CN114558079A - Chinese patent medicine preparation for benefiting qi and nourishing blood and preparation method thereof - Google Patents
Chinese patent medicine preparation for benefiting qi and nourishing blood and preparation method thereof Download PDFInfo
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Abstract
The invention belongs to the field of traditional Chinese medicine preparations, and particularly relates to a Chinese patent medicine preparation for benefiting qi and nourishing blood and a preparation method thereof, wherein the Chinese patent medicine preparation comprises the following traditional Chinese medicine raw materials in parts by weight: 139 parts of tuber fleeceflower root, 113.5 parts of prepared rehmannia root, 172 parts of cortex lycii radicis, 103.5 parts of rehmannia root, 172 parts of tuckahoe, 103.5 parts of asparagus, 103.5 parts of dwarf lilyturf tuber and 103 parts of ginseng. The preparation method of the invention solves the problem of relatively low bioavailability of the Chinese patent medicine, namely the Shoukang pill, clinically used at present by adding a grinding aid with specific type and dosage and a freezing treatment method of liquid nitrogen freezing in the process of processing the Chinese patent medicine raw materials. The Chinese patent medicine preparation for benefiting qi and nourishing blood prepared by the preparation method improves the bioavailability of the medicine, increases the drug effect, and reduces the single administration dosage of patients, thereby improving the administration compliance of the patients.
Description
Technical Field
The invention belongs to the field of traditional Chinese medicine preparations, and particularly relates to a Chinese patent medicine preparation for benefiting qi and nourishing blood and a preparation method thereof.
Background
Kangshou pill is prepared from Polygoni Multiflori radix, radix rehmanniae Preparata, cortex Lycii, rehmanniae radix, Poria, radix asparagi, radix Ophiopogonis, and Ginseng radix, and its prescription is from "Life prolonging Bulaodan" in page 1252 of Chinese medicine dictionary (Shen Zun Sheng Fang), "Kangshou pill", proposed by professor of Royuan Cai of Guangzhou Chinese medicinal university, and developed into pill preparation by Guangzhou Baiyunshu Jing Yi Tang pharmaceutical industry Gmby, and named as "Kangshou pill". The preparation process of Kangshou pills (WS 3-B-2231-96 in the eleventh volume of the ministry of health pharmaceutical Standard Chinese medicine preparations) is as follows: taking half of the prescription amount of the polygonum multiflorum, uniformly stirring with the black bean juice, moistening thoroughly, drying, uniformly stirring with the liquorice juice, and drying; washing cortex Lycii and Poria with Chinese liquor, and drying; soaking radix rehmanniae Preparata and rehmanniae radix with Chinese liquor overnight; soaking radix asparagi and radix Ophiopogonis in Chinese liquor for 3 hr, and drying respectively; pulverizing the above seven materials, Ginseng radix and the rest Polygoni Multiflori radix into fine powder, sieving, mixing, making into pill with water, drying, coating with Glycyrrhrizae radix carbon powder, and polishing. The Kangshou pill has the functions of tonifying qi and nourishing blood, and moistening lung and nourishing kidney, and can be used for treating body weakness, mental fatigue and hypodynamia, dizziness and amnesia, hyperhidrosis, dry cough and less phlegm, palpitation and shortness of breath, and soreness and weakness of waist and knees caused by deficiency of both qi and blood and deficiency of essence and blood. The application method of KANGSHOU pill comprises taking 5g of the pill in light saline or Mel solution 2-3 times a day.
The conventional processing and crushing method can not effectively destroy the cell structure of the medicinal materials and influence the dissolution, release and absorption of the effective components of the Chinese patent medicine. The existing Kangshou pills have the problem of relatively low bioavailability, so that the single dose is large, patients have certain difficulty in taking the pills, and the compliance of the patients in taking the pills is reduced.
The superfine grinding technology has the characteristics of improving the physical and chemical properties of materials, strengthening the use effect of the materials, expanding the application range of the materials and the like. The current superfine grinding technology comprises air-flow type superfine grinding, rotary ball grinding type superfine grinding, mechanical shearing type superfine grinding, high-frequency vibration type superfine grinding and other superfine grinding technologies. However, the superfine grinding technology has poor grinding effect on traditional Chinese medicinal materials with high sugar content and high toughness, causes the problems of large granularity, bonding and the like of finished products, and heat generated in the grinding process easily causes loss and decomposition of active ingredients. In the prescription of the Kangshou pill, the medicinal materials such as the tuber fleeceflower root, the prepared rehmannia root, the cortex lycii radicis, the rehmannia root and the like are all high-sugar and multi-toughness fibers, and the aim of the invention cannot be achieved by adopting a superfine powder technology.
Disclosure of Invention
Aiming at the defects of the prior art, the invention aims to provide a Chinese patent medicine preparation for tonifying qi and nourishing blood and a preparation method thereof on the basis of Kangshou pills. The Chinese patent medicine preparation for benefiting qi and nourishing blood prepared by the preparation method of the invention improves the bioavailability of the medicine, increases the drug effect, and reduces the single administration dosage of patients, thereby improving the administration compliance of the patients.
