CN111375041A - Traditional Chinese medicine composition for treating depression and preparation method thereof - Google Patents

Traditional Chinese medicine composition for treating depression and preparation method thereof Download PDF

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CN111375041A
CN111375041A CN201811643818.XA CN201811643818A CN111375041A CN 111375041 A CN111375041 A CN 111375041A CN 201811643818 A CN201811643818 A CN 201811643818A CN 111375041 A CN111375041 A CN 111375041A
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张贵民
高艳红
杨梅
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Lunan Pharmaceutical Group Corp
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Abstract

The invention relates to a traditional Chinese medicine composition for treating depression and a preparation method thereof, belonging to the technical field of traditional Chinese medicines. The traditional Chinese medicine composition is prepared from 10 traditional Chinese medicines including radix bupleuri, pinellia ternate, scutellaria baicalensis, ginseng, liquorice, mangnolia officinalis, ginger, rhizoma acori graminei, poria cocos and perilla leaves. The traditional Chinese medicine composition can dredge qi movement in an early stage, and ensure that the generation, distribution and operation of qi, blood and body fluid of the whole body are normal, thereby preventing the pathogenesis of depression from developing towards the directions of phlegm obstruction, blood fatigue, stagnated heat, qi deficiency, blood deficiency, body fluid deficiency, yin deficiency and fire excess and the like, and preventing the further deterioration of the disease condition. Animal experiments show that the traditional Chinese medicine composition can obviously improve the symptoms of a reserpine-induced mouse depression model and has an anti-depression effect.

Description

Traditional Chinese medicine composition for treating depression and preparation method thereof
Technical Field
The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine composition for treating depression, and a traditional Chinese medicine composition pellet preparation and a preparation method thereof for treating depression.
Background
Disability losses from depression have been ranked second in all diseases worldwide. According to the statistics of the world health organization, the incidence rate of the global depression is 3.1 percent, while the incidence rate of China is higher than the average level in the world and is in a continuously rising trend in recent years. Mental diseases such as depression exceed cardiovascular and cerebrovascular diseases and cancers, become the biggest challenge for Chinese medical health systems, and bring heavy economic and psychological burden to families of patients. It is worth noting that Chinese depression patients have a tendency of becoming younger, and a study of the psychological research institute of the Chinese academy of sciences shows that the mental stress is highest in people between 20 and 30 years old, the young people are in the initial stages of graduation and job fighting, the life pattern is not determined, and the people are easy to overstock in the future due to confusion and anxiety, so that depression is generated.
Modern medicine considers that depression is an affective disorder, is clinically characterized by significant and persistent emotional depression and has corresponding thought and behavior changes such as slow thinking, psychomotor inhibition and the like; clinically, it is manifested as depressed mood, thought retardation, decreased interest, decreased mental activities, anxiety, physical pain, decreased appetite, sexual dysfunction, and sleep disorder. The treatment effect of the existing main anti-depression western medicines has considerable limitations, such as 5-HT reuptake inhibitor (SSRIs) which needs to be taken for several weeks to take effect, part of patients are easy to relapse, and the other part of patients do not respond to chemical medicines.
The traditional Chinese medicine theory considers that depression mostly belongs to the category of depression syndrome, the depression is located in the liver, the core of pathological change is depression of liver qi, and qi circulation is the basic great method for treating depression. The heart stores spirit, the liver stores soul, and the five internal organs are closely related to mental activities such as thinking, emotional changes and the like, and the liver is the heart except the heart. Ming Dynasty Zhao dedication can be thought in Yi guan & Yu Bing Lun (treatise on diseases with stagnation of wood), so it is proposed that "one method replaces five methods, the spirit is clear, and the effect is obtained. One approach is to treat the depression of the liver and gallbladder, and relieve all the depression. Meanwhile, modern epidemiological investigation also shows that depression has a close relationship with liver depression. In the traditional Chinese medicine theory, there are interdependencies and relationships between the zang-fu organs, so when performing syndrome differentiation treatment on depression, the treatment should not be limited to one zang-fu organ, but should be mainly performed on one zang-organ or one fu-organ, and should be combined with other zang-organs. Therefore, different therapeutic methods and medicines are provided for different syndrome types of depression, and the traditional Chinese medicine has unique clinical advantages.
Disclosure of Invention
The invention aims to provide a traditional Chinese medicine composition for treating depression, which is prepared from 10 traditional Chinese medicines of radix bupleuri, pinellia ternate, radix scutellariae, ginseng, liquorice, mangnolia officinalis, ginger, rhizoma acori graminei, poria cocos and folium perillae, has the effects of promoting qi circulation, reducing phlegm, lowering adverse qi, harmonizing stomach, excreting dampness and tonifying spleen, and is used for treating depression.
The traditional Chinese medicine composition is prepared from the following traditional Chinese medicine components:
Figure BDA0001931632910000021
preferably, the traditional Chinese medicine composition is prepared from the following traditional Chinese medicine components:
Figure BDA0001931632910000022
preferably, the traditional Chinese medicine composition is prepared from the following traditional Chinese medicine components:
Figure BDA0001931632910000023
preferably, the pinellia ternate in the traditional Chinese medicine composition is ginger processed pinellia ternate, and the licorice is honey-fried licorice root.
In the recipe, radix bupleuri is cool in nature, bitter in taste and pungent in flavor, enters liver and gallbladder meridians mainly, has the effects of regulating qi stagnation and eliminating shaoyang pathogens, and has the effect of regulating emotion, namely, the syndrome of wood depression; magnolia officinalis, which belongs to spleen, stomach and large intestine channels, can descend qi to remove fullness, and emphasizes on qi circulation to stagnate qi in chest, combines with Bupleurum root, and can treat phlegm accumulation, qi stagnation, phlegm-qi descending to promote qi circulation, and phlegm-qi descending to relieve stagnation, and is used as monarch drug.
Pinellia tuber is warm in nature and pungent in flavor, enters spleen, stomach and lung meridians, reduces phlegm and resolves masses, lowers adverse qi and harmonizes stomach, emphasizes on lowering adverse qi, and helps magnolia officinalis to reduce phlegm; the tuckahoe, which is sweet in taste and mild in nature, has the effects of nourishing heart, lung, spleen and kidney channels, excreting dampness and strengthening spleen, and has the effects of eliminating dampness and reducing phlegm together with the pinellia ternate; the scutellaria baicalensis is bitter and cold in nature, enters the channels of the lung, the stomach, the gallbladder and the large intestine, clears heat and dries dampness, purges fire and detoxifies, cools blood and stops bleeding; ginseng, radix Ginseng, sweet in taste and slightly bitter in flavor, enters heart, lung and spleen channels, supplements primordial qi, benefits spleen and lung, promotes fluid production, soothes the nerves, has the effects of invigorating qi, soothing nerves and benefiting intelligence, and is used as ministerial drug.
Folium Perillae, slightly pungent in flavor, fragrant in smell, and has effects of ventilating lung, regulating qi and relieving chest stuffiness, dredging qi stagnation in chest, and benefiting Magnolia officinalis; ginger, pungent in flavor and warm in nature, enters lung, spleen and stomach meridians, and has the effects of harmonizing stomach, lowering adverse qi, arresting vomiting and relieving the toxicity of pinellia ternate; the grassleaf sweelflag rhizome, rhizoma acori graminei, pungent in nature, warm and bitter in taste, enters heart and stomach meridians, induces resuscitation, calms mind, and dissipates dampness to harmonize stomach, and the three are adjuvant drugs.
