CN105012461B - The preparation method of turtle turtle fruit flavones drop pills of reducing blood fat - Google Patents
The preparation method of turtle turtle fruit flavones drop pills of reducing blood fat Download PDFInfo
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- CN105012461B CN105012461B CN201510415641.8A CN201510415641A CN105012461B CN 105012461 B CN105012461 B CN 105012461B CN 201510415641 A CN201510415641 A CN 201510415641A CN 105012461 B CN105012461 B CN 105012461B
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Abstract
The present invention provides a kind of preparation methods of turtle turtle fruit flavones drop pills of reducing blood fat, comprising: the polyethylene glycol for taking 2~5 parts by weight is heated to 65 DEG C~85 DEG C meltings, the turtle turtle fruit extractive of general flavone fine powder of 1 parts by weight is added, mixes well, obtains medical fluid；Medical fluid is moved into pill dripping machine trickle irrigation and is maintained at 65 DEG C~85 DEG C, medical fluid drops in 10 DEG C of condensate liquid, drips speed 40d/min, drop is away from 5~20cm；Dripping pill is finally taken out, ball is wiped, dries.Turtle turtle fruit flavones drop pills of reducing blood fat of the invention, dissolution rapidly in vivo after taking orally, hence it is evident that improve effective component turtle turtle fruit extractive of general flavone solubility in water, dissolution in vitro behavior；Improve stability, internal intestinal absorption and its oral administration biaavailability of turtle turtle fruit extractive of general flavone.
Description
Technical field
The present invention relates to a kind of preparation methods of turtle turtle fruit flavones drop pills of reducing blood fat.
Background technique
Turtle turtle also known as from generation to generation (Citrus aurantium L.vardaidai Tanaka), belongs to Rutaceae citrus subgenus and plants
Object is the mutation of bitter orange, is distributed widely in North Fujian, Sichuan, zhejiang and other places.Bitter citrus immature flower is the medicine that the Ministry of Public Health in 2002 announces
Homologous plant is eaten, turtle turtle has similar effect with Fructus Aurantii, and also referred to as Soviet Union Fructus Aurantii, tcm clinical practice is applied to accumulation of food in the stomach and intes tine due to indigestion, phlegm retention, chest
Abdomen expires the illnesss such as bored distending pain.
With having obtained a kind of Chinese patent authorization, Patent No. CN102058701A Chinese invention patent " turtle turtle fruit
In the preparation method of total flavone valid target ", the method that general flavone is extracted from turtle turtle fruit is disclosed, resulting active component is
Turtle turtle fruit extractive of general flavone.Experimental study shows turtle turtle fruit extractive of general flavone, and rich in flavones ingredient, (general flavone content is steady
Determine > 75%), wherein the content of effective component neohesperidin and aurantiin is greater than 50%, and through pharmacological experiment study, turtle turtle fruit is total
Chromocor extract has good reducing blood lipid, norcholesterol, the effect of oxidation and removing free radicals.
The solubility of turtle turtle fruit extractive of general flavone is smaller, and the membrane permeability of flavanone constituents is poor, cause to
Body gastrointestinal tract absorbs poor after medicine, reduces oral bioavilability, may influence the performance of curative effect of medication.
Summary of the invention
The technical problem to be solved in the present invention is to provide the preparation side of turtle turtle fruit flavones drop pills of reducing blood fat described in one kind
Method.
The present invention is implemented as follows: the preparation method of turtle turtle fruit flavones drop pills of reducing blood fat described in one kind, including following step
It is rapid:
(1) polyethylene glycol for taking 2~5 parts by weight, is heated to 65 DEG C of meltings, and the turtle turtle fruit general flavone that 1 parts by weight are added mentions
Object fine powder is taken, is mixed well, medical fluid is obtained；The molecular weight of the polyethylene glycol is 6000；
(2) medical fluid is moved into pill dripping machine trickle irrigation and is maintained at 65 DEG C, medical fluid drops in 10 DEG C of condensate liquid, drips speed 40d/
Min is dripped away from 10cm；Dripping pill is finally taken out, ball is wiped, dries.
Further, the condensate liquid is quality than atoleine: dimethicone=2:1 atoleine and dimethyl
Silicon oil mixture.
Further, the turtle turtle fruit flavones drop pills of reducing blood fat includes the turtle turtle fruit extractive of general flavone fine powder of 1 parts by weight, 2
The polyethylene glycol of~5 parts by weight；The molecular weight of the polyethylene glycol is 6000.