Specifically, the invention is realized by the following technical schemes:
in a first aspect, the invention provides a Chinese patent medicine preparation for benefiting qi and nourishing blood, which comprises the following Chinese medicine raw materials in parts by weight: 69.5-278 parts of tuber fleeceflower root, 56.8-227 parts of prepared rehmannia root, 86-344 parts of cortex lycii radicis, 51.8-207 parts of rehmannia root, 86-344 parts of tuckahoe, 51.8-207 parts of asparagus, 51.8-207 parts of dwarf lilyturf tuber and 51.5-206 parts of ginseng.
Preferably, the Chinese patent medicine preparation is prepared from the following Chinese medicinal raw materials in parts by weight: 69.5-278 parts of tuber fleeceflower root, 56.8-227 parts of prepared rehmannia root, 86-344 parts of cortex lycii radicis, 51.8-207 parts of rehmannia root, 86-344 parts of tuckahoe, 51.8-207 parts of asparagus, 51.8-207 parts of dwarf lilyturf tuber and 51.5-206 parts of ginseng.
As an optional mode, in the Chinese patent medicine preparation, the Chinese patent medicine preparation comprises the following Chinese medicine raw materials in parts by weight: 139 parts of tuber fleeceflower root, 113.5 parts of prepared rehmannia root, 172 parts of cortex lycii radicis, 103.5 parts of rehmannia root, 172 parts of tuckahoe, 103.5 parts of asparagus, 103.5 parts of dwarf lilyturf tuber and 103 parts of ginseng.
Preferably, the Chinese patent medicine preparation is prepared from the following Chinese medicinal raw materials in parts by weight: 139 parts of tuber fleeceflower root, 113.5 parts of prepared rehmannia root, 172 parts of cortex lycii radicis, 103.5 parts of rehmannia root, 172 parts of tuckahoe, 103.5 parts of asparagus, 103.5 parts of dwarf lilyturf tuber and 103 parts of ginseng.
In a second aspect, the present invention provides a method for preparing a Chinese patent medicine preparation according to the first aspect, wherein the method comprises the following steps: the method comprises the following steps:
(1) weighing 1/2-1 parts by weight of the polygonum multiflorum, adding 1/3-1/5 parts by weight of the polygonum multiflorum, uniformly stirring, moistening, drying, adding 1/9-1/11 parts by weight of the liquorice juice, uniformly stirring, and drying for later use;
(2) washing cortex Lycii and Poria with Chinese liquor, and drying;
(3) soaking radix rehmanniae Preparata and rehmanniae radix with Chinese liquor for 2-24 hr, and drying respectively;
(4) soaking radix asparagi and radix Ophiopogonis in Chinese liquor for 2-6 hr, and drying respectively;
(5) mixing the seven ingredients with the ginseng and the rest of the polygonum multiflorum, crushing by using a crusher, and sieving by using a 24-50-mesh pharmacopeia sieve to obtain crude medicinal powder;
(6) adding a grinding aid into the crude powder of the medicinal materials obtained in the step (5) and mixing, wherein the grinding aid accounts for 0-2.0% of the weight of the crude powder of the medicinal materials;
(7) freezing the mixed powder obtained in the step (6) in liquid nitrogen for 0.5-4 h;
(8) placing the mixed powder obtained in the step (7) at a low temperature of-10-0 ℃ for carrying out superfine grinding together to obtain superfine mixed powder;
(9) the Chinese patent medicine preparation for benefiting qi and nourishing blood is any one of common preparation formulations prepared from the mixed powder obtained in the step (8) by using a conventional Chinese medicine preparation method.
Alternatively, in the above production method, the drying treatment in the step (1), the step (2), the step (3) and the step (4) is carried out to a water content of less than 0.5% by weight.
Alternatively, in the above preparation method, in step (6), the auxiliary grinding agent is one or both of silicon dioxide and magnesium stearate, which are pharmaceutical excipients recorded in "chinese pharmacopoeia".
Preferably, the grinding aid is 0.2-1.0% of silicon dioxide or 0.4-2.0% of magnesium stearate or 0.2-1.5% of 50% of silicon dioxide 50% of magnesium stearate.
More preferably, the grinding aid is 0.8% of silicon dioxide or 1.5% of magnesium stearate or 1.0% of 50% of silicon dioxide 50% of magnesium stearate.
Alternatively, in the above production method, in step (7), the mixed powder obtained in step (6) is subjected to preliminary pulverization and then to freezing treatment in liquid nitrogen for 2 hours.
Alternatively, in the above production method, in the step (8), the mixed powder has an average particle diameter of less than 35 μm, preferably 25 to 30 μm.
Alternatively, in the above preparation method, in step (9), the dosage form is selected from a tablet, a powder, a capsule, a pill, a granule, an oral liquid, a granule, a drop pill, a pellet, a intramuscular injection, a drip injection, or an ointment.
Preferably, in step (9), the dosage form is selected from tablets, pills, granules or capsules.
Preferably, in step (9), the tablet is a sugar-coated tablet, a film-coated tablet or an enteric-coated tablet, the capsule is a soft capsule, and the paste is an ointment or plaster.
