CN1729979A - Soft capsule of fibrauretine composition - Google Patents
Soft capsule of fibrauretine composition Download PDFInfo
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- CN1729979A CN1729979A CN 200510041300 CN200510041300A CN1729979A CN 1729979 A CN1729979 A CN 1729979A CN 200510041300 CN200510041300 CN 200510041300 CN 200510041300 A CN200510041300 A CN 200510041300A CN 1729979 A CN1729979 A CN 1729979A
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- fibrauretin
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- capsule
- soft capsule
- polyethylene glycol
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Abstract
The invention discloses a soft capsule composition of Fibrauretin, which comprises soft capsule shells and medicinal composition coated therein, the medicinal composition mainly comprises Fibrauretin, plant oil and / or polyethylene glycol, suspension auxiliary agent.
Description
Technical field
The present invention relates to field of pharmaceutical preparations, be specifically related to the pharmaceutical preparation of natural drug, be i.e. the capsule composition of fibrauretin.
Background technology
The Caulis Fibraureae prime system extracts refining forming from Menispermaceae Herba Aristolochiae platymiscium Caulis Fibraureae (Fibraurea recisa Pierre), have another name called hydrochloride Palmatine, and its chemistry is by name: the chlorination fibrauretin, recorded in Chinese Pharmacopoeia 1977 editions.Fibrauretin has the effect of stronger mould fungus inhibition, staphylococcus, gonococcus, mycoplasma chlamydia, acid-resisting mycobacteria.
Existing pharmacological effect and clinical observation confirm that fibrauretin has the effect of detoxifcation, can significantly strengthen the ability of leukocytes phagocytic antibacterial and virus.Treatment gynecological inflammation effective percentage reaches 92.43%; The urinary tract infection total effective rate is 95.56%; The surgical infection effective percentage is 92.66%; Bacillary dysentery, diarrhoea, enteritis, respiratory tract infection total effective rate are 98.56%.
The fibrauretin dosage form that existing market is sold is tablet, injection and suppository, and limited dosage form has limited being extensive use of of it.
Summary of the invention
Soft capsule preparation has taking convenience, absorption is rapid, rapid-action, bioavailability is high advantage.Do not see at present the report of relevant soft capsule of fibrauretine preparation.
The object of the present invention is to provide a kind of fibrauretin novel formulation, said preparation guaranteeing under the suitable prerequisite of principal agent dosage, by selecting adjuvant and formulation method for use, fibrauretin made liquid be wrapped in and make soft capsule in the rubber, help oral, the absorption of medicine, reach high bioavailability.Simultaneously, also be clinical a kind of renewal, the better dosage form selection of providing.
In soft capsule of fibrauretine preparation manufacture process in advance, the inventor finds that the soft capsule of fibrauretine quality of the pharmaceutical preparations difference that different components and content prepares is very big, some the serious layering of content occurs, content is inhomogeneous, though the content suspendible situation that has is better, but observe through relative humidity 75%, 40 ℃ accelerated test, variations such as leakage of oil, adhesion, distortion or rubber hardening appear in pill.Such result does not obviously meet drug standard, more can not be in clinic trial.
The inventor is through a large amount of tests, successfully prepares steady quality finally, is suitable for the soft capsule preparation that contains fibrauretin of clinical use, and concrete technical scheme is as follows:
Soft capsule of fibrauretine composition of the present invention is made up of soft capsule rubber and the pharmaceutical composition that is wrapped in the rubber, it is characterized in that described pharmaceutical composition mainly contains following component and weight ratio:
Fibrauretin 1
Vegetable oil and/or Polyethylene Glycol 0.5～50
Suspending agent 0～20.
The preferred weight ratio of each component of aforementioned pharmaceutical compositions is:
Fibrauretin 1
Vegetable oil and/or Polyethylene Glycol 0.5～30
Suspending agent 0.05～10.
The weight ratio of further preferred each component is:
Fibrauretin 1
Vegetable oil and/or Polyethylene Glycol 1～3
Suspending agent 0.05～0.1.
