Daurici drop pill yet.Because Oleum Rhododendri Daurici drop pill active ingredient is a volatile ingredient, rounding rate, dissolve scattered time limit and the hardness number of drop pill are difficult for reaching the preparation requirement during preparation drop pill, and in storage process, owing to the volatilization of effective ingredient significantly reduces its content, become a great problem of Oleum Rhododendri Daurici dropping pill formulation.By a large amount of pharmaceutical formulation screening tests, and, finally solved above-mentioned difficult point, determined Oleum Rhododendri Daurici drop pill prescription and preparation technology by drop pill is carried out Cotton seeds.The more former preparation of the dissolve scattered time limit of Oleum Rhododendri Daurici drop pill obviously shortens, and the more former preparation of curative effect also obviously strengthens.
Summary of the invention
One of purpose of the present invention provides a kind of Oleum Rhododendri Daurici drop pill of eliminating phlegm and stopping cough.
Another object of the present invention provides the preparation method of this drop pill.
Oleum Rhododendri Daurici drop pill of the present invention is to be made by the active ingredient that contains Oleum Rhododendri Daurici, suitable substrate and the coating materials of making drop pill.
The active ingredient active ingredient of drop pills of dahurian rhododendron leaf agent of the present invention is except that containing Folium Rhododendri Daurici, and other can contain in white oil all over the mountain, Oleum Viticis Negundo, Oleum Folium Artemisiae Argyi, Rhizoma Menispermi total bases, Mentholum, Oleum menthae, geraniol, Herba Melastomatis Candii extractum, Radix Glycyrrhizae fluidextract, the Radix Glycyrrhizae extractum one or more.
The suitable substrate of making drop pill of the present invention is selected from Polyethylene Glycol (2000,4000,6000,8000,10000,20000), one or more in pharmaceutically suitable carrier such as polyoxyethylene stearate 40 esters, betacyclodextrin, tween 80, poloxamer, carboxymethyl starch sodium, sodium lauryl sulphate, stearic acid, sodium stearate, glycerol;
Described coating materials is commercially available stomach dissolution type coating pre-mixing agent, is selected from commercially available Ai Leyi stomach dissolution type coating pre-mixing agent, Ka Lekang stomach dissolution type coating pre-mixing agent etc.
The weight proportion of Oleum Rhododendri Daurici drop pill active ingredient of the present invention and substrate, coating materials is 1: 1: 0～1: 9: 2;
Oleum Rhododendri Daurici drop pill active ingredient of the present invention and substrate, the preferred weight proportion of coating materials are 1: 2: 0.4～1: 5: 1.Wherein preferred active ingredient is an Oleum Rhododendri Daurici; Preferred matrix components is Polyethylene Glycol (4000), Polyethylene Glycol (6000), tween 80, sodium stearate; Preferred coating materials is commercially available Ai Leyi stomach dissolution type coating pre-mixing agent.
Drop pill of the present invention can prepare by the following method:
Accurately take by weighing active ingredient and substrate, earlier substrate is placed and be heated to fusion in the heating container while stirring, active ingredient can be made into suitable solution in addition, and gradation progressively adds active ingredient or active ingredient solution and stirs again, until the fused solution that obtains containing active ingredient and substrate, standby;
Adopt homemade or general drop pill machine, and adjust the temperature control system of drop pill machine, make the water dropper temperature heating of drop pill machine and remain on 50 ℃～110 ℃, the temperature cooling of condensing agent also remains on-5 ℃～40 ℃; When treating that the temperature of condensing agent in dropping-pill machine head and the condensation column is stable respectively and being in the desired state of temperature of above step, will contain the fused solution of active ingredient and substrate, place in the water dropper jar of drop pill machine, splash in the condensing agent by water dropper; The drop pill that will be shunk molding by drop pill machine outlet takes out, and removes the surface condensation agent, drying, or other coating, promptly.
The specific embodiment
Embodiment 1
(a) according to active ingredient and substrate be 1: 7 ratio, take by weighing Oleum Rhododendri Daurici 25g, Oleum Folium Artemisiae Argyi 10g, Radix Glycyrrhizae fluidextract 12g and Polyethylene Glycol (4000) 330g respectively, earlier Polyethylene Glycol (4000) is placed in the heating container, be heated to molten condition, gradation adds Oleum Rhododendri Daurici, Oleum Folium Artemisiae Argyi, Radix Glycyrrhizae fluidextract, stirs.
