Traditional Chinese medicine composition for treating constipation and preparation method thereof

Abstract

The invention discloses a traditional Chinese medicine composition for treating constipation. The traditional Chinese medicine composition is prepared by extracting the following traditional Chinese medicines in parts by weight: 15-25 parts of prepared rehmannia root, 10-20 parts of barbary wolfberry fruit, 8-12 parts of Chinese magnoliavine fruit, 15-25 parts of yerbadetajo herb, 10-20 parts of uncaria, 15-25 parts of cape jasmine, 12-18 parts of asparagus fern, 5-9 parts of bulbus fritillariae cirrhosae, 20-30 parts of astragalus membranaceus, 15-25 parts of codonopsis pilosula, 18-22 parts of radix polygonati officinalis, 10-20 parts of Chinese magnoliavine fruit, 15-25 parts of ginseng, 12-18 parts of poria cocos, 20-30 parts of Chinese yam, 10-20 parts of bunge cherry seed, 8-12 parts of peach kernel, 10-14 parts of almond and 15-25 parts of angelica sinensis. The traditional Chinese medicine composition can nourish yin and tonify kidney, enrich blood and nourish liver, calm liver wind, clear heat and reduce phlegm, tonify lung qi, nourish lung yin, tonify spleen and stomach, relax bowel and promote blood circulation to remove blood stasis, and achieves the purpose of treating constipation caused by Parkinson's disease.

Description

Technical Field

[0001] The present invention belongs to the technical field of traditional Chinese medicine compositions, and particularly relates to a traditional Chinese medicine composition for treating constipation and a preparation method thereof, and more particularly to constipation caused by Parkinson's patients. Background Art

[0002] Parkinson's disease is the second most common neurodegenerative disease mainly characterized by motor symptoms such as bradykinesia, muscle rigidity, and resting tremor, and accompanied by non-motor symptoms such as constipation, hyposmia, sleep disorders, depression and anxiety. Among many non-motor symptoms, constipation is one of the most common symptoms in Parkinson's disease, and the constipation symptom makes Parkinson's patients extremely painful. At present, it is considered that the main pathogenesis of Parkinson's disease constipation is due to delayed colonic transit. The basal ganglia mainly regulate the lower digestive tract and are called the centers for urination and defecation. These lesions may cause a reduction in colonic contractions in patients, resulting in constipation. Moreover, the process of Parkinson's disease may directly affect the pelvic floor muscles and anal sphincter abnormalities, leading to defecation obstruction and constipation.

[0003] Traditional Chinese medicine believes that Parkinson's disease belongs to the categories of "tremor syndrome", "muscle bi syndrome", "convulsion disease", etc. "Nineteen Articles on Pathogenesis" in "Plain Questions: Treatise on the Most Important Pathogenic Factors" states: "All wind-induced dizziness and vertigo belong to the liver... all sudden stiffness and rigidity belong to wind", suggesting that muscle rigidity and limb tremors are mostly related to internal movement of liver wind; "All dampness-induced swelling and fullness belong to the spleen... all convulsions and neck stiffness belong to dampness", indicating that the spleen deficiency fails to transport and transform water and dampness, and phlegm and stasis are mutually knotted, then the tendons and vessels lose nourishment, resulting in body stiffness and heaviness, and restricted movement of the limbs; "All cold-induced contraction and retraction belong to the kidney... all diseases with clear and cold body fluids belong to cold", explaining that the deficiency of yang qi in the kidney fails to warm and transform cold and dampness, then qi and blood yin and yang cannot reach the four extremities, presenting manifestations such as restricted stretching of the limbs and bradykinesia. The etiology and pathogenesis are complex. Traditional Chinese medicine believes that the disease location is in the tendons and vessels, and the pathogenesis is deficiency in origin and excess in superficiality, and is closely related to the liver, spleen, kidney and other organs. The common syndromes of this disease include qi and blood deficiency syndrome, marrow sea deficiency syndrome, liver and kidney yin deficiency syndrome, blood stasis and wind movement syndrome, phlegm heat and wind movement syndrome. Among them, the most common type of constipation caused by Parkinson's disease in the later stage is the liver and kidney yin deficiency syndrome, and is often accompanied by spleen and kidney yang deficiency and qi and blood deficiency. Summary of the Invention

[0004] The purpose of the present invention is to provide a pharmaceutical composition for treating constipation in Parkinson's patients, which is effective, safe, convenient to use, has few side effects, and good repeatability, and can achieve the effects of nourishing yin and tonifying the kidney and nourishing blood and nourishing the liver.