The Chinese patent medicine preparation for tonifying qi and nourishing blood contains prepared rehmannia root and rehmannia root, wherein the prepared rehmannia root is sweet and mild in taste and can enrich blood, nourish kidney and nourish yin; rehmannia root (also called as radix rehmanniae) is sweet in taste and cool in nature, has the functions of clearing heat, nourishing yin, strengthening heart and inducing diuresis, and has the functions of nourishing blood, nourishing yin, tonifying kidney water, strengthening heart, inducing diuresis and resisting allergy and the like by matching the two medicines.
Compared with the prior art, the invention has the following beneficial effects:
the preparation method of the invention solves the problem of relatively low bioavailability of the Chinese patent medicine Huokang pill clinically used at present by adding a grinding aid of specific type and dosage and a freezing treatment method of liquid nitrogen freezing in the process of treating the Chinese medicinal raw materials. The Chinese patent medicine preparation for benefiting qi and nourishing blood prepared by the preparation method improves the bioavailability of the medicine, increases the drug effect, and reduces the single administration dosage of patients, thereby improving the administration compliance of the patients.
Drawings
FIG. 1: graph of relationship between liquid nitrogen freezing time and superfine powder particle size.
FIG. 2: a curve chart of the relationship between the addition amount of the grinding aid and the granularity of the superfine powder.
FIG. 3: the cumulative dissolution curve chart of the longevity pill and the Chinese patent medicine preparation for benefiting qi and nourishing blood.
Detailed Description
The invention is further illustrated with reference to specific examples. It should be understood that the specific embodiments described herein are illustrative only and are not limiting upon the scope of the invention.
The examples do not show the specific techniques or conditions, according to the technical or conditions described in the literature in the field, or according to the product specifications. The reagents or instruments used are conventional products which are not known to manufacturers and are available from normal sources.
The experimental procedures in the following examples are conventional unless otherwise specified. The test materials used in the following examples are all commercially available products unless otherwise specified.
Example 1:
A. 139g of tuber fleeceflower root, 113.5g of prepared rehmannia root, 172g of cortex lycii radicis, 103.5g of rehmannia root, 172g of tuckahoe, 103.5g of asparagus, 103.5g of dwarf lilyturf tuber and 103g of ginseng are taken for standby.
B. Mixing 69.5g of Polygoni Multiflori radix with 17.4g of semen Sojae Atricolor juice, moistening, drying, mixing with 7.0g of Glycyrrhrizae radix juice, and drying; washing cortex Lycii and Poria with Chinese liquor, and drying; soaking radix rehmanniae Preparata and rehmanniae radix with Chinese liquor for 24 hr; soaking radix asparagi and radix Ophiopogonis in Chinese liquor for 6 hr, and drying respectively;
mixing the processed seven ingredients with the ginseng and the rest of the polygonum multiflorum, crushing by using a crusher, and sieving by using a 24-mesh pharmacopeia sieve to obtain crude medicinal powder;
adding silicon dioxide with the weight of 0.8 percent of the crude powder into the crude powder of the medicinal materials and mixing;
freezing the obtained mixed powder in liquid nitrogen for 2 h;
placing the above coarse powders in low temperature environment of 0-10 deg.C, micronizing to obtain micropowder mixture powder with average particle diameter of less than 28 μm;
C. oral preparation:
adding appropriate amount of water into the obtained superfine powder mixed powder, wet-processing into pills, and drying;
coating with powdered Glycyrrhrizae radix charcoal, and polishing.
Example 2:
A. 139g of tuber fleeceflower root, 113.5g of prepared rehmannia root, 172g of cortex lycii radicis, 103.5g of rehmannia root, 172g of tuckahoe, 103.5g of asparagus, 103.5g of dwarf lilyturf tuber and 103g of ginseng are taken for standby.
B. Mixing 69.5g of Polygoni Multiflori radix with 17.4g of semen Sojae Atricolor juice, moistening, drying, mixing with 7.0g of Glycyrrhrizae radix juice, and drying; washing cortex Lycii and Poria with Chinese liquor, and drying; soaking radix rehmanniae Preparata and rehmanniae radix with Chinese liquor for 24 hr; soaking radix asparagi and radix Ophiopogonis in Chinese liquor for 6 hr, and drying respectively;
mixing the processed seven ingredients with the ginseng and the rest of the polygonum multiflorum, crushing by using a crusher, and sieving by using a 50-mesh pharmacopoeia sieve to obtain crude medicinal powder;
adding magnesium stearate 1.5 wt% into the coarse powder, and mixing;
freezing the obtained mixed powder in liquid nitrogen for 2 h;
placing the above coarse powders in low temperature environment of 0-10 deg.C, micronizing to obtain micropowder mixture powder with average particle diameter of less than 28 μm;
C. oral preparation:
adding appropriate amount of water into the obtained superfine powder mixed powder, granulating by wet method, and drying;
sieving, and making into capsule.
Example 3: liquid nitrogen freezing time test
1. Test materials
139g of tuber fleeceflower root, 113.5g of prepared rehmannia root, 172g of cortex lycii radicis, 103.5g of rehmannia root, 172g of tuckahoe, 103.5g of asparagus, 103.5g of dwarf lilyturf tuber and 103g of ginseng are taken for standby.
