CN111437333A - Application of traditional Chinese medicine composition in treating mental disorder - Google Patents

Application of traditional Chinese medicine composition in treating mental disorder Download PDF

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CN111437333A
CN111437333A CN202010387678.5A CN202010387678A CN111437333A CN 111437333 A CN111437333 A CN 111437333A CN 202010387678 A CN202010387678 A CN 202010387678A CN 111437333 A CN111437333 A CN 111437333A
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parts
disorder
aloe
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depression
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孙成磊
李发余
程国良
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Lunan Pharmaceutical Group Corp
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Abstract

The invention relates to a new application of a traditional Chinese medicine composition developed on the basis of a patent Z L200410073958. X, wherein the traditional Chinese medicine composition is mainly prepared from immature bitter orange, largehead atractylodes rhizome, ginseng, barbary wolfberry fruit, donkey-hide gelatin, tuber fleeceflower root, cassia seed and aloe.

Description

Application of traditional Chinese medicine composition in treating mental disorder
Technical Field
The invention relates to a new application of a traditional Chinese medicine composition, in particular to an application of the traditional Chinese medicine composition in preparing a medicine for treating mental disorder diseases, and belongs to the technical field of traditional Chinese medicines.
Background
Mental disorders are the general term for disorders of different degrees of mental activity such as cognition, emotion, behavior and will due to disturbance of brain function. Affective disorder, organic mental disorder of brain, etc. are common. The pathogenic factors are manifold: innate heredity, individual characteristics, physical factors, social environmental factors and the like.
Depression (depression) is a common mental disorder, also called depressive disorder, mainly manifested as depressed mood, decreased interest, pessimism, slow thinking, lack of initiative, guilt, poor diet and sleep, worrying about various diseases, feeling of discomfort in many places throughout the body, and suicidal thoughts and behaviors of the serious person, and is the disease with the highest suicidal rate in the psychiatric department. The etiology and pathogenesis of depression are unknown, and many factors such as physiology, genetics, psychology, environment or medicine may be involved.
In DSM-5, depression is uniformly typed as an independent class of disease, including a total of 8 types: disruptive mood disorder, major depressive disorder, persistent depressive disorder, premenstrual dysphoric disorder, substance/drug depressive disorder, depressive disorder due to other body disorders, other specific depressive disorder, unspecified depressive disorder.
Antidepressants are currently the primary means of treating depressive disorders, and the following are the commonly used therapeutic agents: tricyclic and tetracyclic antidepressants (e.g., imipramine, clomipramine, amitriptyline, doxepin, maprotiline, etc.), monoamine oxidase inhibitors (e.g., ipratropium, phenformin, tranylcypromine, etc.), selective 5-hydroxytryptamine reuptake inhibitors (e.g., fluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalopram, etc.). In addition, treatment of depression includes treatment modalities such as psychotherapy (e.g., supportive psychotherapy, interpersonal psychotherapy, cognitive behavioral therapy).
Chinese patent Z L200410073958 discloses a composition with functions of relaxing bowels, expelling toxin, losing weight and reducing blood fat and a preparation method thereof, the composition is composed of eight traditional Chinese medicines of fleece-flower root, aloe, cassia seed, medlar, donkey-hide gelatin, ginseng, largehead atractylodes rhizome and immature bitter orange, and has good treatment effect on constipation caused by toxin accumulation and yin fluid deficiency.
Disclosure of Invention
Through clinical application feedback, when the aloe-barbadensis capsule is used for treating constipation of patients with mild depression, the aloe barbadensis capsule is unexpectedly found to improve the depression symptoms of individual patients, so that the interestingness of the patients can be improved, and the pessimistic mood of the patients can be improved.
Based on the clinical feedback of the aloe laxative capsule, the inventor develops new application of the traditional Chinese medicine composition disclosed in the Chinese patent Z L200410073958. X in treating mental disorders, and aims to provide a new Chinese patent medicine product for treating mental disorders, particularly depression, and increase the medication selectivity of patients.
The invention aims to provide application of a traditional Chinese medicine composition mainly prepared from polygonum multiflorum, cassia seed, aloe, medlar, donkey-hide gelatin, ginseng, immature bitter orange and bighead atractylodes rhizome in preparing a medicament for treating mental disorder.
