CN107137412A - Otoginsenoside oral fat breast and preparation method thereof - Google Patents
Otoginsenoside oral fat breast and preparation method thereof Download PDFInfo
- Publication number
- CN107137412A CN107137412A CN201710212956.1A CN201710212956A CN107137412A CN 107137412 A CN107137412 A CN 107137412A CN 201710212956 A CN201710212956 A CN 201710212956A CN 107137412 A CN107137412 A CN 107137412A
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- CN
- China
- Prior art keywords
- otoginsenoside
- oral fat
- aescinate
- fat breast
- oral
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- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/7028—Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages
- A61K31/7034—Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages attached to a carbocyclic compound, e.g. phloridzin
- A61K31/704—Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages attached to a carbocyclic compound, e.g. phloridzin attached to a condensed carbocyclic ring system, e.g. sennosides, thiocolchicosides, escin, daunorubicin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/44—Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/10—Dispersions; Emulsions
- A61K9/107—Emulsions ; Emulsion preconcentrates; Micelles
Abstract
The invention discloses a kind of otoginsenoside oral fat breast, it is made up of the composition of following weight proportion：Aescinate A 0.1~0.2%, Aescinate B 0.02~0.08%, vegetable oil 10~30%, phosphatidase 0 .8~1.5%, oleic acid 0.1~0.5%, poloxamer 1.5~2.5%, glycerine 2~3%, EDTA 2Na 0.05~0.2%, essence 0.01~0.1%, citrate buffer 65~80%.Otoginsenoside oral fat disclosed by the invention is newborn compared with existing Sodium Aescinate piece, better efficacy, and faster, and gastrointestinal side effect is few for action speed, and security is more preferable.
Description
Technical field
The invention belongs to pharmaceutical field, and in particular to a kind of otoginsenoside oral fat breast and preparation method thereof.
Background technology
Otoginsenoside be also known as otoginsenoside acid, be from Hippocastanaceae buckeye seed extract obtain total saposins,
The general name of β-otoginsenoside or different otoginsenoside etc., belongs to triterpene saponin.The water solubility of otoginsenoside is poor, to increase it
Solubility, is often made into sodium salt, and research has shown that, the higher composition of content is Aescinate A, B, C, D in Sodium Aescinate.Seven
Leaf saponin(e sodium can reduce pathologic capillary permeability and increase, and increase intravenous tension, reduce Inflammatory substances and ooze out, with anti-
The effects such as inflammation, detumescence, analgesic, improvement blood circulation, the recovery of promotion acute and closed soft tissue injury.
Using injection or the administration of oral approach more than Sodium Aescinate, when using drug administration by injection, Sodium Aescinate has
Stronger blood vessel irritation, also with stronger renal toxicity, easily causes acute renal failure；When using being administered orally, seven
Leaf saponin(e sodium stimulating gastrointestinal road, often occurs the gastrointestinal side effects such as nausea and vomiting, anorexia, abdominal pain and distension.
The Sodium Aescinate being administered orally at present only has tablet, and oral Sodium Aescinate piece can reduce vasopermeability, right
It is impervious go out, so as to reduce venous hyperemia, mitigate swollen tissue, soft tissue swells caused by being clinically usually used in treatment a variety of causes
The diseases such as swollen, venous edema.
The content of the invention
The purpose of the present invention is asked for existing Sodium Aescinate oral formulations gastrointestinal side effect is big, curative effect is not good enough etc.
There is provided a kind of otoginsenoside oral fat breast and preparation method thereof for topic.
The otoginsenoside oral fat breast that the present invention is provided, it is made up of the composition of following weight proportion：
Preferably, the weight proportion of each composition is：
Preferably, the vegetable oil is soybean oil.
Preferably, the phosphatide is egg yolk lecithin.
Preferably, the pH of the citrate buffer is 5.5~6.5.