Mixing 69.5g of Polygoni Multiflori radix with 17.4g of semen Sojae Atricolor juice, moistening, drying, mixing with 7.0g of Glycyrrhrizae radix juice, and drying; washing cortex Lycii and Poria with Chinese liquor, and drying; soaking radix rehmanniae Preparata and rehmanniae radix with Chinese liquor for 24 hr; soaking radix asparagi and radix Ophiopogonis in Chinese liquor for 6 hr, and drying respectively; mixing the processed seven ingredients with ginseng and the rest of polygonum multiflorum, crushing by a crusher, sieving by a 24-mesh pharmacopeia sieve, adding silicon dioxide accounting for 1.0% of the crude powder of the medicinal materials into the obtained crude powder of the medicinal materials, and mixing to obtain a test sample.
2. Test method
Under the condition of the same rotation speed of a pulverizer and the same water content of the medicinal powder, respectively placing the test sample in liquid nitrogen for freezing treatment for 0, 0.5, 1, 2 and 4 hours, placing in a low-temperature environment of 0-10 ℃ for jointly carrying out superfine grinding, measuring the granularity of the powder sample, and analyzing.
3. Conclusion
The effect of freezing time on the particle size of the submicron powder is shown in FIG. 1. As is clear from FIG. 1, under otherwise identical conditions, the particle size of the ultrafine powder (D90) decreased significantly as the time of freezing in liquid nitrogen increased, and the particle size (D90) changed greatly from 0h to 0.5h in freezing. Through liquid nitrogen freezing, the interaction force among molecules in the coarse powder is reduced, and the material is brittle and easy to crush. When the freezing time reaches 2h to 4h, the change of the particle size (D90) is small, which indicates that the intermolecular force reaches the optimal value when the freezing time reaches 2h, and the influence of the subsequent continuous lengthening of the freezing time is not large. Therefore, the freezing time can be 2 hours as the best material in practical production practice.
Example 4: grinding aid addition test
1. Test materials
139g of tuber fleeceflower root, 113.5g of prepared rehmannia root, 172g of cortex lycii radicis, 103.5g of rehmannia root, 172g of tuckahoe, 103.5g of asparagus, 103.5g of dwarf lilyturf tuber and 103g of ginseng are taken for standby.
Mixing 69.5g of Polygoni Multiflori radix with 17.4g of semen Sojae Atricolor juice, moistening, drying, mixing with 7.0g of Glycyrrhrizae radix juice, and drying; washing cortex Lycii and Poria with Chinese liquor, and drying; soaking radix rehmanniae Preparata and rehmanniae radix with Chinese liquor for 24 hr; soaking radix asparagi and radix Ophiopogonis in Chinese liquor for 6 hr, and drying respectively;
mixing the processed seven ingredients with the ginseng and the rest of the polygonum multiflorum, crushing the mixture by using a crusher, and sieving the crushed mixture by using a 24-mesh pharmacopoeia sieve to obtain crude medicinal powder serving as a test sample.
2. Test method
Respectively mixing silicon dioxide, magnesium stearate and 50% silicon dioxide and 50% magnesium stearate mixed powder with the weight of 0%, 0.2%, 0.4%, 0.6%, 0.8%, 1.0%, 1.5%, 2.0% of the sample under the condition that the rotation speed of a pulverizer and the water content of the medicinal powder are the same, and freezing the mixed powder in liquid nitrogen for 4 hours; placing the powder in a low-temperature environment of 0-10 ℃ for carrying out superfine grinding together, measuring the granularity of a powder sample, and analyzing.
3. Conclusion
The effect of the amount of grinding aid added on the particle size of the submicron powder is shown in figure 2. As can be seen from FIG. 2, under the same conditions, the particle size (D90) of the ultrafine powder is obviously reduced along with the increase of the grinding aid, the grinding aid can reduce the adhesion and aggregation of the ultrafine powder on the inner wall of equipment, reduce the mutual adhesion among powder bodies of polysaccharide substances, reduce the moisture absorption rate of the powder, reduce the saturated moisture absorption capacity of the powder, and enable the ultrafine powder to be more easily dispersed and crushed. The granularity of the superfine powder is obviously reduced after the grinding aid is added; when the adding amount of silicon dioxide reaches 0.8%, the adding amount of magnesium stearate reaches 1.5%, the adding amount of 50% silicon dioxide and 50% magnesium stearate reaches 1.0%, the superfine powder particle size reaches the optimal value, and the influence on the particle size is not obvious when the adding amount of the grinding aid is continuously increased subsequently.
Preferably, the grinding aid is 0.2-1.0% of silicon dioxide or 0.4-2.0% of magnesium stearate or 0.2-1.5% of 50% of silicon dioxide 50% of magnesium stearate. Preferably, the grinding aid is 0.8 percent of silicon dioxide or 1.5 percent of magnesium stearate or 1.0 percent of 50 percent of silicon dioxide 50 percent of magnesium stearate based on the weight of the crude powder.
Example 5: dissolution test
1. Instruments and reagents
One in ten thousand electronic balance (mettleltordo corporation); agilent 1260 hplc (with quaternary pump, autosampler, column oven and DAD detector), OpenLab CDS chromatography workstation. 2,3,5, 4' -tetrahydroxystilbene-2-O-beta-D-glucoside was purchased from the Chinese food and drug testing institute. Acetonitrile is chromatographically pure, water is ultrapure water, and other reagents are analytically pure. Kangshou pill sample is provided by Guangzhou Baiyunshijing pharmaceutical industry GmbH (batch number: B11013); a Chinese patent medicine preparation for benefiting qi and nourishing blood is prepared according to the method of the embodiment 1.