The traditional Chinese medicine composition is prepared from the following components:
80-120 parts of polygonum multiflorum, 100 parts of cassia seed, 120 parts of aloe and 160 parts of aloe
50-80 parts of medlar, 40-80 parts of donkey-hide gelatin, 20-50 parts of ginseng
80-120 parts of immature bitter orange and 30-50 parts of bighead atractylodes rhizome;
preferably, the traditional Chinese medicine composition is prepared from the following components:
120 parts of polygonum multiflorum, 140 parts of cassia seed and 160 parts of aloe
75 parts by weight of medlar, 75 parts by weight of donkey-hide gelatin, 50 parts by weight of ginseng
120 parts of immature bitter orange and 50 parts of bighead atractylodes rhizome.
The mental disorder refers to mental disorder caused by mental active substances.
Preferably, the psychiatric disorder is depressive syndrome.
The psychiatric disorder of the invention may also be an affective disorder.
Preferably, the affective disorder is depressive episode, bi-directional affective disorder.
Further preferably, the depressive episode includes, but is not limited to, minor depression, depression without psychotic symptoms, recurrent depression and other depressive disorders.
The psychotic disorder according to the invention includes, but is not limited to, disruptive mood disorder, persistent depressive disorder, premenstrual dysphoric disorder.
The second purpose of the invention is to provide the application of the traditional Chinese medicine composition in preparing a medicine for treating depression accompanied with constipation.
The invention also aims to provide a traditional Chinese medicine preparation containing the traditional Chinese medicine composition, and the traditional Chinese medicine composition can be prepared into clinically acceptable dosage forms directly through conventional procedures or after medically acceptable auxiliary materials are added;
preferably, the clinically acceptable dosage form comprises one or more of capsules, tablets, granules, pills and powder.
Further preferably, the capsule is a aloe cathartic capsule.
The fourth purpose of the invention is to provide a preparation method of the aloe laxative capsule, which comprises the following preparation steps:
(1) pulverizing colla Corii Asini into fine powder, and sieving with 80 mesh sieve;
(2) reflux-extracting Ginseng radix, Polygoni Multiflori radix, semen Cassiae and Aloe with 60% ethanol for 2 times, 10 times for the first time and 8 times for the second time, each time for 2 hr, filtering, and mixing filtrates to obtain filtrate I;
(3) decocting the wolfberry fruit, the bighead atractylodes rhizome and the immature bitter orange twice by adding water, adding 8 times of water for the first time, soaking for 1 hour, decocting for 1.5 hours, filtering, adding 6 times of water for the second time, decocting for 1.5 hours, filtering, combining the filtrates, concentrating to obtain clear paste with the relative density of 1.10-1.20 (80 ℃), placing at room temperature, stirring, adding ethanol to ensure that the purity reaches 60 percent (20 ℃), refrigerating, standing for more than 24 hours, and filtering to obtain filtrate II for later use;
(4) and (3) mixing the filtrate I obtained in the step (2) and the filtrate II obtained in the step (3), concentrating to obtain thick paste with the relative density of 1.30-1.35(70 ℃), drying, crushing, adding the donkey-hide gelatin fine powder prepared in the step (1) and a proper amount of dextrin, uniformly mixing, performing dry granulation, and filling into capsules to obtain the donkey-hide gelatin capsule.
Compared with the prior art, the invention has the following remarkable technical effects:
after the traditional Chinese medicine composition is used for treating rats, the body mass of the rats is obviously increased, the sugar water preference rate is obviously improved, the total horizontal movement distance and the number of crossing lattices of the rats are obviously increased in an open field experiment, the struggling time of the rats is obviously increased in a forced swimming experiment, the floating time is obviously reduced, and the content of 5-HT and DA in serum is obviously increased.
DETAILED DESCRIPTION OF EMBODIMENT (S) OF INVENTION
First, the detailed description of the invention
The following examples are provided to further disclose the present invention, and it should be noted that these examples are only preferred embodiments of the present invention, and do not limit the scope of the present invention as claimed.
