CN1823747B - Paeonol film coated drip pill and its preparation method - Google Patents
Paeonol film coated drip pill and its preparation method Download PDFInfo
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- CN1823747B CN1823747B CN2005100424654A CN200510042465A CN1823747B CN 1823747 B CN1823747 B CN 1823747B CN 2005100424654 A CN2005100424654 A CN 2005100424654A CN 200510042465 A CN200510042465 A CN 200510042465A CN 1823747 B CN1823747 B CN 1823747B
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- paeonol
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- film coated
- pill
- drop pill
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Abstract
A coated dripping pill of paeonol and its preparing process are disclosed. Its advantages are no educing and sublimating, high stability and high dissolving speed.
Description
Technical field
The present invention relates to a kind of paeonol film coated drip pill and preparation method thereof.
Background technology
Paeonol is the main effective ingredient of conventional Chinese medicine material Cortex Moutan and Radix Cynanchi Paniculati, has analgesia, antiinflammatory, analgesic and suppress allergic effect.To pressing the pain due to physics such as tail, acetic acid or the chemical factor to have significant analgesia role.To by the inflammatory reaction due to carrageenin, Ovum Gallus domesticus album, formaldehyde, histamine, 5-hydroxytryptamine, Kallidin I, dimethylbenzene and the endotoxin etc., has the obvious suppression effect.To the fervescence that Typhoid Vaccine, triple vaccine etc. causes, has tangible refrigeration function.All inhibited to II, III, IV allergic reaction type.
At present existing paeonol sheet (coated tablet) listing, but its disintegrate and dissolution rate are all relatively poor, have therefore influenced curative effect of medication.Prepare drop pill according to a conventional method, promptly adopt drop pill adjuvant Polyethylene Glycol commonly used, the preparation drop pill, we find because the paeonol fusing point is 48-51 ℃, therefore the drop pill of preparation very easily distils, cause drop pill content to descend, and the drop pill disintegration and the dissolution rate of preparation according to a conventional method can't satisfy officinal regulation.Therefore the inventor has carried out a large amount of prescription screenings through long-term experiment research, provides that a kind of disintegrate is rapid, dissolution rate is high, steady quality, paeonol film coated drip pill easy to prepare.
Summary of the invention
The invention provides a kind of paeonol film coated drip pill.
The invention provides the preparation method of paeonol film coated drip pill.
The parts by weight proportioning of principal agent and each adjuvant is in the paeonol film coated drip pill provided by the invention: paeonol 5～15, Tween 80 1～3, starch 1～3, poloxamer 3～10, Polyethylene Glycol substrate 20～50.
Polyethylene Glycol can be polyethylene glycol 6000, Macrogol 4000 or its mixing in the paeonol film coated drip pill provided by the invention.
The ratio of drop pill and film-coat is 100:1～5 in the paeonol film coated drip pill provided by the invention.
Film-coat material provided by the invention is Opadry II.
The invention provides the preparation technology of paeonol film coated drip pill, the steps include:
(1) take by weighing poloxamer 3～10 by umber, Polyethylene Glycol 20～50 is put in 60～80 ℃ of water-baths, is heated to molten condition, adds paeonol 5～15 again, Tween 80 1～3, and starch 1～3, stirring makes and is uniformly dispersed;
(2) regulate the drop pill machine, 60～80 ℃ of fluid temperature, 0～20 ℃ of coolant temperature is dripped and is made plain ball, removes coolant;
(3) plain ball is inserted in the coating pan, 60～80 rev/mins of coating pan rotating speeds, 30～40 ℃ of the bottom of a pan inlet temperature atomize under pressure 2～4bar condition, with the charging of 3～4g/min flow velocity, drying under reduced pressure, the bag film-coat, packing, promptly.
Drop pill provided by the invention adopts starch to do short disintegrate, makes drop pill disintegrate fast; The present invention adopts tween and mixtures of poloxamers to do adjuvant, has accelerated the dissolution rate of medicine; Adopt low-temperature reduced-pressure dry coationg technology, avoided the destruction of paeonol in the coating process and the loss that the high temperature distillation causes; Adopt the film coating means, reduced separating out and distilling of paeonol in the put procedure, increased the steady quality of preparation, guaranteed drug effect effectively.
The specific embodiment
Preparation example 1: preparation paeonol film coated drip pill
Get 31g polyethylene glycol 6000 and 6g poloxamer, put heating and melting in 80 ℃ of water-baths, under agitation add 1.5g tween 80,1.5g starch and 10g paeonol raw material, 80 ℃ of insulations are stirred down to make in 60 minutes and are uniformly dispersed, medicinal liquid is transferred in 80 ℃ of constant temperature storings of drop pill machine pipe, at the water dropper bore is 3.6/5.0mm, drip 60 droplets/minute of speed, coolant is a dimethicone, under 10 ℃ of conditions of coolant temperature, regulating the drop pill ball heavily is 50mg, drip and make plain ball, remove the lip-deep liquid coolant of plain ball, the bag film-coat, packing promptly gets 1000 balls.(dissolve scattered time limit 8 minutes)
Preparation example 2: preparation method is with 1, write out a prescription following (dissolve scattered time limit 10 minutes)
Preparation example 3: method is with 1, write out a prescription following (dissolve scattered time limit 7 minutes)
Preparation example 4: method is with 1, and it is as follows to write out a prescription: (dissolve scattered time limit 9 minutes)
Test example 1: disintegration, dissolution and stability are relatively
Paeonol film coated drip pill: according to preparation example 1 preparation;
The plain ball of paeonol: by preparation example 1 preparation
The paeonol sheet: available from Guangxi Yikang Pharmaceutical Industry Co., Ltd., lot number 030603.