[0005] To achieve the above technical purposes and achieve the above technical effects, the present invention is realized through the following technical solutions:

[0006] A traditional Chinese medicine composition for treating constipation is prepared by extracting the following traditional Chinese medicines in parts by weight: 15 - 25 parts of Rehmannia glutinosa preparata, 10 - 20 parts of Lycium barbarum, 8 - 12 parts of Schisandra chinensis, 15 - 25 parts of Eclipta prostrata, 10 - 20 parts of Uncaria rhynchophylla, 15 - 25 parts of Gardenia jasminoides, 12 - 18 parts of Asparagus cochinchinensis, 5 - 9 parts of Fritillaria cirrhosa, 20 - 30 parts of Astragalus membranaceus, 15 - 25 parts of Codonopsis pilosula, 18 - 22 parts of Polygonatum odoratum, 10 - 20 parts of Schisandra chinensis, 15 - 25 parts of Panax ginseng, 12 - 18 parts of Poria cocos, 20 - 30 parts of Dioscorea opposita, 10 - 20 parts of Prunus davidiana, 8 - 12 parts of Prunus persica, 10 - 14 parts of Armeniaca vulgaris, 15 - 25 parts of Angelica sinensis, 8 - 12 parts of Salvia miltiorrhiza.

[0007] The traditional Chinese medicine composition for treating constipation is prepared by extracting the following traditional Chinese medicines in parts by weight: 20 parts of Rehmannia glutinosa preparata, 15 parts of Lycium barbarum, 10 parts of Schisandra chinensis, 20 parts of Eclipta prostrata, 15 parts of Uncaria rhynchophylla, 20 parts of Gardenia jasminoides, 15 parts of Asparagus cochinchinensis, 7 parts of Fritillaria cirrhosa, 25 parts of Astragalus membranaceus, 20 parts of Codonopsis pilosula, 20 parts of Polygonatum odoratum, 15 parts of Schisandra chinensis, 20 parts of Panax ginseng, 15 parts of Poria cocos, 25 parts of Dioscorea opposita, 15 parts of Prunus davidiana, 10 parts of Prunus persica, 12 parts of Armeniaca vulgaris, 20 parts of Angelica sinensis, 10 parts of Salvia miltiorrhiza.

[0008] The traditional Chinese medicine composition for treating constipation is prepared by extracting the following traditional Chinese medicines in parts by weight: 15 parts of Rehmannia glutinosa preparata, 20 parts of Lycium barbarum, 8 parts of Schisandra chinensis, 25 parts of Eclipta prostrata, 10 parts of Uncaria rhynchophylla, 25 parts of Gardenia jasminoides, 12 parts of Asparagus cochinchinensis, 9 parts of Fritillaria cirrhosa, 20 parts of Astragalus membranaceus, 25 parts of Codonopsis pilosula, 18 parts of Polygonatum odoratum, 20 parts of Schisandra chinensis, 15 parts of Panax ginseng, 18 parts of Poria cocos, 20 parts of Dioscorea opposita, 20 parts of Prunus davidiana, 8 parts of Prunus persica, 14 parts of Armeniaca vulgaris, 15 parts of Angelica sinensis, 12 parts of Salvia miltiorrhiza.