EXAMPLE 1 preparation of Hui Tongbiang Capsule
The prescription is as follows:
120g of polygonum multiflorum, 140g of cassia seed, 160g of aloe
75g of medlar, 75g of donkey-hide gelatin, 50g of ginseng
120g of immature bitter orange and 50g of bighead atractylodes rhizome;
the preparation method comprises the following steps:
taking the donkey-hide gelatin in the prescription amount, crushing into fine powder, and sieving with a 80-mesh sieve for later use; reflux-extracting Ginseng radix, Polygoni Multiflori radix, semen Cassiae and Aloe with 60% ethanol for 2 times, 10 times for the first time and 8 times for the second time, each time for 2 hr, filtering, and mixing filtrates to obtain filtrate I; decocting wolfberry fruit, bighead atractylodes rhizome and immature bitter orange according to the prescription amount twice by adding water, adding 8 times of water for the first time, soaking for 1 hour, decocting for 1.5 hours, filtering, adding 6 times of water for the second time, decocting for 1.5 hours, filtering, combining filtrates, concentrating to obtain clear paste with the relative density of 1.10-1.20 (80 ℃), standing at room temperature, stirring, adding ethanol until the purity reaches 60% (20 ℃), refrigerating and standing for more than 24 hours, and filtering to obtain a filtrate II; mixing the filtrate I and the filtrate II, concentrating to obtain soft extract with relative density of 1.30-1.35(70 deg.C), drying, pulverizing, adding colla Corii Asini fine powder and appropriate amount of dextrin, mixing, dry granulating, and making into capsule with 1000 granules.
EXAMPLE 2 Capsule preparation
The prescription is as follows:
120g of polygonum multiflorum, 100g of cassia seed, 120g of aloe
50g of medlar, 80g of donkey-hide gelatin, 20g of ginseng
80g of immature bitter orange and 30g of bighead atractylodes rhizome;
the preparation method comprises the following steps: the preparation method is the same as that of example 1.
EXAMPLE 3 Capsule preparation
The prescription is as follows:
polygonum multiflorum 80g cassia seed 150g aloe 160g
80g of medlar, 40g of donkey-hide gelatin, 50g of ginseng
120g of immature bitter orange and 50g of bighead atractylodes rhizome;
the preparation method of the traditional Chinese medicine composition comprises the following steps: the preparation method is the same as that of example 1.
Comparative example 1 preparation of capsules
The prescription is as follows:
radix Curcumae 120g semen Cassiae 140g Aloe 160g
75g of medlar, 75g of donkey-hide gelatin, 50g of ginseng
120g of immature bitter orange and 50g of bighead atractylodes rhizome;
the preparation method comprises the following steps:
taking the donkey-hide gelatin in the prescription amount, crushing into fine powder, and sieving with a 80-mesh sieve for later use; reflux-extracting Ginseng radix, radix Curcumae, semen Cassiae and Aloe with 60% ethanol for 2 times, 10 times for the first time and 8 times for the second time, each time for 2 hr, filtering, and mixing filtrates to obtain filtrate I; decocting wolfberry fruit, bighead atractylodes rhizome and immature bitter orange according to the prescription amount twice by adding water, adding 8 times of water for the first time, soaking for 1 hour, decocting for 1.5 hours, filtering, adding 6 times of water for the second time, decocting for 1.5 hours, filtering, combining filtrates, concentrating to obtain clear paste with the relative density of 1.10-1.20 (80 ℃), standing at room temperature, stirring, adding ethanol until the purity reaches 60% (20 ℃), refrigerating and standing for more than 24 hours, and filtering to obtain a filtrate II; mixing the filtrate I and the filtrate II, concentrating to obtain soft extract with relative density of 1.30-1.35(70 deg.C), drying, pulverizing, adding colla Corii Asini fine powder and appropriate amount of dextrin, mixing, dry granulating, and making into capsule with 1000 granules.
Secondly, the traditional Chinese medicine composition has influence on the behaviourology of rats in depression models.
In order to verify the efficacy of the Chinese medicinal composition for treating mental disorder diseases, particularly depression, the inventor carries out the following animal experimental study, only a part of experimental models are taken as an example for the following description, and pharmacological experimental study is also carried out on mental disorder or depression caused by other reasons recorded in the specification, so that the composition can achieve the same or similar effect, and the effect is not described any more.