The present invention has the advantages that turtle turtle fruit flavones drop pills of reducing blood fat, dissolution rapidly in vivo after taking orally, hence it is evident that improve medicine
Imitate ingredient turtle turtle fruit extractive of general flavone solubility in water, dissolution in vitro behavior；Improve the extraction of turtle turtle fruit general flavone
The stability of object, internal intestinal absorption and its oral administration biaavailability.
Detailed description of the invention
The present invention is further illustrated in conjunction with the embodiments with reference to the accompanying drawings.
Fig. 1 is the HPLC characteristic spectrum of turtle turtle fruit extractive of general flavone in the present invention.
Fig. 2 is the HPLC characteristic spectrum of turtle turtle fruit flavones drop pills of reducing blood fat in the present invention.
Fig. 3 is the graph of relation of the accumulation dissolution rate and time of turtle turtle fruit flavones drop pills of reducing blood fat in the present invention.
Wherein, 1, mark 2 is identified, mark 3 distinguishes reference embodiments 1, turtle turtle fruit flavones made from embodiment 2, embodiment 3
Drop pills of reducing blood fat.
Fig. 4 a is bent in the dissolution of different pH value dissolution mediums for aurantiin in turtle turtle fruit flavones drop pills of reducing blood fat in the present invention
Line chart.
Fig. 4 b is that neohesperidin is bent in the dissolution of different pH value dissolution mediums in turtle turtle fruit flavones drop pills of reducing blood fat in the present invention
Line chart.
Fig. 5 is the HPLC characteristic spectrum of turtle turtle fruit flavones drop pills of reducing blood fat different time accumulation dissolution in the present invention.
Fig. 6 is the accumulation dissolution rate of each shared ingredient of turtle turtle fruit flavones drop pills of reducing blood fat composition and effectiveness group and time in the present invention
Graph of relation.
Fig. 7 is the jejunum in rats Heavy metal amount of neohesperidin in the present invention and the graph of relation of time.
Wherein, A is identified, mark B is respectively referred to for new in turtle turtle fruit extractive of general flavone and turtle turtle fruit flavones drop pills of reducing blood fat
Aurantiamarin jejunum in rats Heavy metal curve.
Fig. 8 is the jejunum in rats Heavy metal amount of aurantiin in the present invention and the graph of relation of time.
Wherein, C is identified, mark D is respectively referred to for the shaddock in turtle turtle fruit extractive of general flavone and turtle turtle fruit flavones drop pills of reducing blood fat
Skin glycosides jejunum in rats Heavy metal curve.
Specific embodiment
A kind of turtle turtle fruit flavones drop pills of reducing blood fat, turtle turtle fruit extractive of general flavone, 2~5 parts by weight including 1 parts by weight gather
Ethylene glycol.The molecular weight of the polyethylene glycol be 6000 or 4000, or both mixture.
The preparation method of the turtle turtle fruit flavones drop pills of reducing blood fat, comprising the following steps:
(1) polyethylene glycol for taking 2~5 parts by weight, is heated to 65 DEG C~85 DEG C meltings, and the turtle turtle fruit that 1 parts by weight are added is total
Chromocor extract fine powder, mixes well, and obtains medical fluid；
Wherein, in embodiment 1, polyethylene glycol (PEG6000:PEG4000=1:1) is 5 parts by weight, heats 85 DEG C；Implement
In example 2, polyethylene glycol (PEG6000) is 4 parts by weight, heats 65 DEG C；In embodiment 3, polyethylene glycol (PEG4000) is 2 weight
Part, heat 75 DEG C；
(2) medical fluid is moved into pill dripping machine trickle irrigation and is maintained at 65 DEG C~85 DEG C, medical fluid drops in 10 DEG C of condensate liquid, drop speed
40d/min is dripped away from 5~20cm；Dripping pill is finally taken out, ball is wiped, dries.The condensate liquid is quality than atoleine: dimethyl
Silicone oil=2:1 atoleine and simethicone mixture.Wherein, in embodiment 1, pill dripping machine is maintained at 65 DEG C, drop away from
5cm；In embodiment 2, pill dripping machine is maintained at 75 DEG C, drips away from 10cm；In embodiment 3, pill dripping machine is maintained at 85 DEG C, drips away from 20cm.