Licorice root, radix Glycyrrhizae is sweet and neutral in nature and flavor, and enters heart, lung, spleen and stomach meridians. Tonify qi, strengthen the middle-jiao, clear heat and remove toxicity, dispel phlegm, relieve cough, relieve spasm and alleviate pain. It can moderate the property of the medicine, harmonize the effects of all the herbs, and make the whole formula warm and cold properly, and is used as a guiding drug.
The composition of the invention follows 'assistant and guide' in traditional Chinese medicine, has precise and appropriate compatibility, and integrates the functions of eliminating evil, strengthening body resistance and treating wood and soil. The basic pathogenesis of depression is that pathogen stagnates shaoyang and the pivot is unfavorable, the formula can dredge qi stagnation as soon as possible, and ensure that the generation, distribution and operation of qi, blood and body fluid of the whole body are normal, thereby preventing the development of the pathogenesis of depression in the directions of phlegm stagnation, blood fatigue, stagnated heat, qi deficiency, blood deficiency, body fluid deficiency, yin deficiency and fire excess and the like, and preventing the further deterioration of the disease condition.
The invention also aims to provide a pellet preparation containing the traditional Chinese medicine composition and a preparation method thereof, and preferably, the pellet preparation can be further prepared into pellet tablets and/or pellet capsules.
The traditional Chinese medicine composition pellet preparation comprises: fine powder of extract prepared from Chinese medicinal composition, pill forming promoter, and viscosity regulator.
Preferably, the pellet formulation comprises:
a. 27-35% of extract fine powder
b. 49 to 61 weight percent of pelleting accelerant
c. 8-16% of viscosity regulator;
preferably, the pellet formulation comprises:
a. fine powder of extract 34 wt%
b. 55 wt% of pelleting accelerant
c. 11% of viscosity modifier.
The pelleting accelerant is one or more of hydroxypropyl methyl cellulose, cellulose acetate, ethyl cellulose, microcrystalline cellulose and chitosan, and the viscosity regulator is one or more of sodium carboxymethyl starch, lactose, dextrin and superfine silica gel powder;
preferably, the pelleting accelerator is a mixture of microcrystalline cellulose and hydroxypropyl methyl cellulose, and the viscosity regulator is a mixture of micropowder silica gel and sodium carboxymethyl starch.
Further preferably, the microcrystalline cellulose: hydroxypropyl methylcellulose ═ 1: 0.5-1.0, and the optimal proportion is microcrystalline cellulose: hydroxypropyl methylcellulose ═ 1: 0.5; the micro silica gel powder: sodium carboxymethyl starch ═ 1: 0.2-0.6; the optimal proportion is micropowder silica gel: sodium carboxymethyl starch ═ 1: 0.6.
the invention also discloses a preparation method of the compound traditional Chinese medicine pellet preparation for treating depression, which comprises the following steps:
A. weighing bupleuri radix, cortex Magnolia officinalis, rhizoma Zingiberis recens, rhizoma Acori Graminei and folium Perillae, soaking in water, distilling, collecting volatile oil, and collecting residue and medicinal liquid after distillation;
B. adding β -cyclodextrin into the volatile oil obtained in the step A to prepare an inclusion compound for later use;
C. decocting the residues distilled in the step A, pinellia ternate, scutellaria baicalensis, ginseng, liquorice and poria cocos with water, mixing the decoction with the liquid medicine distilled in the step A, filtering, concentrating the filtrate to obtain an extract with the relative density of 1.15-1.22(50 ℃), adding an ethanol solution until the ethanol concentration is 50% -70%, uniformly stirring, refrigerating for 24 hours, and filtering to obtain an ethanol precipitation solution;
D. c, taking the alcohol precipitation liquid in the step C, concentrating under reduced pressure and recovering ethanol to obtain thick paste, drying the thick paste in a vacuum belt type, and then crushing the thick paste into fine powder;
E. d, uniformly mixing the fine powder obtained in the step D and the volatile oil inclusion compound obtained in the step B to obtain fine powder of the traditional Chinese medicine extract for later use;
F. weighing the fine powder of the extract obtained in the step E, a pelleting accelerator and a viscosity regulator, uniformly mixing, adding an ethanol solution, kneading to prepare a soft material, and extruding to obtain a strip-shaped object;
G. opening the spheronizer, putting the strip-shaped objects in the step F into the spheronizer, preparing pellets, drying and screening to obtain the finished product;
H. g, taking the pellets obtained in the step G as a raw material, and preparing pellet tablets or pellet capsules according to a conventional preparation method;
preferably, the above preparation method comprises the steps of:
A. weighing bupleuri radix, cortex Magnolia officinalis, rhizoma Zingiberis recens, rhizoma Acori Graminei and folium Perillae, soaking in water for 15-45min, distilling for 6-8 hr, collecting volatile oil, and collecting the residue and medicinal liquid after distillation;
B. adding β -cyclodextrin into the volatile oil obtained in step A to prepare an inclusion compound for later use;
C. decocting the residues in the step A, pinellia ternate, scutellaria baicalensis, ginseng, liquorice and poria cocos with water for 2 times, adding 8-12 times of water, decocting for 1-3h each time, combining the decoction with the liquid medicine obtained after distillation in the step A, filtering, concentrating the filtrate to obtain an extract with the relative density of 1.20(50 ℃), adding an ethanol solution until the ethanol concentration of the supernatant is 60%, uniformly stirring, refrigerating for 24 hours, and filtering to obtain an ethanol precipitation solution;
D. c, taking the alcohol precipitation liquid in the step C, concentrating under reduced pressure and recovering ethanol to obtain thick paste, drying the thick paste in a vacuum belt manner, and crushing the thick paste into fine powder;
E. and D, uniformly mixing the fine powder obtained in the step D and the volatile oil inclusion compound obtained in the step B to obtain extract fine powder for later use.
F. Weighing the fine powder of the extract obtained in the step E, a pelleting accelerant and a viscosity regulator, uniformly mixing, adding 35-45% of 25-40% ethanol solution by weight, kneading to prepare a soft material, and extruding the soft material into strips through a sieve plate with the aperture of 0.9-1.1 mm of an extruder;
G. opening a spheronizer, putting the strip-shaped objects in the step F into the spheronizer to prepare a pellet semi-finished product, taking out the pellet semi-finished product, drying at 75-90 ℃, and screening to obtain pellets of 20-30 meshes;
H. and G, taking the pellet obtained in the step G as a raw material, and preparing a pellet tablet or a pellet capsule according to a conventional preparation method.
In the preparation method, the belt type vacuum drying condition of the step D is that the vacuum degree is-0.08 MPa to-0.10 MPa, and the drying temperature is 75 ℃ to 90 ℃; preferably, the belt type vacuum drying condition is that the vacuum degree is-0.08 MPa-0.10 MPa, and the drying temperature is 85 ℃.
G, the rotating speed of the rounding machine is 950-1100 rpm, and the rounding time is 6-8 min; preferably, the speed of the rounding machine in the step G is 1050rpm, and the rounding time is 7 min.
The pellet prepared by the invention is spherical or spheroidal, has regular appearance, smooth and round surface, good fluidity, large drug-loading capacity and small dosage, and reduces the drug administration times of patients; has the advantages of rapid release, high bioavailability, good stability, and no influence by gastrointestinal rhythm. In addition, the pellet can be used as common granules, and can also be further used as an intermediate to be filled into capsules, pressed into tablets and the like, so that pellet tablets and pellet capsules can be obtained.
In-vitro cumulative release dissolution rate tests show that the pellet tablet and the capsule of the invention achieve more than 80% dissolution within 40min and more than 90% dissolution within 60min, and test results show that the pellet preparation of the invention has good drug dissolution effect.