The inventor explains that the following experimental studies are carried out on the basis of the safety of the drug proved by acute toxicity tests and long-term toxicity tests, and the administration dose in the experimental studies is within a safe dose range.
1 Material
1.1 animals:
wistar rat, weight 180-220 g, license number of experimental animal: SYXK (lu) 20180008, provided by lumnan pharmaceutical group ltd, was acclimatized for one week prior to the experiment.
1.2 drugs, reagents
1.2.1 medicaments
The capsules obtained in examples 1 and 2 of the invention;
comparative example 1 the capsule obtained in example 1;
a positive drug fluoxetine hydrochloride capsule.
1.2.3 dosage for rats
Example 1 capsule: 0.378g/kg (high dose), 0.189g/kg (medium dose), 0.0945g/kg (low dose);
example 2 capsules: 0.189 g/kg;
comparative example 1 capsule: 0.189 g/kg;
fluoxetine hydrochloride capsules: 5.4 mg/kg.
2. Grouping, modeling and dosing
80 rats were randomly divided into a blank group, a model group, a positive drug group, three dose groups of example 1 (high, medium, and low), an example 2 group, and a comparative example 1 group.
The rats in the blank group are normally bred in a social manner, and the rats in the other groups are bred in a single cage. The group of positive drugs, the group of example 1 (high, medium and low) three doses, the group of example 2 and the group of comparative example 1 were gavaged with the corresponding drugs, and the blank group and the model group were gavaged with the same amount of distilled water. Once daily for 28 days.
After 1h of administration, except for the blank group, rats in other groups are subjected to chronic unpredictable mild stimulation, and a rat depression model is established by matching the chronic unpredictable mild stimulation with an isolated culture method. Chronic unpredictable mild stimuli include: fasting (24h), water deprivation (24h), ice-water bath (4 ℃, 6min), thermal stimulation (40 ℃, 10min), binding (3h), tail clamping (2min), wet padding (24h), ultrasound (60W, 3h), day and night reversal, and 24h illumination. One stimulation mode is randomly selected for stimulation every day, and the same stimulation mode cannot appear for 2 days continuously and is stimulated for 28 days continuously. The rats in the blank group were not given any stimulation.
3. Examination item
3.1 changes in body Mass
On days 0, 7, 14, 21, and 28 of the administration, the body mass of each rat was measured.
3.2 sweet Water preference experiment
Sugar water preference experiments were performed on days 0, 7, 14, 21, 28 of dosing, respectively. Rats were deprived of water for 14h before the experiment began. In the experiment, a rat is given a quantitative bottle of pure water and a bottle of 1% sucrose aqueous solution, the water bottle is taken away after 60min, quantitative determination is carried out, pure water consumption, sugar water consumption and total liquid consumption (the sum of the pure water consumption and the sugar water consumption) of the rat are calculated, and sugar water preference rate is calculated.
Figure BDA0002484404360000061
3.3 open field experiment
On day 27 of dosing, open field experiments were performed. The experiments were performed in a quiet room.
Dividing the open field into 4 × 4 squares, placing the rats in a black-coated open field with four sides of 100cm × 100cm × 40cm, recording the action tracks of the rats by a camera after the experiment is started, recording the total horizontal movement distance and the number of the penetrated squares of the rats by a computer, completely cleaning the box after each rat is measured for 3min, and then performing the experiment by using the next rat to prevent the influence of excrement smell and the like on the experiment result.
3.4 forced swimming test
On day 28 of dosing, forced swim experiments were performed.
And sequentially placing the rats in each group into a forced swimming device, controlling the water temperature to be about 25 ℃, and recording struggling state time and floating state time of the rats within 6 min. Before each rat carries out the experiment, the experiment water in the transparent glass cylinder should be replaced, so that the influence of the odor of excrement and the like on the experiment result is avoided.
3.5 measurement of the content of monoamine neurotransmitters 5-HT and DA in the serum of rats.
After the forced swimming test is finished, collecting blood of rats from femoral artery, centrifuging at 10000r/min for 15min at 4 ℃, removing supernatant fluid, and measuring the content of 5-HT and DA in the blood serum of each group of rats.