Above-mentioned capsule composition, wherein vegetable oil is preferably from soybean oil, Oleum Brassicae campestris or Semen Ricini wet goods.Further preferred vegetable oil is a soybean oil.
Above-mentioned capsule composition, wherein Polyethylene Glycol is preferably PEG400.
Above-mentioned capsule composition, wherein suspending agent selects excellent in Cera Flava, hard paraffin, animal stearic acid, ethyl cellulose, polyvidone or solid polyethylene glycol.
Above-mentioned capsule composition can also further contain antiseptic, and preferred antiseptic is a parabens, as ethylparaben.
Above-mentioned capsule composition wherein preferably contains fibrauretin 5-500 milligram in every soft capsule.
Capsule composition of the present invention, soft capsule rubber preferably is made up of following component and weight ratio:
Gelatin 1
Water 0.8-1.2
Glycerol 0.25-0.45.
Soft capsule of fibrauretine composition steady quality of the present invention was placed six months through accelerated test (relative humidity 75%, 40 ℃), and outward appearance (color and luster, character), disintegration, content have no significant change.Illustrate that capsule composition of the present invention meets drug standard, be fit to clinical use.
Chinese medicine of the present invention is wrapped in the soft capsule with liquid form, therefore can be absorbed rapidly at oral back medicine, and rapid-action, bioavailability is than conventional tablet height.Because the fibrauretin taste is extremely bitter, it is wrapped in the bitterness that can hide itself in the soft capsule on the other hand, makes things convenient for taking of extensive patients.
Be described more specifically the present invention below by embodiment, but these embodiment should not be construed as the restriction to any aspect of the present invention.
The specific embodiment
Embodiment 1
The soybean oil that takes by weighing 100g is put in the rustless steel container, adds the 5g Cera Flava, heat fused.Add fibrauretin 100g after placing room temperature, after stirring.It is standby to measure the cubage loading amount.Be heated with stirring to 70 ℃ in joining of the glycerol glue jar with the water of 10kg and 3kg, add 10kg gelatin stirring and dissolving again to transparence, vacuumizing and defoaming adds the ethylparaben of 13g again, puts to storing container after stirring, and 60 ℃ of insulations are standby.Medicinal liquid is incorporated in the machine of preparation soft capsule, regulates this machine and make the medicinal liquid that injects 0.205g in each soft capsule, preparation contains the soft capsule of fibrauretin liquid in gelatin shell.
Embodiment 2
Composition weight (mg/ grain)
Fibrauretin 100
Ethyl cellulose 10
Oleum Ricini 100
Preparation method is with embodiment 1.
Embodiment 3
Composition weight (mg/ grain)
Fibrauretin 200
Cera Flava 15
Oleum Brassicae campestris 250
Preparation method is with embodiment 1.
Embodiment 4
Composition weight (mg/ grain)
Fibrauretin 200
Hard paraffin 10
Soybean salad oil 250
Preparation method is with embodiment 1.
Embodiment 5
Composition weight (mg/ grain)
Fibrauretin 300
Animal stearic acid 12
Oleum Ricini 300
Preparation method is with embodiment 1.
Embodiment 6
Composition weight (mg/ grain)
Fibrauretin 300
Cera Flava 15
Soybean salad oil 300
Preparation method is with embodiment 1.
Embodiment 7
Composition weight (mg/ grain)
Fibrauretin 100
Macrogol 4000 15
PEG400 100
Preparation method is with embodiment 1.
Embodiment 8
Composition weight (mg/ grain)
Fibrauretin 200
Polyethylene glycol 6000 16
PEG400 250
Preparation method is with embodiment 1.
Embodiment 9
Composition weight (mg/ grain)
Fibrauretin 300
Polyvidone 15
Macrogol 600 400
Preparation method is with embodiment 1.
