CN1969932A - Drop pills of rhogodendron lutescens franch for treating chronic bronchitis and preparation process thereof - Google Patents
Drop pills of rhogodendron lutescens franch for treating chronic bronchitis and preparation process thereof Download PDFInfo
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- CN1969932A CN1969932A CN 200610165791 CN200610165791A CN1969932A CN 1969932 A CN1969932 A CN 1969932A CN 200610165791 CN200610165791 CN 200610165791 CN 200610165791 A CN200610165791 A CN 200610165791A CN 1969932 A CN1969932 A CN 1969932A
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Abstract
The invention discloses a pharmaceutical composition for treating chronic trachitis aimed at overcoming the drawbacks of the conventional preparations. The composition has 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 volatile oil extracted from fragrant rhododendron leaf as the medicinal active constituent and medicinal carrying agent as the base material.
Description
Technical field
The present invention relates to a kind of Hemerocallis citrina Baroni Cuculus polioephalus dropping pill formulation that is used for the treatment of chronic bronchitis, the invention still further relates to the preparation method of this drop pill.
Background technology
Hemerocallis citrina Baroni Cuculus polioephalus soft gelatin capsule records (two) fascicle in Chinese patent medicine provincial standard rising national standard part internal medicine lung system, and the effect of have relieving cough and expelling phlegm, relievining asthma is used for the treatment of chronic bronchitis, is clinical and family is used for the treatment of the common dosage forms of chronic bronchitis.This product is rich in r-selinene, ten various active compositions such as yak ketone, benzylacetone, Cuculus polioephalus alkene, Cuculus polioephalus time alkene, pharmacological screening confirms that compositions such as contained benzylacetone of this product and r-selinene can effectively improve CAMP level in the cell, contraction to antihistaminic and bronchial smooth muscle, can also remove bronchial muscular spasm, suppress the permeability and the edema of blood capillary.Simultaneously, this product has stronger inhibition inhibitory action to the respiratory tract pathogenic bacterium, thereby reaches the treatment to tracheitis.
Because of the envelop materials for preparing 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 enjoys great popularity as a kind of new pharmaceutical dosage form, and drop pill is made by solid dispersion method, 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 Hemerocallis citrina Baroni Cuculus polioephalus dropping pill formulation at present, do not have the relevant report of Hemerocallis citrina Baroni Cuculus polioephalus dropping pill formulation yet.Because Hemerocallis citrina Baroni Cuculus polioephalus drop pill active ingredient is the effumability composition, 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 preparation is in storage process, owing to the volatilization of effective ingredient significantly reduces its content, become a great problem of Ledum palustre L. var. dilatatum Wahl.oil dropping pill formulation.By a large amount of pharmaceutical formulation screening tests, and, finally solved above-mentioned difficult point, determined Ledum palustre L. var. dilatatum Wahl.oil drop pill prescription and preparation technology, successfully prepared qualified Hemerocallis citrina Baroni Cuculus polioephalus drop pill by drop pill is carried out Cotton seeds.The results showed that the more former soft gelatin capsule of dissolve scattered time limit of Hemerocallis citrina Baroni Cuculus polioephalus drop pill obviously shortens; Clinical efficacy has been compared significant difference with former soft gelatin capsule, enhancing evident in efficacy.
Summary of the invention
One of purpose of the present invention provides a kind of Hemerocallis citrina Baroni Cuculus polioephalus dropping pill formulation that is used for the treatment of chronic bronchitis.
Another object of the present invention provides the preparation method of this drop pill.
Rhododendron is extracted the active ingredient of the volatile oil that obtains to Hemerocallis citrina Baroni Cuculus polioephalus drop pill of the present invention, suitable substrate and the coating materials of making drop pill formed by containing.
The active ingredient of Hemerocallis citrina Baroni Cuculus polioephalus drop pill of the present invention extracts the volatile oil that obtains except that containing by Rhododendron, 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 etc. one or more in addition.
The suitable substrate of making Hemerocallis citrina Baroni Cuculus polioephalus 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 tween 80, stearic acid, sodium stearate, polyoxyethylene stearate 40 esters, poloxamer, carboxymethyl starch sodium, sodium lauryl sulphate, betacyclodextrin, glycerol.
The coating materials of Hemerocallis citrina Baroni Cuculus polioephalus drop pill of the present invention 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.
The weight proportion of active ingredient, substrate and the coating materials of Hemerocallis citrina Baroni Cuculus polioephalus drop pill of the present invention is 1: 1: 0～1: 9: 2.