The indices of turtle turtle fruit flavones drop pills of reducing blood fat made from above-described embodiment are as shown in table 1:
1 verification test result (n=3) of table
Investigate turtle turtle fruit flavones drop pills of reducing blood fat preparation process composition and effectiveness mobility
It is total to be investigated by similarity evaluation for turtle turtle fruit based on turtle turtle fruit flavones drop pills of reducing blood fat HPLC characteristic spectrum (see Fig. 2)
Flavones lipid-loweringing extract is in the overall mobility that turtle turtle fruit flavones drop pills of reducing blood fat process composition and effectiveness group is made, it is ensured that Chinese medicine is effective
The component group quality of parts formulation is stablized.
Fig. 1 and Fig. 2 are please referred to, the evaluation of the overall mobility of turtle turtle fruit flavones drop pills of reducing blood fat composition and effectiveness shows to be based on
Characteristic spectrum, the overall mobility of follow-up evaluation turtle turtle fruit flavones drop pills of reducing blood fat preparation process composition and effectiveness group.Turtle turtle fruit is always yellow
Ketone lipid-loweringing extract and turtle turtle fruit flavones drop pills of reducing blood fat respectively detect 9 shared peaks；Parallel relatively extract, End Product characteristics respectively
Each corresponding shared peak area and Relative quantification analysis is carried out in map, turtle turtle fruit flavones drop pills of reducing blood fat and raw material turtle turtle fruit
Each test solution concentration of general flavone lipid-loweringing extract is equivalent to 0.1mgmL-1, then calculate turtle turtle fruit general flavone lipid-loweringing
Extract, which feeds intake, is made the mobility of the composition and effectiveness group of dripping pill.The experimental results showed that new orange in turtle turtle fruit flavones drop pills of reducing blood fat
The mobility of skin glycosides and aurantiin is respectively 96.56% and 96.36%, the results are shown in Table 2.
2 turtle turtle fruit flavones drop pills of reducing blood fat preparation process of table shares peak area mobility based on the composition and effectiveness group of characteristic spectrum
Note: each effective component mobility of turtle turtle fruit flavones drop pills of reducing blood fat=(each ingredient conversion of turtle turtle fruit flavones drop pills of reducing blood fat
Each ingredient of peak area/raw material turtle turtle fruit general flavone lipid-loweringing extract converts peak area) × 100%
The similarity analysis of turtle turtle fruit general flavone lipid-loweringing extract and turtle turtle fruit flavones drop pills of reducing blood fat composition and effectiveness group migration
Show with 18.0 software of SPSS, respectively to six batches of turtle turtle fruit general flavone lipid-loweringing extracts and turtle turtle fruit flavones drop pills of reducing blood fat
The conversion peak area at 9 shared peaks carries out linear regression analysis, using Pearson correlation coefficient evaluation result, differentiates raw material turtle
Turtle fruit general flavone lipid-loweringing extract prepares the reservation situation of each composition and effectiveness of turtle turtle fruit flavones drop pills of reducing blood fat process.Experimental result table
Bright, linear regression Pearson correlation coefficient is shown as 1.000 (level 0.01, two-sided tests), and migration similarity is 1.000, mentions
Show the rate of transform of drug effect component group and migration similarity in turtle turtle fruit general flavone lipid-loweringing extract and turtle turtle fruit flavones drop pills of reducing blood fat
It is high, symbolize the composition and effectiveness group that dripping pill integrally remains extract.Composition and effectiveness in six batches of turtle turtle fruit flavones drop pills of reducing blood fat
Group's migration similarity evaluation the results are shown in Table 3, HPLC characteristic spectrum and see Fig. 1 and Fig. 2.
3 six batches of sample characteristic spectrum entirety drug effect component groups of table migrate similarity evaluation result
Under normal circumstances, blood circulation, certain blood medicine to be achieved must be first absorbed into after oral solid formulation administration
After concentration, the drug effect of preparation can work.The dissolution situation of drug directly affects the curative effect of drug, dissolution in vitro characteristic
It is one of the bioavilability index for evaluating oral drugs.To characterize turtle turtle fruit flavones drop pills of reducing blood fat active component composition and effectiveness group
Whole dissolved corrosion, research establish based on general flavone content in turtle turtle fruit flavones drop pills of reducing blood fat and combine HPLC method measure
Active component content investigates drug in four kinds of different pH value dissolutions with HPLC characteristic spectrum, simulated in vivo environment of the present invention is compared
The In Vitro Dissolution behavior of medium, concrete outcome are shown in Table 4, table 5, Fig. 3, Fig. 4 a, Fig. 4 b, Fig. 5.
