CN114010732B

CN114010732B - Traditional Chinese medicine composition for treating vertigo and preparation method and application thereof

Info

Publication number: CN114010732B
Application number: CN202111313378.3A
Authority: CN
Inventors: 颜新; 李文娟; 吴晓玮; 黄文琦; 潘燕君; 孙靖; 王安安; 舒碧莹; 蔡舒放; 孙璐
Original assignee: Shanghai Jing'an Traditional Chinese Medicine Hospital
Current assignee: Yan Xin
Priority date: 2021-11-08
Filing date: 2021-11-08
Publication date: 2022-10-28
Anticipated expiration: 2041-11-08
Also published as: CN114010732A

Abstract

The invention relates to a traditional Chinese medicine composition for treating vertigo and a preparation method and application thereof, wherein the traditional Chinese medicine composition comprises the following raw material medicines in parts by weight: 2-10 parts of cimicifugae foetidae, 10-20 parts of kudzu root, 6-12 parts of rhizoma atractylodis, 6-12 parts of raw bighead atractylodes rhizome, 2-10 parts of lotus leaf, 6-12 parts of stiff silkworm, 10-20 parts of raw coix seed, 6-12 parts of herba lycopi and 1-5 parts of mint. The traditional Chinese medicine composition accords with the compatibility principle of monarch, minister, assistant and guide, and takes 'health transportation, middle school, ascending transportation and yang clearing' as the treatment principle. The formula can clear qi of spleen and stomach, reduce turbid yin of phlegm-fluid, recuperate the spleen and stomach, calm liver and suppress yang, strengthen spleen and transform damp-turbidity, transform damp-turbidity and transform qi-transformation, and self-eliminate vertigo. The composition and the proportion of the traditional Chinese medicine composition are obtained based on a large number of experiments, and the treatment effect is most outstanding. The traditional Chinese medicine composition has the advantages of abundant and easily-obtained raw materials, low price, easy preparation and suitability for popularization and use.

Description

Traditional Chinese medicine composition for treating vertigo and preparation method and application thereof

Technical Field

The invention relates to the technical field of traditional Chinese medicine compositions, in particular to a traditional Chinese medicine composition for treating dizziness and a preparation method and application thereof.

Background

Functional vertigo is a new name, which is used to distinguish the conventional somatization form obstructive vertigo or psychosomatic vertigo, and is manifested by vestibule-like symptoms: dizziness, vertigo and postural imbalance. The Braini Association promulgates a PPPD medical guideline draft which is classified as a chronic functional vestibular disease, and the diagnosis standard, differential diagnosis and the like of the PPPD are formally proposed for the first time.

Epidemiology of persistent postural-perceived dizziness (PPPD) has shown that more women than men in PPPD patients and the age of onset is mostly between 40-60 years. However, as the disease is redefined as a new disease, the disease incidence and the disease incidence rate of the department of neurology, the department of otorhinolaryngology, the department of psychiatry and the like are not accurate at present, and only the disease is shown to occupy an important proportion in the vertigo clinic. Dizziness of the patient is easy to relapse, and due to the long-term existence of uncomfortable symptoms such as dizziness, patients are often accompanied with anxiety and depression conditions of different degrees, and the anxiety and depression can induce the dizziness to a certain extent, so that vicious circle is formed, the life quality of the patients is seriously affected, and therefore, PPPD increasingly causes clinical attention.

At present, the pathophysiological mechanism of PPPD is not yet clear. Possible mechanisms include: classical and operative conditioned reflex establishment theories, re-adaptation failure hypothesis, cortical multi-sensory integration abnormalities, molecular pathology mechanisms. Among them, the theory of conditioned reflex establishment and the hypothesis of failure in re-adaptation are closely related to dizziness. Such as classical conditional reflection: the initial vestibular dysfunction is usually induced by acute vestibular diseases, is a powerful unconditional stimulation, and the cortex senses discomfort such as dizziness, instability and the like, so that related memory (dizziness, instability and the like) is established in the cortex, and then, even if the vestibular function is recovered, when the induction of some conditional stimulation (such as vision, motion induction) occurs again, a patient still has feelings such as dizziness, instability and the like.

In terms of treating the disease, the western medicine mainly takes anxiolytic and antidepressant drugs such as 5-hydroxytryptamine (5-HT) reuptake inhibitor (SSRI) and the like as main drugs, thereby achieving the purpose of relieving dizziness. Citalopram 5-HT reuptake inhibition effect is higher in SSRI, has stronger 5-HT transporter inhibition effect, can improve emotional symptoms of patients, and can regulate the response of nerve pathways to motor stimulation through 5-HT so as to influence the balance function of organisms. The citalopram has strong specific selectivity on 5-HT, good oral absorption condition and less adverse reaction, so the clinical utilization rate is higher than that of other SSRI medicines. However, several prospective studies have shown that SSRIs have poor efficacy in treating PPPD. The traditional Chinese medicine treatment has a long history of vertigo, and has certain significance for treating PPPD by combining with the traditional Chinese medicine treatment.