The preferred weight proportion of active ingredient, substrate and coating materials of Hemerocallis citrina Baroni Cuculus polioephalus drop pill of the present invention is 1: 2: 0.4～1: 5: 1; Wherein preferred active ingredient is that Rhododendron is extracted resulting volatile oil, and preferred substrate is Polyethylene Glycol (4000), Polyethylene Glycol (6000), tween 80, sodium stearate, and preferred coating materials is commercially available Ai Leyi stomach dissolution type coating pre-mixing agent.
Hemerocallis citrina Baroni Cuculus polioephalus drop pill of the present invention can prepare (wherein, 440g Rhododendron medical material adopts steam distillation to extract and obtains 1g Rhododendron volatile oil) by the following method:
Accurately take by weighing Rhododendron, extract volatile oil according to steam distillation, redistillation to volatile oil relative density is 0.95 (20 ℃), and is standby; According to the given ratio of prescription, accurately take by weighing each active ingredient and substrate, substrate placed 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, suspension or emulsion, 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 ℃, and dropper mouth internal diameter is 1.0～4.0 millimeters; 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, drop surface condensation agent to the greatest extent, and drying, or other coating, promptly.
The specific embodiment
Embodiment 1
(a) according to the weight proportion of active ingredient and substrate 1: 7, take by weighing Rhododendron 11000g (wherein, 440g Rhododendron medical material adopts steam distillation to extract and obtains 1g Rhododendron volatile oil), extract volatile oil according to steam distillation, redistillation to volatile oil relative density is 0.95 (20 ℃);
(b) take by weighing Oleum menthae 21g, Rhizoma Menispermi total bases 4g, Polyethylene Glycol (4000) 350g respectively, place in the heating container, heating while stirring is until the fused solution that obtains containing active ingredient and substrate, suspension or emulsion;
(c) 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 (75～90) ℃, and the thermograde that makes condensing agent is (30～20) ℃ → (5～-5) ℃;
(d) temperature for the treatment of dropping-pill machine head and condensing agent is stable respectively was in for the 3rd step during institute's claimed condition, and fused material is splashed in the liquid paraffin with suitable speed by the water dropper (dropper mouth internal diameter is 1.0～4.0 millimeters) of drop pill machine;
(e) drop pill that will shrink molding by the outlet of drop pill machine takes out, and drop is the condensing agent on surface to the greatest extent, drying.
Embodiment 2
(a) according to the weight proportion of active ingredient and substrate 1: 5, take by weighing Rhododendron 11000g (wherein, 440g Rhododendron medical material adopts steam distillation to extract and obtains 1g Rhododendron volatile oil), extract volatile oil according to steam distillation, redistillation to volatile oil relative density is 0.95 (20 ℃);
(b) take by weighing Oleum Folium Artemisiae Argyi 25g, Polyethylene Glycol (4000) 220g and Polyethylene Glycol (20000) 21g respectively, sodium stearate 9g places in the heating container, and heating while stirring is until the fused solution that obtains containing active ingredient and substrate, suspension or emulsion;
(c) 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 (75～90) ℃, and the thermograde that makes condensing agent is (30～20) ℃ → (5～-5) ℃;
(d) temperature for the treatment of dropping-pill machine head and condensing agent is stable respectively was in for the 3rd step during institute's claimed condition, and fused material is splashed in the liquid paraffin with suitable speed by the water dropper (dropper mouth internal diameter is 1.0～4.0 millimeters) of drop pill machine;
(e) drop pill that will shrink molding by the outlet of drop pill machine takes out, and drop is the condensing agent on surface to the greatest extent, drying;
(f) with drop pill with 45g Ai Leyi stomach dissolution type coating pre-mixing agent coating, promptly.
Embodiment 3
(a) according to the weight proportion of active ingredient and substrate 1: 3, take by weighing Rhododendron 22000g (wherein, 440g Rhododendron medical material adopts steam distillation to extract and obtains 1g Rhododendron volatile oil), extract volatile oil according to steam distillation, redistillation to volatile oil relative density is 0.95 (20 ℃);
(b) taking by weighing tween 80 respectively is 1.0g, Polyethylene Glycol (6000) 60g, and Polyethylene Glycol (4000) 90g places in the heating container, and heating while stirring is until the fused solution that obtains containing active ingredient and substrate, suspension or emulsion;
(c) 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 (75～90) ℃, and the thermograde that makes condensing agent is (30～20) ℃ → (5～-5) ℃;
(d) temperature for the treatment of dropping-pill machine head and condensing agent is stable respectively was in for the 3rd step during institute's claimed condition, and fused material is splashed in the liquid paraffin with suitable speed by the water dropper (dropper mouth internal diameter is 1.0～4.0 millimeters) of drop pill machine;
(e) drop pill that will shrink molding by the outlet of drop pill machine takes out, and drop is the condensing agent on surface to the greatest extent, drying;
(f) with drop pill with 30g Ai Leyi stomach dissolution type coating pre-mixing agent coating, promptly.