2. Method and results
2.1. Preparation of artificial gastric juice
Taking 16.4mL of dilute hydrochloric acid, adding 800mL of water and 10g of pepsin, shaking up, adding water to dilute to 1000mL, and obtaining the product, wherein the detected pH value is 1.8.
2.2. Preparation of test solution
The Kangshou pill or qi-invigorating and blood-nourishing Chinese patent medicine preparation containing about 3g of radix Polygoni Multiflori is measured according to the second method (paddle method) of 0931 dissolution and release determination method of the four-part general regulation in 2020 edition of Chinese pharmacopoeia. The artificial gastric juice of item 2.1 is used as dissolution medium, the rotating speed is 75r/min, and the temperature is 37.0 +/-0.5 ℃. Respectively sampling 1mL at 5, 10, 15, 20, 30, 40, 50, and 60min, timely supplementing equal-temperature equal-volume dissolution medium, filtering with 0.45 μm microporous filter membrane, and collecting the filtrate as test solution.
2.3. Preparation of control solutions
Taking about 6mg of 2,3,5, 4' -tetrahydroxystilbene-2-O-beta-D-glucoside reference substance, precisely weighing, placing in a 100mL measuring flask, adding 5mL of methanol, dissolving, diluting to scale with dissolution medium, and shaking up to obtain reference substance solution.
2.4. Chromatographic conditions
A chromatographic column: thermo ODS-2 HYPERSIL (250 mm. times.4.6 mm, 5 μm, Saimer Feishel, USA); mobile phase acetonitrile-water (volume ratio is 20: 80); detection wavelength: 320 nm; the flow rate is 1.0m L/min; the column temperature is 40 ℃; the injection volume is 10 muL.
2.5. Dissolution determination
According to the chromatographic conditions under the condition of '2.4', respectively taking the test solution and the reference solution, injecting the test solution and the reference solution into a liquid chromatograph, recording the chromatogram, calculating the accumulated dissolution amount by the peak area according to an external standard method, and drawing a dissolution curve, wherein the result is shown in figure 3.
3. Conclusion
Compared with the Kangshou pill prepared by the prior process, the content of 2,3,5, 4' -tetrahydroxystilbene-2-O-beta-D-glucoside is improved by about 30 percent, which shows that cell walls are damaged in the crushing process, effective components can be released without penetrating the cell walls, the release speed and the release amount are improved, and the original drug effect of the medicinal materials can be maintained.
Example 6: pharmacodynamic experiment
1. Experimental Material
SPF-level Kunming white mice are purchased from Guangdong province medical experimental animal center, and the animal production license number is as follows: scff 2018-. Kangshou pill sample is provided by Guangzhou Baiyunshijing pharmaceutical industry GmbH (batch number: B11013); a Chinese patent medicine preparation for benefiting qi and nourishing blood, which is prepared according to the method of the embodiment 1; physiological saline.
2. Statistical treatment
All data were input into EXCEL2010 for statistical analysis, and mean. + -. standard deviation was calculated in different groups
Analysis of variance was performed and comparisons between groups were made using the t-test.
3. Mouse normal pressure hypoxia tolerance test
54 mice with 18-22 g of body weight are shared, and the mice with both male and female are randomly divided into a Kangshou pill administration group, an qi-tonifying and blood-nourishing Chinese patent medicine preparation administration group and a normal saline control group 3 groups, wherein each group comprises 18 mice. The administration group is administered with 5g/kg Kangshou pill or Chinese medicinal preparation for invigorating qi and nourishing blood, and the control group is administered with 0.5 mL/body of normal saline with equal volume. After 1 hour of gavage, mice were placed in 250mL ground bottles pre-filled with 5g of soda lime. One for each bottle, the mouth was sealed with petrolatum and the survival time was recorded using death as an indicator and the results are shown in table 1.
TABLE 1 mouse Normal pressure hypoxia tolerance test
As shown in Table 1, the survival time of the mice in the Chinese patent medicine preparation group for benefiting qi and nourishing blood is obviously prolonged (P is less than 0.01) compared with the life-prolonging pill group, which shows that the medicine has the function of improving the normal-pressure hypoxia tolerance of the mice.
4. Memory test for aged mice
The test took 66 mice for 15 months, and the average body weight was 37.5 g/mouse. Randomly dividing into Kangshou pill administration group, Chinese medicinal preparation administration group for invigorating qi and nourishing blood and physiological saline control group 3 groups. Each group had 22 individuals, both male and female. The administration groups are respectively infused with 2.7g/kg of Kangshou pills or Chinese patent medicine preparations for benefiting qi and nourishing blood, once a day and continuously administered for 8 days. The control group was given an equal volume of physiological saline 0.5 mL/body. The memory was determined by the maze method, which was preceded by a half-day fast with 2 passes through the maze with the mice to understand the pathway to the maze endpoint, before each mouse was measured for memory. The time required for the mouse to walk from the entrance of the maze to the end point is used as an index of the memory, the shorter the time is, the better the memory is shown, and the experimental results are shown in table 2.
