Linggui curcuma zedoary licorice decoction preparation

Abstract

The invention relates to the technical field of schizophrenia treatment, and discloses a poria cocos, cassia twig, rhizoma atractylodis macrocephalae and honey-fried licorice root decoction preparation, the poria cocos content is about 36%, the cassia twig content is about 27%, the rhizoma atractylodis macrocephalae content is about 18%, the honey-fried licorice root content is about 19%, the poria cocos is peeled and cut into block-shaped pieces, and the block-shaped pieces are filled with the honey-fried licorice root. The cassia twig is dry thick slices which are cut after impurities are removed and the cassia twig is thoroughly soaked with water, the bighead atractylodes rhizome is an irregular slice body which is cut into thick slices after fibrous roots are removed, and the honey-fried licorice root is prepared by braising and frying licorice root and ripened honey; the Linggui curcuma zedoary and liquorice decoction preparation is combined with traditional Chinese medicines to treat schizophrenia, so that the occurrence rate of adverse reactions of the medicines can be reduced, the adverse reactions of the schizophrenia medicines can be effectively prevented, and the safety is higher than that of single western medicines for treatment; therefore, the application effect, the prevention effect and the safety of the Linggui curcuma zedoary licorice decoction in the adverse reaction of antipsychotic drugs in schizophrenia can be ensured.

Description

Technical Field

[0001] The present invention relates to the technical field of schizophrenia treatment, and more specifically to a Ling Gui Zhu Gan decoction preparation. Background Art

[0002] Schizophrenia is one of the common severe mental illnesses in psychiatry, often accompanied by abnormalities in perception, emotion, thinking, cognition and behavior, with a protracted course, complex condition, repeated attacks and a low cure rate. At present, the clinical treatment of schizophrenia is mainly based on antipsychotic drugs, which are often accompanied by many adverse reactions. Severe adverse reactions can affect the patient's treatment effect, prolong the course of the disease, and reduce medication compliance and long-term prognosis;

[0003] Schizophrenia patients need long-term antipsychotic treatment, but with the widespread use of second-class antipsychotics, metabolic syndrome manifestations such as abnormal blood sugar and lipid metabolism and weight gain have become common adverse reactions, which not only increase the risk of diabetes and cardiovascular and cerebrovascular diseases in patients, but also seriously affect patients' medication compliance, efficacy and relapse rate. The weight gain and metabolic disorders caused by long-term medication increase the potential risk of schizophrenia patients with metabolic syndrome, which easily forms a vicious circle. Therefore, in order to solve the above problems, it is very necessary to have a Ling Gui Zhu Gan Tang preparation that assists Western medicine in the treatment of schizophrenia. Summary of the invention

[0004] The main technical problem solved by the present invention is to provide a Ling Gui Zhu Gan Tang preparation, which can solve the above technical problems.

[0005] To solve the above technical problems, according to one aspect of the present invention, more specifically a Ling Gui Zhu Gan Tang preparation includes Poria, cinnamon twig, Atractylodes macrocephala and roasted licorice root, wherein the content of Poria is about 36%, the content of cinnamon twig is about 27%, the content of Atractylodes macrocephala is about 18%, and the content of roasted licorice root is about 19%.

[0006] Furthermore, the Poria cocos is peeled and cut into thick block slices;

[0007] The cassia twigs are cut into dry thick slices after removing impurities and soaking them in water thoroughly;

[0008] The Atractylodes macrocephala is an irregular slice body cut into thick slices after removing the fibrous roots;

[0009] The roasted licorice root is prepared by stewing and frying licorice root and cooked honey.

[0010] According to another aspect of the present invention, a method for preparing a Lingguishugan decoction preparation is provided, comprising the following steps:

[0011] S1. Raw material ratio: Take appropriate amount of raw materials, remove impurities and mix them to form a material bag;

[0012] S2, medicine decoction: put the prepared material bag into the medicine decoction machine, and add appropriate amount of water for decoction;

[0013] S3. Patients take: Coordinate with the patient's western medicine treatment course, specifically take it twice a day, morning and evening;

[0014] S4. Experimental comparison: A number of patients with schizophrenia were selected and divided into a control group and a case group with the same number of people according to the random number table method. The control group was treated with Western medicine, and the case group was treated with Ling Gui Zhu Gan Tang combined with Western medicine. The indicators and judgment criteria were observed, and the incidence of adverse reactions in the treatment of schizophrenia, PANSS scores before and after treatment, and various physical and biochemical indicators were compared between the two groups.

