CN108992549A - A kind of pharmaceutical composition and preparation method thereof, application - Google Patents
A kind of pharmaceutical composition and preparation method thereof, application Download PDFInfo
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- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/25—Araliaceae (Ginseng family), e.g. ivy, aralia, schefflera or tetrapanax
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- A61K2236/30—Extraction of the material
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- A61K2236/50—Methods involving additional extraction steps
- A61K2236/51—Concentration or drying of the extract, e.g. Lyophilisation, freeze-drying or spray-drying
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Abstract
The present invention relates to field of medicaments, in particular to a kind of pharmaceutical composition and preparation method thereof, application.The raw material of pharmaceutical composition mainly includes following components according to parts by weight: 13-16 parts of Radix Salviae Miltiorrhizae, 2-5 parts of west safflower, 2-5 parts of Radix Notoginseng and 13-16 parts of radix cyathulae.Radix Salviae Miltiorrhizae, west safflower, Radix Notoginseng and the mutual compatibility resolving stagnation for tranquilization of radix cyathulae, activating microcirculation and removing stasis medicinal, decompression.Stabilization is played with systolic pressure, significantly reduces diastolic pressure.And on heart rate without influence.Pharmaceutical composition provided in an embodiment of the present invention can to SHR rat systolic pressure rise stabilization, significantly reduce diastolic pressure, effective dose be 1.83g~3.66g crude drug/kg, and under the dosage on heart rate without influence.Pharmaceutical composition provided in an embodiment of the present invention has the function of reducing blood pressure to SHR rat, and effect is better than Amlodipine Besylate Tablet.
Description
Technical field
The present invention relates to field of medicaments, in particular to a kind of pharmaceutical composition and preparation method thereof, application.
Background technique
Hypertension has become a kind of frequently-occurring disease, and depressor in the prior art has an impact to heart rate after taking, meeting
Cause increased heart rate and blood pressure is caused to increase.
Summary of the invention
The purpose of the present invention is to provide a kind of pharmaceutical compositions and preparation method thereof, application, are intended to improve existing
The problem of depressor can cause increased heart rate after taking.
The present invention provides a kind of technical solution:
A kind of pharmaceutical composition, the raw material of pharmaceutical composition mainly include following components according to parts by weight:
13-16 parts of Radix Salviae Miltiorrhizae, 2-5 parts of west safflower, 2-5 parts of Radix Notoginseng and 13-16 parts of radix cyathulae.
In other embodiments of the invention, above-mentioned raw materials mainly include following components according to parts by weight:
15 parts of Radix Salviae Miltiorrhizae, 3 parts of west safflower, 3 parts of Radix Notoginseng and 15 parts of radix cyathulae.
In other embodiments of the invention, aforementioned pharmaceutical compositions further include pharmaceutically acceptable auxiliary material.
The present invention also provides a kind of technical solutions:
The preparation method of above-mentioned pharmaceutical composition, comprising:
Mixed raw material is extracted twice with the water of 4-5 times of weight of raw material, is mentioned every time 2 hours, merging filtrate, and filter is concentrated under reduced pressure
Liquid at relative density 1-1.2 medicinal extract.
The present invention also provides a kind of technical solutions:
Above-mentioned pharmaceutical composition is in preparing the application in depressor.
In other embodiments of the invention, the dosage of aforementioned pharmaceutical compositions be daily 1.83g-3.66g crude drug/
kg。
In other embodiments of the invention, the dosage of aforementioned pharmaceutical compositions is daily 1.83g crude drug/kg.
In other embodiments of the invention, it is administered once within above-mentioned one day.
In other embodiments of the invention, the administration time of aforementioned pharmaceutical compositions is 21 days.
In other embodiments of the invention, the administration route of aforementioned pharmaceutical compositions is oral.
