Traditional Chinese medicine composition, and preparation method therefor and use thereof
Provided are a traditional Chinese medicine composition, a preparation method therefor, and use thereof, the following in percentage by mass: 0.214% or above of gallic acid, 0.008% or above of 4-hydroxybenzoic acid, 0.083% or above of oxypaeoniflorin, 1.112% or above of paeoniflorin, 0.010% or above of ethyl gallate, 0.155% or above of 1,2,3,4,6-O-pentagalloylglucose, 0.041% or above of benzoic acid, 0.015% or above of cinnamic acid, 0.093% or above of benzoyl paeoniflorin, 0.037% or The traditional Chinese medicine composition can alleviate dysmenorrhea.
1 . A medicine composition, in a dosage form and therapeutically-effective amounts for the treatment or improvement of dysmenorrhea or a condition characterized thereby, the composition comprising active ingredients derived from Cinnamomi ramulus, Poria cocos, Moutan cortex, Persicae semen , and Paeoniae radix alba , quantified in mass percentages, the active ingredients comprising, by weight of the medicine composition:
0.433-0.740 parts by weight of gallic acid,
0.011-0.054 parts by weight of p-hydroxybenzoic acid,
0.097-0.201 parts by weight of oxidized paeoniflorin,
1.235-1.991 parts by weight of paeoniflorin,
0.012-0.094 parts by weight of ethyl gallate,
0.294-0.702 parts by weight of 1,2,3,4,6-O-penta-galloylglucose,
0.045-0.135 parts by weight of benzoic acid,
0.021-0.062 parts by weight of cinnamic acid,
0.101-0.236 parts by weight of benzoylpaeoniflorin,
0.045-0.511 parts by weight of cinnamaldehyde,
0.728-1.202 parts by weight of paeonol,
1.114-1.492 parts by weight of amygdalin,
1.851-3.702 parts by weight of water-soluble polysaccharides,
30.198-40.206 parts by weight of alkali-soluble polysaccharides, and
9.966-15.438 parts by weight of monosaccharides and disaccharides.
2 . The medicine composition according to claim 1 , wherein the dosage form is selected from the group consisting of a tablet, capsule, pill, granule, powder, and pellet.
3 . A medicine composition according to claim 1 , wherein composition is obtainable by a method comprising:
weighing raw medicinal materials including Cinnamomi ramulus, Poria cocos, Moutan cortex, Persicae semen , and Paeoniae radix alba;
wherein 80% of the amount of Poria cocos is powdered; and
wherein the Moutan cortex is steam-distilled with water vapor to collect the distillate, from which volatile components are separated and set aside; wherein the residue thereof, along with the Cinnamomi ramulus, Paeoniae radix alba, Persicae semen and the remaining 20% of the amount Poria cocos , is extracted twice with 90% ethanol and the ethanolic extracts combined;
wherein ethanol is removed from the combined extracts by evaporation, and the resulting residue is further extracted twice with water and the aqueous filtrates combined, concentrated under reduced pressure, and mixed with finely powdered Poria cocos and the volatile components of Moutan cortex.
4 . The medicine composition according to claim 3 , wherein, the HPLC chromatogram fingerprint characteristics of the raw materials comprise:
(A) Cinnamomi ramulus having the following characteristics:
Peak
Relative Retention Times
Relative Peak Areas
1
0.594-0.726
0.020-0.065
2
0.685-0.837
3
0.762-0.932
0.025-0.170
4
0.865-0.990
S
1.000
1.000
5
1.050-1.284
0.045-0.153
(B) Poria cocos having the following characteristics:
Peak
Relative Retention Times
Relative Peak Areas
1
0.371-0.557
2
0.388-0.582
3
0.401-0.601
4
0.407-0.679
0.312-0.52
5
0.431-0.718
0.461-0.769
6
0.482-0.724
7
0.495-0.743
8
0.556-0.834
9
0.591-0.887
10
0.713-1.070
11
0.742-1.112
12
0.673-1.251
0.211-0.393
13
1.000
1.000
14
0.881-1.321
15
0.886-1.330
16
0.916-1.374
(C) Moutan cortex having the following characteristics:
Peak
Relative Retention Times
Relative Peak Areas
1
0.097-0.140
0.035-0.210
2
0.388-0.557
0.055-0.330
3
0.544-0.750
0.240-0.750
4
0.592-0.813
0.015-0.225
5
0.798-0.997
0.040-0.160
S
1.000
1.000
(D) Paeoniae radix alba having the following characteristics:
Peak
Relative Retention Times
Relative Peak Areas
1
0.177-0.330
0.025-0.350
2
0.522-0.971
3
0.532-0.988
4
0.653-1.213
0.110-0.580
5(S)
1.000
1.000
6
0.942-1.750
0.200-0.888
7
1.367-2.539
0.025-0.080
and (E) Persicae semen having the following characteristics:
Peak
Relative Retention Times
Relative Peak Areas
1
0.383-0.542
0.010-0.050
2
0.433-0.665
0.025-0.110
S
1.000
1.000
3
1.033-1.321.