[0015] Furthermore, the specific method of taking the S4 Chinese medicine decoction Ling Gui Zhu Gan Tang is: 19-21g of Poria cocos, 14-16g of cinnamon twig, 9-11g of Atractylodes macrocephala, 9-11g of roasted liquorice, 1 dose per day, decocted in a decoction machine to obtain 400±10mL of juice, taken warm twice a day in the morning and evening, and both groups were treated for 12 weeks.

[0016] Furthermore, the control group in S4 was treated with antipsychotic drugs, while the case group was treated with Ling Gui Zhu Gan Tang combined with antipsychotic drugs. The antipsychotic drug treatment regimen was the same as that of the control group, and on this basis, the Chinese medicine decoction Ling Gui Zhu Gan Tang was taken at the same time.

[0017] Furthermore, the observation indicators and judgment criteria in S4 include the treatment effect of schizophrenia, the occurrence of adverse reactions, PANSS score, body weight and biochemical indicators, specifically:

[0018] Schizophrenia treatment effect: marked effect means PANSS score reduction rate ≥ 50%, effective means PANSS score reduction rate ≥ 25% and < 50%, ineffective means PANSS score reduction rate < 25%, total effective rate of schizophrenia treatment = (number of markedly effective cases + number of effective cases) / total number of cases × 100%;

[0019] Adverse reactions: The occurrence of adverse reactions such as insomnia, tremor and gastrointestinal reactions in the two groups were counted, and the total incidence rate of the two groups was counted;

[0020] PANSS score: This scoring standard includes negative scale, positive scale and general psychopathology score, which include 7, 7 and 16 evaluation indicators respectively. The score range of each indicator is 1 to 7 points. The lower the evaluation score of each aspect and the total score, the milder the condition.

[0021] Body weight: measured and recorded at enrollment and after 4, 8, and 12 weeks of treatment;

[0022] Biochemical indicators: venous blood samples were collected at the time of enrollment and after 4, 8, and 12 weeks of treatment. The test items included routine blood tests, liver function, kidney function, blood lipids, and blood sugar. The tests were performed and the results were reviewed by experienced personnel.

[0023] Furthermore, the data testing software for statistical processing in S4 is SPSS27.0, the measurement data are expressed as (x±s), and the comparison is performed by t test, the counting data are expressed as rate (%), and the comparison is performed by χ2 test, and P<0.05 is considered statistically significant.

[0024] The beneficial effects of a Ling Gui Shu Gan Tang preparation of the present invention are:

[0025] The combination of Ling Gui Zhu Gan Tang preparation and traditional Chinese medicine in the treatment of schizophrenia can reduce the incidence of adverse drug reactions and effectively prevent the adverse reactions of schizophrenia drugs. Its safety is higher than that of western medicine alone. Therefore, it is relatively certain that Ling Gui Zhu Gan Tang has an application effect, preventive effect and safety in the adverse reactions of antipsychotic drugs in schizophrenia.

[0026] Ling Gui Zhu Gan Decoction has a good effect in warming the yang and transforming fluid, strengthening the spleen and removing dampness, and balancing the functions of various organs. Ling Gui Zhu Gan Decoction combined with antipsychotic drugs to treat schizophrenia can reduce the occurrence of adverse drug reactions, has a high safety level, and can significantly improve patients' weight and blood lipids, and positively affect uric acid indicators. BRIEF DESCRIPTION OF THE DRAWINGS

[0027] The present invention is further described in detail below with reference to the accompanying drawings and specific implementation methods.

[0028] Figure 1 A schematic diagram of the preparation process of a Ling Gui Shu Gan Tang preparation of the present invention;

[0029] Figure 2 This is a flow chart of the research method for a Ling Gui Zhu Gan Tang preparation and its preparation method. DETAILED DESCRIPTION

[0030] The present invention will be described in detail below with reference to the accompanying drawings and in combination with embodiments. It should be noted that the embodiments and features in the embodiments of the present application can be combined with each other without conflict.

[0031] According to one aspect of the present invention, Figure 1 As shown, a Ling Gui Shu Gan Tang preparation is provided, including Poria, cinnamon twig, Atractylodes macrocephala and roasted licorice root, wherein the content of the Poria is about 36%, the content of the cinnamon twig is about 27%, the content of the Atractylodes macrocephala is about 18%, and the content of the roasted licorice root is about 19%.