Experimental example 1 dissolution test
Pellets of the present invention in example 5 and pellets of example 9 were prepared in accordance with the dissolution method (third method of 0931, the fourth general rule of the 2015 th pharmacopoeia) using 200ml of distilled water as a dissolution medium, a water bath temperature of 37 ℃. + -. 0.5 ℃ and a rotation speed of 100r & min-1In vitro dissolution test was performed under the conditions of (1) and the evaluation was conducted using baicalin as an index.
The chromatographic conditions were octadecyl silane-bonded silica gel as filler, methanol-water-phosphoric acid ═ 47: 53: 0.2 is mobile phase; the detection wavelength was 280 nm. The number of theoretical plates is not less than 2500 calculated by baicalin peak.
Preparation of reference solution A proper amount of baicalin reference is precisely weighed, and methanol is added to obtain a solution containing 60 μ g of baicalin per 1 ml.
Preparing a sample solution to be tested, taking 5ml of a sample at each time point, simultaneously adding 5ml of isothermal distilled water, filtering the sample through a 0.45-micron microporous membrane, precisely measuring 2ml of subsequent filtrate, placing the subsequent filtrate in a 10ml measuring flask, adding methanol to prepare scales, and shaking uniformly to obtain the sample solution.
The determination method precisely absorbs 10ul of each of the reference solution and the sample solution, injects into the liquid chromatograph, calculates the baicalin content in the sample by adopting an external standard two-point method logarithmic equation, and calculates the cumulative dissolution percentage of the baicalin at each time point, and the result is shown in table 1.
TABLE 1 cumulative percent dissolution for different samples
Figure BDA0001931632910000051
Figure BDA0001931632910000061
The dissolution curve was plotted with the dissolution time (min) as abscissa and the cumulative dissolution percentage (%) as ordinate, as shown in FIG. 1. As shown in figure 1, the pellet tablet and the pellet capsule can be dissolved out by more than 80% in 40min and more than 90% in 60min, and the pellet preparation of the invention can be dissolved out rapidly and comprehensively, which shows that the prepared pellet has good in-vitro dissolution effect.
Experimental example 2 Effect on behavioral despair model of depression
1. Medicine the fine powder of the Chinese medicinal composition obtained in example 9 of the present invention; venlafaxine was used as a positive control drug.
2. Animal SPF grade ICR mice, 100 mice, weight range 18-22g, male and female half.
3. In the experimental grouping and administration adaptation period, the mice were randomly divided into a model group (administered with distilled water), a positive control group (venlafaxine 0.05g/kg), a test group 1 (high dose group, equivalent to a crude drug amount of 32g/kg), a test group 2 (medium dose group, equivalent to a crude drug amount of 16g/kg), a test group 3 (low dose group, equivalent to a crude drug amount of 8g/kg), and 20 mice per group. Wherein venlafaxine is dissolved in a suitable amount of distilled water; the Chinese medicinal composition is dissolved in proper hot water after being converted according to the crude drug amount.
Each group of mice was gavaged with 20mL/kg/d of the corresponding distilled water or drug suspension for 14 consecutive days.
4. In the tail suspension test of the mice, 10 mice are selected from each group 1h after the last administration, the 1cm position of the tail tip of each mouse is adhered to a suspension loop by using a medical adhesive tape, so that each mouse is in an independent quiet space and does not interfere with each other, and after the mice are adapted for 2min, the immobility time (four limbs stop struggling) within 4min after the mice are analyzed and recorded.
5. Forced swimming test of mice the remaining 10 mice in each group were taken, placed in a transparent organic glass jar containing water, adapted for 2min, and analyzed for immobility time (no struggle of the limbs, overall floating state) during swimming of the mice within 4 min.
6. Statistical analysis the test data were statistically analyzed using the sps software.
7. Results and discussion the immobility time of the mice in each group is shown in table 1.
Table 1 test immobility time (X ± SD, n ═ 10) for each group of mice
Figure BDA0001931632910000071
Note: in comparison with the blank set, the results,*P<0.05,**P<0.01。
as can be seen from the above table, the positive control group and the test group (i.e. the high, medium and low dose groups of the composition) can significantly reduce the immobility time in the tail suspension test and forced swimming test of the mice, and have significant differences compared with the blank group. Therefore, the traditional Chinese medicine composition provided by the invention has a remarkable anti-depression effect.
Experimental example 3 Effect on reserpine-induced mouse model of Depression
1. Medicine the fine powder of the extract of the traditional Chinese medicine obtained in example 9 of the present invention; venlafaxine was used as a positive control drug. The above drugs are dissolved with distilled water to appropriate concentration.
Reserpine solution: a proper amount of reserpine standard substance is weighed and dissolved in 2% acetic acid solution to ensure that the concentration of the reserpine standard substance is 2.0 mg/mL.
2. Animals male SPF grade ICR mice, 60, body weights ranged from 18-22 g.
3. In the experimental grouping and administration adaptation period, the mice were randomly divided into a blank control group (given distilled water), a model group (given distilled water), a positive control group (0.05 g/kg venlafaxine), a test group 1 (high dose group, equivalent to a crude drug amount of 32g/kg), a test group 2 (medium dose group, equivalent to a crude drug amount of 16g/kg), a test group 3 (low dose group, equivalent to a crude drug amount of 8g/kg), and 10 mice per group. Wherein venlafaxine is dissolved in a suitable amount of distilled water; the Chinese medicinal composition is dissolved in proper hot water after being converted according to the crude drug amount.
Each group of mice was gavaged with the corresponding drug at 20 mL/kg/day for 14 consecutive days.
4. After the test method and the determination index are administered for 1 hour at the last time, the model group, the positive control group and each test group are respectively administered with reserpine solution with the dose of 4mg/kg, the blank control group is administered with the same amount of physiological saline, and the following indexes are respectively observed:
1) drooping eyelid: after 2h of administration, mice were observed for ptosis of the upper eyelid. The mice were placed on a horizontal surface consistent with the height of the experimenter's eye line during observation, and scored according to the degree of eyelid prolapse: eye closure 1/4 is 1 minute, eye closure 1/2 is 2 minutes, eye closure 3/4 is 3 minutes, and closure is 4 minutes.
2) Body temperature: after 4h of dosing, the anal temperature of each group of mice was tested using an infrared thermometer.
5. Results and discussion groups of mice were tested for blepharoptosis score and body temperature change, see table 2.
Table 2 effects on reserpine induced depression model mice eyelid ptosis and body temperature (X ± SD, n ═ 10)
Figure BDA0001931632910000081
Note: in comparison with the set of models,*P<0.05,**P<0.01。
as can be seen from the above table, the positive control group and the composition provided by the present invention both significantly reduce the score of mouse eyelid ptosis, increase the body temperature of mice, and have significant differences compared with the model group.
Reserpine (Reserpine) is an indole-type alkaloid, and antagonism of behavioral and physiological changes caused by Reserpine is the earliest developing animal model of depression. The animals treated by reserpine have symptoms of upper eyelid ptosis, body temperature drop and rigidity, so the eyelid ptosis score and the body temperature are often used as the judgment criteria of the depression degree of the animals. The test result shows that the composition provided by the invention can obviously improve the symptoms of a reserpine-induced mouse depression model and has a good anti-depression effect.
Drawings
FIG. 1 is a graph of the cumulative dissolution percentage of pellet tablets and pellet capsules.