[0009] The traditional Chinese medicine composition for treating constipation is prepared by extracting the following traditional Chinese medicines in parts by weight: 25 parts of Rehmannia glutinosa preparata, 10 parts of Lycium barbarum, 12 parts of Schisandra chinensis, 15 parts of Eclipta prostrata, 20 parts of Uncaria rhynchophylla, 15 parts of Gardenia jasminoides, 18 parts of Asparagus cochinchinensis, 5 parts of Fritillaria cirrhosa, 30 parts of Astragalus membranaceus, 15 parts of Codonopsis pilosula, 22 parts of Polygonatum odoratum, 10 parts of Schisandra chinensis, 25 parts of Panax ginseng, 12 parts of Poria cocos, 30 parts of Dioscorea opposita, 10 parts of Prunus davidiana, 12 parts of Prunus persica, 10 parts of Armeniaca vulgaris, 25 parts of Angelica sinensis, 8 parts of Salvia miltiorrhiza.

[0010] The preparation method of the traditional Chinese medicine composition for treating constipation includes the following steps:

[0011] (1) Mix the above Schisandra chinensis, Prunus davidiana, Prunus persica, Armeniaca vulgaris, Angelica sinensis, and Salvia miltiorrhiza with 6 times the weight of the medicinal materials of 95% ethanol, heat and reflux at 80 °C for 2 times, 3 hours each time, filter, and concentrate the filtrate under reduced pressure at a pressure of 2.5 kPa and a temperature of 60 °C for 10 h to obtain a thick paste with a relative density of 1.35 - 1.38 at 60 °C. Vacuum dry it, and the obtained dry extract is pulverized and passed through an 80 - mesh sieve to obtain powder I for standby;

[0012] (2) Decoct the medicinal residues from step (1) and other medicinal materials except Fritillaria cirrhosa in water three times. For the first time, decoct with 12 times the weight of the medicinal materials in water for 3 hours; for the second time, decoct with 10 times the weight of the medicinal materials in water for 2 hours; for the third time, decoct with 8 times the weight of the medicinal materials in water for 1.5 hours. Filter the extraction liquid, and concentrate the filtrate under reduced pressure at a pressure of 2.5 kPa and a temperature of 80 °C for 12 h to obtain a thick paste with a relative density of 1.35 - 1.38 at 60 °C. Dry it under vacuum. The obtained dry extract is pulverized and sieved through a 80-mesh sieve to obtain powder II for standby.

[0013] (3) Pulverize Fritillaria cirrhosa into fine powder, sieve it through a 80-mesh sieve, and mix it evenly with powder I prepared in step (1) and powder II prepared in step (2) for standby.

[0014] (4) Make the fine powder of the mixture obtained in step (3) into soft material, granulate it with a 20-mesh sieve in a granulator, dry it in a drying chamber at a temperature of 60 °C for 2 hours, and screen it through a 20-mesh sieve to prepare a preparation.

[0015] The traditional Chinese medicine composition for treating constipation, and the preparation is one of tablets, granules or capsules.

[0016] Application of the traditional Chinese medicine composition for treating constipation in the preparation of drugs for constipation caused by Parkinson's disease.

[0017] Application of the traditional Chinese medicine composition for treating constipation in the preparation of drugs for reducing the dopamine content in the substantia nigra.

[0018] Application of the traditional Chinese medicine composition for treating constipation in the preparation of drugs for constipation caused by Parkinson's disease, and the syndrome types of constipation caused by Parkinson's disease are mainly liver-kidney yin deficiency, spleen-kidney yang deficiency, and qi and blood deficiency.

[0019] Parkinson's disease for 7 - 8 years and above belongs to the late stage. The condition is lingering and difficult to cure. The deficiency symptoms of constipation are prominent, mainly liver-kidney yin deficiency, spleen-kidney yang deficiency, and qi and blood deficiency. For those with liver-kidney yin deficiency, the stools are dry and hard like sheep feces, the body is emaciated, the head shakes and the limbs tremble, the hands are unstable when holding objects, there is dizziness and tinnitus, the cheeks are flushed, there is tidal fever and night sweats, the waist and knees are weak, the tongue is red with little coating, and the pulse is thready and rapid. This syndrome belongs to kidney deficiency with marrow depletion. The liver and kidney share the same origin. When water fails to nourish wood, liver-kidney yin deficiency occurs, and liver wind stirs internally, resulting in high shaking due to lower deficiency. The treatment should seek the root cause, and the therapeutic principle of nourishing yin and tonifying the kidney, nourishing blood and nourishing the liver should be adopted. Rehmannia glutinosa, Lycium barbarum, Schisandra chinensis, and Eclipta prostrata are selected as the monarch drugs.

