PREPARATION METHOD OF KAIXINSAN POWDER
20230181663 · 2023-06-15
Inventors
- Caiyun Zhang (Hefei, CN)
- Shujie Lv (Hefei, CN)
- Fangfang Gao (Hefei, CN)
- Xiaoxiao Shan (Hefei, CN)
- Junying Li (Hefei, CN)
- Xuan Yang (Hefei, CN)
- Yaoyao Xiao (Hefei, CN)
- Lanlan Ju (Hefei, CN)
- Shuangqing Yin (Hefei, CN)
Cpc classification
A61K2236/15
HUMAN NECESSITIES
A61K36/882
HUMAN NECESSITIES
International classification
A61K36/882
HUMAN NECESSITIES
Abstract
The present disclosure provides a preparation method of a Kaixinsan powder, including the following steps: pulverizing Radix Polygalae, Rhizoma Acori Graminei, ginseng, and Poria into a fine powder separately; and mixing each fine powder evenly in sequence according to a backing register method to obtain the Kaixinsan powder; where in the Kaixinsan powder, the fine powders each are required to pass through an 80-mesh sieve, and at least 95 wt% of each of the fine powders passes through a 100-mesh sieve. In the present disclosure, the fine powder of each medicinal material is capable of being mixed evenly, and has desirable dissolution effect and stability; and the Kaixinsan powder meets requirements for traditional Chinese medicine powders stipulated in Chinese Pharmacopoeia 2020 edition.
Claims
1. A preparation method of a Kaixinsan powder, comprising the following steps: pulverizing Radix Polygalae, Rhizoma Acori Graminei, ginseng, and Poria into a fine powder separately; and mixing each fine powder evenly in sequence according to a backing register method to obtain the Kaixinsan powder; wherein in the Kaixinsan powder, the fine powders each are required to pass through an 80-mesh sieve, and at least 95 wt% of each of the fine powders passes through a 100-mesh sieve.
2. The preparation method of a Kaixinsan powder according to claim 1, wherein the fine powders of the Radix Polygalae, the Rhizoma Acori Graminei, the ginseng, and the Poria have a same particle size.
3. The preparation method of a Kaixinsan powder according to claim 1, wherein the fine powders of the Radix Polygalae, the Rhizoma Acori Graminei, the ginseng, and the Poria each have a particle size of 80 mesh to 150 mesh.
4. The preparation method of a Kaixinsan powder according to claim 2, wherein the fine powders of the Radix Polygalae, the Rhizoma Acori Graminei, the ginseng, and the Poria each have a particle size of 80 mesh to 150 mesh.
5. The preparation method of a Kaixinsan powder according to claim 1, wherein the fine powders of the Radix Polygalae, the Rhizoma Acori Graminei, the ginseng, and the Poria each have a particle size of 100 mesh to 120 mesh.
6. The preparation method of a Kaixinsan powder according to claim 2, wherein the fine powders of the Radix Polygalae, the Rhizoma Acori Graminei, the ginseng, and the Poria each have a particle size of 100 mesh to 120 mesh.
7. The preparation method of a Kaixinsan powder according to claim 3, wherein the fine powders of the Radix Polygalae, the Rhizoma Acori Graminei, the ginseng, and the Poria each have a particle size of 100 mesh to 120 mesh.
8. The preparation method of a Kaixinsan powder according to claim 4, wherein the fine powders of the Radix Polygalae, the Rhizoma Acori Graminei, the ginseng, and the Poria each have a particle size of 100 mesh to 120 mesh.
9. The preparation method of a Kaixinsan powder according to claim 1, wherein during gradually mixing according to the backing register method, the Radix Polygalae, the Rhizoma Acori Graminei, the ginseng, and the Poria are added in sequence.
10. The preparation method of a Kaixinsan powder according to claim 2, wherein during gradually mixing according to the backing register method, the Radix Polygalae, the Rhizoma Acori Graminei, the ginseng, and the Poria are added in sequence.
11. The preparation method of a Kaixinsan powder according to claim 3, wherein during gradually mixing according to the backing register method, the Radix Polygalae, the Rhizoma Acori Graminei, the ginseng, and the Poria are added in sequence.
12. The preparation method of a Kaixinsan powder according to claim 4, wherein during gradually mixing according to the backing register method, the Radix Polygalae, the Rhizoma Acori Graminei, the ginseng, and the Poria are added in sequence.
13. The preparation method of a Kaixinsan powder according to claim 5, wherein during gradually mixing according to the backing register method, the Radix Polygalae, the Rhizoma Acori Graminei, the ginseng, and the Poria are added in sequence.
14. The preparation method of a Kaixinsan powder according to claim 6, wherein during gradually mixing according to the backing register method, the Radix Polygalae, the Rhizoma Acori Graminei, the ginseng, and the Poria are added in sequence.
15. The preparation method of a Kaixinsan powder according to claim 7, wherein during gradually mixing according to the backing register method, the Radix Polygalae, the Rhizoma Acori Graminei, the ginseng, and the Poria are added in sequence.