TABLE 2 memory test in elderly mice
As can be seen from Table 2, the time required for the mice with the Chinese patent medicine preparation for benefiting qi and nourishing blood to reach the labyrinth terminal point is shorter than that of the Kangshou pill group (P is less than 0.05), which indicates that the Chinese patent medicine preparation for benefiting qi and nourishing blood has the function of improving the labyrinth memory of the aged mice.
5. Endurance test for swimming
33 male mice with weight of 17-19 g are randomly divided into a Kangshou pill administration group, an qi-tonifying and blood-nourishing Chinese patent medicine preparation administration group and a normal saline control group 3 groups, wherein each group comprises 11 mice. The administration group is administered with 5g/kg Kangshou pill or Chinese medicinal preparation for benefiting qi and nourishing blood, once per day for 8 days, and the control group is administered with 0.5 mL/body of normal saline with equal volume. The endurance test adopts a method of swimming under load to complete fatigue, namely, a copper wire ring with the weight of 5 percent of the body weight of the mouse is firstly tied on the tail root of the mouse, then the mouse is put into a glass water pool with the water temperature of 27 ℃ to be forced to swim, the time from the water entering to the water sinking to the water bottom is recorded and is the time of swimming under load, the influence of each group on the swimming time of the mouse is observed, and the result is shown in table 3.
TABLE 3 swimming endurance test
The weight swimming time can truly reflect the exercise endurance of the animals. The results in table 3 show that the qi-invigorating and blood-nourishing Chinese patent medicine preparation has the effect of enhancing the swimming endurance of mice, and the difference is very obvious when the weight-bearing swimming time of the mice is less than 0.01 compared with the Kangshou pill group.
6. Androgen activity assay
The test adopts a prostate and seminal vesicle weight increasing method, 39 male mice young mice weighing 12-14g are randomly divided into 3 groups of kang shou pill administration group, qi-tonifying and blood-nourishing Chinese patent medicine preparation administration group and normal saline control group, 13 of kang shou pill administration group and qi-tonifying and blood-nourishing Chinese patent medicine preparation administration group respectively, 13 of control group, 6g/kg of kang shou pills or qi-tonifying and blood-nourishing Chinese patent medicine preparation are respectively used for gastric lavage for the administration group, 0.4 mL/physiological saline with the same volume is used for the control group, 1 time per day and 9 days are used for administration, the weight of the prostate and the seminal vesicle are tested on the 10 th day, the weight of the prostate and the seminal vesicle are compared according to the average weight of the prostate and the seminal vesicle per 10g of the weight, and the results are shown in Table 4.
TABLE 4 androgen activity assay
The results in table 4 show that the weight of prostate and seminal vesicle per 10g of weight of male mice in the Chinese patent medicine preparation for benefiting qi and nourishing blood is less than 0.01, the difference is very obvious, and the Chinese patent medicine preparation for benefiting qi and nourishing blood is considered to have the effect of enhancing the activity of androgen according to the fact that the growth and development of accessory organs such as seminal vesicle and prostate depend on androgen.
7. Estrogen activity assay
The experiment adopts a uterus weight increasing method, 33 young female mice weighing 12-14g are randomly divided into 3 groups of a life-prolonging pill administration group, an qi-tonifying and blood-nourishing Chinese patent medicine preparation administration group and a normal saline control group, 11 mice in each group are respectively administrated, the administration group is respectively infused with 6g/kg of life-prolonging pills or qi-tonifying and blood-nourishing Chinese patent medicine preparations, the control group is administrated with 0.4 mL/mouse of normal saline with equal volume, 1 time every day and 9 days in total, the test is carried out on the 10 th day, the uterus is taken out and weighed, the average uterus weight of each 10g of body weight is compared, and the result is shown in table 5.
TABLE 5 estrogen activity assay
As seen from the results in Table 5, the uterus weight of each 10g of mouse in the Kangshou pill group is less than 0.05, the difference is very obvious, and the qi-tonifying and blood-nourishing Chinese patent medicine preparation is considered to have the effect of enhancing the activity of female hormone according to the fact that the growth and development of the uterus depend on male hormone.
8. Age-old mouse longevity test
The experiment totally uses 48 Kunming old mice with 15 months age, has both male and female, and is randomly divided into 3 groups of Kangshou pill administration group, qi-tonifying and blood-nourishing Chinese patent medicine preparation administration group and normal saline control group, wherein 16 mice in each group have the same total weight, and 3 groups have the same total weight. The administration method comprises two stages, wherein the first stage is intragastric administration, namely the mice in the administration group are respectively intragastric administered with 3.3g/kg of Kangshou pills or Chinese patent medicine preparations for benefiting qi and nourishing blood, 1 time per day for 13 consecutive days, and the control group is administered with 0.5 mL/mouse of physiological saline with equal volume; the second stage is administration, 2.5g of biscuit soaked in the pill liquid is fed to each mouse (soaked in 100mg/mL pill liquid) at a dose of 6g/kg, 1 time per day for 47 days, and the administration is carried out for 13 days by combining the first stage of intragastric administration for 60 days. The control group was treated with normal saline at the same volume as the administration group except that the control group was changed to normal saline at the same volume. The life span of each mouse was calculated by registering the number of dead animals day by day, and the results of the statistical treatment of the two groups of animals are shown in Table 6.