[0020] In addition, due to liver-kidney yin deficiency, the deficiency fire flares up, and liver wood invades the spleen-earth, resulting in abnormal spleen transportation and transformation; or due to the preference for fatty, sweet, and thick-flavored foods, the spleen transportation is insufficient, phlegm-dampness is generated internally, stagnates and transforms into heat, and extreme heat generates wind, leading to the occurrence of tremor syndrome. It is advisable to suppress liver wind and extinguish wind, clear heat and resolve phlegm, and Uncaria rhynchophylla, Gardenia jasminoides, Asparagus cochinchinensis, and Fritillaria cirrhosa are selected as the ministerial drugs.

[0021] After a long illness, Parkinson's disease can easily consume qi and damage yin. Deficiency of qi leads to weakness in blood production, resulting in deficiency of both qi and blood. When qi and blood are deficient, the intestines lack the power to promote transportation. A long illness can also damage the spleen and stomach, causing damage to the middle yang of the spleen, failure of the clear yang to rise, disorder of the qi movement of ascending and descending, and failure of the turbid yin in the stomach and intestines to descend, thus impairing intestinal peristalsis and excretion. In "The Spiritual Pivot - The Channels Chapter": "The lung meridian of hand taiyin starts from the middle jiao, descends to connect with the large intestine, then circles back to the opening of the stomach, ascends through the diaphragm and pertains to the lung." The lung is an internal organ, pertaining to yin, while the large intestine pertains to yang. Through the mutual connection of the meridians, they form an exterior-interior relationship between the zang-fu organs, and there is a close relationship between them in terms of physiology and pathology. Therefore, for the constipation in the late stage of Parkinson's disease, it is necessary to tonify the qi of the lung and nourish the yin of the lung, and use astragalus membranaceus, codonopsis pilosula, polygonatum odoratum, and schizandra chinensis.

[0022] At the same time, the spleen is the mother of the lung. When the spleen is weak, the production of the vital qi responsible for respiration is insufficient because earth fails to generate metal. The lung and the large intestine are exterior-interiorly related. The lung's purging and descending function and the large intestine's conduction of feces depend on the normal purging and descending of the lung qi. Insufficient lung qi leads to weak intestinal conduction, and the feces accumulate. Spleen qi deficiency causes slow intestinal purging and constipation. The spleen's transportation function is weak, resulting in insufficient production of water and grain essence, dry stools due to lack of lubrication, and weakness of the limbs and muscles due to lack of nourishment. In addition, the spleen and stomach are the hubs for the transportation and transformation of qi in the middle jiao. When the spleen qi fails to rise, the pivot function is impaired, leading to stagnation of the middle qi, accumulation and non-movement, and difficulty in the stomach's purging and descending. Therefore, the qi in the lower jiao and the intestines also descends slowly. Using ginseng, poria cocos, and Chinese yam, which can tonify the spleen and stomach and benefit the lung qi, can promote the recovery of spleen and stomach functions and relieve the problems of spleen deficiency and constipation. The present invention uses astragalus membranaceus, codonopsis pilosula, polygonatum odoratum, schizandra chinensis, ginseng, poria cocos, and Chinese yam as adjuvant drugs.

[0023] In the late stage of Parkinson's disease, the patient's kidney essence is deficient and qi and blood are exhausted, unable to promote and nourish intestinal conduction. Dry feces, phlegm, and stasis are mutually knotted to form masses, aggravating qi stagnation and blood stasis. It is advisable to moisten the intestines and promote defecation, and activate blood circulation and remove stasis. Use prunus davidiana, peach kernel, apricot kernel, angelica sinensis, and salvia miltiorrhiza as guiding drugs.