Detailed Description
EXAMPLE 1 preparation of pellet tablets
Prescription:
Figure BDA0001931632910000082
the preparation method comprises the following steps:
A. weighing bupleuri radix, cortex Magnolia officinalis, rhizoma Zingiberis recens, rhizoma Acori Graminei and folium Perillae, soaking in water for 15min, distilling for 6 hr, collecting volatile oil, and collecting residue and medicinal liquid after distillation;
B. adding β -cyclodextrin into the volatile oil obtained in step A to prepare an inclusion compound for later use;
C. decocting the residues in the step A, pinellia ternate, scutellaria baicalensis, ginseng, liquorice and poria cocos with water for 2 times, decocting the residues in water for 3 hours in an amount which is 8 times that of the residues in the step A for 3 hours in the first time, decocting the residues in water for 1.5 hours in an amount which is 6 times that of the residues in the second time, mixing the decoction with the liquid medicine distilled in the step A, filtering, concentrating the filtrate to obtain an extract with the relative density of 1.15(50 ℃), adding an ethanol solution until the ethanol concentration is 50%, stirring uniformly, refrigerating for 24 hours, and filtering;
D. taking the ethanol precipitation liquid in the step C, concentrating under reduced pressure, recovering ethanol to obtain thick paste, belt-type vacuum drying at a vacuum degree of-0.08 MPa to-0.10 MPa and a drying temperature of 75 ℃, and crushing into fine powder;
E. mixing the fine powder obtained in step D and the volatile oil inclusion compound obtained in step B uniformly to obtain 276g of extract fine powder for later use;
F. weighing
a. Fine powder of the extract: 276g
b. Microcrystalline cellulose: 610g
c. Dextrin: 114g
Mixing the above extract fine powder, microcrystalline cellulose and dextrin, adding 40 wt% 35% ethanol solution, kneading, making into soft material, and extruding with sieve plate with 1.0mm aperture into strips;
G. opening a spheronizer, placing the strip-shaped objects obtained in the step F into the spheronizer at the rotating speed of 1100rpm for 8min to prepare semi-finished pellets, taking out the semi-finished pellets, drying at 80 ℃, and screening to obtain 881.9g of pellets of 20-30 meshes;
adding microcrystalline cellulose 103.1g into the pellet obtained by the above method, mixing, granulating into coarse granules, drying, pulverizing, sieving, granulating, drying at low temperature, grading, adding magnesium stearate 6g and pulvis Talci 9g, mixing, and tabletting to obtain pellet tablet.
Example 2 preparation of pellet capsules
Prescription:
Figure BDA0001931632910000091
the preparation method comprises the following steps:
A. weighing bupleuri radix, cortex Magnolia officinalis, rhizoma Zingiberis recens, rhizoma Acori Graminei and folium Perillae, soaking in water for 45min, distilling for 8 hr, collecting volatile oil, and collecting residue and medicinal liquid after distillation;
B. adding β -cyclodextrin into the volatile oil obtained in step A to prepare an inclusion compound for later use;
C. decocting the residues in the step A, pinellia ternate, scutellaria baicalensis, ginseng, liquorice and poria cocos with water for 2 times, decocting the residues in water for 1 hour by 12 times for the first time, decocting the residues in water for 0.5 hour by 10 times for the second time, mixing the decoction with the liquid medicine distilled in the step A, filtering, concentrating the filtrate to obtain an extract with the relative density of 1.22(50 ℃), adding an ethanol solution until the ethanol concentration of the supernatant is 70%, uniformly stirring, refrigerating for 24 hours, and filtering to obtain an ethanol precipitation solution;
D. taking the ethanol precipitation liquid in the step C, concentrating under reduced pressure, recovering ethanol to obtain thick paste, belt-type vacuum drying at a vacuum degree of-0.08 MPa to-0.10 MPa and a drying temperature of 85 ℃, and crushing into fine powder;
E. mixing the fine powder obtained in step D and the volatile oil inclusion compound obtained in step B uniformly to obtain 338g of fine extract powder for later use;
F. weighing
a. Fine powder of the extract: 338g
b. Microcrystalline cellulose: 305.6g
Hydroxypropyl methylcellulose: 244.4g
c. Silica gel micropowder: 86.2g
Sodium carboxymethyl starch: 25.8g
Mixing the above extract fine powder, microcrystalline cellulose, hydroxypropyl methylcellulose, silica gel micropowder, and sodium carboxymethyl starch, adding 35% (by weight) ethanol solution with concentration of 40%, kneading, making into soft material, and extruding with sieve plate with aperture of 1.1mm to obtain strip;
G. opening a spheronizer, placing the strip-shaped objects obtained in the step F into the spheronizer, wherein the rotating speed of the spheronizer is 950rpm, the spheronization time is 6min, preparing a pellet semi-finished product, taking out the pellet semi-finished product, drying at 90 ℃, and screening to obtain 895.6g of pellets with 20-30 meshes;
adding starch 104.4g into the pellet obtained by the above method, filling, polishing in a polishing machine, and removing damaged capsule to obtain pellet capsule.
EXAMPLE 3 preparation of pellet capsules
Prescription:
Figure BDA0001931632910000101
the preparation method comprises the following steps:
A. weighing bupleuri radix, cortex Magnolia officinalis, rhizoma Zingiberis recens, rhizoma Acori Graminei and folium Perillae, soaking in water for 30min, distilling for 7 hr, collecting volatile oil, and collecting residue and medicinal liquid after distillation;
B. adding β -cyclodextrin into the volatile oil obtained in step A to prepare an inclusion compound for later use;
C. decocting the residues in the step A, pinellia ternate, scutellaria baicalensis, ginseng, liquorice and poria cocos with water for 2 times, decocting the residues in water for 2 hours in a manner of 10 times the amount of the residues in the first time, decocting the residues in water for 1 hour in a manner of 8 times the amount of the residues in the second time, mixing the decoction with the liquid medicine distilled in the step A, filtering, concentrating the filtrate to obtain an extract with the relative density of 1.20(50 ℃), adding an ethanol solution until the ethanol concentration of the supernatant is 60%, stirring uniformly, refrigerating for 24 hours, and filtering to obtain an ethanol precipitation;
D. taking the ethanol precipitation liquid in the step C, concentrating under reduced pressure, recovering ethanol to obtain thick paste, belt-type vacuum drying at the vacuum degree of-0.08 MPa to-0.10 MPa and the drying temperature of 90 ℃, and crushing into fine powder;
E. uniformly mixing the fine powder obtained in the step D and the volatile oil inclusion compound obtained in the step B to obtain 275g of fine extract powder for later use;
F. weighing
a. Fine powder of the extract: 275g
b. Cellulose acetate: 565g
c. Dextrin: 50g
Sodium carboxymethyl starch: 110g
Mixing the above extract fine powder, cellulose acetate, dextrin, and sodium carboxymethyl starch, adding 45% (by weight) ethanol solution with concentration of 25%, kneading, making into soft material, and extruding with sieve plate with aperture of 0.9mm to obtain strip;
G. opening a spheronizer, placing the strip-shaped objects obtained in the step F into the spheronizer at the rotating speed of 1000rpm for 7.5min to prepare a pellet semi-finished product, taking out the pellet semi-finished product, drying at 75 ℃, and screening to obtain 893.4g of pellets with 20-30 meshes;
adding starch 106.6g into the pellet obtained by the above method, filling, polishing in a polishing machine, and removing damaged capsule to obtain pellet capsule.