Pharmaceutical composition provided in an embodiment of the present invention and preparation method thereof, the beneficial effect of application are:
Radix Salviae Miltiorrhizae, west safflower, Radix Notoginseng and the mutual compatibility resolving stagnation for tranquilization of radix cyathulae, activating microcirculation and removing stasis medicinal, decompression.It is risen with systolic pressure
Stabilization significantly reduces diastolic pressure.And on heart rate without influence.
Pharmaceutical composition provided in an embodiment of the present invention can play stabilization to SHR rat systolic pressure, significantly reduce and relax
Pressure, effective dose be 1.83g~3.66g crude drug/kg, and under the dosage on heart rate without influence.It is provided in an embodiment of the present invention
Pharmaceutical composition has the function of reducing blood pressure to SHR rat, and effect is better than Amlodipine Besylate Tablet.
Specific embodiment
It in order to make the object, technical scheme and advantages of the embodiment of the invention clearer, below will be in the embodiment of the present invention
Technical solution be clearly and completely described.The person that is not specified actual conditions in embodiment, according to normal conditions or manufacturer builds
The condition of view carries out.Reagents or instruments used without specified manufacturer is the conventional production that can be obtained by commercially available purchase
Product.
Below in other embodiments of the invention to the embodiment of the present invention, above-mentioned to be specifically described.
A kind of pharmaceutical composition, the raw material of pharmaceutical composition mainly include following components according to parts by weight:
13-16 parts of Radix Salviae Miltiorrhizae, 2-5 parts of west safflower, 2-5 parts of Radix Notoginseng and 13-16 parts of radix cyathulae.
The effect of Radix Salviae Miltiorrhizae has promoting blood circulation, inducing meastruation to relieve menalgia, relieving restlessness and restlessness, cool blood to disappear carbuncle.For chest impediment and cardialgia, stomach duct and abdomen
Hypochondriac pain, the accumulation of lump in the abdomen lump in the abdomen, hot numbness pain, dysphoria and insomnia, irregular menstruation, dysmenorrhea menostasis, sore swell and ache curative.
West safflower has the effect of activating microcirculation and removing stasis medicinal, removing pattogenic heat from the blood and toxic material from the body, resolving stagnation for tranquilization.For menostasis abdominal mass, postpartum stasis, temperature
Malicious macular eruption, melancholy ruffian is bored, and palpitation with fear is gone mad.
Radix Notoginseng dissipating stasis and stanching bleeding, detumescence ding-tong.For spitting blood, haematemesis, bleeding from five sense organs or subcutaneous tissue, hematochezia, metrorrhagia and metrostaxis, traumatic hemorrhage, chest and abdomen shouting pain,
Tumbling and swelling.
Radix cyathulae is sweet in flavor, slight bitter, mild-natured.Dispelling stasis of blood and stimulating the menstrual flow, easing joint movement, inducing diuresis for treating strangurtia.
Radix Salviae Miltiorrhizae, west safflower, Radix Notoginseng and the mutual compatibility resolving stagnation for tranquilization of radix cyathulae, activating microcirculation and removing stasis medicinal, decompression.It is risen with systolic pressure
Stabilization significantly reduces diastolic pressure.And on heart rate without influence.
Further, in the present embodiment, raw material mainly includes following components according to parts by weight: 15 parts of Radix Salviae Miltiorrhizae, west
3 parts of safflower, 3 parts of Radix Notoginseng and 15 parts of radix cyathulae.
Further, in the present embodiment, pharmaceutical composition further includes pharmaceutically acceptable auxiliary material.Such as disintegrating agent,
Preservative, adhesive, antioxidant, lubricant, stabilizer, thickener, emulsifier etc..
The present invention also provides a kind of technical solutions: the preparation method of above-mentioned pharmaceutical composition, comprising:
Mixed raw material is extracted twice with the water of 4-5 times of weight of raw material, is mentioned every time 2 hours, merging filtrate, and filter is concentrated under reduced pressure
Liquid at relative density 1-1.2 medicinal extract.