[0024] The whole formula contains rehmannia glutinosa, wolfberry fruit, schizandra chinensis, eclipta prostrata, uncaria rhynchophylla, gardenia jasminoides, asparagus cochinchinensis, fritillaria cirrhosa, astragalus membranaceus, codonopsis pilosula, polygonatum odoratum, schizandra chinensis, ginseng, poria cocos, Chinese yam, prunus davidiana, peach kernel, apricot kernel, angelica sinensis, and salvia miltiorrhiza. Among them, rehmannia glutinosa, wolfberry fruit, schizandra chinensis, and eclipta prostrata are the sovereign drugs, uncaria rhynchophylla, gardenia jasminoides, asparagus cochinchinensis, and fritillaria cirrhosa are the ministerial drugs, astragalus membranaceus, codonopsis pilosula, polygonatum odoratum, schizandra chinensis, ginseng, poria cocos, and Chinese yam are the adjuvant drugs, and prunus davidiana, peach kernel, apricot kernel, angelica sinensis, and salvia miltiorrhiza are the guiding drugs. It can nourish yin and benefit the kidney, nourish blood and soothe the liver, suppress the liver and extinguish wind, clear heat and resolve phlegm, tonify the qi of the lung, nourish the yin of the lung, tonify the spleen and stomach, moisten the intestines and promote defecation, activate blood circulation and remove stasis, so as to achieve the purpose of treating constipation caused by Parkinson's disease.

[0025] The above traditional Chinese medicines all meet the pharmacopoeia standards.

[0026] Pharmacodynamic study. The level of DA in the substantia nigra of the operative side in the model group was detected by HPLC method. It was found that the dopamine (DA) in the substantia nigra of the model group was significantly decreased, indicating that the model was successfully established. After administration of the granules in Example 1 of the present invention, the level of dopamine (DA) in the substantia nigra was significantly higher than that in the model group, indicating that the present invention can increase the content of striatal DA, has a certain regulatory effect on the balance of neurotransmitters, and has a certain therapeutic effect on constipation caused by Parkinson's disease.

[0027] The first defecation time of the model group was longer than that of the control group, and the number of defecation pellets was less. After administration of the granules in Example 1 of the present invention, the first defecation time was shortened and the number of defecation pellets was increased, indicating that the present invention can promote defecation and has a certain therapeutic effect on constipation caused by Parkinson's disease.

[0028] Comparison of clinical efficacy: The total effective rate of the observation group was 88%, and the total effective rate of the control group was 76%. The difference was statistically significant (P < 0.05), indicating that the present invention has a good therapeutic effect on liver-kidney yin deficiency constipation caused by Parkinson's disease. Specific embodiments

[0029] The present invention will be further described below in conjunction with specific embodiments. It should be understood that these embodiments are only used to illustrate the present invention and not to limit the scope of the present invention. In addition, it should be understood that after reading the content recorded in the present invention, those skilled in the art can make various changes or modifications to the present invention, but these equivalent forms also fall within the scope defined by the appended claims of the present application.

[0030] Example 1:

[0031] Take 200 g of Rehmannia glutinosa preparata, 150 g of Lycium barbarum, 100 g of Schisandra chinensis, 200 g of Eclipta prostrata, 150 g of Uncaria rhynchophylla, 200 g of Gardenia jasminoides, 150 g of Asparagus cochinchinensis, 70 g of Fritillaria cirrhosa, 250 g of Astragalus membranaceus, 200 g of Codonopsis pilosula, 200 g of Polygonatum odoratum, 150 g of Schisandra chinensis, 200 g of Panax ginseng, 150 g of Poria cocos, 250 g of Dioscorea opposita, 150 g of Prunus japonica, 100 g of Prunus persica, 120 g of Armeniaca vulgaris, 200 g of Angelica sinensis, 100 g of Salvia miltiorrhiza. The preparation method includes the following steps:

[0032] (1) Add 95% ethanol 6 times the weight of the above Schisandra chinensis, Prunus japonica, Prunus persica, Armeniaca vulgaris, Angelica sinensis, and Salvia miltiorrhiza to the medicinal materials, heat and reflux at 80 °C for 2 times, 3 hours each time, filter, and concentrate the filtrate under reduced pressure at a pressure of 2.5 kPa and a temperature of 60 °C for 10 h to obtain a thick paste with a relative density of 1.36 at 60 °C. Vacuum dry it, and the obtained dry extract is pulverized and passed through an 80-mesh sieve to obtain powder I for standby;