Chinese patent document CN102462753A discloses a traditional Chinese medicine composition for treating cervical vertigo and a preparation method thereof. The traditional Chinese medicine composition is a medicament prepared from the following raw material medicines and a pharmaceutically acceptable carrier or excipient in parts by weight: 200-800 parts of monarch drug, 400-1300 parts of ministerial drug, 20-50 parts of adjuvant drug and 200-800 parts of messenger drug, wherein the monarch drug is selected from kudzuvine root, chinese thorowax root, largetrifolioliolious bugbane rhizome or dahurian angelica root, the ministerial drug is selected from szechuan lovage rhizome, incised notopterygium rhizome, turmeric root tuber, turmeric or cassia twig, the adjuvant drug is selected from scorpion, centipede, antelope horn, tall gastrodia tuber or stiff silkworm, and the messenger drug is selected from photinia leaf, beautiful sweetgum fruit, erycibe stem or common clubmoss herb. The traditional Chinese medicine composition for treating cervical vertigo has the effects of dispelling wind, activating blood, dispelling cold and eliminating dampness, and the traditional Chinese medicine composition effectively plays a role in preventing and treating the cervical vertigo by combining the medicines. Chinese patent document CN112741890A discloses a Chinese medicinal composition for treating vertigo, wherein the Chinese medicinal composition comprises 18 Chinese herbal medicines of radix astragali, ginseng, radix scutellariae, rhizoma pinellinae praeparata, radix bupleuri, rhizoma alismatis, fried rhizoma atractylodis macrocephalae, radix glycyrrhizae preparata, angelica sinensis, radix puerariae, rhizoma gastrodiae, rhizoma acori graminei, rhizoma cimicifugae, rhizoma ligustici wallichii, notopterygium root, bamboo shavings, radix paeoniae alba and radix curcumae. Can be used for treating vertigo caused by chronic cerebral circulation inefficiency, especially vertigo caused by qi deficiency and phlegm stagnation due to chronic cerebral circulation inefficiency. However, the traditional Chinese medicine composition for treating vertigo, and the preparation method and application thereof are not reported at present.

Disclosure of Invention

The invention aims to provide a traditional Chinese medicine composition for treating functional vertigo aiming at the defects in the prior art.

The invention also aims to provide a preparation method of the traditional Chinese medicine composition.

Another purpose of the invention is to provide application of the traditional Chinese medicine composition.

In order to achieve the purpose, the invention adopts the technical scheme that:

a traditional Chinese medicine composition for treating functional vertigo is composed of the following raw material medicines in parts by weight: 2-10 parts of cimicifugae foetidae, 10-20 parts of kudzu root, 6-12 parts of rhizoma atractylodis, 6-12 parts of raw bighead atractylodes rhizome, 2-10 parts of lotus leaf, 6-12 parts of stiff silkworm, 10-20 parts of raw coix seed, 6-12 parts of herba lycopi and 1-5 parts of mint.

Preferably, the traditional Chinese medicine composition consists of the following raw material medicines in parts by weight: 4-8 parts of cimicifugae foetidae, 13-18 parts of kudzu root, 8-10 parts of rhizoma atractylodis, 8-10 parts of raw bighead atractylodes rhizome, 4-8 parts of lotus leaf, 8-10 parts of stiff silkworm, 13-18 parts of raw coix seed, 8-10 parts of herba lycopi and 2-4 parts of mint.

More preferably, the traditional Chinese medicine composition consists of the following raw material medicines in parts by weight: 6 parts of cimicifuga foetida, 15 parts of kudzuvine root, 9 parts of rhizoma atractylodis, 9 parts of raw bighead atractylodes rhizome, 6 parts of lotus leaf, 9 parts of stiff silkworm, 15 parts of raw coix seed, 9 parts of herba lycopi and 3 parts of mint.

In order to achieve the second object, the invention adopts the technical scheme that:

the preparation method of the traditional Chinese medicine composition comprises the following steps: weighing the raw materials according to the weight part ratio, respectively crushing and uniformly mixing (removing mint) to obtain a medicine mixture, adding water which is 3-5 times of the total weight of the medicine mixture, decocting with slow fire for 30-60 minutes (after mint is put down), filtering, and collecting filtrate.

In order to achieve the third object, the invention adopts the technical scheme that:

the application of the traditional Chinese medicine composition in preparing the medicine for treating vertigo.