The present invention further provides the preparation method of otoginsenoside oral fat breast, it comprises the following steps：
1) under nitrogen protection, Aescinate A, Aescinate B, vegetable oil and phosphatide are added in oil phase tank, are heated to
55~65 DEG C, stirring are until dissolving forms oil phase；
2) glycerine, oleic acid, poloxamer, EDTA-2Na, essence are added in citrate buffer, it is heated to 55~
65 DEG C, stirring are until dissolving forms aqueous phase；
3) under nitrogen protection, oil phase is slowly added in intensively stirred aqueous phase, 2000~4000rpm/min speed
Stirring forms colostrum；
4) colostrum is transferred in high pressure homogenizer, homogeneous 3~6 times under 500~1000bar pressure；
5) nitrogen charging is filling, pressure sterilizing, produces.
The beneficial effects of the invention are as follows：
1) present invention provide otoginsenoside oral fat breast is only made up of Aescinate A, B two kinds of active components, with by
The Sodium Aescinate of Multiple components composition is compared, and definitely, quality is more controllable for composition；
2) the newborn stability of the otoginsenoside oral fat that the present invention is provided is good, and Storage period is long, will not be layered, be demulsified,
The phenomenons such as floating oil；
3) the otoginsenoside oral fat that the present invention is provided is newborn compared with existing Sodium Aescinate piece, and better efficacy rises
Imitate speed faster；
4) the otoginsenoside oral fat that the present invention is provided is newborn compared with existing Sodium Aescinate piece, and intestines and stomach are bad anti-
It should lack, security is more preferable.
Embodiment
The present invention is described in detail with reference to embodiments.
Embodiment 1
Composition：
Preparation technology：1) under nitrogen protection, Aescinate A, Aescinate B, soybean oil and egg yolk lecithin are added
In oil phase tank, 60 DEG C, stirring are heated to until dissolving forms oil phase；
2) glycerine, oleic acid, PLURONICS F87, EDTA-2Na, orange essence are added into the citrate that pH is 6.2 to delay
In fliud flushing, 60 DEG C, stirring are heated to until dissolving forms aqueous phase；
3) under nitrogen protection, oil phase is slowly added in intensively stirred aqueous phase, 3000rpm/min speed stirring shape
Into colostrum；
4) colostrum is transferred in high pressure homogenizer, homogeneous 6 times under 800bar pressure；
5) nitrogen charging is filling, 121 DEG C of pressure sterilizing 15min, produces.
Embodiment 2
Composition：
Preparation method：1) under nitrogen protection, Aescinate A, Aescinate B, soybean oil and egg yolk lecithin are added
In oil phase tank, 55 DEG C, stirring are heated to until dissolving forms oil phase；
2) glycerine, oleic acid, PLURONICS F87, EDTA-2Na, orange essence are added into the citrate that pH is 5.5 to delay
In fliud flushing, 55 DEG C, stirring are heated to until dissolving forms aqueous phase；
3) under nitrogen protection, oil phase is slowly added in intensively stirred aqueous phase, 2000rpm/min speed stirring shape
Into colostrum；
4) colostrum is transferred in high pressure homogenizer, homogeneous 3 times under 1000bar pressure；
5) nitrogen charging is filling, 121 DEG C of pressure sterilizing 15min, produces.
Embodiment 3
Composition：
Preparation method：1) under nitrogen protection, Aescinate A, Aescinate B, soybean oil and egg yolk lecithin are added
In oil phase tank, 65 DEG C, stirring are heated to until dissolving forms oil phase；
2) glycerine, oleic acid, PLURONICS F87, EDTA-2Na, orange essence are added into the citrate that pH is 6.5 to delay
In fliud flushing, 65 DEG C, stirring are heated to until dissolving forms aqueous phase；
3) under nitrogen protection, oil phase is slowly added in intensively stirred aqueous phase, 4000rpm/min speed stirring shape
Into colostrum；
4) colostrum is transferred in high pressure homogenizer, homogeneous 6 times under 500bar pressure；
5) nitrogen charging is filling, 121 DEG C of pressure sterilizing 15min, produces.