EXAMPLE 4 preparation of pellet tablets
Prescription:
Figure BDA0001931632910000111
the preparation method comprises the following steps:
A. weighing bupleuri radix, cortex Magnolia officinalis, rhizoma Zingiberis recens, rhizoma Acori Graminei and folium Perillae, soaking in water for 15min, distilling for 8 hr, collecting volatile oil, and collecting residue and medicinal liquid after distillation;
B. adding β -cyclodextrin into the volatile oil obtained in step A to prepare an inclusion compound for later use;
C. decocting the residues in the step A, pinellia ternate, scutellaria baicalensis, ginseng, liquorice and poria cocos with water for 2 times, decocting the residues in water for 2 hours in an amount which is 8 times that of the residues in the step A for 2 hours in the first time, decocting the residues in water for 1.5 hours in an amount which is 10 times that of the residues in the second time, mixing the decoction with the liquid medicine distilled in the step A, filtering, concentrating the filtrate to obtain an extract with the relative density of 1.19(50 ℃), adding an ethanol solution until the ethanol concentration of the supernatant is 70%, stirring uniformly, refrigerating for 24 hours;
D. taking the ethanol precipitation liquid in the step C, concentrating under reduced pressure, recovering ethanol to obtain thick paste, belt-type vacuum drying at a vacuum degree of-0.08 MPa to-0.10 MPa and a drying temperature of 85 ℃, and crushing into fine powder;
E. d, uniformly mixing the fine powder obtained in the step D and the volatile oil inclusion compound obtained in the step B to obtain 293g of extract fine powder for later use;
F. weighing
a. Fine powder of the extract: 293g
b. Ethyl cellulose: 199g
And (3) chitosan: 400
c. Lactose: 108g
Mixing the above extract fine powder, ethyl cellulose, chitosan, and lactose, adding 35% (by weight) ethanol solution with concentration of 40% to knead, making into soft material, and extruding with sieve plate with aperture of 1.1mm to obtain strip;
G. opening a spheronizer, placing the strip-shaped objects obtained in the step F into the spheronizer at the rotating speed of 1050rpm for 8min to prepare semi-finished pellets, taking out the semi-finished pellets, drying at 85 ℃, and screening to obtain 911.1g of pellets of 20-30 meshes;
adding 71.9g of starch into the pellets obtained by the method, uniformly mixing, preparing into coarse granules, drying, crushing, sieving, preparing into granules, drying at low temperature, granulating, adding 7g of magnesium stearate and 10g of talcum powder, uniformly mixing, and tabletting to obtain the pellet tablets.
EXAMPLE 5 preparation of pellet tablets
Prescription:
Figure BDA0001931632910000121
the preparation method comprises the following steps:
A. weighing bupleuri radix, cortex Magnolia officinalis, rhizoma Zingiberis recens, rhizoma Acori Graminei and folium Perillae, soaking in water for 45min, distilling for 7 hr, collecting volatile oil, and collecting residue and medicinal liquid after distillation;
B. adding β -cyclodextrin into the volatile oil obtained in step A to prepare an inclusion compound for later use;
C. decocting the residues in the step A, pinellia ternate, scutellaria baicalensis, ginseng, liquorice and poria cocos with water for 2 times, decocting for 2.5 hours with 11 times of water for the first time, decocting for 1 hour with 9 times of water for the second time, mixing the decoction with the liquid medicine distilled in the step A, filtering, concentrating the filtrate to obtain an extract with the relative density of 1.18(50 ℃), adding an ethanol solution until the ethanol concentration of the supernatant is 50%, stirring uniformly, refrigerating for 24 hours, and filtering to obtain an ethanol precipitation solution;
D. taking the ethanol precipitation liquid in the step C, concentrating under reduced pressure, recovering ethanol to obtain thick paste, belt-type vacuum drying at a vacuum degree of-0.08 MPa to-0.10 MPa and a drying temperature of 75 ℃, and crushing into fine powder;
E. d, uniformly mixing the fine powder obtained in the step D and the volatile oil inclusion compound obtained in the step B to obtain 281g of fine extract powder for later use;
F. weighing
a. Fine powder of the extract: 281g
b. Microcrystalline cellulose: 289g
Hydroxypropyl methylcellulose: 289
c. Silica gel micropowder: 117.5g
Sodium carboxymethyl starch 23.5
Mixing the above extract fine powder, microcrystalline cellulose, hydroxypropyl methylcellulose, silica gel micropowder, and sodium carboxymethyl starch, adding 45% (by weight) 30% ethanol solution, kneading, making into soft material, and extruding with sieve plate with aperture of 0.9mm to obtain strip;
G. opening a spheronizer, placing the strip-shaped objects obtained in the step F into the spheronizer, wherein the rotating speed of the spheronizer is 950rpm, the spheronizer is used for 6.5min, preparing a pellet semi-finished product, taking out the pellet semi-finished product, drying the pellet semi-finished product at 80 ℃, and screening to obtain 922.4g of pellets with 20-30 meshes;
adding 60.6g of sodium carboxymethyl starch into the pellets obtained by the method, uniformly mixing, preparing into coarse granules, drying, crushing, sieving, preparing into granules, drying at low temperature, finishing granules, adding 6g of magnesium stearate and 11g of talcum powder, uniformly mixing, and tabletting to obtain the pellet tablets.
EXAMPLE 6 preparation of pellet capsules
Prescription:
Figure BDA0001931632910000131
the preparation method comprises the following steps:
A. weighing bupleuri radix, cortex Magnolia officinalis, rhizoma Zingiberis recens, rhizoma Acori Graminei and folium Perillae, soaking in water for 15min, distilling for 6 hr, collecting volatile oil, and collecting residue and medicinal liquid after distillation;
B. adding β -cyclodextrin into the volatile oil obtained in step A to prepare an inclusion compound for later use;
C. decocting the residues in the step A, pinellia ternate, scutellaria baicalensis, ginseng, liquorice and poria cocos with water for 2 times, decocting the residues in water for 1.5 hours in a 9-time manner for the first time, decocting the residues in water for 1 hour in a 7-time manner for the second time, mixing the decoction with the liquid medicine distilled in the step A, filtering, concentrating the filtrate to obtain an extract with the relative density of 1.16(50 ℃), adding an ethanol solution until the ethanol concentration of the supernatant is 60%, uniformly stirring, refrigerating for 24 hours, and filtering to obtain an ethanol precipitation solution;
D. taking the ethanol precipitation liquid in the step C, concentrating under reduced pressure, recovering ethanol to obtain thick paste, belt-type vacuum drying at a vacuum degree of-0.08 MPa to-0.10 MPa and a drying temperature of 80 ℃, and crushing into fine powder;
E. uniformly mixing the fine powder obtained in the step D and the volatile oil inclusion compound obtained in the step B to obtain 336g of fine extract powder for later use;
F. weighing
a. Fine powder of the extract: 336g
b. Microcrystalline cellulose: 234g
And (3) chitosan: 350
c. Lactose: 80g of
Mixing the above extract fine powder, microcrystalline cellulose, chitosan, and lactose, adding 35% (by weight) 25% ethanol solution, kneading, making into soft material, and extruding with sieve plate with aperture of 1.0mm to obtain strip;
G. opening a spheronizer, placing the strip-shaped objects obtained in the step F into the spheronizer at the rotating speed of 1000rpm for 7min to prepare semi-finished pellets, taking out the semi-finished pellets, drying at 90 ℃, and screening to obtain 875.4g of 20-30 meshes;
adding 124.6g of micro-emulsion sugar into the micro-pill obtained by the method, filling, polishing in a polishing machine, and removing damaged capsules to obtain the micro-pill capsule.