Preferably, the pharmaceutical dosage form is an oral formulation.

More preferably, the oral preparation is in the form of granules, tablets, pills, powder, granules, oral liquid or capsules.

Preferably, the vertigo is functional vertigo.

More preferably, the functional vertigo is spleen deficiency and dampness obstruction type functional vertigo.

The invention has the advantages that:

1. the traditional Chinese medicine composition accords with the compatibility principle of monarch, minister, assistant and guide, and takes 'health transportation, middle school, ascending transportation and yang clearing' as the treatment principle. In the formula, the cimicifuga foetida belongs to yang, is light in weight and pungent in taste, is light and clear and ascends, and the kudzuvine root is pungent and sweet, mainly enters yangming and has the effects of ascending, ascending and diverging, and the cimicifuga foetida and the kudzuvine root are used together to ascend yang qi, invigorate spleen to clear yang and ascend upwards to expel parietal evil, so that the cimicifuga foetida is regarded as a monarch drug. Dampness is yin pathogen, which is easy to block qi movement, and spleen is yin earth, which is a key organ for transporting and resolving water dampness, prefers dryness and dislikes dampness, so the cang-bai-shu can be used together, one is kept and one is taken, the spleen is transported and dampness is removed, the spleen is self-healthy, and the spleen is self-healthy, so the spleen is a ministerial drug; the monarch and the minister are matched to regulate the qi movement of the spleen and the stomach, and the spleen qi is ascended and descended, so that the effect of ascending the clear and descending the turbid is achieved. The lotus leaf can rise to clear the stomach; the muscardine silkworm is a wind medicine, and has the effects of eliminating dampness by wind energy, calming wind, dredging collaterals, calming liver, suppressing yang, ascending yang, and enabling the soil to be more than wood; raw coix seed belongs to earth, and aims at strengthening middle energizer, promoting diuresis and excreting dampness; herba Lycopi can enter liver and spleen channels, enter spleen qi system, liver blood system, aromatic and relax spleen, promote diuresis and promote blood circulation without damaging yin, and can be used together with folium Nelumbinis, bombyx Batryticatus, and Coicis semen as adjuvant drugs; wherein the ze lan is used together with cang and Bai Zhu, which is the meaning of ze Xie Tang from jin Kui Yao L ü e, and Xie Tang mainly refers to the case of dizziness and dizziness of people with heart-yin deficiency. The atractylodes rhizome establishes the middle zhou and vortex centers, and the atractylodes rhizome and the vortex centers are used together to promote diuresis and eliminate pathogenic factors, guide turbid yin to descend, strengthen spleen and eliminate dampness and advocate local water. Bo He is a guiding drug for its mild and clear property, good at moving head and face, pungent and cool smell, pungent flavor and pungent flavor for ventilating and inducing diuresis. In conclusion, the recipe can clear qi and reduce turbid yin of phlegm-fluid by ascending the spleen and stomach, strengthen the middle energizer to recover the ascending and descending, calm the liver and subdue yang, strengthen the spleen to transform damp-turbidity into damp-turbidity, recover the ascending and descending, and treat vertigo.

2. The composition and the proportion of the traditional Chinese medicine composition are obtained based on a large number of experiments, and the treatment effect is most prominent.

3. The traditional Chinese medicine composition has the advantages of abundant and easily-obtained raw materials, low price, easy preparation and suitability for popularization and use.

Detailed Description

EXAMPLE 1 preparation of the Chinese medicinal composition of the present invention

Weighing 6 parts of cimicifuga foetida, 15 parts of kudzuvine root, 9 parts of rhizoma atractylodis, 9 parts of raw bighead atractylodes rhizome, 6 parts of lotus leaf, 9 parts of stiff silkworm, 15 parts of raw coix seed, 9 parts of herba lycopi and 3 parts of mint according to the weight part ratio.

Example 2 preparation of the Chinese medicinal composition of the present invention

Weighing 2 parts of cimicifuga foetida, 10 parts of kudzuvine root, 6 parts of rhizoma atractylodis, 6 parts of raw bighead atractylodes rhizome, 2 parts of lotus leaf, 6 parts of stiff silkworm, 10 parts of raw coix seed, 6 parts of herba lycopi and 1 part of mint according to the weight part ratio.

Example 3 preparation of the Chinese medicinal composition of the present invention

Weighing 10 parts of cimicifugae foetidae, 20 parts of kudzuvine root, 12 parts of rhizoma atractylodis, 12 parts of raw bighead atractylodes rhizome, 10 parts of lotus leaf, 12 parts of stiff silkworm, 20 parts of raw coix seed, 12 parts of herba lycopi and 5 parts of mint according to the weight part ratio.