The stability test of the oral fat of test example 1 breast
By the otoginsenoside oral fat breast of preparation, it is put under 40 DEG C, 60 DEG C and intense light conditions, is taken in 5 days, 10 days respectively
Go out to determine its pH value, particle diameter, current potential, content and relevant material.Simultaneously as -20 DEG C of multigelations three times, pH value, grain are determined
Footpath, current potential.As a result it see the table below：
The stability test measurement result of table 1
Remarks：Frozen-thaw process, substantially without influence, is not detected on the content and impurity of medicine during stability.
From upper table measurement result, otoginsenoside oral fat emulsion particle diameter and zeta current potentials at 0 day, 5 days, 10 days and
Had almost no change under Freezing-Melting Condition；Particle diameter is also basically unchanged in 10 days in influence factor, is increased slightly under Freezing-Melting Condition；It is main
Medicine composition A and B content are on a declining curve under 40 DEG C, 60 DEG C of influence factor 10 days and intense light conditions, and relevant material has
Increased, point out us said preparation to be suitable for shading and Cord blood.In terms of measurement result, the content of embodiment 2 and 3 declines, had
Close material to increase substantially, and part floating oil phenomenon occur；In addition the high temperature of embodiment 3, which is placed, there is lamination in 10 days.
The curative effect and adverse reaction rate of soft tissue swelling after the oral fat of test example 2 breast treatment fracture
Limbs soft tissue swelling patient after 60 are fractured, is randomly divided into test group and control group, every group 30.Swelling point
Level standard：Slightly, more normal skin turgor, but dermatoglyph remains, ruler method and strong side contrast swelling centre-height≤0.5cm；
Moderate, skin turgor centre-height is 0.5~lcm, and dermatoglyph disappears, but blister；Severe, skin severe swelling, centre-height>
, there is bubble in 1cm.Man 21, female 9 in treatment group；Year at age 18~56 (33.6 ± 11.3)；Swelling degree：Slight 7,
Moderate 18, severe 5.Man 19, female 11 in test group；Year at age 19~58 (31.54 ± 10.8)；Swelling degree：Gently
Degree 7, moderate 15, severe 8.All patients have obvious trauma history, are gone to a doctor after wound in 3d, without obvious intestines and stomach
It is uncomfortable.Two groups of sexes, age and swelling degree compare, no significant difference (P>0.05), with comparativity.
Treatment method：Two groups using lying up, lifting affected limb, analgesic, the supportive treatment of suiting the medicine to the illness such as cold/hot dressing.Test group
Fat Emulsion 15ml in oral embodiment 1, early, late each 1 time, the oral Sodium Aescinate piece of control group, early, late each 1 (30mg),
Totally 7 days.Respectively at the 3rd, 7 days statistics, two groups of curative effects, the results are shown in Table 2 and table 3.
Two groups of Comparison of therapeutic n (%) of table 23 day
| Group | n | It is effective | Effectively | It is invalid | Total effective rate |
| Test group | 30 | 6 | 18 | 6 | 80.0 |
| Control group | 30 | 5 | 11 | 14 | 53.3 |
Two groups of Comparison of therapeutic n (%) of table 37 day
| Group | n | It is effective | Effectively | It is invalid | Total effective rate |
| Test group | 30 | 8 | 18 | 4 | 86.6 |
| Control group | 30 | 7 | 18 | 5 | 83.3 |
As can be seen from the above results, 3 days two groups of curative effects have significant difference (P<0.05), 7 days two groups of Different therapeutical effects are not
Greatly, show action speed of the present invention faster, simultaneously because the total effective rate of test group is higher than control group, illustrate the present invention than existing
Sodium Aescinate piece better efficacy.
Observe gastrointestinal symptom after two groups of treatments 7 days, by gastrointestinal side effect symptom be divided into without, it is light, in, weigh 4 grades (see
Table 4), evaluated by two doctors, wherein academic title doctor must be cured mainly or more including one, take academic title high when a discrepancy exists
Doctor's opinion, the results are shown in Table 5.