The preparation process of preparation method provided by the invention is simple, is extracted to the greatest extent to active principle.
The present invention also provides a kind of technical solutions: above-mentioned pharmaceutical composition is in preparing the application in depressor.
Further, the dosage of pharmaceutical composition is daily 1.83g-3.66g crude drug/kg.
In the present embodiment, the dosage of pharmaceutical composition is daily 1.83g crude drug/kg.It is administered once within one day.Medicine group
The administration time for closing object is 21 days.The administration route of pharmaceutical composition is oral.
It should be noted that in other embodiments of the invention, dosage may be daily 2.01 crude drugs/kg,
Other dosage such as 2.55 crude drugs/kg, 3.28 crude drugs/kg, can also be with one day administered twice, three inferior, the administrations of pharmaceutical composition
Approach can also be using injection etc..
Feature and performance of the invention are described in further detail with reference to embodiments.
Embodiment 1
A kind of pharmaceutical composition is present embodiments provided, is mainly made by following steps.
Weigh drug: Radix Salviae Miltiorrhizae 130g, west safflower 20g, Radix Notoginseng 20g and radix cyathulae 130g.
Mixed raw material is extracted twice with the water of 4 times of weight of raw material, is mentioned every time 2 hours, merging filtrate, and filtrate is concentrated under reduced pressure
At the medicinal extract of relative density 1.2.
Embodiment 2
A kind of pharmaceutical composition is present embodiments provided, is mainly made by following steps.
Weigh drug: Radix Salviae Miltiorrhizae 160g, west safflower 50g, Radix Notoginseng 50g and radix cyathulae 160g.
Mixed raw material is extracted twice with the water of 5 times of weight of raw material, is mentioned every time 2 hours, merging filtrate, and filtrate is concentrated under reduced pressure
At the medicinal extract of relative density 1.2.
Embodiment 3
A kind of pharmaceutical composition is present embodiments provided, is mainly made by following steps.
Weigh drug: Radix Salviae Miltiorrhizae 150g, west safflower 30g, Radix Notoginseng 30g and radix cyathulae 150g.
Mixed raw material is extracted twice with the water of 4 times of weight of raw material, is mentioned every time 2 hours, merging filtrate, and filtrate is concentrated under reduced pressure
At the medicinal extract of relative density 1.2.
Comparative example
This comparative example is tested using the pharmaceutical composition that embodiment 3 provides.
Drug: the medicinal extract that embodiment 3 provides, every gram of medicinal extract are equivalent to 1.8000g crude drug.Amlodipine besylate tablets are (blue
Enlightening), source: Yangzijiang Pharmaceutical Group, Shanghai Haini Pharmaceutical Co., Ltd.
The preparation method for the medicinal composition solution that embodiment 3 provides:
For preparing 10mL medical fluid.Weigh respectively embodiment 3 offer pharmaceutical composition (medicinal extract) 1.02g, 2.03g,
4.07g is separately added into suitable pure water, stirs evenly in different beakers, medical fluid is transferred in graduated cylinder respectively, then again
It is added appropriate amount of purified water rinse 2~3 times into beaker, then medical fluid is transferred in graduated cylinder respectively, it is finally again into graduated cylinder plus pure
Water is configured to the medical fluid that concentration is 0.102gmL-1,0.203gmL-1,0.407gmL-1, is used for embodiment 3 to 10mL
The low, middle and high dose groups (hereinafter referred to as low dose group, middle dose group, high dose group) of the pharmaceutical composition of offer;Match before administration
System, i.e., with i.e. use;When administration, magnetic stirrer is used.
The preparation method of reagent solution:
It takes amlodipine besylate tablets (Lan Di) 1 to be placed in a beaker, is added suitable pure water, it, will after stirring and dissolving
Medical fluid is transferred in graduated cylinder, is then added appropriate amount of purified water rinse 2~3 times into beaker again, then medical fluid is transferred in graduated cylinder, most
Add pure water to 100mL into graduated cylinder again afterwards, is configured to the medical fluid that concentration is 0.05mgmL-1, is used for Amlodipine Besylate Tablet
Group;It is prepared before administration, that is, matches and use;When administration, magnetic stirrer is used.