Example 4 preparation of the Chinese medicinal composition of the present Invention (IV)

Weighing 4 parts of cimicifugae foetidae, 13 parts of kudzuvine root, 8 parts of rhizoma atractylodis, 8 parts of raw bighead atractylodes rhizome, 4 parts of lotus leaf, 8 parts of stiff silkworm, 13 parts of raw coix seed, 8 parts of herba lycopi and 2 parts of mint according to the weight part ratio.

Example 5 preparation of the Chinese medicinal composition of the present invention (V)

Weighing 8 parts of cimicifuga foetida, 18 parts of kudzuvine root, 10 parts of rhizoma atractylodis, 10 parts of raw bighead atractylodes rhizome, 8 parts of lotus leaf, 10 parts of stiff silkworm, 18 parts of raw coix seed, 10 parts of herba lycopi and 4 parts of mint according to the weight part ratio.

Example 6 preparation of the Chinese medicinal composition of the present invention (VI)

Weighing 2 parts of cimicifugae foetidae, 15 parts of kudzuvine root, 9 parts of rhizoma atractylodis, 9 parts of raw bighead atractylodes rhizome, 6 parts of lotus leaf, 9 parts of stiff silkworm, 15 parts of raw coix seed, 9 parts of herba lycopi and 3 parts of mint according to the weight part ratio.

EXAMPLE 7 preparation of the Chinese medicinal composition of the present invention (VII)

Weighing 2 parts of cimicifuga foetida, 10 parts of kudzuvine root, 9 parts of rhizoma atractylodis, 9 parts of raw bighead atractylodes rhizome, 6 parts of lotus leaf, 9 parts of stiff silkworm, 15 parts of raw coix seed, 9 parts of herba lycopi and 3 parts of mint according to the weight part ratio.

EXAMPLE 8 preparation of the Chinese medicinal composition of the present invention (eight)

Weighing 2 parts of cimicifuga foetida, 10 parts of kudzuvine root, 6 parts of rhizoma atractylodis, 9 parts of raw bighead atractylodes rhizome, 6 parts of lotus leaf, 9 parts of stiff silkworm, 15 parts of raw coix seed, 9 parts of herba lycopi and 3 parts of mint according to the weight part ratio.

Example 9 preparation of the Chinese medicinal composition of the present invention (nine)

Weighing 2 parts of cimicifugae foetidae, 10 parts of kudzuvine root, 6 parts of rhizoma atractylodis, 6 parts of raw bighead atractylodes rhizome, 6 parts of lotus leaf, 9 parts of stiff silkworm, 15 parts of raw coix seed, 9 parts of herba lycopi and 3 parts of mint according to the weight part ratio.

Example 10 preparation of the Chinese medicinal composition of the present invention (ten)

Weighing 2 parts of cimicifuga foetida, 10 parts of kudzuvine root, 6 parts of rhizoma atractylodis, 6 parts of raw bighead atractylodes rhizome, 2 parts of lotus leaf, 9 parts of stiff silkworm, 15 parts of raw coix seed, 9 parts of herba lycopi and 3 parts of mint according to the weight part ratio.

EXAMPLE 11 preparation of an aqueous decoction of the Chinese medicinal composition of the present invention (eleven)

Weighing the raw materials according to the weight part ratio of any one of the embodiments 1-10, mixing uniformly (except for mint), adding 3-5 times of water, decocting with slow fire for 30-60 minutes (after the mint is put down), (filtering with two layers of medical gauze), and collecting filtrate to obtain the water decoction.

Example 12 preparation of granules of the Chinese medicinal composition of the present invention (twelve)

Weighing the raw materials according to the weight part ratio in any one of the embodiments 1-10, adding water, decocting for 3 times (after mint is added), mixing filtrates, and concentrating to obtain a clear paste with a relative density of 1.1. Adding ethanol into the fluid extract, standing for 24 hours, filtering, recovering ethanol, and concentrating to obtain a thick paste with a relative density of 1.2. Spray drying the soft extract to obtain dry extract fine powder. Adding dextrin into the dry extract fine powder, mixing, granulating by conventional method, drying, and making into granule.

Example 13 preparation of a tablet of the Chinese medicinal composition of the present invention (thirteen)

Weighing the raw materials according to the weight part ratio of any one of embodiments 1-10, adding water, decocting for 3 times (after mint is added), combining the filtrates, and concentrating to obtain a clear paste with a relative density of 1.1. Spray drying the fluid extract to obtain dry extract fine powder. Mixing the dry extract fine powder with sodium carboxymethyl starch and microcrystalline cellulose, granulating by conventional method, drying, adding magnesium stearate and silicon dioxide, mixing, tabletting by conventional method, and making into dispersible tablet.