Embodiment 10
Composition weight (mg/ grain)
Fibrauretin 100
Macrogol 4000 15
PEG400 50
Soybean oil 100
Preparation method is with embodiment 1.
Embodiment 11
Composition weight (m/g grain)
Fibrauretin 200
Cera Flava 16
PEG400 50
Soybean oil 200
Preparation method is with embodiment 1.
Embodiment 12
Composition weight (m/g grain)
Fibrauretin 300
Polyvidone 15
PEG400 150
Oleum Ricini 300
Preparation method is with embodiment 1.
Claims (10)
1, the capsule composition of fibrauretin is made up of soft capsule rubber and the pharmaceutical composition that is wrapped in the rubber, it is characterized in that described pharmaceutical composition mainly contains following component and weight ratio:
Fibrauretin 1
Vegetable oil and/or Polyethylene Glycol 0.5～50
Suspending agent 0～20.
2, the capsule composition of claim 1, wherein the weight ratio of each component is:
Fibrauretin 1
Vegetable oil and/or Polyethylene Glycol 0.5～30
Suspending agent 0.05～10.
3, the capsule composition of claim 2, wherein the weight ratio of each component is:
Fibrauretin 1
Vegetable oil and/or Polyethylene Glycol 1～3
Suspending agent 0.05～0.1.
4, claim 1,2 or 3 capsule composition, wherein vegetable oil is selected from soybean oil, Oleum Brassicae campestris or Oleum Ricini.
5, the capsule composition of claim 4, wherein vegetable oil is a soybean oil.
6, claim 1,2 or 3 capsule composition, wherein Polyethylene Glycol is a PEG400.
7, claim 1,2 or 3 capsule composition, wherein suspending agent is selected from Cera Flava, hard paraffin, animal stearic acid, ethyl cellulose, polyvidone or solid polyethylene glycol.
8, claim 1,2 or 3 capsule composition further contain antiseptic.
9, claim 1,2 or 3 capsule composition wherein contain fibrauretin 5-500 milligram in every soft capsule.
10, the capsule composition of claim 1, wherein soft capsule rubber is made up of following component and weight proportion:
Gelatin 1
Water 0.8-1.2
Glycerol 0.25-0.45.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200510041300 CN1729979A (en) | 2005-08-02 | 2005-08-02 | Soft capsule of fibrauretine composition |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200510041300 CN1729979A (en) | 2005-08-02 | 2005-08-02 | Soft capsule of fibrauretine composition |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN1729979A true CN1729979A (en) | 2006-02-08 |
Family
ID=35962425
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 200510041300 Pending CN1729979A (en) | 2005-08-02 | 2005-08-02 | Soft capsule of fibrauretine composition |
Country Status (1)
| Country | Link |
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| CN (1) | CN1729979A (en) |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103690538A (en) * | 2013-12-03 | 2014-04-02 | 深圳松乐生物科技有限公司 | Traditional Chinese medicine extract and traditional Chinese medicine composition having poultry and livestock mycoplasma resistant activity |
| CN112315937A (en) * | 2020-11-05 | 2021-02-05 | 广东广发制药有限公司 | Fibrauretine soft capsule and preparation method thereof |
-
2005
- 2005-08-02 CN CN 200510041300 patent/CN1729979A/en active Pending
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103690538A (en) * | 2013-12-03 | 2014-04-02 | 深圳松乐生物科技有限公司 | Traditional Chinese medicine extract and traditional Chinese medicine composition having poultry and livestock mycoplasma resistant activity |
| CN103690538B (en) * | 2013-12-03 | 2018-07-13 | 深圳松乐生物科技有限公司 | With the active Chinese medical extract of anti-poultry mycoplasma, Chinese medicine composition |
| CN112315937A (en) * | 2020-11-05 | 2021-02-05 | 广东广发制药有限公司 | Fibrauretine soft capsule and preparation method thereof |
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| C02 | Deemed withdrawal of patent application after publication (patent law 2001) | ||
| WD01 | Invention patent application deemed withdrawn after publication |