16. The preparation method of a Kaixinsan powder according to claim 8, wherein during gradually mixing according to the backing register method, the Radix Polygalae, the Rhizoma Acori Graminei, the ginseng, and the Poria are added in sequence.
17. The preparation method of a Kaixinsan powder according to claim 1, wherein the water content of the Poria is less than or equal to 5.5 wt%.
18. The preparation method of a Kaixinsan powder according to claim 1, wherein the water content of the Radix Polygalae is less than or equal to 7 wt%.
19. The preparation method of a Kaixinsan powder according to claim 1, wherein the water content of the ginseng is less than or equal to 7 wt%.
20. The preparation method of a Kaixinsan powder according to claim 1, wherein the water content of the Rhizoma Acori Graminei is less than or equal to 3 wt%.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0026]
[0027]
DETAILED DESCRIPTION OF THE EMBODIMENTS
[0028] The technical solutions of the present disclosure will be described in detail below with reference to specific examples.
Examples 1 to 5
[0029] 100 g of a Radix Polygalae coarse powder (in a particle size of 50 mesh) with a water content of 6 wt% to 6.5 wt% was divided into 5 parts of a same weight, and then pulverized into fine powders of 80 mesh, 100 mesh, 120 mesh, 150 mesh, and 200 mesh, respectively;
[0030] 100 g of a ginseng coarse powder (in a particle size of 50 mesh) with a water content of 6 wt% to 6.5 wt% was divided into 5 parts of a same weight, and then pulverized into fine powders of 80 mesh, 100 mesh, 120 mesh, 150 mesh, and 200 mesh, respectively;
[0031] 100 g of a Rhizoma Acori Graminei coarse powder (in a particle size of 50 mesh) with a water content of 2.5 wt% to 3 wt% was divided into 5 parts of a same weight, and then pulverized into fine powders of 80 mesh, 100 mesh, 120 mesh, 150 mesh, and 200 mesh, respectively;
[0032] 200 g of a Poria coarse powder (in a particle size of 50 mesh) with a water content of 4 wt% to 5 wt% was divided into 5 parts of a same weight, and then pulverized into fine powders of 80 mesh, 100 mesh, 120 mesh, 150 mesh, and 200 mesh, respectively; and
[0033] According to a weight ratio of the Radix Polygalae, the ginseng, the Rhizoma Acori Graminei, and the Poria at 1:1:1:2, the fine powder of each medicinal material of each mesh was weighed separately, and then compounde d and mixed according to Table 1.
TABLE-US-00001 Compounding situation Groups Mesh of medicinal material Mixing method Example 1 4 kinds of medicinal materials each are 80 mesh Backing register method Example 2 4 kinds of medicinal materials each are 100 mesh Example 3 4 kinds of medicinal materials each are 120 mesh Example 4 4 kinds of medicinal materials each are 150 mesh Example 5 4 kinds of medicinal materials each are 200 mesh
[0034] The mixing by backing register method specifically included: a small amount of light-colored and heavy Poria fine powder was added into a mortar to moisten and saturated the mortar, and the Poria fine powder was poured; a dark-colored and light Radix Polygalae fine powder was added into the mortar to make a base, a same volume of Rhizoma Acori Graminei fine powder was added, and then a mixed powder 1 was obtained by grinding and mixing; a ginseng fine powder with a same volume as the mixed powder 1 was added, and then ground and mixed to obtain a mixed powder 2; and the Poria fine powder with a same volume as the mixed powder 2 was added, and then ground and mixed to obtain the Kaixinsan powder.
[0035] The Kaixinsan powders prepared in Examples 1 to 5 were tested, and the results were shown in Table 2 and
[0036] A mixing standard was tested according to the appearance uniformity, specifically as follows: an appropriate amount of a test sample was placed on a smooth paper, tiled into about 5 cm.sup.2, a surface of the test sample was flattened, and observed in a bright place. The test sample should have uniform color and luster, without patterns and color spots.
[0037] A moisture absorption rate detection method was as follows: a sample with a thickness of about 3 mm was placed on a bottom of a constant-weight open weighing bottle, and a weight of the sample was precisely weighed and recorded as M.sub.sample, and a total weight of the sample and the open weighing bottle was recorded as M.sub.0; the open weighing bottle was placed in a closed environment with a relative humidity of 75%. After 2 d, a total weight of the sample and the open weighing bottle was accurately weighed and recorded as M.sub.1, and the moisture absorption rate was calculated by: moisture absorption rate = (M.sub.1-M.sub.0)/M.sub.sample.
TABLE-US-00002 Detection results Groups Mixing time (min) Mixing uniformity Angle of repose (°) Moisture absorption rate Example 1 5 Uniform 34.1 6.9 Example 2 10 Uniform 34.6 6.9 Example 3 15 Uniform 34.9 7.0 Example 4 25 Uniform 35.7 8.8 Example 5 30 Uniform 37.4 9.5
[0038] It was seen from Table 2 that: when the particle size is 80 mesh to 120 mesh, the Kaixinsan powder had shorter mixing time, lower moisture absorption rate, and better stability.