Example 14 preparation of a Capsule of the Chinese medicinal composition of the present invention (fourteen)

Weighing the raw materials according to the weight part ratio of any one of embodiments 1-10, adding water, decocting for 3 times (after mint is added), combining the filtrates, and concentrating to obtain a clear paste with a relative density of 1.15. Spray drying the fluid extract to obtain dry extract fine powder. Adding magnesium stearate and pulvis Talci, mixing, adding hollow capsule by conventional method, and making into capsule.

Example 15 preparation of the Chinese medicinal composition drop pill of the invention (fifteen)

Weighing the raw materials according to the weight part ratio of any one of embodiments 1-10, adding water, decocting for 3 times (after mint is added), combining the filtrates, and concentrating to obtain a clear paste with a relative density of 1.18. Spray drying the fluid extract to obtain fine powder. Adding appropriate amount of water or/and yellow wine, and making into watered pill. Or adding appropriate amount of ethanol and soybean oil to make soft mass, making into pill with pellet making machine, drying, sieving, and making into pellet. Or making dripping pill with polyethylene glycol as matrix and dimethyl silicone oil as condensate.

EXAMPLE 16 preparation of oral liquid of Chinese medicinal composition of the present invention (sixteen)

Weighing the raw materials according to the weight part ratio of any one of embodiments 1-10, adding water, decocting for 3 times (after mint is added), combining the filtrates, and concentrating to obtain a clear paste with a relative density of 1.1. Adding ethanol into the fluid extract, standing for 24 hours, filtering, recovering ethanol, and concentrating to obtain a thick paste with a relative density of 1.2. Dissolving stevioside in pure water by conventional method, adding sodium benzoate and purified water, mixing with the soft extract, and making into oral liquid.

Example 17 clinical trial of the Chinese medicinal composition of the present invention for the treatment of functional vertigo

1 study object

1.1 basic information

60 complete effective cases meeting the diagnostic criteria, 30 cases in the treatment group and 30 cases in the control group. The age is 40-75 years, and the average age is 60.3 +/-6.61 years.

1.2 PPPD diagnostic standard

PPPD is a chronic vestibular disorder that must be diagnosed to meet all of the following 5 criteria:

1. over a majority of days of 3 months or more, one or more of dizziness or unstable or non-rotational vertigo occurs: (1) symptoms last for hours at each attack, and the degree can gradually increase and gradually decrease. (2) It is not necessary that symptoms be present continuously throughout the day.

2. There are no specific triggers for each persistent symptom, but the following 3 factors may exacerbate it: (1) upright posture, (2) active or passive motion regardless of direction and position, (3) exposure to moving visual stimuli or complex visual environments.

3. This disorder is caused by the following diseases that cause vertigo, instability, dizziness or a balance disorder: acute, paroxysmal or chronic vestibular syndrome, other neurological or medical disorders or psychological anxiety. (1) When the trigger disease is acute or episodic, the form of symptom appearance is consistent with that described in diagnostic criteria 1. When the trigger disease has been alleviated, symptoms first appear intermittently, and then fix on a persistent course. (2) When the trigger disease is chronic syndrome, the symptoms begin to appear slowly and then gradually worsen.

4. The symptoms cause significant anxiety or dysfunction.

5. Symptoms cannot be explained by other diseases or disorders.

1.3 syndrome diagnosis

Refer to the diagnosis standard of vertigo caused by spleen deficiency and dampness obstruction in the version of the standard of curative effect for diagnosis of traditional Chinese medicine symptoms (2012).

TABLE 1 quantification of spleen deficiency and dampness retention syndrome

2 research methods

2.1 methods of treatment

Treatment groups: the traditional Chinese medicine composition (Yang-invigorating and dizziness-stopping formula) is taken by water decoction, 180ml of liquid medicine is taken in each bag, twice a day, and the decoction is taken warm in the morning and at night. The treatment period was 4 weeks.

( The preparation method of the Chinese medicinal composition (Yang-invigorating and dizziness-stopping formula) water decoction comprises the following steps: 6g of rhizoma cimicifugae, 15g of radix puerariae, 9g of rhizoma atractylodis, 9g of raw rhizoma atractylodis macrocephalae, 6g of lotus leaf, 9g of stiff silkworm, 15g of raw semen coicis, 9g of herba lycopi and 3g of mint (added later), and the raw materials are decocted by a traditional Chinese medicine decocting machine in a hospital. )

Control group: citalopram hydrobromide tablets were administered orally. Citalopram hydrobromide tablets (Jing Gu an, southwestern pharmaceutical industry Co., ltd., approval No.: national Standard H20090083, specification: 20 mg/tablet) were orally administered 1 time a day, 1 tablet at a time.