By table 4 as it can be seen that in 20min, the dissolution rate of the general flavone in turtle turtle fruit flavones drop pills of reducing blood fat is up to 90%.Fig. 4
Show that turtle turtle fruit flavones drop pills of reducing blood fat produced by the present invention is a kind of quick-acting Chinese traditional medicine pill of non-pH-dependent.
Dissolution rate is accumulated when general flavone 20min in 4 turtle turtle fruit flavones drop pills of reducing blood fat of table
The whole drug release feature of turtle turtle fruit flavones drop pills of reducing blood fat component group based on HPLC characteristic spectrum is evaluated
1~No. 9 shared peak in the HPLC characteristic spectrum of turtle turtle fruit flavones drop pills of reducing blood fat is chosen, peak area is recorded, is calculated
The accumulation dissolution rate of different time sampling；Simultaneously using similarity estimate in turtle turtle fruit flavones drop pills of reducing blood fat HPLC characteristic spectrum
9 shared peaks carry out similarity evaluation.The experimental results showed that 9 shared peaks of turtle turtle fruit flavones drop pills of reducing blood fat composition and effectiveness group
Similar factors are all larger than 50, and feature effective component aurantiin is 94.86 to the similar factors of neohesperidin, prompt the Chinese materia medica preparation
Active component component group dissolution curve is similar, realizes synchronous release substantially, the results are shown in Table 5, Fig. 5, Fig. 6.Wherein, in Fig. 6
Mark 1,2,3,4,5,6,7,8,9 refer respectively to ingredient 1, ingredient 2 (aurantiin), ingredient 3, ingredient 4 (neohesperidin), ingredient 5,
Ingredient 6, ingredient 7, ingredient 8, ingredient 9.
The similar factors evaluation result of 9 shared peak ingredients in 5 turtle turtle fruit flavones drop pills of reducing blood fat HPLC characteristic spectrum of table
Turtle turtle fruit extractive of general flavone bulk pharmaceutical chemicals are investigated with ultra performance liquid chromatography-mass spectrometric hyphenated technique and turtle turtle fruit is yellow
For ketone drop pills of reducing blood fat in the absorption characteristic of rat small intestine, concrete outcome is shown in Table 6, Fig. 7.
As shown in Table 6, under same dose, neohesperidin in the turtle turtle fruit flavones drop pills of reducing blood fat 90min in jejunum in rats
Heavy metal amount be 12.00 ± 0.12, be the 1.6 of 9.52 ± 0.05 of the neohesperidin in turtle turtle fruit extractive of general flavone
Times；Equally, the Heavy metal amount of 90min in jejunum in rats of the aurantiin in turtle turtle fruit flavones drop pills of reducing blood fat is that turtle turtle fruit is always yellow
1.5 times of ketone extract.It can be seen that from Fig. 7 and Fig. 8, turtle turtle fruit flavones drop pills of reducing blood fat produced by the present invention is remarkably improved turtle turtle
The intestinal absorption of effective component neohesperidin and aurantiin in fruit extractive of general flavone.
In 6 intestines capsule of table after neohesperidin and aurantiin 90min Heavy metal amount (N=3)
Bioavilability refers to that drug is absorbed by organisms the relative quantity and rate into body circulation, is to measure different preparation agent
One important indicator of type curative effect, bioavilability are divided into absolute bioavailability and relative bioavailability again.Herein by
Bioavilability experiment, investigation compare oral administration turtle turtle fruit flavones drop pills of reducing blood fat and turtle turtle fruit extractive of general flavone bulk pharmaceutical chemicals
Pharmacokinetic parameter.It is by table 7-8 it is found that yellow by gastric infusion turtle turtle fruit general flavone lipid-loweringing extract respectively, turtle turtle fruit
After ketone drop pills of reducing blood fat, the maximum plasma concentration C of neohesperidinmaxRespectively (1.68 ± 0.02) and (5.54 ± 0.09), aurantiin
Maximum plasma concentration CmaxRespectively (1.50 ± 0.05) and (4.83 ± 0.10)；The half-life period t of neohesperidin1/2Respectively
(9.00 ± 0.38) and (3.91 ± 0.10), the half-life period t of aurantiin1/2Respectively (9.97 ± 0.84) and (4.19 ± 0.27)；
The C of turtle turtle fruit flavones drop pills of reducing blood fatmaxHigher than turtle turtle fruit general flavone lipid-loweringing extract (P < 0.05), compared to turtle turtle fruit general flavone
The pharmacokinetic parameter of lipid-loweringing extract bulk pharmaceutical chemicals, is made the C of neohesperidin and aurantiin after dripping pillmax、AUC0-24、AUC0-∞
It significantly improves, t1/2Shorten with MRT；The relative bioavailability of neohesperidin and aurantiin point in turtle turtle fruit flavones drop pills of reducing blood fat
Indescribably a height of 278.52% and 258.59%.According to the experimental results, turtle turtle fruit is made in turtle turtle fruit general flavone lipid-loweringing extract
After flavones drop pills of reducing blood fat, feature effective component neohesperidin and aurantiin in turtle turtle fruit general flavone lipid-loweringing extract can be significantly improved
Blood concentration, hence it is evident that improve the oral administration biaavailability of effective component.