TABLE 6 Life test of aged mice
As shown in Table 6, the mean life of the qi-tonifying and blood-nourishing Chinese patent medicine preparation is prolonged by 25.9 days compared with that of the Kangshou pill group mice, the statistical treatment shows that the P is less than 0.05, the difference is obvious, and the skill of the qi-tonifying and blood-nourishing Chinese patent medicine preparation group mice can prolong the minimum life and also can increase the maximum life, which indicates that the qi-tonifying and blood-nourishing Chinese patent medicine preparation has the function of prolonging the life of the old mice.
9. Conclusion
The experimental results show that the Kangshou pill and the Chinese patent medicine preparation for tonifying qi and nourishing blood both have the effects of enhancing the normal-pressure hypoxia tolerance of mice, improving the maze memory of old mice, enhancing the swimming endurance of the mice, enhancing the activity of male and female sex hormones of the mice and prolonging the life of the old mice. Therefore, the Kangshou pill and the Chinese patent medicine preparation for tonifying qi and nourishing blood have the effects of tonifying qi and nourishing blood, moistening lung and nourishing kidney, strengthening body and prolonging life; in the experiments, the Chinese patent medicine preparation for tonifying qi and nourishing blood has more obvious effect than the life-prolonging pill.
Example 7: safety test
1. Experimental Material
SPF-grade Kunming-breed white mice are purchased from Guangdong province medical experimental animal center, and the animals produce license numbers: scff 2018-.
2. Statistical treatment
All data were input into EXCEL2010 for statistical analysis, and mean. + -. standard deviation was calculated for different groups
Analysis of variance was performed and comparisons between groups were made using the t-test.
3. Preparation of test article
139g of tuber fleeceflower root, 113.5g of prepared rehmannia root, 172g of cortex lycii radicis, 103.5g of rehmannia root, 172g of tuckahoe, 103.5g of asparagus, 103.5g of dwarf lilyturf tuber and 103g of ginseng are taken for standby.
Mixing 69.5g of Polygoni Multiflori radix with 17.4g of semen Sojae Atricolor juice, moistening, drying, mixing with 7.0g of Glycyrrhrizae radix juice, and drying; washing cortex Lycii and Poria with Chinese liquor, and drying; soaking radix rehmanniae Preparata and rehmanniae radix with Chinese liquor for 24 hr; soaking radix asparagi and radix Ophiopogonis in Chinese liquor for 6 hr, and drying respectively;
mixing the processed seven ingredients with the ginseng and the rest of the polygonum multiflorum, crushing by a crusher, and sieving by a 24-mesh pharmacopeia sieve to obtain crude medicinal powder. Respectively mixing silicon dioxide or magnesium stearate with the weight of 2.0% of the crude powder of the medicinal materials under the condition of the same rotating speed of a pulverizer and the same water content of the medicinal powder, and freezing the obtained mixed powder in liquid nitrogen for 4 hours; placing in low temperature environment of 0-10 deg.C, micronizing to obtain silicon dioxide preparation sample and magnesium stearate preparation sample.
4. Test method
The test uses 48 Kunming old mice, has both male and female functions, is randomly divided into 3 groups of silicon dioxide preparation administration group, magnesium stearate preparation administration group and normal saline control group, the administration group is continuously irrigated with stomach for 10 days, 7g/kg of silicon dioxide preparation test sample and magnesium stearate preparation test sample are respectively administered, the control group is irrigated with deionized water with corresponding volume, and the stomach irrigation is performed twice at fixed time every day. And 14d are observed continuously. Body mass, behavior, diet and excretion were recorded for each group of animals. On day 14, the mice were subjected to eyeball blood sampling and liver and kidney sampling, and biochemical index measurement and pathological staining observation were performed.
5. Conclusion
The body mass, diet, behavior, excretion and measured values of serum glucose, total protein, creatinine and triglyceride of the mice after drug administration are not obviously changed compared with those before drug administration (P is more than 0.05), and the two groups after drug administration have no obvious difference compared with the control group; the pathological staining of the liver and the kidney does not show any change of toxicology. The research results show that the preparation prepared by adding silicon dioxide or magnesium stearate into the Chinese patent medicine for benefiting qi and nourishing blood has no acute toxicity under the experimental conditions.
It will be apparent to those skilled in the art that various changes and modifications may be made in the present invention without departing from the spirit and scope of the invention. Thus, if such modifications and variations of the present invention fall within the scope of the claims of the present invention and their equivalents, the present invention is also intended to include such modifications and variations.
Claims (10)
1. A Chinese patent medicine preparation for benefiting qi and nourishing blood is characterized in that: the Chinese patent medicine preparation comprises the following Chinese medicine raw materials in parts by weight: 69.5-278 parts of tuber fleeceflower root, 56.8-227 parts of prepared rehmannia root, 86-344 parts of cortex lycii radicis, 51.8-207 parts of rehmannia root, 86-344 parts of tuckahoe, 51.8-207 parts of asparagus, 51.8-207 parts of dwarf lilyturf tuber and 51.5-206 parts of ginseng.
