CN1969832A - P-Cymene drop pill for treating chronic tracheitis and preparation process thereof - Google Patents
P-Cymene drop pill for treating chronic tracheitis and preparation process thereof Download PDFInfo
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- CN1969832A CN1969832A CN 200610167785 CN200610167785A CN1969832A CN 1969832 A CN1969832 A CN 1969832A CN 200610167785 CN200610167785 CN 200610167785 CN 200610167785 A CN200610167785 A CN 200610167785A CN 1969832 A CN1969832 A CN 1969832A
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Abstract
The invention discloses a drug composition to treat chronic tracheitis, which is characterized by the following: improving biological utilizing degree; accelerating drug releasing speed; naming the portable oral agent as p-cymene pillar through combining drug component and drug carrier as substrate.
Description
Technical field
The present invention relates to a kind of p-cymene drop pill for the treatment of chronic tracheitis, the invention still further relates to the preparation method of this drop pill.
Background technology
P-cymene records in national chemical drugs provincial standard rising national standard (the 11), is achromaticity and clarification, has volatile oily liquids, and peat-reek is arranged.Be used for chronic tracheitis.
Pharmacological evaluation shows: p-cymene has and eliminates the phlegm and antiinflammatory action.Its phlegm-dispelling functions may be owing to stimulate the gastric mucosa sensor, makes to reflexive due to the respiratory tract glandular secretion increase.Speed line mucosal epithelium ciliary movement is still arranged, thereby increase the effect of expectoration function.
Toxicological experiment shows: rat is by 50 times of continuous orals of people's consumption p-cymene 21 days, no abnormality seen performance.Liver, kidney, the heart, lung, spleen tissue slice are checked, there is no unusual.The subacute toxicity test result of dog and rabbit does not see the overt toxicity performance.LD50 (mice is oral) 2.797g/kg.
The p-cymene soft gelatin capsule records in chemical drugs provincial standard rising national standard (the 11), is the oral formulations that is used for the treatment of chronic bronchitis, is the oral drug preparation commonly used that clinical and family is used for the treatment of chronic tracheitis.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, and this phenomenon improved seeking.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 unmatchful at present-the p-Cymene drop pill, there is not the relevant report of p-cymene drop pill yet.Because p-cymene 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 preparation is in storage process, owing to the volatilization of effective ingredient significantly reduces its content, become a great problem of p-cymene drop pill preparation.By a large amount of pharmaceutical formulation screening tests, and, finally solved above-mentioned difficult point, determined p-cymene drop pill prescription and preparation technology by drop pill is carried out Cotton seeds.The more former preparation p-cymene of the dissolve scattered time limit of p-cymene drop pill soft gelatin capsule 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 p-cymene drop pill for the treatment of chronic tracheitis.
Another object of the present invention provides the preparation method of this drop pill.
P-cymene drop pill of the present invention is to be made by the active ingredient that contains p-cymene, suitable substrate and the coating materials of making drop pill.
Active ingredient of the present invention is except that containing p-cymene, 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 etc. 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;
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.
The weight proportion of p-cymene drop pill active ingredient of the present invention and substrate, coating materials is 1: 1: 0～1: 9: 2;
P-cymene 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 a p-cymene; Preferred matrix components is Macrogol 4000 (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 p-cymene 24g, white oil 10g all over the mountain, Radix Glycyrrhizae fluidextract 5g and Polyethylene Glycol (4000) 273g respectively, earlier Polyethylene Glycol (4000) is placed in the heating container, be heated to molten condition; Gradation adds p-cymene, white oil all over the mountain and 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 p-cymene 24g, Oleum Viticis Negundo 10g, Polyethylene Glycol (4000) 155g and Polyethylene Glycol (20000) 10g, sodium stearate 5g, earlier with Polyethylene Glycol (4000), Polyethylene Glycol (20000) and sodium stearate, place in the heating container, be heated to molten condition; Gradation adds p-cymene and 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 Ai Leyi stomach dissolution type coating pre-mixing agent 30g coating, promptly.
Embodiment 3
(a) according to active ingredient and substrate be 1: 3 ratio, take by weighing p-cymene 24g, tween 80 is 0.5g, Polyethylene Glycol (6000) 40g and Polyethylene Glycol (4000) 32g, earlier tween 80, Polyethylene Glycol (6000) and Polyethylene Glycol (4000) are placed in the heating container, be heated to molten condition; Adding p-cymene 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 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 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 p-cymene drop pill made from present embodiment 3 methods carries out clinical trial, chronic tracheitis patient 170 examples have been summed up altogether, the result shows that clinical efficacy is remarkable, and 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 | The example that is almost recovered (%) | Produce effects (%) | Effectively (%) | Invalid (%) | Effective percentage (%) |
| Treatment group (p-cymene drop pill) matched group (p-cymene soft gelatin capsule) | 95 75 | 29(30.52) 14(18.67) | 53(55.79) 20(26.66) | 10(10.53) 35(46.67) | 3(3.16) 6(8.00) | 86.31 45.33 |
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 86.31%, 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 treatment chronic tracheitis disease.
Claims (7)
1. a p-cymene drop pill for the treatment of chronic tracheitis is characterized in that being made up of active ingredient that contains p-cymene and suitable substrate and the coating materials of making drop pill, and the weight proportion of active ingredient, substrate and coating materials is 1: 1: 0～1: 9: 2.
2. the described p-cymene drop pill of claim 1, it is characterized in that described active ingredient except that containing p-cymene, 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. the described p-cymene 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 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. 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 a p-cymene;
Preferred matrix components is Macrogol 4000, polyethylene glycol 6000, tween 80, sodium stearate;
Preferred coating materials is a 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 p-cymene 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 p-cymene drop pill as claimed in claim 5 is characterized in that also can carrying out the coating process after the drop pill drying.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200610167785 CN1969832A (en) | 2006-12-21 | 2006-12-21 | P-Cymene drop pill for treating chronic tracheitis and preparation process thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200610167785 CN1969832A (en) | 2006-12-21 | 2006-12-21 | P-Cymene drop pill for treating chronic tracheitis and preparation process thereof |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN1969832A true CN1969832A (en) | 2007-05-30 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 200610167785 Pending CN1969832A (en) | 2006-12-21 | 2006-12-21 | P-Cymene drop pill for treating chronic tracheitis and preparation process thereof |
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| Country | Link |
|---|---|
| CN (1) | CN1969832A (en) |
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2006
- 2006-12-21 CN CN 200610167785 patent/CN1969832A/en active Pending
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Open date: 20070530 |