Example 7 preparation of pellet capsules
Prescription:
Figure BDA0001931632910000141
the preparation method comprises the following steps:
A. weighing bupleuri radix, cortex Magnolia officinalis, rhizoma Zingiberis recens, rhizoma Acori Graminei and folium Perillae, soaking in water for 30min, distilling for 8 hr, collecting volatile oil, and collecting residue and medicinal liquid after distillation;
B. adding β -cyclodextrin into the volatile oil obtained in step A to prepare an inclusion compound for later use;
C. decocting the residues in the step A, pinellia ternate, scutellaria baicalensis, ginseng, liquorice and poria cocos with water for 2 times, decocting the residues in water for 1 hour in a 10-time manner for the first time, decocting the residues in water for 1 hour in a 7-time manner for the second time, mixing the decoction with the liquid medicine distilled in the step A, filtering, concentrating the filtrate to obtain an extract with the relative density of 1.17(50 ℃), adding an ethanol solution until the ethanol concentration of the supernatant is 60%, uniformly stirring, refrigerating for 24 hours, and filtering to obtain an ethanol precipitation solution;
D. taking the ethanol precipitation liquid in the step C, concentrating under reduced pressure, recovering ethanol to obtain thick paste, belt-type vacuum drying at the vacuum degree of-0.08 MPa to-0.10 MPa and the drying temperature of 90 ℃, and crushing into fine powder;
E. uniformly mixing the fine powder obtained in the step D and the volatile oil inclusion compound obtained in the step B to obtain 270g of extract fine powder for later use;
F. weighing
a. Fine powder of the extract: 270g
b. Hydroxypropyl methylcellulose: 598g
c. Sodium carboxymethyl starch: 132g
Mixing the above extract fine powder, hydroxypropyl methylcellulose, and carboxymethyl starch sodium, adding 45% (by weight) 30% ethanol solution, kneading, making into soft material, and extruding with sieve plate with aperture of 1.1mm to obtain strip;
G. opening a spheronizer, placing the strip-shaped objects obtained in the step F into the spheronizer at the rotating speed of 1050rpm for 8min to prepare semi-finished pellets, taking out the semi-finished pellets, drying at 80 ℃, and screening to obtain 902.3g of 20-30 meshes;
adding 97.7g of starch into the pellet obtained by the method, filling, polishing in a polishing machine, and removing damaged capsules to obtain the pellet capsule.
EXAMPLE 8 preparation of pellet tablets
Prescription:
Figure BDA0001931632910000151
the preparation method comprises the following steps:
A. weighing bupleuri radix, cortex Magnolia officinalis, rhizoma Zingiberis recens, rhizoma Acori Graminei and folium Perillae, soaking in water for 45min, distilling for 7 hr, collecting volatile oil, and collecting residue and medicinal liquid after distillation;
B. adding β -cyclodextrin into the volatile oil obtained in step A to prepare an inclusion compound for later use;
C. decocting the residues in the step A, pinellia ternate, scutellaria baicalensis, ginseng, liquorice and poria cocos with water for 2 times, decocting for 2 hours with 11 times of water for the first time, decocting for 1.5 hours with 9 times of water for the second time, mixing the decoction with the liquid medicine distilled in the step A, filtering, concentrating the filtrate to an extract with the relative density of 1.19(50 ℃), adding an ethanol solution until the ethanol concentration of the supernatant is 70%, stirring uniformly, refrigerating for 24 hours, and filtering to obtain an ethanol precipitation solution;
D. taking the ethanol precipitation liquid in the step C, concentrating under reduced pressure, recovering ethanol to obtain thick paste, belt-type vacuum drying at a vacuum degree of-0.08 MPa to-0.10 MPa and a drying temperature of 80 ℃, and crushing into fine powder;
E. d, uniformly mixing the fine powder obtained in the step D and the volatile oil inclusion compound obtained in the step B to obtain 278g of extract fine powder for later use;
F. weighing
a. Fine powder of the extract: 278g
b. Ethyl cellulose: 200g
And (3) chitosan: 409g
c. Silica gel micropowder: 80g of
Dextrin 13g
Sodium carboxymethyl starch: 20g of
Mixing the above extract fine powder, ethyl cellulose, chitosan, silica gel micropowder, dextrin, and sodium carboxymethyl starch, adding 35% (by weight) ethanol solution with concentration of 40%, kneading, making into soft material, and extruding with sieve plate with aperture of 0.9mm to obtain strip;
G. opening a spheronizer, placing the strip-shaped objects obtained in the step F into the spheronizer, wherein the rotating speed of the spheronizer is 950rpm, the spheronization time is 6min, preparing a pellet semi-finished product, taking out the pellet semi-finished product, drying the pellet semi-finished product at 75 ℃, and screening to obtain 910.1g of 20-30 meshes;
adding 69.9g of microcrystalline cellulose into the pellets obtained by the method, uniformly mixing, preparing into coarse granules, drying, crushing, sieving, preparing into granules, drying at low temperature, finishing granules, adding 8g of magnesium stearate and 12g of talcum powder, uniformly mixing, and tabletting to obtain pellet capsules.
Example 9 preparation of pellet capsules
Prescription:
Figure BDA0001931632910000161
the preparation method comprises the following steps:
A. weighing bupleuri radix, cortex Magnolia officinalis, rhizoma Zingiberis recens, rhizoma Acori Graminei and folium Perillae, soaking in water for 30min, distilling for 7 hr, collecting volatile oil, and collecting residue and medicinal liquid after distillation;
B. adding β -cyclodextrin into the volatile oil obtained in step A to prepare an inclusion compound for later use;
C. decocting the residues in the step A, pinellia ternate, scutellaria baicalensis, ginseng, liquorice and poria cocos with water for 2 times, decocting for 2 hours with 11 times of water for the first time, decocting for 1.0 hour with 8 times of water for the second time, mixing the decoction with the liquid medicine distilled in the step A, filtering, concentrating the filtrate to an extract with the relative density of 1.20(50 ℃), adding an ethanol solution until the ethanol concentration of the supernatant is 60%, stirring uniformly, refrigerating for 24 hours, and filtering to obtain an ethanol precipitation solution;
D. taking the ethanol precipitation liquid in the step C, concentrating under reduced pressure, recovering ethanol to obtain thick paste, belt-type vacuum drying at a vacuum degree of-0.08 MPa to-0.10 MPa and a drying temperature of 85 ℃, and crushing into fine powder;
E. d, uniformly mixing the fine powder obtained in the step D and the volatile oil inclusion compound obtained in the step B to obtain 310g of extract fine powder for later use;
F. weighing
a. Fine powder of the extract: 310g
b. Microcrystalline cellulose: 380g
Hydroxypropyl methylcellulose: 190g of
c. Silica gel micropowder: 72g
Sodium carboxymethyl starch: 48g
Respectively weighing the extract fine powder, microcrystalline cellulose, hydroxypropyl methyl cellulose, micro silica gel powder and sodium carboxymethyl starch in the step E, fully and uniformly mixing, adding 40% (by weight) of 35% ethanol solution in the formula, kneading to prepare a soft material, and extruding the soft material into strips through a sieve plate with the aperture of 1.0mm of an extruder;
G. opening a spheronizer, placing the strip-shaped objects obtained in the step F into the spheronizer at the rotating speed of 1050rpm for 7min to prepare semi-finished pellets, taking out the semi-finished pellets, drying at 85 ℃, and screening to obtain 927.1g of pellets of 20-30 meshes;
adding lactose 72.9g into the pellet obtained by the above method, filling, polishing in a polishing machine, and removing damaged capsule to obtain pellet capsule.