[0039] The Kaixinsan powders prepared in Examples 1 to 5 were subjected to component detection, specifically as follows: 200 mg of the Kaixinsan powder was added to 4 ml of pure water, and allowed to stand in hot water at 80° C. to 100° C. for 10 min; 0.5 ml of a supernatant was added into chromatographic methanol until a methanol volume fraction was 75%, to obtain a solution to be tested; and contents of polygalaxanthone III, 3,6′-disinapoylsucrose, tenuifoliside A, and β-asarone in the Kaixinsan powder were detected by ultra-high liquid chromatography.
[0040] The chromatographic conditions of the ultra-high liquid chromatography were: [0041] 1) ultra-high liquid phase system: Thermo Fisher Ultimate 3000rs; [0042] 2) chromatographic column: ACQUITY UPLC BEHC18 column (2.1×100 mm, 1.7 .Math.m); [0043] 3) a mobile phase A was acetonitrile, a mobile phase B was a 0.05% phosphoric acid aqueous solution, gradient elution was conducted; [0044] 4) the gradient elution procedure included: [0045] a. at 0 min to 9 min, the volume fraction of mobile phase A was 7% to 14%; [0046] b. at 9 min to 13 min, the volume fraction of mobile phase A gradually changed to 14% to 16%; [0047] c. at 13 min to 19 min, the volume fraction of mobile phase A gradually changed to 16% to 19%; [0048] d. at 19 min to 23 min, the volume fraction of mobile phase A gradually changed to 19% to 23%; [0049] e. at 23 min to 32 min, the volume fraction of mobile phase A gradually changed to 23% to 36%; [0050] f. at 32 min to 37 min, the volume fraction of mobile phase A gradually changed to 36% to 38%; and [0051] g. at 37 min to 41 min, the volume fraction of mobile phase A gradually changed to 38% to 42%; [0052] 5) after the gradient elution procedure was completed, at a volume fraction 7% of the mobile phase A, the gradient elution was continued for 10 min for next detection; [0053] 6) the column temperature was 30° C., the injection volume was 2 .Math.L, the detection wavelength was 203 nm, and the flow rate was 0.2 mL/min.
[0054] The detection results were shown in
[0055] As shown in
[0056] Taking into account comprehensively, the four medicinal materials each have a particle size of 80 mesh to 150 mesh, more preferably 100 mesh to 120 mesh.
Examples 6 to 9
[0057] A 100-mesh Radix Polygalae fine powder, a 100-mesh ginseng fine powder, a 100-mesh Rhizoma Acori Graminei fine powder, and a 100-mesh Poria fine powder were mixed according to a weight ratio of 1:1:1:2 in different orders through increment by equal quantity, and the state when mixing for 15 min, time required for mixing, and moisture absorption rate after mixing well were counted. The results were shown in Table 3 and
[0058]
[0059] A mixing standard was tested according to the appearance uniformity, specifically as follows: an appropriate amount of a test sample was placed on a smooth paper, tiled into about 5 cm.sup.2, a surface of the test sample was flattened, and observed in a bright place. The test sample should have uniform color and luster, without patterns and color spots.
[0060] A moisture absorption rate detection method was as follows: a sample with a thickness of about 3 mm was placed on a bottom of a constant-weight open weighing bottle, and a weight of the sample was precisely weighed and recorded as M.sub.sample, and a total weight of the sample and the open weighing bottle was recorded as M.sub.0; the open weighing bottle was placed in a closed environment with a relative humidity of 75%. After 2 d, a total weight of the sample and the open weighing bottle was accurately weighed and recorded as M.sub.1, and the moisture absorption rate was calculated by: moisture absorption rate = (M.sub.1-M.sub.0)/M.sub.sample.
TABLE-US-00003 Groups Adding sequence State when mixing for 15 min Time required for mixing (min) Moisture absorption rate after mixing well (%) Example 6 Radix Polygalae, Rhizoma Acori Graminei, ginseng, Poria Uniform 15 7.0 Example 7 Radix Polygalae, Rhizoma Acori Graminei, Poria, ginseng Non-uniform 20 7.3 Example 8 Radix Polygalae, Poria, Rhizoma Acori Graminei, ginseng Non-uniform 26 7.7 Example 9 Poria, Radix Polygalae, Rhizoma Acori Graminei, ginseng Non-uniform 26 7.8
[0061] As shown in Table 3 and
[0062] The foregoing are merely descriptions of preferred specific embodiments of the present disclosure, but the protection scope of the present disclosure is not limited thereto. Any equivalent replacement or modification made within a technical scope of the present disclosure by a person skilled in the art according to the technical solutions of the present disclosure and inventive concepts thereof shall fall within the protection scope of the disclosure.