[0033] (2) Decoct the medicinal residues from step (1) and the other medicinal materials except Fritillaria cirrhosa D. Don with water three times. For the first time, decoct with 12 times the weight of the medicinal materials in water for 3 hours; for the second time, decoct with 10 times the weight of the medicinal materials in water for 2 hours; for the third time, decoct with 8 times the weight of the medicinal materials in water for 1.5 hours. Filter the extract, and concentrate the filtrate under reduced pressure at a pressure of 2.5 kPa and a temperature of 80 °C for 12 h to obtain a thick paste with a relative density of 1.36 at 60 °C. Dry it under vacuum. The obtained dry extract is pulverized and passed through an 80-mesh sieve to obtain Powder II, which is reserved for use.

[0034] (3) Pulverize Fritillaria cirrhosa D. Don into fine powder, pass it through an 80-mesh sieve, and mix it evenly with Powder I prepared in step (1) and Powder II prepared in step (2) for reserve.

[0035] (4) Make the fine powder of the mixture obtained in step (3) into soft material, granulate it with a 20-mesh sieve in a granulator, dry it in a drying chamber at a temperature of 60 °C for 2 hours, and screen it through a 20-mesh sieve to prepare granules.

[0036] Example 2:

[0037] Take 150 g of Rehmannia glutinosa Libosch. f. hueichingensis (Chao & Schih) Hsiao & Keng, 200 g of Lycium barbarum L., 80 g of Schisandra chinensis (Turcz.) Baill., 250 g of Eclipta prostrata L., 100 g of Uncaria rhynchophylla (Miq.) Jacks., 250 g of Gardenia jasminoides Ellis, 120 g of Asparagus cochinchinensis (Lour.) Merr., 90 g of Fritillaria cirrhosa D. Don, 200 g of Astragalus membranaceus (Fisch.) Bunge, 250 g of Codonopsis pilosula (Franch.) Nannf., 180 g of Polygonatum odoratum (Mill.) Druce, 200 g of Schisandra chinensis (Turcz.) Baill., 150 g of Panax ginseng C. A. Mey., 180 g of Poria cocos (Schw.) Wolf, 200 g of Dioscorea opposita Thunb., 200 g of Prunus davidiana (Carr.) Franch. var. ansu (Maxim.) Yü, 80 g of Prunus persica (L.) Batsch, 140 g of Armeniaca vulgaris Lam., 150 g of Angelica sinensis (Oliv.) Diels, 120 g of Salvia miltiorrhiza Bunge. The preparation method includes the following steps:

[0038] (1) Heat and reflux the above Schisandra chinensis (Turcz.) Baill., Prunus davidiana (Carr.) Franch. var. ansu (Maxim.) Yü, Prunus persica (L.) Batsch, Armeniaca vulgaris Lam., Angelica sinensis (Oliv.) Diels, and Salvia miltiorrhiza Bunge with 6 times the weight of the medicinal materials in 95% ethanol at 80 °C for 2 times, 3 hours each time. Filter, and concentrate the filtrate under reduced pressure at a pressure of 2.5 kPa and a temperature of 60 °C for 10 h to obtain a thick paste with a relative density of 1.35 at 60 °C. Dry it under vacuum. The obtained dry extract is pulverized and passed through an 80-mesh sieve to obtain Powder I, which is reserved for use.

[0039] (2) Decoct the medicinal residues from step (1) and the other medicinal materials except Fritillaria cirrhosa D. Don with water three times. For the first time, decoct with 12 times the weight of the medicinal materials in water for 3 hours; for the second time, decoct with 10 times the weight of the medicinal materials in water for 2 hours; for the third time, decoct with 8 times the weight of the medicinal materials in water for 1.5 hours. Filter the extract, and concentrate the filtrate under reduced pressure at a pressure of 2.5 kPa and a temperature of 80 °C for 12 h to obtain a thick paste with a relative density of 1.38 at 60 °C. Dry it under vacuum. The obtained dry extract is pulverized and passed through an 80-mesh sieve to obtain Powder II, which is reserved for use.