EXAMPLE 10 preparation of pellet tablets
Prescription:
Figure BDA0001931632910000171
preparation method
A. Weighing bupleuri radix, cortex Magnolia officinalis, rhizoma Zingiberis recens, rhizoma Acori Graminei and folium Perillae, soaking in water for 15min, distilling for 8 hr, collecting volatile oil, and collecting residue and medicinal liquid after distillation;
B. adding β -cyclodextrin into the volatile oil obtained in step A to prepare an inclusion compound for later use;
C. decocting the residues in the step A, pinellia ternate, scutellaria baicalensis, ginseng, liquorice and poria cocos with water for 2 times, decocting the residues in water for 1 hour by 12 times for the first time, decocting the residues in water for 1.5 hours by 8 times for the second time, mixing the decoction with the liquid medicine distilled in the step A, filtering, concentrating the filtrate to obtain an extract with the relative density of 1.20(50 ℃), adding an ethanol solution until the ethanol concentration of the supernatant is 50%, stirring uniformly, refrigerating for 24 hours, and filtering to obtain an ethanol precipitation solution;
D. taking the ethanol precipitation liquid in the step C, concentrating under reduced pressure, recovering ethanol to obtain thick paste, belt-type vacuum drying at the vacuum degree of-0.08 MPa to-0.10 MPa and the drying temperature of 90 ℃, and crushing into fine powder;
E. uniformly mixing the fine powder obtained in the step D and the volatile oil inclusion compound obtained in the step B to obtain 350g of extract fine powder for later use;
F. weighing
a. Fine powder of the extract: 350g
b. Hydroxypropyl methylcellulose: 377g
And (3) chitosan: 113g
c. Silica gel micropowder: 160g
Mixing the above extract fine powder, hydroxypropyl methylcellulose, chitosan, and silica gel micropowder, adding 45% (by weight) ethanol solution with concentration of 25%, kneading, making into soft material, and extruding with sieve plate with aperture of 1.1mm to obtain strip;
G. opening a spheronizer, placing the strip-shaped objects obtained in the step F into the spheronizer at the rotating speed of 1050rpm for 8min to prepare semi-finished pellets, taking out the semi-finished pellets, drying at 90 ℃, and screening to obtain 894.0g of 20-30 meshes;
adding 82g of hydroxypropyl cellulose into the pellets obtained by the method, uniformly mixing, preparing into coarse granules, drying, crushing, sieving, preparing into granules, drying at low temperature, finishing granules, adding 10g of magnesium stearate and 14g of talcum powder, uniformly mixing, and tabletting to obtain the pellet tablets.
EXAMPLE 11 preparation of pellet capsules
Prescription:
Figure BDA0001931632910000181
the preparation method comprises the following steps:
A. weighing bupleuri radix, cortex Magnolia officinalis, rhizoma Zingiberis recens, rhizoma Acori Graminei and folium Perillae, soaking in water for 45min, distilling for 6 hr, collecting volatile oil, and collecting residue and medicinal liquid after distillation;
B. adding β -cyclodextrin into the volatile oil obtained in step A to prepare an inclusion compound for later use;
C. decocting the residues in the step A, pinellia ternate, scutellaria baicalensis, ginseng, liquorice and poria cocos with water for 2 times, decocting for 2 hours with 11 times of water for the first time, decocting for 1.5 hours with 8 times of water for the second time, mixing the decoction with the liquid medicine distilled in the step A, filtering, concentrating the filtrate to obtain an extract with the relative density of 1.22(50 ℃), adding an ethanol solution until the ethanol concentration of the supernatant is 70%, uniformly stirring, refrigerating for 24 hours, and filtering to obtain an ethanol precipitation solution;
D. taking the ethanol precipitation liquid in the step C, concentrating under reduced pressure, recovering ethanol to obtain thick paste, belt-type vacuum drying at a vacuum degree of-0.08 MPa to-0.10 MPa and a drying temperature of 75 ℃, and crushing into fine powder;
E. uniformly mixing the fine powder obtained in the step D and the volatile oil inclusion compound obtained in the step B to obtain 291g of extract fine powder for later use;
F. weighing
a. Fine powder of the extract: 291g
b. Microcrystalline cellulose: 430g
Ethyl cellulose: 60g of
And (3) chitosan: 60g of
c. Silica gel micropowder: 129g of
Lactose: 30g of
Mixing the above extract fine powder, microcrystalline cellulose, ethyl cellulose, chitosan, silica gel micropowder, and lactose, adding 35 wt% ethanol solution with concentration of 30%, kneading, making into soft material, and extruding with sieve plate with aperture of 1.0mm to obtain strip;
G. opening a spheronizer, putting the strip-shaped objects obtained in the step F into the spheronizer, wherein the rotating speed of the spheronizer is 1100rpm, the spheronizer is 7.5min, preparing a pellet semi-finished product, taking out the pellet semi-finished product, drying the pellet semi-finished product at 80 ℃, and screening to obtain 911.5g of micro pellets with 20-30 meshes;
adding 88.5g of silica gel micropowder into the pellet obtained by the method, filling, polishing in a polishing machine, and removing damaged capsules to obtain the pellet capsule.
EXAMPLE 12 preparation of pellet capsules
Prescription:
Figure BDA0001931632910000191
the preparation method comprises the following steps:
A. weighing bupleuri radix, cortex Magnolia officinalis, rhizoma Zingiberis recens, rhizoma Acori Graminei and folium Perillae, soaking in water for 30min, distilling for 7 hr, collecting volatile oil, and collecting residue and medicinal liquid after distillation;
B. adding β -cyclodextrin into the volatile oil obtained in step A to prepare an inclusion compound for later use;
C. decocting the residues in the step A, pinellia ternate, scutellaria baicalensis, ginseng, liquorice and poria cocos with water for 2 times, decocting the residues in 10 times of water for 2 hours for the first time, decocting the residues in 7 times of water for 0.5 hour for the second time, mixing the decoction with the liquid medicine distilled in the step A, filtering, concentrating the filtrate to obtain an extract with the relative density of 1.19(50 ℃), adding an ethanol solution until the ethanol concentration of the supernatant is 60%, uniformly stirring, refrigerating for 24 hours, and filtering to obtain an ethanol precipitation solution;
D. taking the ethanol precipitation liquid in the step C, concentrating under reduced pressure, recovering ethanol to obtain thick paste, belt-type vacuum drying at a vacuum degree of-0.08 MPa to-0.10 MPa and a drying temperature of 80 ℃, and crushing into fine powder;
E. d, uniformly mixing the fine powder obtained in the step D and the volatile oil inclusion compound obtained in the step B to obtain 342g of extract fine powder for later use;
F. weighing
a. Fine powder of the extract: 342g
b. Cellulose acetate: 567g of
c. Silica gel micropowder: 51g
Sodium carboxymethyl starch: 40g of
Mixing the above extract fine powder, cellulose acetate, silica gel micropowder, and sodium carboxymethyl starch, adding 40 wt% ethanol solution with concentration of 35%, kneading, making into soft material, and extruding with sieve plate with aperture of 0.9mm to obtain strip;
G. opening a spheronizer, placing the strip-shaped objects obtained in the step F into the spheronizer, wherein the rotating speed of the spheronizer is 950rpm, the spheronization time is 6.5min, preparing a pellet semi-finished product, taking out the pellet semi-finished product, drying the pellet semi-finished product at 85 ℃, and screening to obtain 908.7g with 20-30 meshes;
adding sucrose powder 70.3g into the pellet obtained by the above method, mixing well, making into coarse granules, drying, pulverizing, sieving, making into granules, drying at low temperature, grading, adding magnesium stearate 9g and pulvis Talci 12g, mixing well, and tabletting to obtain pellet tablet.

Claims (12)

1. A traditional Chinese medicine composition for treating depression is characterized by comprising the following traditional Chinese medicines: radix bupleuri, pinellia ternate, radix scutellariae, ginseng, liquorice, mangnolia officinalis, ginger, rhizoma acori graminei, poria cocos and perilla leaves.