5 . A method of preparing the medicine composition according to claim 1 , wherein the method comprises the following steps:
weighing raw medicinal materials including Cinnamomi ramulus, Poria cocos, Moutan cortex, Persicae semen , and Paeoniae radix alba , to obtain said raw materials in a 1:1:1:1:1 ratio by weight;
obtaining (a) a first portion of the P. cocos consisting of 80% of the P. cocos raw material, wherein the first portion is in the form of a powder and (b) a second portion of the P. cocos consisting of 20% of the P. cocos raw material;
obtaining the Moutan cortex , wherein the M. cortex is obtained by steam-distilling the raw material with water vapor to collect the distillate thereof, separating and setting aside volatile components from the distillate, and thereby obtaining a residual M. cortex distillate;
mixing the residual M. cortex distillate, along with the C. ramulus, P. radix alba, P. semen and the second portion of P. cocos;
extracting the mixture with ethanolic and aqueous extractions, wherein the ethanolic extraction comprises extracting twice with 90% ethanol, combining the ethanolic extracts, and evaporating the ethanol therefrom to obtain an extraction residue, and wherein the aqueous extraction comprises further extracting said extraction residue twice with water, and combining and concentrating under reduced pressure the filtrates thereof, and
mixing the concentrated filtrate with the first portion of P. cocos and the volatile components of M. cortex , thereby obtaining said medicine composition.
6 . The method according to claim 5 , wherein the step of mixing the concentrated filtrate with the first portion of P. cocos and the volatile components of M. cortex , comprises:
mixing: (i) the first portion of P. cocos , wherein the portion is finely-powdered, with (ii) the concentrated filtrate, and drying to obtain a dry paste therefrom and then
to the dry paste: granulating with dextrin, drying, and encapsulating with the volatile components of M. cortex , thereby obtaining said medicine composition in a capsule dosage form.
7 . A method for preparing the medicine composition according to claim 1 , wherein the method comprises the following steps:
weighing raw medicinal materials including Cinnamomi ramulus, Poria cocos, Moutan cortex, Persicae semen , and Paeoniae radix alba to obtain said raw materials in a 1:1:1:1:1 ratio by weight;
grinding into coarse powder and mixing uniformly the Cinnamomi ramulus, Persicae semen, Paeoniae radix alba, Moutan cortex , and a first half of the amount of Poria cocos
to the uniform mixture, adding 90% ethanol in an amount of 3 times the amount of the medicinal materials, and therewith soaking for 0.5 hours, refluxing for 1 hour, and then filtering to obtain a first filtrate and residue;
refluxing the residue with 90% ethanol at 3 times the amount of raw medicinal materials, and then filtering to obtain a second filtrate and residue, and
combining the first and second filtrates to obtain an ethanolic extract;
refluxing the second residue with 5 times the amount of water for 0.5 h, and then filtering to obtain a third filtrate and residue;
refluxing the third residue with 5 times the amount of water for 0.5 h, and then filtering to obtain a fourth filtrate and residue;
combining the third and fourth filtrates to obtain an aqueous extract, and discarding the residue,
concentrating the ethanolic extract and aqueous extract separately under reduced pressure, comprising recovering the ethanolic extract until no alcohol odor remains, thereby obtaining concentrated solutions of each;
combining the two concentrated solutions to obtain a brown paste;
mixing the paste with the remaining second half of the Poria cocos wherein the P. cocos is finely powdered; and
drying and pulverizing the paste to obtain the medicine composition in the form of a dry paste powder.
8 . A method for treating a condition using the medicine composition according to claim 1 , the method comprising administering a therapeutically-effective amount of the medicine composition to a subject sufficient to treat or improve a condition, wherein the condition is selected from dysmenorrhea or a condition characterized thereby.