2.2 Observation index

(1) General observation items

Gender, age, height, weight, body temperature, pulse, blood pressure, heart rate, marital status, complications (hypertension, diabetes, hyperlipidemia, etc.).

(2) Main observation item

Vertigo disability degree determination table (DHI) (see table 1).

(3) Secondary observation items

Hamilton anxiety scale (HAMA) (see table 2), hamilton depression scale (HAMD) (see table 3).

(4) Security item

Blood routine, liver and kidney functions and electrocardiogram, and safety evaluation. Adverse reactions occurring during observation should be recorded in detail and handled in time.

(5) Observation time points: at the time of group entry, the second and fourth week five 10.

2.3 therapeutic efficacy criteria

2.3.1 evaluation criteria for clinical efficacy

(1) Clinical efficacy (DHI) was assessed by reference to the vertigo disability rating scale score reduction rate.

And (3) curing: the integral reduction rate of DHI is more than or equal to 95 percent;

the effect is shown: the integral reduction rate of DHI is more than or equal to 70 percent and less than 95 percent;

the method has the following advantages: the integral reduction rate of DHI is more than or equal to 30 percent and less than 70 percent;

and (4) invalidation: the integrated DHI reduction rate is less than 30%.

Integral reduction rate = [ (pre-treatment integral-post-treatment integral)/pre-treatment integral ] × 100%.

Effective rate = (cure + show effect + effective)/nx100%

(2) HAMA/HAMD Scale Scoring, comparing score changes before and after treatment

2.3.2 Chinese medicine syndrome integral evaluation Standard

The evaluation is carried out according to the relevant standards in the clinical research guidelines of new traditional Chinese medicines. A Chinese medicine symptom scoring table is formulated according to the 'guiding principle of clinical research of new Chinese medicine' 2002 edition. The principal certificate is divided into 4 grades according to the degree of absence, lightness, middle and weight, and the grades are respectively marked as 0, 2, 4 and 6; the secondary certificate is divided into 4 grades according to the degree of inessential, light, medium and heavy, and the grades are respectively marked as 0, 1, 2 and 3; the tongue pulse is divided into 2 grades according to the absence and presence, which are respectively marked as 0 and 1.

The method is mainly determined according to the integral reduction rate of the traditional Chinese medicine syndrome.

The clinical cure is as follows: the traditional Chinese medicine syndrome integral reduction rate is more than 70%;

the effect is shown: the integral reduction rate of the traditional Chinese medicine syndrome is 30-69%;

the method has the following advantages: the integral reduction rate of the traditional Chinese medicine syndromes is 10-29%;

and (4) invalidation: the integral reduction rate of the traditional Chinese medicine syndrome is less than 10%.

3 results of the experiment

3.1 Total effective rate in clinic

The total effective rate of the treatment group is 86.7% in the observation group and 66.7% in the control group, and the comparison difference of the clinical total effective rates of the two groups has statistical significance (P is less than 0.05), which is shown in Table 2.

Table 2 comparison of clinical total effective rates (%)

Note: p > 0.05 compared to control.

3.2 Chinese medicine syndrome integration before and after two groups of treatment

P is more than 0.05 in each group before treatment, and the integral P values of other symptoms are less than 0.05 and have statistical difference compared with the two groups before treatment except tinnitus and deafness (P is more than 0.05). Differences between groups were compared using independent sample t test: in the aspect of tinnitus and deafness, the two groups of medicines have no obvious abnormality (P is more than 0.05), and the integral P values of other symptoms are all less than 0.05, which has statistical significance and is shown in Table 3.

TABLE 3 integral comparison of TCM syndromes of two groups of patients: (

Minute)

Note: p < 0.05 compared to the same group before treatment; compared between the two groups, # P < 0.05.

3.3 comparison of DHI-S scores before and after treatment in two groups

The pre-treatment DHI-S score of the two groups is obviously reduced compared with that of the two groups before treatment (P is less than 0.01); compared between the two groups, the treated group is better than the control group (P < 0.05), see Table 4.

TABLE 4 comparison of DHI-S scores before and after treatment in two groups: (

Minute)

Note: p < 0.01 compared to the same group before treatment; compared between the two groups, # P < 0.05.

3.4 comparison of HAMA scores in two groups

The HAMA scale scores of the two groups before treatment have no significant difference (P is more than 0.05), the total HAMA score and the somatotropic factor score of the two groups have significant difference (P is less than 0.05) and the psychogenic factor score has no significant difference (P is more than 0.05) after 8 weeks of treatment. HAMA scores of the two groups were significantly reduced (P < 0.05) compared with the group before treatment at 4 and 8 weeks after treatment, wherein the scores of the treatment group after 8 weeks were significantly different (P < 0.01) compared with the scores of the treatment group before treatment, as shown in Table 5.