[0032] The Poria cocos is peeled and cut into thick block slices, the cinnamon twig is soaked in water and cut into dry thick slices after removing impurities, the Atractylodes macrocephala is irregular slices cut into thick slices after removing the rootlets, and the roasted licorice is stewed and fried with cooked honey. Ling Gui Zhu Gan Decoction has a good effect on warming yang and transforming fluid, strengthening the spleen and removing dampness, and balancing the functions of various internal organs. Ling Gui Zhu Gan Decoction combined with antipsychotic drugs to treat schizophrenia can reduce the occurrence of adverse drug reactions, has a high safety, and can significantly improve the patient's weight and blood lipids, and positively affect the uric acid index.

[0033] According to another aspect of the present invention, a method for preparing a Lingguishugan decoction preparation is provided, comprising the following steps:

[0034] S1. Raw material ratio: Take appropriate amount of raw materials, remove impurities and mix them to form a material bag;

[0035] S2, medicine decoction: put the prepared material bag into the medicine decoction machine, and add appropriate amount of water for decoction;

[0036] S3. Patients take: Coordinate with the patient's western medicine treatment course, specifically take it twice a day, morning and evening;

[0037] S4. Experimental comparison: Several patients with schizophrenia were selected and divided into a control group and a case group with the same number of patients according to the random number table method. The control group was treated with western medicine, and the case group was treated with Ling Gui Zhu Gan Tang combined with western medicine. The indicators and judgment criteria were observed, and the incidence of adverse reactions in the treatment of schizophrenia, PANSS scores before and after treatment, and various physical and biochemical indicators were compared between the two groups. The specific method of taking the medicinal decoction Ling Gui Zhu Gan Tang was: 19-21g of Poria, 14-16g of cinnamon twig, 9-11g of Atractylodes macrocephala, 9-11g of licorice root, 1 dose per day, decocted with a decoction machine to obtain 400±10mL of juice, taken warm twice a day in the morning and evening, and both groups were treated for 12 weeks. In S4, the control group was treated with antipsychotic drugs, and the case group was treated with Ling Gui Zhu Gan Tang combined with antipsychotic drugs. The antipsychotic drug treatment regimen was the same as that of the control group. On this basis, the Chinese medicine decoction Ling Gui Zhu Gan Tang was taken at the same time. The observation indicators and judgment criteria included the therapeutic effect of schizophrenia, the occurrence of adverse reactions, PANSS scores, body weight and biochemical indicators, specifically:

[0038] Schizophrenia treatment effect: marked effect means PANSS score reduction rate ≥ 50%, effective means PANSS score reduction rate ≥ 25% and < 50%, ineffective means PANSS score reduction rate < 25%, total effective rate of schizophrenia treatment = (number of markedly effective cases + number of effective cases) / total number of cases × 100%;

[0039] Adverse reactions: The occurrence of adverse reactions such as insomnia, tremor and gastrointestinal reactions in the two groups were counted, and the total incidence rate of the two groups was counted;

[0040] PANSS score: This scoring standard includes negative scale, positive scale and general psychopathology score, which include 7, 7 and 16 evaluation indicators respectively. The score range of each indicator is 1 to 7 points. The lower the evaluation score of each aspect and the total score, the milder the condition.

[0041] Body weight: measured and recorded at enrollment and after 4, 8, and 12 weeks of treatment;

[0042] Biochemical indexes: venous blood was collected for testing at the time of enrollment and after 4, 8, and 12 weeks of treatment. The test items included routine blood tests, liver function, kidney function, blood lipids, and blood sugar. The test was performed and the results were reviewed by experienced personnel. The data testing software for statistical processing was SPSS27.0. The measurement data were expressed as (x±s) and compared with the t test. The counting data were expressed as rate (%) and compared with the χ2 test. P<0.05 was considered statistically significant. The specific implementation was as follows:

[0043] A total of 100 patients with schizophrenia were selected and divided into a control group of 50 cases and a case group of 50 cases according to the random number table method. The control group was treated with Western medicine, and the case group was treated with Linggui Zhugan decoction combined with Western medicine. The incidence of drug adverse reactions, changes in biochemical indicators and PANSS scores were compared between the two groups.