(b) adopt homemade drop pill machine, adjust the temperature control system of drop pill machine, make the water dropper temperature of drop pill machine remain on (75～85) ℃, and the thermograde that makes condensing agent is (30～20) ℃ → (5～-5) ℃;
(c) temperature for the treatment of dropping-pill machine head and condensing agent is stable respectively was in for second step during institute's claimed condition, with fused material by water dropper (the dropper bore: 2mm/4.2mm), splash in the methyl-silicone oil of drop pill machine with suitable speed;
(d) drop pill that will shrink molding by the outlet of drop pill machine takes out, and removes the condensed fluid on surface, drying;
Embodiment 2
(a) according to active ingredient and substrate be 1: 5 ratio, take by weighing Oleum Rhododendri Daurici 25g, Oleum Viticis Negundo 10g, Polyethylene Glycol (4000) 160g and Polyethylene Glycol (20000) 10g, sodium stearate 5g, earlier with Polyethylene Glycol (4000) and Polyethylene Glycol (20000), sodium stearate places in the heating container, be heated to molten condition, gradation adds Oleum Rhododendri Daurici, Oleum Viticis Negundo, stirs.
(b) adopt homemade drop pill machine, adjust the temperature control system of drop pill machine, make the water dropper temperature of drop pill machine remain on (75～85) ℃, and the thermograde that makes condensing agent is (30～20) ℃ → (5～-5) ℃;
(c) temperature for the treatment of dropping-pill machine head and condensing agent is stable respectively was in for second step during institute's claimed condition, with fused material by water dropper (the dropper bore: 2mm/4.2mm), splash in the methyl-silicone oil of drop pill machine with suitable speed;
(d) drop pill that will shrink molding by the outlet of drop pill machine takes out, and removes the condensed fluid on surface, drying;
(e) with drop pill with commercially available Ai Leyi stomach dissolution type coating pre-mixing agent 40g coating, promptly.
Embodiment 3
(a) according to active ingredient and substrate be 1: 3 ratio, take by weighing Oleum Rhododendri Daurici 25g, tween 80 is 0.5g, Polyethylene Glycol (6000) 40g, Polyethylene Glycol (4000) 35g, earlier with tween 80, Polyethylene Glycol (6000), Polyethylene Glycol (4000) places in the heating container, is heated to molten condition, add Oleum Rhododendri Daurici, stir;
(b) adopt homemade drop pill machine, adjust the temperature control system of drop pill machine, make the water dropper temperature of drop pill machine remain on (75～85) ℃, and the thermograde that makes condensing agent is (30～20) ℃ → (5～-5) ℃;
(c) temperature for the treatment of dropping-pill machine head and condensing agent is stable respectively was in for second step during institute's claimed condition, with water dropper by the drop pill machine of fused material (dropper mouth internal diameter: 2～4mm), splash in the methyl-silicone oil with suitable speed;
(d) drop pill that will shrink molding by the outlet of drop pill machine takes out, and removes the condensed fluid on surface, drying;
(e) with drop pill with commercially available Ai Leyi stomach dissolution type coating pre-mixing agent 15g coating, promptly.
Clinical trial example 1
Be the definite safety of estimating clinical efficacy of the present invention and medicine, the Oleum Rhododendri Daurici drop pill made from present embodiment 3 methods carries out clinical trial, sums up acute/chronic bronchitis patient 252 examples altogether, is effective case and receives significant curative effect.Do not find any toxic and side effects, now clinical test results is summarized as follows.
To be almost recovered and produce effects example number total calculating effective percentage.
Therapeutic outcome:
| Group | The example number | Routine % is almost recovered | Produce effects example % | Effective routine % | Invalid routine % | Effective percentage (%) |
| Treatment group (Oleum Rhododendri Daurici drop pill) matched group (Oleum Rhododendri Daurici soft gelatin capsule) | 130 122 | 45(34.60) 28(22.95) | 75(57.69) 32(26.23) | 8(6.15) 46(37.70) | 2(1.54) 16(13.11) | 92.29 49.18 |
Two groups of effective percentage are compared, and P＜0.05 illustrates that treatment group therapeutic effect is significantly higher than matched group.
Treatment group total effective rate is 92.29%, and all cases are not all found obvious toxic and side effects in therapeutic process.The medicine of the present invention's preparation is safe and effective aspect the treatment chronic bronchitis diseases.
Claims (7)
1. one kind is used for the treatment of the Oleum Rhododendri Daurici drop pill for the treatment of acute/chronic bronchitis, it is characterized in that being made up of the active ingredient that contains Oleum Rhododendri Daurici, suitable substrate and the coating materials of making drop pill, the weight proportion of active ingredient, substrate and coating materials is: 1: 1: 0～1: 9: 2.