Table 5 comparison of HAMA scores in two groups of patients: (

Minute)

Note: p < 0.05, P < 0.01, compared to the group before treatment; the comparison of the control group was carried out at the same time, ^# P＜0.05。

3.5 comparison of two sets of HAMD-17 scores

The results of the interclass effect test, F =4736.608 and p =0.000 < 0.01, were statistically different in comparison between the two groups using analysis of variance of the repeated measurements. 4 weeks after treatment (. P =0.031 < 0.05) and 8 weeks after treatment (. P =0.001 < 0.01) were compared to control groups at the corresponding time points using one-way analysis of variance. Comparison in treatment groups employed the LSD-t test: compared with the pretreatment, # P < 0.05, # P < 0.01. Comparison in the control group was performed by LSD-t test: compared with the pretreatment, # P < 0.05, # P < 0.01. The HAMD-17 score can be obviously reduced in both the treatment group and the control group, the curative effect of the treatment group is obviously superior to that of the control group, and the treatment groups have obvious difference at 4 weeks and 8 weeks after treatment, which is shown in Table 6.

TABLE 6 two groups of patients HAMD-17 comparison

Minute)

Note: comparing in group, # P < 0.05, # P < 0.01; compared with the control group at the same period, P is less than 0.05, and P is less than 0.01.

Discussion 4

PPPD is mainly complained of dizziness, and belongs to the category of vertigo in Chinese medicine. Through clinical observation, PPPD is common in spleen deficiency and dampness retention type, and is caused by the factors of improvement of living standard of people, change of living style and dietary structure, excessive eating of paste and thick taste, lack of movement, excessive ease and the like. Spleen and stomach are the hinge for qi movement, and spleen is located in middle and middle, the ascending and descending movement of qi movement of human body all uses spleen as the hinge, the essence of five zang organs is good at transporting to spleen, and spleen is vigorous to clear qi and ascend to distribute. Spleen disease is marked by severe dampness, which can lead to failure of ascending of clear yang, failure of descending of turbid qi, and failure of clear yang to reach the upper orifice, leading to vertigo. Or phlegm turbidity obstructing the middle energizer and affecting the zang-fu organs, manifested as vertigo.

Yan Xinjiao teaches that vertigo is considered to be a syndrome according to its long-term clinical experience, and is usually responsible for the clear-heat failing to ascend. The head is the celestial object, so the user can feel comfortable with the head and feel dizzy and dizzy when the yang qi is not available. The method of raising Yang in Lidongyuan is used for consolidating the constitution, raising the clear and reducing the turbid, and the effect of treating spleen deficiency and dampness resistance type PPPD by using clear and shake soup and flavor is obvious. The prescription of the Qingzhen decoction and the flavor base is Qingzhen decoction, and the Qingzhen decoction Shang Ben is from Jin Daiyi Liu Hezhong Qi Yi Bao Ming Ji (Collection of Qi Yi Yishou machine for disease inquiry). It is combined with herbs to strengthen spleen and resolve dampness, and also to ascend spleen to clear yang, resolve dampness and ascend clear. In the use process of the refreshing soup for treating PPPD patients with spleen deficiency and dampness resistance, the refreshing soup for treating PPPD patients is used as a basic formula, the clinical experience of the PPPD patients treated in our hospital is combined, the refreshing soup for treating PPPD patients is optimized, and a yang-invigorating and dizziness-stopping formula is formulated.