[0044] The general data of the two groups were compared. The control group had 34 males and 16 females, aged 28 to 71 years old, with an average age of (54.32±11.15) years old; weight 44 to 93 kg, with an average weight of (64.47±10.25) kg. The case group had 33 males and 17 females, aged 19 to 74 years old, with an average age of (51.44±11.74) years old; weight 42 to 88 kg, with an average weight of (61.84±11.00) kg. There was no significant difference in the general data between the two groups (P>0.05), and they were comparable. 2.2 Comparison of the efficacy between the two groups The total effective rate of schizophrenia treatment in the case group was higher than that in the control group, and the difference was statistically significant (χ2=19.05, P<0.001), see the table below;

[0045]

[0046] Comparison of the incidence of adverse reactions between the two groups The total incidence of adverse reactions in the case group was lower than that in the control group, and the difference was statistically significant (χ2=5.26, P=0.02), as shown in the table below;

[0047]

[0048] Comparison of PANSS scores between the two groups before and after treatment Before treatment, there was no significant difference in PANSS scores of each dimension between the two groups (P>0.05); after 12 weeks of treatment, the PANSS scores of each dimension in the case group were lower than those in the control group, and the differences in P score, G score and total score were statistically significant (P<0.05), as shown in the table below;

[0049]

[0050] Comparison of blood lipids before and after treatment between the two groups Before treatment, there was no significant difference in triglycerides, total cholesterol, and low-density lipoprotein cholesterol-c between the two groups (P>0.05); after 12 weeks of treatment, all indicators in the case group were lower than those before treatment, and the difference was statistically significant (P<0.05), and all indicators in the control group were also lower than those before treatment, but there was no statistical difference (P>0.05), see the table below;

[0051]

[0052] Comparison of other indicators before and after treatment between the two groups: There was no statistical difference in body weight between the two groups before treatment. After 12 weeks of treatment, the average body weight of the case group (60.32±10.71) kg was lower than that of the control group (64.71±10.78) kg, and the difference was statistically significant (t=2.098, P<0.05); There was no statistical difference in uric acid between the two groups before treatment. After 12 weeks of treatment, the case group (308.76±91.43) umol / L was lower than that of the control group (334.96±98.31) umol / L, and the difference was not statistically significant (t=1.213, P=0.231);

[0053] In the above implementation, the total effective rate of the case group was higher than that of the control group, and the scores of each item of the PANSS scale were lower than those of the control group. The scores of negative mental symptoms, pathological scores and total scores were better than those of the control group (P<0.05), indicating that the clinical efficacy of the Chinese medicine decoction Ling Gui Zhu Gan Tang combined with antipsychotic drugs in the treatment of schizophrenia was significant and beneficial to improving the mental symptoms of patients. The two groups showed that the case group showed that the combined decoction Ling Gui Zhu Gan Tang could reduce the incidence of adverse drug reactions. The total incidence of adverse reactions such as insomnia, tremor, dry mouth and constipation in the case group was lower than that in the control group, and the difference was statistically significant (P<0.05). The weight of the case group was lower than that of the control group (P<0.05). , indicating that the use of Ling Gui Zhu Gan Tang combined with antipsychotic drugs significantly reduced the incidence of adverse reactions compared with antipsychotic drugs alone. Ling Gui Zhu Gan Tang can prevent the adverse reactions of antipsychotic drugs. Before and after treatment, triglycerides, total cholesterol, and low-density lipoprotein cholesterol-c in the case group were all lower than before treatment, and the difference was statistically significant (P<0.05). The indicators of the control group were also lower than before treatment, but there was no statistical difference (P>0.05). The uric acid in the case group was also lower than that in the case group, but there was no statistical difference (P>0.05). It is not excluded that the sample size of this clinical study is small, resulting in conclusion bias. Therefore, the application effect and desirability of Ling Gui Zhu Gan Tang in patients with schizophrenia are confirmed.

[0054] The working principle of this device is: the Ling Gui Zhu Gan Decoction preparation combined with traditional Chinese medicine to treat schizophrenia can reduce the incidence of adverse drug reactions and effectively prevent the adverse reactions of schizophrenia drugs. Its safety is higher than that of Western medicine treatment alone. Therefore, it is relatively certain that the application effect, preventive effect and safety of Ling Gui Zhu Gan Decoction in the treatment of adverse reactions of antipsychotic drugs in schizophrenia.

[0055] The electrical components that appear in this article are all electrical components that exist in reality.

[0056] Of course, the above description is not a limitation of the present invention, and the present invention is not limited to the above examples. Changes, modifications, additions or substitutions made by ordinary technicians in this technical field within the essential scope of the present invention also fall within the protection scope of the present invention.