2. The Chinese patent drug formulation according to claim 1, characterized in that: the Chinese patent medicine preparation comprises the following Chinese medicine raw materials in parts by weight: 139 parts of tuber fleeceflower root, 113.5 parts of prepared rehmannia root, 172 parts of cortex lycii radicis, 103.5 parts of rehmannia root, 172 parts of tuckahoe, 103.5 parts of asparagus, 103.5 parts of dwarf lilyturf tuber and 103 parts of ginseng.
3. The method for preparing a Chinese patent medicine preparation according to claim 1 or claim 2, which is characterized in that: the method comprises the following steps:
(1) weighing 1/2-1 parts by weight of the polygonum multiflorum, adding 1/3-1/5 parts by weight of the polygonum multiflorum, uniformly stirring, moistening, drying, adding 1/9-1/11 parts by weight of the liquorice juice, uniformly stirring, and drying for later use;
(2) washing cortex Lycii and Poria with Chinese liquor, and drying;
(3) soaking radix rehmanniae Preparata and rehmanniae radix with Chinese liquor for 2-24 hr, and drying respectively;
(4) soaking radix asparagi and radix Ophiopogonis in Chinese liquor for 2-6 hr, and drying respectively;
(5) mixing the seven ingredients with the ginseng and the rest of the polygonum multiflorum, crushing by using a crusher, and sieving by using a 24-50-mesh pharmacopeia sieve to obtain crude medicinal powder;
(6) adding a grinding aid into the crude powder of the medicinal materials obtained in the step (5) and mixing, wherein the grinding aid accounts for 0-2.0% of the weight of the crude powder of the medicinal materials;
(7) freezing the mixed powder obtained in the step (6) in liquid nitrogen for 0.5-4 h;
(8) placing the mixed powder obtained in the step (7) at a low temperature of-10-0 ℃ for carrying out superfine grinding together to obtain superfine mixed powder;
(9) the Chinese patent medicine preparation for benefiting qi and nourishing blood is any one of common preparation formulations prepared from the mixed powder obtained in the step (8) by using a conventional Chinese medicine preparation method.
4. The production method according to claim 3, characterized in that: and (3) drying in the step (1), the step (2), the step (3) and the step (4) until the water content is less than 0.5 percent in percentage by weight.
5. The production method according to claim 3 or claim 4, characterized in that: in the step (6), the grinding aid is one or two of silicon dioxide or magnesium stearate which are pharmaceutic adjuvants recorded in Chinese pharmacopoeia.
6. The production method according to any one of claims 3 to 5, characterized in that: in the step (7), the mixed powder obtained in the step (6) is subjected to primary crushing and then is frozen in liquid nitrogen for 2 hours.
7. The production method according to any one of claims 3 to 6, characterized in that: in step (8), the mixed powder has an average particle diameter of less than 35 μm, preferably 25 to 30 μm.
8. The production method according to any one of claims 3 to 7, characterized in that: in step (9), the dosage form is selected from tablets, powders, capsules, pills, granules, oral liquids, granules, drop pills, pellets, intramuscular injections, instillations or ointments.
9. The method of claim 8, wherein: in step (9), the dosage form is selected from tablets, pills, granules or capsules.
10. The production method according to claim 8 or claim 9, characterized in that: in the step (9), the tablet is a sugar-coated tablet, a film-coated tablet or an enteric-coated tablet, the capsule is a soft capsule, and the ointment is an ointment or a plaster.
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| WO2023165399A1 (en) * | 2022-03-02 | 2023-09-07 | 广州白云山敬修堂药业股份有限公司 | Chinese patent medicine preparation for tonifying qi and nourishing blood and preparation method therefor |
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| CN1239674A (en) * | 1999-06-29 | 1999-12-29 | 张家宝 | Nutrient liquid with health care function on prostate |
| CN102362978A (en) * | 2011-10-21 | 2012-02-29 | 北京同仁堂天然药物有限公司 | Chinese medicinal composition having effects of tonifying kidney, replenishing essence, replenishing qi and nourishing blood |
| CN108721564A (en) * | 2017-04-24 | 2018-11-02 | 四川省中医药科学院 | A kind of pharmaceutical composition and its preparation method and application for treating thrombopenia |
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| CN1239674A (en) * | 1999-06-29 | 1999-12-29 | 张家宝 | Nutrient liquid with health care function on prostate |
| CN102362978A (en) * | 2011-10-21 | 2012-02-29 | 北京同仁堂天然药物有限公司 | Chinese medicinal composition having effects of tonifying kidney, replenishing essence, replenishing qi and nourishing blood |
| CN108721564A (en) * | 2017-04-24 | 2018-11-02 | 四川省中医药科学院 | A kind of pharmaceutical composition and its preparation method and application for treating thrombopenia |
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| WO2023165399A1 (en) * | 2022-03-02 | 2023-09-07 | 广州白云山敬修堂药业股份有限公司 | Chinese patent medicine preparation for tonifying qi and nourishing blood and preparation method therefor |
| CN114887069A (en) * | 2022-06-07 | 2022-08-12 | 广州白云山敬修堂药业股份有限公司 | Licorice carbon coating material for reducing drug hepatotoxicity and preparation method and application thereof |
| CN114887069B (en) * | 2022-06-07 | 2024-06-07 | 广州白云山敬修堂药业股份有限公司 | Licorice charcoal coating material for reducing drug hepatotoxicity and preparation method and application thereof |
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