4. Results and conclusions
4.1 changes in body Mass of rats
On the 0 th day of administration, there was no difference in the body mass of rats in each group (P > 0.05);
compared with the blank group, the body mass of the rats in the model groups is obviously reduced on the 7 th, 14 th, 21 th and 28 th days (P is less than 0.01); compared with the model group, except the group of the comparative example 1, the body mass of the rats in the other administration groups is obviously increased from 14 days of the administration (P < 0.05); compared with the positive drug, the rats in the other administration groups have no difference in body mass (P > 0.05) except the group of the comparative example 1.
TABLE 1 variation in body constitution of rats in each group (
Figure BDA0002484404360000071
n=10,g)
Figure BDA0002484404360000072
Note: in contrast to the blank group,@P<0.05,*P<0.01;
in contrast to the model set,P<0.05,#P<0.01;
compared with the positive medicine group,&P<0.05,P<0.01。
4.2 sweet Water preference experiment
On day 0 of dosing, there was no difference in the rate of glucose preference among the groups (P > 0.05);
compared with a blank group, the preference rate of the rats in the model group is obviously reduced (P is less than 0.01); compared with the model group, the sugar water preference rate of rats in the high dose group is obviously increased from the 7 th day of administration (P <0.05, P <0.01), the sugar water preference rate of rats in the low dose group is obviously increased from the 21 st day of administration (P <0.05, P <0.01) and the sugar water preference rate of rats in the positive drug group is obviously increased from the 28 th day of administration (P < 0.01); compared with the positive drug, the rats in the other administration groups except the group of the comparative example 1 have no difference in the sugar water preference rate (P > 0.05) on the 28 th day of administration.
Table 2 sugar water preference rates for various groups of rats: (
Figure BDA0002484404360000073
n=10,%)
Figure BDA0002484404360000074
Figure BDA0002484404360000081
Note: in contrast to the blank group,@P<0.05,*P<0.01;
in contrast to the model set,P<0.05,#P<0.01;
compared with the positive medicine group,&P<0.05,P<0.01。
4.3 open field experiment
Compared with a blank group, the total horizontal movement distance and the number of the crossing lattices of the rats in the model group are obviously reduced (P < 0.01); compared with the model group, the total horizontal movement distance and the number of the crossing lattices of the rats in each administration group are obviously increased (P < 0.01); compared with the positive medicine group, the total horizontal movement distance and the number of the grids passing through the rats in the high-dose group are obviously increased (P <0.05 and P <0.01) in the example 1, the total horizontal movement distance and the number of the grids passing through the rats in the comparative example 1 are not obviously increased (P <0.01) in the example 2 and the comparative example 1, and the rest groups are not different (P > 0.05).
TABLE 3 open field behavior of rats (
Figure BDA0002484404360000082
n=10)
Figure BDA0002484404360000083
Note: in contrast to the blank group,@P<0.05,*P<0.01;
in contrast to the model set,P<0.05,#P<0.01;
compared with the positive medicine group,&P<0.05,P<0.01。
4.4 swimming test
Compared with the blank group, the struggling time of the rats in the model group is obviously reduced, and the floating time is obviously increased (P < 0.01); compared with the model group, the struggling time of rats in each administration group is obviously increased, and the floating time is obviously reduced (P < 0.01); compared with the positive drug group, the rats in the group of the comparative example 1 have no obvious change in struggling time and floating time (P <0.01), and the rest groups have no difference (P > 0.05).
TABLE 4 struggle time and float time for each group of rats
Figure BDA0002484404360000091
Figure BDA0002484404360000092
Note: in contrast to the blank group,@P<0.05,*P<0.01;
in contrast to the model set,P<0.05,#P<0.01;
compared with the positive medicine group,&P<0.05,P<0.01。
4.5 rat serum 5-HT, DA content
Compared with the blank group, the 5-HT content in the serum of the rats in the model group is obviously reduced (P < 0.01); compared with the model group, the 5-HT content in the serum of the rat of each administration group is obviously increased (P is less than 0.05, and P is less than 0.01); compared with the positive drug group, the increase of the 5-HT content in the serum of the rats in the group of the comparative example 1 is not obvious (P <0.01), and the rest groups have no difference (P > 0.05).