Claims

1. A Ling Gui Shu Gan Tang preparation, comprising Poria cocos, cinnamon twig, Atractylodes macrocephala and roasted licorice root, Features: The content of the Poria cocos is about 36%, the content of the cinnamon twig is about 27%, the content of the Atractylodes macrocephala is about 18%, and the content of the roasted liquorice root is about 19%.

2. A Ling Gui Shu Gan Tang preparation according to claim 1, Features: The Poria cocos is peeled and cut into thick block slices; The cassia twigs are cut into dry thick slices after removing impurities and soaking them in water thoroughly; The Atractylodes macrocephala is an irregular slice body cut into thick slices after removing the fibrous roots; The roasted licorice root is prepared by stewing and frying licorice root and cooked honey.

3. A method for preparing a Ling Gui Shu Gan Tang preparation, comprising the Ling Gui Shu Gan Tang preparation according to any one of claims 1 to 2, It is characterized in that The following steps are involved: S1. Raw material ratio: Take appropriate amount of raw materials, remove impurities and mix them to form a material bag; S2, medicine decoction: put the prepared material bag into the medicine decoction machine, and add appropriate amount of water for decoction; S3. Patients take: Coordinate with the patient's western medicine treatment course, specifically take it twice a day, morning and evening; S4. Experimental comparison: A number of patients with schizophrenia were selected and divided into a control group and a case group with the same number of people according to the random number table method. The control group was treated with Western medicine, and the case group was treated with Ling Gui Zhu Gan Tang combined with Western medicine. The indicators and judgment criteria were observed, and the incidence of adverse reactions in the treatment of schizophrenia, PANSS scores before and after treatment, and various physical and biochemical indicators were compared between the two groups.

4. The method for preparing the Ling Gui Shu Gan Tang preparation according to claim 1, Features: The specific method of taking the S4 Chinese medicine decoction Ling Gui Zhu Gan Tang is: 19-21g of Poria, 14-16g of cinnamon twig, 9-11g of Atractylodes macrocephala, 9-11g of roasted liquorice, one dose per day, decoct the medicine in a decoction machine to obtain 400±10mL of juice, take it warm twice a day, morning and evening, and both groups were treated for 12 weeks.

5. The method for preparing the Ling Gui Shu Gan Tang preparation according to claim 1, Features: The control group in S4 was treated with antipsychotic drugs, while the case group was treated with Ling Gui Zhu Gan Tang combined with antipsychotic drugs. The antipsychotic drug treatment regimen was the same as that of the control group, and on this basis, the Chinese medicine decoction Ling Gui Zhu Gan Tang was taken at the same time.

6. The method for preparing the Ling Gui Shu Gan Tang preparation according to claim 1, Features: The observation indicators and judgment criteria in S4 include the treatment effect of schizophrenia, the occurrence of adverse reactions, PANSS score, body weight and biochemical indicators, specifically: Schizophrenia treatment effect: marked effect means PANSS score reduction rate ≥ 50%, effective means PANSS score reduction rate ≥ 25% and < 50%, ineffective means PANSS score reduction rate < 25%, total effective rate of schizophrenia treatment = (number of markedly effective cases + number of effective cases) / total number of cases × 100%; Adverse reactions: The occurrence of adverse reactions such as insomnia, tremor and gastrointestinal reactions in the two groups were counted, and the total incidence rate of the two groups was counted; PANSS score: This scoring standard includes negative scale, positive scale and general psychopathology score, which include 7, 7 and 16 evaluation indicators respectively. The score range of each indicator is 1 to 7 points. The lower the evaluation score of each aspect and the total score, the milder the condition. Body weight: measured and recorded at enrollment and after 4, 8, and 12 weeks of treatment; Biochemical indicators: venous blood samples were collected at the time of enrollment and after 4, 8, and 12 weeks of treatment. The test items included routine blood tests, liver function, kidney function, blood lipids, and blood sugar. The tests were performed and the results were reviewed by experienced personnel.

7. The method for preparing the Ling Gui Shu Gan Tang preparation according to claim 1, Features: The data analysis software used in the statistical analysis of S4 was SPSS 27.

0. The quantitative data were expressed as (x±s) and compared using the t test. The enumeration data were expressed as rate (%) and compared using the χ2 test. P<0.05 was considered statistically significant.

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