Table 7 be administered orally extract, after dripping pill the main pharmacokinetic parameters of neohesperidin compare (n=6,)
Extract is administered orally in table 8, after dripping pill after aurantiin main pharmacokinetic parameters compare (n=6,)
With in the prior art, other traditional Chinese medicine preparation products are made as bulk pharmaceutical chemicals using turtle turtle fruit extractive of general flavone and are compared, this
Invention is the fusion method using solid dispersion method, i.e., after melting polyethylene glycol, turtle turtle fruit extractive of general flavone fine powder is added, leads to
Dropper is crossed to instill in not miscible condensate liquid, since the effect of surface tension makes droplet retracts glomeration, and cooled and solidified and
At dripping pill；The solubility for increasing insoluble drug using water-soluble base, accelerates the dissolution rate of drug, while but also with solid
The advantages that preparation increases medicine stability, extends Chinese medicine period of storage, reduces gastrointestinal irritation, convenient to take.In short, this hair
Bright turtle turtle fruit flavones drop pills of reducing blood fat obtained improves effective component turtle turtle fruit extractive of general flavone solubility in water, body
Outer dissolution rate and internal intestinal absorption, improve oral administration biaavailability.
Claims (2)
1. a kind of preparation method of turtle turtle fruit flavones drop pills of reducing blood fat, it is characterised in that: the following steps are included:
(1) polyethylene glycol for taking 2~5 parts by weight is heated to 65 DEG C of meltings, the turtle turtle fruit extractive of general flavone of 1 parts by weight is added
Fine powder mixes well, and obtains medical fluid；The molecular weight of the polyethylene glycol is 6000；
(2) medical fluid is moved into pill dripping machine trickle irrigation and is maintained at 65 DEG C, medical fluid drops in 10 DEG C of condensate liquid, drips speed 40d/min, drips
Away from 10cm；Dripping pill is finally taken out, ball is wiped, dries；The condensate liquid is quality than atoleine: dimethicone=2:1 liquid
Body paraffin and simethicone mixture.
2. the preparation method of turtle turtle fruit flavones drop pills of reducing blood fat as described in claim 1, it is characterised in that: the turtle turtle fruit flavones
Drop pills of reducing blood fat, the polyethylene glycol of turtle turtle fruit extractive of general flavone fine powder, 2~5 parts by weight including 1 parts by weight；The poly- second two
The molecular weight of alcohol is 6000.
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Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102058701A (en) * | 2010-11-23 | 2011-05-18 | 福建中医药大学 | Method for preparing flavonoid effective part of dai-dai fruit |
| CN102552491A (en) * | 2012-01-11 | 2012-07-11 | 福建中医药大学 | Dai-dai fruit total flavonoid self-microemulsion micro pill and preparation method thereof |
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2015
- 2015-07-16 CN CN201510415641.8A patent/CN105012461B/en active Active
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102058701A (en) * | 2010-11-23 | 2011-05-18 | 福建中医药大学 | Method for preparing flavonoid effective part of dai-dai fruit |
| CN102552491A (en) * | 2012-01-11 | 2012-07-11 | 福建中医药大学 | Dai-dai fruit total flavonoid self-microemulsion micro pill and preparation method thereof |
Non-Patent Citations (2)
| Title |
|---|
| 玳玳果滴丸的制备工艺优选;邱红鑫等;《中国医院药学杂志》;20111231;第31卷(第05期);357-361 |
| 玳玳果黄酮滴丸对高脂血症大鼠的降血脂作用研究;邱红鑫等;《中国现代应用药学》;20111231;第28卷(第07期);597-601 |
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