Compared with the blank group, the DA content in the serum of the rats in the model group is obviously reduced (P < 0.01); compared with the model group, the DA content in the serum of rats in the other administration groups except the group of the comparative example 1 is obviously increased (P < 0.01); compared with the positive drug group, the content of DA in the serum of the rats in the group of the comparative example 1 is not obviously increased (P <0.05), and the other groups have no difference (P > 0.05).
TABLE 5 serum 5-HT and DA content in rats of each group: (
Figure BDA0002484404360000093
n=10)
Figure BDA0002484404360000094
Figure BDA0002484404360000101
Note: in contrast to the blank group,@P<0.05,*P<0.01;
in contrast to the model set,P<0.05,#P<0.01;
compared with the positive medicine group,&P<0.05,P<0.01。
the above experimental results show that the body mass of a rat treated by the traditional Chinese medicine composition is obviously increased, the sugar water preference rate is obviously increased, the total horizontal movement distance and the number of crossing lattices of the rat in an open field experiment are obviously increased, the struggling time of the rat in a forced swimming experiment is obviously increased, the floating time is obviously reduced, the content of 5-HT and DA in serum is obviously increased, and the effect is equivalent to or better than that of a fluoxetine hydrochloride capsule.

Claims (10)

1. A Chinese medicinal composition for treating mental disorder is prepared from Polygoni Multiflori radix, semen Cassiae, Aloe, fructus Lycii, colla Corii Asini, Ginseng radix, fructus Aurantii Immaturus, and Atractylodis rhizoma.
2. Use according to claim 1, wherein the psychiatric disorder is a substance-induced psychotic disorder.
3. Use according to claim 2, wherein the psychiatric disorder is depression syndrome.
4. Use according to claim 1, wherein the psychiatric disorder is an affective disorder.
5. The use according to claim 4, wherein the affective disorder includes, but is not limited to, depressive episode, bilateral disorder.
6. The use as claimed in claim 5, wherein the depressive episode includes, but is not limited to, minor depression, depression without psychotic symptoms, recurrent depression and other depressive disorders.
7. The use according to claim 1, wherein the psychiatric disorder includes, but is not limited to, disruptive mood disorder, persistent depressive disorder, premenstrual dysphoric disorder.
8. The use of the Chinese medicinal composition of claim 1 in the preparation of a medicament for treating depression with constipation.
9. The use of any one of claims 1-8, wherein the traditional Chinese medicine composition is prepared from the following components:
80-120 parts of polygonum multiflorum, 100 parts of cassia seed, 120 parts of aloe and 160 parts of aloe
50-80 parts of medlar, 40-80 parts of donkey-hide gelatin, 20-50 parts of ginseng
80-120 parts of immature bitter orange and 30-50 parts of bighead atractylodes rhizome;
preferably, the traditional Chinese medicine composition is prepared from the following components:
120 parts of polygonum multiflorum, 140 parts of cassia seed and 160 parts of aloe
75 parts by weight of medlar, 75 parts by weight of donkey-hide gelatin, 50 parts by weight of ginseng
120 parts of immature bitter orange and 50 parts of bighead atractylodes rhizome.
10. The use of claim 9, wherein the Chinese medicinal composition can be prepared into clinically acceptable dosage forms by conventional processes directly or after adding pharmaceutically acceptable adjuvants; preferably, the clinically acceptable dosage form is one or more of capsules, tablets, granules and pills; further preferably, the capsule is a aloe cathartic capsule.
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CN109464570A (en) * 2018-11-23 2019-03-15 鲁南制药集团股份有限公司 A kind of head luxuriant growth Tongbian capsule preparation process
CN110354196A (en) * 2018-04-09 2019-10-22 鲁南制药集团股份有限公司 A kind of Chinese medicine composition and its preparation method and application
CN110522841A (en) * 2018-05-25 2019-12-03 鲁南制药集团股份有限公司 A kind of Chinese medicine composition and preparation method thereof, purposes

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CN110354196A (en) * 2018-04-09 2019-10-22 鲁南制药集团股份有限公司 A kind of Chinese medicine composition and its preparation method and application
CN110522841A (en) * 2018-05-25 2019-12-03 鲁南制药集团股份有限公司 A kind of Chinese medicine composition and preparation method thereof, purposes
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