Experimental animal
Wistar rat 12, male and female each 6;SHR rat 54, male and female each 27.Wistar rat 56~63 days;
SHR rat 56~62 days.
The weight of animals range when on-test: ♀ Wistar rat body weight maximum value is 231.2g, weight when experiment starts
Minimum value is 205.3g, Weight averages 214.5g;♂ Wistar rat body weight maximum value is 246.0g, and weight minimum value is
204.5g, Weight averages 227.0g;♀ SHR rat body weight maximum value is 148.4g, and weight minimum value is 129.6g, weight
Average value is 138.9g;♂ SHR rat body weight maximum value is 223.2g, and weight minimum value is 195.6g, and Weight averages are
209.1g;The weight of animals is no more than or lower than the 20% of average weight when experiment starts.
This test sets 6 experimental groups altogether, Normal group, model control group, Amlodipine Besylate Tablet group, low dose group,
Middle dose group, high dose group.It is shown in Table 1.Every group 10, half male and half female.50 SHR for selecting adaptive feeding observation qualified are big
Mouse, half male and half female are grouped by SOP-T-Ad-03 with Excel at random.Be divided into model control group, Amlodipine Besylate Tablet group,
Low dose group, middle dose group, 5 groups of high dose group, are layered SHR rat by gender and mean pressure, 5 every layer, then will
Every layer of SHR rat is randomly assigned to each group, and every group 10, half male and half female.In addition, eliminating two different sexes at random
Wistar rat, 10 Wistar rats for selecting adaptive feeding observation qualified, half male and half female, as Normal group.
1 animal packet of table
The equivalent dose of rat is 3.66gkg-1.The equivalent dose that the dosage of middle dose group uses people's clinic to intend is low
Dosage group dosage is 0.5 times of middle dosage, and high dose group dosage is 2 times of middle dosage.
Amlodipine Besylate Tablet group uses 0.5mgkg-1 Amlodipine Besylate Tablet (relative to people's clinical equivalent dosage).
Normal group and model control group give the pure water of same administered volume.See Table 2 for details.
2 drug of table designs the decompression drug effect test dose of SHR rat
Note: * is the dosage of amlodipine besylate tablets (Lan Di).
By SOP-T-Ad-14 every morning gastric infusion 1 time, order of administration is Normal group, model control group, low dose
Amount group, middle dose group, high dose group, Amlodipine Besylate Tablet group.Administered volume: 10mL/kg.Weekly administration 7 days, while weekly
It is adjusted dosage 1 time according to changes of weight.Successive administration 21 days.It is detected according to index, content and the time in table 3.
Decompression drug effect test observation index, content and time of 3 drug of table to SHR rat
The systolic pressure of each group rat, diastolic pressure, heart rate, weight are carried out statistical processing and illustrated by tabulation, and draw contraction
Pressure, diastolic pressure, changes in heart rate curve.
Systolic pressure, diastolic pressure, heart rate, weight initial data are subjected to Statistics Division using SPSS19.0 statistics analysis software package
It manages and indicates plus or minus standard deviation from the meanMeasurement data meets normal distribution-test and homogeneity test of variance, then into
One-way analysis of variance (LSD inspection) between row each group, does not meet normal distribution and heterogeneity of variance, then carries out Kruskal-
Wallis rank sum test.Systolic pressure, diastolic pressure, heart rate each group of data are compared two-by-two.Each SHR rat body weight is and model
Control group compares.
Experimental result is shown in Table 4, table 5, table 6 and table 7.
Influence of 4 drug of table to the decompression pharmacodynamic test of SHR rat to systolic pressure (mmHg)
Note: * is indicated compared with Normal group, there is statistical difference (P < 0.05);#It indicates compared with model control group,
There is statistical difference (P < 0.05).