2. The traditional Chinese medicine composition of claim 1, wherein the traditional Chinese medicine composition is prepared from the following traditional Chinese medicine components:
Figure FDA0001931632900000011
preferably, the traditional Chinese medicine composition is prepared from the following traditional Chinese medicine components:
Figure FDA0001931632900000012
preferably, the traditional Chinese medicine composition is prepared from the following traditional Chinese medicine components:
Figure FDA0001931632900000013
3. the Chinese medicinal composition according to claim 1 or 2, wherein the pinellia ternate is ginger processed pinellia ternate, and the licorice is honey-fried licorice root.
4. A traditional Chinese medicine pellet preparation, characterized in that the pellet preparation contains the traditional Chinese medicine composition according to any one of claims 1 to 3.
5. The traditional Chinese medicine pellet formulation of claim 4, wherein the pellet formulation comprises: fine extract powder, a pill-forming promoter, and a viscosity regulator, which are prepared from the Chinese medicinal composition of any one of claims 1 to 3.
6. The traditional Chinese medicine pellet formulation of claim 5, wherein the pellet formulation comprises:
a. 27-35% of extract fine powder
b. 49 to 61 weight percent of pelleting accelerant
c. 8-16% of viscosity regulator;
preferably, the pellet formulation comprises:
a. fine powder of extract 34 wt%
b. 55 wt% of pelleting accelerant
c. 11% of viscosity modifier.
7. The traditional Chinese medicine pellet preparation as claimed in any one of claims 5 or 6, wherein the pelleting accelerator is one or more of hydroxypropyl methyl cellulose, cellulose acetate, ethyl cellulose, microcrystalline cellulose and chitosan, and the viscosity modifier is one or more of sodium carboxymethyl starch, lactose, dextrin and aerosil; preferably, the pelleting accelerator is a mixture of microcrystalline cellulose and hydroxypropyl methyl cellulose, and the viscosity regulator is a mixture of micropowder silica gel and sodium carboxymethyl starch.
8. The traditional Chinese medicine pellet preparation of claim 7, wherein the ratio of microcrystalline cellulose: hydroxypropyl methylcellulose ═ 1: 0.5-1.0, silica gel micropowder: sodium carboxymethyl starch ═ 1: 0.2-0.6; preferably, the microcrystalline cellulose: hydroxypropyl methylcellulose ═ 1: 0.5, silica gel micropowder: sodium carboxymethyl starch ═ 1: 0.6.
9. the traditional Chinese medicine pellet preparation of claim 4, wherein the pellet preparation is a pellet tablet and/or a pellet capsule.
10. The traditional Chinese medicine pellet preparation of any one of claims 5 to 10, wherein the preparation method of the traditional Chinese medicine pellet preparation comprises the following steps:
A. weighing bupleuri radix, cortex Magnolia officinalis, rhizoma Zingiberis recens, rhizoma Acori Graminei and folium Perillae, soaking in water, distilling, collecting volatile oil, and collecting residue and medicinal liquid after distillation;
B. adding β -cyclodextrin into the volatile oil obtained in the step A to prepare an inclusion compound for later use;
C. decocting the residues distilled in the step A, pinellia ternate, scutellaria baicalensis, ginseng, liquorice and poria cocos with water, mixing the decoction with the liquid medicine distilled in the step A, filtering, concentrating the filtrate to obtain an extract with the relative density of 1.15-1.22(50 ℃), adding an ethanol solution until the ethanol concentration is 50% -70%, uniformly stirring, refrigerating for 24 hours, and filtering to obtain an ethanol precipitation solution;
D. c, taking the alcohol precipitation liquid in the step C, concentrating under reduced pressure and recovering ethanol to obtain thick paste, drying the thick paste in a vacuum belt type, and then crushing the thick paste into fine powder;
E. d, uniformly mixing the fine powder obtained in the step D and the volatile oil inclusion compound obtained in the step B to obtain fine powder of the traditional Chinese medicine extract for later use;
F. weighing the fine powder of the extract obtained in the step E, a pelleting accelerator and a viscosity regulator, uniformly mixing, adding an ethanol solution, kneading to prepare a soft material, and extruding to obtain a strip-shaped object;
G. opening the spheronizer, putting the strip-shaped objects in the step F into the spheronizer, preparing pellets, drying and screening to obtain the finished product;
H. g, taking the pellets obtained in the step G as a raw material, and preparing pellet tablets or pellet capsules according to a conventional preparation method;
preferably, the preparation method of the pellet preparation comprises the following steps:
A. weighing bupleuri radix, cortex Magnolia officinalis, rhizoma Zingiberis recens, rhizoma Acori Graminei and folium Perillae, soaking in water for 15-45min, distilling for 6-8 hr, collecting volatile oil, and collecting the residue and medicinal liquid after distillation;
B. adding β -cyclodextrin into the volatile oil obtained in step A to prepare an inclusion compound for later use;
C. decocting the residues in the step A, pinellia ternate, scutellaria baicalensis, ginseng, liquorice and poria cocos with water for 2 times, decocting the residues in water for 1-3 hours in an amount which is 8-12 times that of the residues in the step A for the first time, decocting the residues in water for 0.5-1.5 hours in an amount which is 6-10 times that of the residues in the step A for the second time, mixing the decoction and the liquid medicine distilled in the step A, filtering, concentrating the filtrate to obtain an extract with the relative density of 1.20(50 ℃), adding an ethanol solution until the ethanol concentration of the supernatant is 60%, uniformly stirring, refrigerating for 24 hours;
D. c, taking the alcohol precipitation liquid in the step C, concentrating under reduced pressure and recovering ethanol to obtain thick paste, drying the thick paste in a vacuum belt manner, and crushing the thick paste into fine powder;
E. d, uniformly mixing the fine powder obtained in the step D and the volatile oil inclusion compound obtained in the step B to obtain extract fine powder for later use;
F. weighing the fine powder of the extract obtained in the step E, a pelleting accelerant and a viscosity regulator, uniformly mixing, adding 35-45% of 25-40% ethanol solution by weight, kneading to prepare a soft material, and extruding the soft material into strips through a sieve plate with the aperture of 0.9-1.1 mm of an extruder;
G. opening a spheronizer, putting the strip-shaped objects in the step F into the spheronizer to prepare a pellet semi-finished product, taking out the pellet semi-finished product, drying at 75-90 ℃, and screening to obtain pellets of 20-30 meshes;
H. and G, taking the pellet obtained in the step G as a raw material, and preparing a pellet tablet or a pellet capsule according to a conventional preparation method.
11. The method according to claim 10, wherein the belt vacuum drying conditions in step D are vacuum degree of-0.08 MPa-0.10 MPa, drying temperature of 75-90 ℃; preferably, the belt type vacuum drying condition is that the vacuum degree is-0.08 MPa-0.10 MPa, and the drying temperature is 85 ℃.
12. The method according to claim 11, wherein the rotational speed of the rounding machine in the step G is 950rpm to 1100rpm, and the rounding time is 6min to 8 min; preferably, the speed of the rounding machine in the step G is 1050rpm, and the rounding time is 7 min.
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Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102283910A (en) * 2011-08-05 2011-12-21 浙江省中医药研究院 Chinese medicinal composition with anti-depression effect and preparation and preparation method thereof

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Publication number Priority date Publication date Assignee Title
CN102283910A (en) * 2011-08-05 2011-12-21 浙江省中医药研究院 Chinese medicinal composition with anti-depression effect and preparation and preparation method thereof

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叶民珠,等: "中药抗抑郁症研究进展", 《亚太传统医药》 *
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