Clinical trial example 1
Be the definite safety of estimating clinical efficacy of the present invention and medicine, the Hemerocallis citrina Baroni Cuculus polioephalus drop pill made from present embodiment 3 methods carries out clinical trial, sum up chronic bronchitis 190 examples, obstructive emphysema 115 examples, bronchial asthma infection 45 examples, lang-QI disease 20 examples respectively, the produce effects case reaches 301 examples (obvious effective rate reaches 81.35%), receives significant curative effect.Now the clinical efficacy result is summarized as follows:
| Grouping | The example number | Produce effects | Effectively | Invalid | Total obvious effective rate (%) | Total effective rate (%) |
| Chronic bronchitis obstructive emphysema bronchial asthma sense lang-QI disease adds up to | 190 115 45 20 370 | 160 91 35 15 301 | 25 21 9 3 58 | 5 3 1 2 11 | 81.35 | 97.03 |
All cases are not all found obvious toxic-side effects in therapeutic process.
Comprehensive above clinical trial example, the medicine of the present invention's preparation is safe and effective at aspects such as treatment chronic bronchitiss.
Claims (7)
1. Hemerocallis citrina Baroni Cuculus polioephalus dropping pill formulation that is used for the treatment of chronic tracheitis, it is characterized in that Rhododendron is extracted the active ingredient of volatile oil, suitable substrate and the coating materials of making drop pill formed by containing, the weight proportion of active ingredient, substrate and coating materials is 1: 1: 0～1: 9: 2.
2. Hemerocallis citrina Baroni Cuculus polioephalus drop pill as claimed in claim 1, it is characterized in that described active ingredient except that containing Rhododendron volatile oil, 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 etc. one or more in addition.
3. Hemerocallis citrina Baroni Cuculus polioephalus drop pill as claimed in 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 tween 80, stearic acid, sodium stearate, polyoxyethylene stearate 40 esters, poloxamer, carboxymethyl starch sodium, sodium lauryl sulphate, betacyclodextrin, glycerol;
Described coating materials is a 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.
4. Hemerocallis citrina Baroni Cuculus polioephalus drop pill as claimed in 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.It is preferred that wherein preferred active ingredient is that Rhododendron is extracted the volatile oil that obtains, and substrate is Polyethylene Glycol (4000), Polyethylene Glycol (6000), tween 80, sodium stearate, and preferred coating materials is commercially available Ai Leyi stomach dissolution type coating pre-mixing agent.
5. the preparation method of Hemerocallis citrina Baroni Cuculus polioephalus drop pill as claimed in claim 1 is characterized in that step is as follows:
1, take by weighing Rhododendron, extract volatile oil according to steam distillation, redistillation to volatile oil relative density is 0.95 (20 ℃), and is standby;
2, according to the given ratio of prescription, accurately take by weighing each active ingredient and substrate, substrate placed 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, suspension or emulsion, standby;
3, 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 ℃, and dropper mouth internal diameter is 1.0～4.0 millimeters;
4, treating that the temperature of condensing agent in dropping-pill machine head and the condensation column is stable respectively is in above the 4th 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;
5, the drop pill that will shrink molding by drop pill machine outlet takes out, drop surface condensation agent to the greatest extent, and drying, or other coating, promptly.
6. the preparation method of Hemerocallis citrina Baroni Cuculus polioephalus 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 Hemerocallis citrina Baroni Cuculus polioephalus 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 200610165791 CN1969932A (en) | 2006-12-19 | 2006-12-19 | Drop pills of rhogodendron lutescens franch for treating chronic bronchitis and preparation process thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200610165791 CN1969932A (en) | 2006-12-19 | 2006-12-19 | Drop pills of rhogodendron lutescens franch for treating chronic bronchitis and preparation process thereof |
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| Publication Number | Publication Date |
|---|---|
| CN1969932A true CN1969932A (en) | 2007-05-30 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 200610165791 Pending CN1969932A (en) | 2006-12-19 | 2006-12-19 | Drop pills of rhogodendron lutescens franch for treating chronic bronchitis and preparation process thereof |
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| Country | Link |
|---|---|
| CN (1) | CN1969932A (en) |
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2006
- 2006-12-19 CN CN 200610165791 patent/CN1969932A/en active Pending
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