The gastrointestinal side effect Symptomatic classification of table 4
Gastrointestinal side effect incidence after 5 two groups of treatments of table
As can be seen from the above results, the control group abdominal distension adverse reaction rate that Sodium Aescinate piece is treated is used for (6
+ 3+0)/30=30%；Stool abnormity adverse reaction rate is 43.3%；Adverse reaction rate of suffering from abdominal pain is 70%, and nausea is vomitted
It is 40% to tell adverse reaction rate, and anorexia adverse reaction rate is 50%.And use the treatment of the Fat Emulsion of embodiment 1
Each adverse reaction rate is respectively 16.7%, 30%, 43.3%, 23.3%, 40%, significantly lower than control group.Illustrate this
Invention has more preferable security than existing Sodium Aescinate piece.
Claims (6)
1. a kind of otoginsenoside oral fat breast, it is characterised in that be made up of the composition of following weight proportion：
2. otoginsenoside oral fat breast as claimed in claim 1, it is characterised in that be made up of the composition of following weight proportion：
3. otoginsenoside oral fat breast as claimed in claim 1, it is characterised in that：The vegetable oil is soybean oil.
4. otoginsenoside oral fat breast as claimed in claim 1, it is characterised in that：The phosphatide is egg yolk lecithin.
5. otoginsenoside oral fat breast as claimed in claim 1, it is characterised in that：The pH of the citrate buffer is
5.5~6.5.
6. the preparation method of the otoginsenoside oral fat breast as described in Claims 1 to 5 any one, it is characterised in that including
Following steps：
1) under nitrogen protection, vegetable oil and phosphatide are added in oil phase tank, 55~65 DEG C, stirring are heated to until dissolving is formed
Oil phase；
2) Aescinate A, Aescinate B, glycerine, oleic acid, poloxamer, EDTA-2Na, essence are added into citrate to delay
In fliud flushing, 55~65 DEG C, stirring are heated to until dissolving forms aqueous phase；
3) under nitrogen protection, oil phase is slowly added in intensively stirred aqueous phase, 2000~4000rpm/min speed stirring
Form colostrum；
4) colostrum is transferred in high pressure homogenizer, homogeneous 3~6 times under 500~1000bar pressure；
5) nitrogen charging is filling, pressure sterilizing, produces.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201710212956.1A CN107137412A (en) | 2017-04-01 | 2017-04-01 | Otoginsenoside oral fat breast and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201710212956.1A CN107137412A (en) | 2017-04-01 | 2017-04-01 | Otoginsenoside oral fat breast and preparation method thereof |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN107137412A true CN107137412A (en) | 2017-09-08 |
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ID=59784010
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201710212956.1A Pending CN107137412A (en) | 2017-04-01 | 2017-04-01 | Otoginsenoside oral fat breast and preparation method thereof |
Country Status (1)
| Country | Link |
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Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101084911A (en) * | 2006-06-08 | 2007-12-12 | 中国科学院上海药物研究所 | Notoginsenoside sodium freezing-dried emulsion and preparation method thereof |
| CN102793664A (en) * | 2012-09-13 | 2012-11-28 | 太极集团有限公司 | Sodium aescinate micro-emulsification injection and preparation method thereof |
| CN104873469A (en) * | 2015-06-04 | 2015-09-02 | 武汉爱民制药有限公司 | Preparation method for sodium aescinate freeze-dried emulsion for injection |
-
2017
- 2017-04-01 CN CN201710212956.1A patent/CN107137412A/en active Pending
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101084911A (en) * | 2006-06-08 | 2007-12-12 | 中国科学院上海药物研究所 | Notoginsenoside sodium freezing-dried emulsion and preparation method thereof |
| CN102793664A (en) * | 2012-09-13 | 2012-11-28 | 太极集团有限公司 | Sodium aescinate micro-emulsification injection and preparation method thereof |
| CN104873469A (en) * | 2015-06-04 | 2015-09-02 | 武汉爱民制药有限公司 | Preparation method for sodium aescinate freeze-dried emulsion for injection |
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| PB01 | Publication | ||
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| RJ01 | Rejection of invention patent application after publication |
Application publication date: 20170908 |
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| RJ01 | Rejection of invention patent application after publication |