With disintegration, dissolution, stability is index, presses two appendix prescriptive procedures of Chinese Pharmacopoeia version in 2000 and checks that paeonol film coating drop pill and paeonol sheet that the present invention is prepared compare.
(1) disintegration
| The sample title | Disintegration time (minute) |
| Paeonol film coated drip pill | 8 |
| The paeonol sheet | 21 |
Experimentize by official method, the drop pill disintegrate that discovery the present invention makes is rapid, obviously is better than tablet.
(2) stripping curve
Pressing dissolution method (two appendix XC first methods of Chinese Pharmacopoeia version in 2000), is solvent with water, presses high-efficient liquid phase technique (two appendix VD of Chinese Pharmacopoeia version in 2000) test, is filler with the octadecyl silane post; Methanol-water (50:50) is a mobile phase, detects wavelength 275nm.
Paeonol film coated drip pill and paeonol sheet stripping curve are seen accompanying drawing.
Find drop pill dissolution rate and the dissolution that the present invention makes by contrast, obviously be better than tablet, the disintegrate and the release that have promoted drop pill in drop pill behind the adding starch are described.
(3) stability relatively
Press Chinese Pharmacopoeia appendix accelerated test condition and placed 3 months, by high effective liquid chromatography for measuring content, by the percentage composition calculating of labelled amount.The stability that compares the plain ball of paeonol, paeonol film coated drip pill, paeonol sheet.
| The sample title | Paeonol content (%) |
| The plain ball of paeonol | 56.4 |
| Paeonol film coating drop pill | 99.6 |
| The paeonol sheet | 99.7 |
Find that by contrast film coating drop pill and tablet stability that the present invention makes are suitable, and plain ball poor stability, separating out and volatilizing of obvious minimizing paeonol behind the bag film-coat be described.
Claims (1)
1. paeonol film coated drip pill, its drop pill is made up of following parts by weight proportioning: paeonol 5～15, Tween 80 1～3, starch 1～3, poloxamer 3～10, Polyethylene Glycol 25～50, the ratio of its drop pill and film-coat is 100: 1～5, wherein Polyethylene Glycol is polyethylene glycol 6000, Macrogol 4000 or its mixing, and the film-coat material is Opadry II.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2005100424654A CN1823747B (en) | 2005-02-25 | 2005-02-25 | Paeonol film coated drip pill and its preparation method |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2005100424654A CN1823747B (en) | 2005-02-25 | 2005-02-25 | Paeonol film coated drip pill and its preparation method |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1823747A CN1823747A (en) | 2006-08-30 |
| CN1823747B true CN1823747B (en) | 2010-07-21 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN2005100424654A Expired - Fee Related CN1823747B (en) | 2005-02-25 | 2005-02-25 | Paeonol film coated drip pill and its preparation method |
Country Status (1)
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Families Citing this family (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102697846B (en) * | 2012-06-12 | 2013-08-28 | 浙江尖峰药业有限公司 | Yufengningxin coated dripping pill and preparation method thereof |
| CN105287421A (en) * | 2015-12-01 | 2016-02-03 | 上海中医药大学 | Paeonol gastric floating tablet and preparation method thereof |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1493275A (en) * | 2003-09-06 | 2004-05-05 | 南昌弘益科技有限公司 | Paeonol drip pill and its preparation method |
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2005
- 2005-02-25 CN CN2005100424654A patent/CN1823747B/en not_active Expired - Fee Related
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1493275A (en) * | 2003-09-06 | 2004-05-05 | 南昌弘益科技有限公司 | Paeonol drip pill and its preparation method |
Non-Patent Citations (2)
| Title |
|---|
| 胡向青等.滴丸剂的研究进展.药学进展28 12.2004,28(12),537-541. |
| 胡向青等.滴丸剂的研究进展.药学进展28 12.2004,28(12),537-541. * |
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| Publication number | Publication date |
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| CN1823747A (en) | 2006-08-30 |
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Effective date of registration: 20170608 Address after: 264670, No. 15, pioneering Road, hi tech Zone, Shandong, Yantai Patentee after: Shandong Luye Pharma Co., Ltd. Address before: 264003 Laishan, Shandong Province Bao Road, No. 9 District, No. Patentee before: Luye Natural Medicinal Research Developing Co., Ltd., Shandong Prov. |
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Effective date of registration: 20191015 Address after: 264005, Qingquan Road, Laishan District, Shandong, Yantai, 30 Patentee after: Yantai University Address before: 264670, No. 15, pioneering Road, hi tech Zone, Shandong, Yantai Patentee before: Shandong Luye Pharma Co., Ltd. |
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| CF01 | Termination of patent right due to non-payment of annual fee | ||
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Granted publication date: 20100721 Termination date: 20210225 |