Influence of 5 drug of table to the decompression pharmacodynamic test of SHR rat to diastolic pressure (mmHg)
Note: * is indicated compared with Normal group, there is statistical difference (P < 0.05);#It indicates compared with model control group,
There is statistical difference (P < 0.05).
Influence of 6 drug of table to the decompression pharmacodynamic test of SHR rat to heart rate (/min)
Note: * is indicated compared with Normal group, there is statistical difference (P < 0.05).
Influence of 7 drug of table to the decompression pharmacodynamic test of SHR rat to weight (g)
It was found from table 4- table 7:
Systolic pressure: the systolic pressure of each group SHR rat has different ascendant trends.The systolic pressure of each group SHR rat is being given
Before medicine, there is statistical difference (P < 0.05) compared with Normal group within administration 7 days, administration 14 days, administration 21 days.Each administration
Compared with model control group before administration, 7 days, administration 14 days, equal no difference of science of statistics (P is administered in the systolic pressure of group SHR rat
> 0.05).21 days low dose groups and middle dose group are administered compared with model control group, there is statistical difference (P < 0.05).See
Table 4.
By giving the pharmaceutical composition of Amlodipine Besylate Tablet and the offer of embodiment 3 to SHR rat therapeutic intervention 21 days
Afterwards, though failing that SHR rat systolic pressure is made to be restored to normal level, pass through 1.83g crude drug/two agent of kg, 3.66g crude drug/kg
The medicine composite for curing that the embodiment 3 of amount provides, can effectively control the systolic pressure of SHR rat, prevent systolic pressure after of continuing rising
It is high.
Diastolic pressure: in addition to model control group, the diastolic pressure of each group SHR rat is relatively stable, and has different degrees of reduction.
The diastolic pressure of each group SHR rat before administration, administration 7 days, administration 14 days, administration 21 days compared with Normal group, have system
Meter learns difference (P < 0.05).The diastolic pressure of each administration group SHR rat before administration, is administered 7 days, gives compared with model control group
Medicine 14 days, equal no difference of science of statistics (P > 0.05).21 days Amlodipine Besylate Tablet groups, low dose group, middle dose group and mould is administered
Type control group compares, and has statistical difference (P < 0.05).It is shown in Table 5.
By giving the pharmaceutical composition of Amlodipine Besylate Tablet and the offer of embodiment 3 to SHR rat therapeutic intervention 21 days
Afterwards, though failing that SHR rat diastolic pressure is made to be restored to normal level, pass through 0.5mgkg-1Amlodipine Besylate Tablet treatment, energy
The diastolic pressure of enough effectively control SHR rats persistently increases.In addition, passing through 1.83g crude drug/two dosage of kg, 3.66g crude drug/kg
Embodiment 3 provide medicine composite for curing, can be effectively reduced the diastolic pressure of SHR rat, prevent diastolic pressure from continuing to increase.
The pharmaceutical composition that embodiment 3 provides reduces diastolic pressure effect and is better than Amlodipine Besylate Tablet.
Heart rate: the heart rate of each administration group SHR rat before administration, administration 7 days, administration 14 days, administration 21 days with model pair
Compare according to group, equal no difference of science of statistics (P > 0.05).The heart rate of each group SHR rat removes mould compared with Normal group before administration
Other than type control group, the equal no difference of science of statistics of remaining each group (P > 0.05);Administration 7 days, the equal no difference of science of statistics of each group;Administration
14 days, administration 21 days, in addition to model control group, Amlodipine Besylate Tablet group, high dose group, remaining each group is poor without statistics
Different (P > 0.05).It is shown in Table 6.