2. the described Oleum Rhododendri Daurici drop pill of claim 1, it is characterized in that described active ingredient except that containing Oleum Rhododendri Daurici, can contain in white oil all over the mountain, Oleum Viticis Negundo, Oleum Folium Artemisiae Argyi, Rhizoma Menispermi total bases, Mentholum, Oleum menthae, geraniol, Herba Melastomatis Candii extractum, Radix Glycyrrhizae fluidextract, the Radix Glycyrrhizae extractum one or more in addition.
3. the described Oleum Rhododendri Daurici drop pill of claim 1, it is characterized in that described drop pill substrate is selected from Polyethylene Glycol (2000,4000,6000,8000,10000,20000), one or more in pharmaceutically suitable carrier such as polyoxyethylene stearate 40 esters, betacyclodextrin, tween 80, poloxamer, carboxymethyl starch sodium, sodium lauryl sulphate, stearic acid, sodium stearate, glycerol.
Described coating materials is commercially available coating pre-mixing agent, is selected from commercially available Ai Leyi stomach dissolution type coating pre-mixing agent, Ka Lekang stomach dissolution type coating pre-mixing agent etc.
4. drop pill according to claim 1, the preferred weight proportioning that it is characterized in that described active ingredient, substrate and coating materials is 1: 2: 0.4～1: 5: 1.Wherein preferred active ingredient is an Oleum Rhododendri Daurici; Preferred matrix components is Macrogol 4000, polyethylene glycol 6000, tween 80, sodium stearate; Preferred coating materials is commercially available Ai Leyi stomach dissolution type coating pre-mixing agent.
5. the preparation method of the described drop pill of claim 1 is characterized in that step is as follows:
1. according to the given ratio of prescription, accurately take by weighing active ingredient and substrate, earlier substrate is placed and be heated to fusion in the heating container while stirring, active ingredient can be made into suitable solution in addition, gradation progressively adds active ingredient or active ingredient solution and stirs again, until the fused solution that obtains containing active ingredient and substrate, standby;
2. adopt homemade or general drop pill machine, and adjust the temperature control system of drop pill machine, make the water dropper temperature heating of drop pill machine and remain on 50 ℃～110 ℃, the temperature cooling of condensing agent also remains on-5 ℃～40 ℃; Dropper mouth internal diameter: 2～4mm;
3. treating that the temperature of condensing agent in dropping-pill machine head and the condensation column is stable respectively is in above the 2nd step during desired state of temperature, will contain the fused solution of active ingredient and substrate, places in the water dropper jar of drop pill machine, splashes in the condensing agent by water dropper;
4. the drop pill that will shrink molding by drop pill machine outlet takes out, and removes the surface condensation agent, drying, or other coating, promptly.
6. the preparation method of Oleum Rhododendri Daurici drop pill as claimed in claim 5, it is characterized in that described condensing agent be methyl-silicone oil or/and liquid paraffin or/and vegetable oil.
7. the preparation method of Oleum Rhododendri Daurici drop pill as claimed in claim 5 is characterized in that also can carrying out coating after the drop pill drying.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200610165793 CN1969933A (en) | 2006-12-19 | 2006-12-19 | Drop pills of Dahurian rhododendron leaf oil for stopping cough and resolving phlegm and preparation process thereof |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200610165793 CN1969933A (en) | 2006-12-19 | 2006-12-19 | Drop pills of Dahurian rhododendron leaf oil for stopping cough and resolving phlegm and preparation process thereof |
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| CN1969933A true CN1969933A (en) | 2007-05-30 |
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| CN 200610165793 Pending CN1969933A (en) | 2006-12-19 | 2006-12-19 | Drop pills of Dahurian rhododendron leaf oil for stopping cough and resolving phlegm and preparation process thereof |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105106287A (en) * | 2015-09-30 | 2015-12-02 | 成都乾坤动物药业有限公司 | Animal medicinal composition for relieving cough and removing phlegm and preparation method of animal medicinal composition |
| CN109549246A (en) * | 2019-01-18 | 2019-04-02 | 薪火高科(深圳)有限公司 | A kind of tobacco juice for electronic smoke and preparation method thereof of adjustable function of human body |
-
2006
- 2006-12-19 CN CN 200610165793 patent/CN1969933A/en active Pending
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105106287A (en) * | 2015-09-30 | 2015-12-02 | 成都乾坤动物药业有限公司 | Animal medicinal composition for relieving cough and removing phlegm and preparation method of animal medicinal composition |
| CN109549246A (en) * | 2019-01-18 | 2019-04-02 | 薪火高科(深圳)有限公司 | A kind of tobacco juice for electronic smoke and preparation method thereof of adjustable function of human body |
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Addressee: Wang Lijuan Document name: Written notice of preliminary examination of application for patent for invention |
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Open date: 20070530 |