The traditional Chinese medicine composition disclosed by the invention comprises the following medicinal components: 6g of cimicifuga foetida, 15g of kudzuvine root, 9g of rhizoma atractylodis, 9g of raw bighead atractylodes rhizome, 6g of lotus leaf, 9g of stiff silkworm, 15g of raw coix seed, 9g of herba lycopi and 3g of mint. The recipe takes the treatment principle of strengthening middle energizer and clearing yang. In the formula, the cimicifuga foetida belongs to yang, is light in weight and pungent in taste, is light and clear and ascends, and the kudzuvine root is pungent and sweet, mainly enters yangming and has the effects of ascending, ascending and diverging, and the cimicifuga foetida and the kudzuvine root are used together to ascend yang qi, invigorate spleen to clear yang and ascend upwards to expel parietal evil, so that the cimicifuga foetida is regarded as a monarch drug. Dampness is yin pathogen, which is easy to block qi movement, and spleen is yin earth, which is a key organ for transporting and resolving water dampness, prefers dryness and dislikes dampness, so the cang-bai-shu can be used together, one is kept and one is taken, the spleen is transported and dampness is removed, the spleen is self-healthy, and the spleen is self-healthy, so the spleen is a ministerial drug; the monarch and the minister are matched to regulate the qi movement of the spleen and the stomach, and the spleen qi is ascended and descended, so that the effect of ascending the clear and descending the turbid is achieved. The lotus leaves are light and clear and rise upwards, so that the stomach can be ascended to clear qi; the stiff silkworm is a wind medicine, and has the effects of eliminating dampness by wind energy, calming wind, dredging collaterals, calming liver, suppressing yang, and enabling yang to ascend and clear, so that the soil can be reached; raw Job's tears belongs to earth, and aims at strengthening middle energizer, promoting diuresis and excreting dampness; herba Lycopi can enter liver and spleen channels, enter spleen qi system, liver blood system, and has effects of dispersing spleen qi, promoting diuresis, and promoting blood circulation without damaging yin, and can be used together with folium Nelumbinis, bombyx Batryticatus, and Coicis semen as adjuvant drugs; wherein the ze lan is used together with cang and Bai Zhu, which is the meaning of ze Xie Tang from jin Kui Yao L ü e, and Xie Tang mainly refers to the case of dizziness and dizziness of people with heart-yin deficiency. The atractylodes and the Chinese atractylodes are used together to promote diuresis and eliminate evil, guide turbid yin downward, strengthen spleen and eliminate dampness, and Chong soil water. Bo He is a guiding drug for its mild and clear property, good at moving head and face, pungent and cool smell, pungent flavor and pungent flavor for ventilating and inducing diuresis. In conclusion, the recipe can clear qi and reduce turbid yin of phlegm-fluid by ascending the spleen and stomach, strengthen the middle energizer to recover the ascending and descending, calm the liver and subdue yang, strengthen the spleen to transform damp-turbidity into damp-turbidity, recover the ascending and descending, and treat vertigo. The traditional Chinese medicine composition (Yang-invigorating and dizziness-stopping formula) can effectively reduce DHI scores, HAMA scores and HAMD scores of PPPD patients; wherein 1 case is cured, 7 cases are obviously effective, 9 cases are effective, and 2 cases are ineffective; the total effective rate is 89.5%, and no adverse reaction occurs.

The above description is only a preferred embodiment of the present invention, and it should be noted that, for those skilled in the art, several modifications and additions can be made without departing from the method of the present invention, and these modifications and additions should also be regarded as the protection scope of the present invention.

Table 1:

table 2:

all the projects adopt a grade 5 grading method of 0-4, and the standards of all the grades are as follows: (0) is asymptomatic; (1) light; (2) medium; (3) heavy; (4): is extremely heavy.

Analysis of anxiety factors: HAMA classifies anxiety factors into two major categories, somatic and psychogenic. Somatic anxiety: the scores of items 7-13 were relatively high. Psychogenic anxiety: scores of 1-6 and 14 were relatively high.

According to the data provided by the national scale cooperation group: a total score of 29 or more may be severe anxiety; not less than 21 points, obvious anxiety is certainly caused; not less than 14 points, anxiety is certainly caused; not less than 7 points, anxiety may occur; < 7 points, no anxiety symptoms.

Table 3:

and (4) analyzing results: no depression: the total score is less than 7; mild depression: 7 or more and 17 or less; moderate depression: the total score is more than 17 and less than or equal to 24; major depression: the total score is > 24.

Claims

1. A traditional Chinese medicine composition for treating spleen deficiency and dampness stagnation type functional vertigo is composed of the following raw material medicines in parts by weight: 6 parts of cimicifugae foetidae, 15 parts of kudzuvine root, 9 parts of rhizoma atractylodis, 9 parts of raw white atractylodes rhizome, 6 parts of lotus leaf, 9 parts of stiff silkworm, 15 parts of raw coix seed, 9 parts of herba lycopi and 3 parts of mint.

2. The traditional Chinese medicine composition of claim 1, wherein the preparation method of the traditional Chinese medicine composition comprises the following steps: weighing the raw materials according to the weight part ratio, respectively crushing, removing mint, uniformly mixing to obtain a medicine mixture, adding water which is 3-5 times of the total weight of the medicine mixture, decocting with slow fire for 30-60 minutes, adding mint, filtering, and collecting filtrate.

3. The use of any one of the Chinese medicinal compositions according to claims 1-2 in the preparation of a medicament for treating spleen deficiency and dampness stagnation type functional vertigo.

4. The use of claim 3, wherein the dosage form of the Chinese medicinal composition is an oral preparation.

5. The use of claim 4, wherein the oral formulation is in the form of granules, tablets, pills, powders, granules, oral liquids or capsules.