After the medicine composite for curing provided using 1.83g crude drug/kg and 3.66g crude drug/kg embodiment 3, SHR is big
Mouse heart rate is not significantly affected.When use 0.5mgkg-1The pharmaceutical composition that Amlodipine Besylate Tablet or embodiment 3 provide
Agent amount be greater than 3.66g crude drug/kg, and administration time be greater than 7 days when, then make SHR rat heart rate accelerate.Infer accordingly, works as reality
When applying the pharmaceutical composition taking dose of the offer of example 3 greater than 3.66g crude drug/kg, or increased heart rate can be caused and lead to blood pressure liter
Height, therefore fail to play significant blood pressure lowering drug action.
Weight: each administration group weight in D0, D7, D14, D21 compared with model control group, equal no difference of science of statistics (P >
0.05).It is shown in Table 7.Each administration group SHR rat normally ingests, embodiment 3 provide pharmaceutical composition to SHR rat body weight without
Obvious intervention effect.
General clinical observation: during administration, observe daily each group rat appearance, behavior, spirit, to the reaction of stimulation,
Secretion, excreta etc., it is no abnormal.
Under this experiment condition, by giving the pharmaceutical composition of the offer of embodiment 3 to SHR rat therapeutic intervention 21 days
Afterwards, can to SHR rat systolic pressure rise stabilization, significantly reduce diastolic pressure, effective dose be 1.83g~3.66g crude drug/
Kg, and under the dosage on heart rate without influence.The pharmaceutical composition that embodiment 3 provides has the function of reducing blood pressure to SHR rat,
Effect is better than Amlodipine Besylate Tablet.
The systolic pressure of each rat, diastolic pressure, heart rate, the number for testing weight in each experimental group experimentation of subordinate list 8-11
According to.
Decompression pharmacodynamic test systolic pressure (mmHg) data of 8 SHR rat of table
Decompression pharmacodynamic test diastolic pressure (mmHg) data of 9 SHR rat of table
Decompression pharmacodynamic test heart rate (/min) data of 10 SHR rat of table
Decompression drug effect test body weight (g) data of 11 SHR rat of table
The foregoing is only a preferred embodiment of the present invention, is not intended to restrict the invention, for the skill of this field
For art personnel, the invention may be variously modified and varied.All within the spirits and principles of the present invention, made any to repair
Change, equivalent replacement, improvement etc., should all be included in the protection scope of the present invention.
Claims (10)
1. a kind of pharmaceutical composition, which is characterized in that the raw material of described pharmaceutical composition mainly include according to parts by weight with
Lower component:
13-16 parts of Radix Salviae Miltiorrhizae, 2-5 parts of west safflower, 2-5 parts of Radix Notoginseng and 13-16 parts of radix cyathulae.
2. pharmaceutical composition according to claim 1, which is characterized in that the raw material mainly includes according to parts by weight
Following components:
15 parts of the Radix Salviae Miltiorrhizae, 3 parts of the west safflower, 3 parts of the Radix Notoginseng and 15 parts of the radix cyathulae.
3. pharmaceutical composition according to claim 1, which is characterized in that described pharmaceutical composition further includes that can pharmaceutically connect
The auxiliary material received.
4. the preparation method of pharmaceutical composition as described in any one of claims 1-3 characterized by comprising
The raw material is mixed, is extracted twice, is mentioned every time 2 hours, merging filtrate with the water of 4-5 times of weight of the raw material, is depressurized dense
Contract the filtrate at relative density 1-1.2 medicinal extract.
5. the described in any item pharmaceutical compositions of claim 1-3 are in preparing the application in depressor.
6. application according to claim 5, which is characterized in that the dosage of described pharmaceutical composition is daily 1.83g-
3.66g crude drug/kg.
7. application according to claim 5, which is characterized in that the dosage of described pharmaceutical composition is raw for daily 1.83g
Medicine/kg.
8. application according to claim 5, which is characterized in that be administered once within one day.
9. application according to claim 5, which is characterized in that the administration time of described pharmaceutical composition is 21 days.
10. application according to claim 5, which is characterized in that the administration route of described pharmaceutical composition is oral.
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