[0040] (3) Pulverize Fritillaria cirrhosa D. Don into fine powder, pass it through an 80-mesh sieve, and mix it evenly with Powder I prepared in step (1) and Powder II prepared in step (2) for reserve.

[0041] (4) Make the fine powder of the mixture obtained in step (3) into soft material, granulate it with a 20-mesh sieve in a granulator, dry it in a drying chamber at a temperature of 60 °C for 2 hours, and screen it through a 20-mesh sieve to prepare tablets.

[0042] Example 3:

[0043] Take 250 g of Rehmannia glutinosa, 100 g of Lycium barbarum, 120 g of Schisandra chinensis, 150 g of Eclipta prostrata, 200 g of Uncaria rhynchophylla, 150 g of Gardenia jasminoides, 180 g of Asparagus cochinchinensis, 50 g of Fritillaria cirrhosa, 300 g of Astragalus membranaceus, 150 g of Codonopsis pilosula, 220 g of Polygonatum odoratum, 100 g of Schisandra chinensis, 250 g of Panax ginseng, 120 g of Poria cocos, 300 g of Dioscorea opposita, 100 g of Prunus japonica, 120 g of Prunus persica, 100 g of Armeniaca vulgaris, 250 g of Angelica sinensis, 80 g of Salvia miltiorrhiza. The preparation method includes the following steps:

[0044] (1) Heat and reflux the above Schisandra chinensis, Prunus japonica, Prunus persica, Armeniaca vulgaris, Angelica sinensis, and Salvia miltiorrhiza with 6 times the weight of the medicinal materials of 95% ethanol at 80 °C for 2 times, 3 hours each time, filter, and concentrate the filtrate under reduced pressure at a pressure of 2.5 kPa and a temperature of 60 °C for 10 h to obtain a thick paste with a relative density of 1.38 at 60 °C. Vacuum dry it, and the obtained dry extract is pulverized and screened through an 80-mesh sieve to obtain powder I for standby;

[0045] (2) Decoct the medicinal residues in step (1) and other medicinal materials except Fritillaria cirrhosa with water three times. The first time, decoct with 12 times the weight of the medicinal materials of water for 3 hours, the second time, decoct with 10 times the weight of the medicinal materials of water for 2 hours, and the third time, decoct with 8 times the weight of the medicinal materials of water for 1.5 hours; filter the extract, and concentrate the filtrate under reduced pressure at a pressure of 2.5 kPa and a temperature of 80 °C for 12 h to obtain a thick paste with a relative density of 1.35 at 60 °C. Vacuum dry it, and the obtained dry extract is pulverized and screened through an 80-mesh sieve to obtain powder II for standby;

[0046] (3) Pulverize Fritillaria cirrhosa into fine powder, screen it through an 80-mesh sieve, and mix it evenly with powder I prepared in step (1) and powder II prepared in step (2) for standby;

[0047] (4) Make the fine powder of the mixture obtained in step (3) into soft material, granulate it with a 20-mesh sieve in a granulator, dry it in a drying chamber at a temperature of 60 °C for 2 hours, and screen it through a 20-mesh sieve to prepare capsules.

[0048] Example 4: Pharmacodynamic experiment

[0049] 60 clean-grade male C57 mice were randomly divided into 3 groups, with 20 mice in each group. They were the control group, the model group, and the group of Example 1 of the present invention. Except for the control group, the mice were ip MPTP·HCl, 25 mg / kg -1 ·d-1 Once every 2 days for 18 consecutive times. The number of spontaneous activities and the rotarod time of the mice were measured at least 4 hours after each injection. After the last measurement, the activity of the mice was statistically analyzed. Mice with decreased spontaneous activity and rotarod time were selected as successfully modeled mice. After stopping the injection of MPTP, the mice in Example 1 group of the present invention were orally administered with the granules prepared in Example 1 at a dose of 10 g of crude drug per kg once a day for 7 consecutive days. The control group and the model group were orally administered with the same dose of normal saline. After the last behavioral test, the change of DA in the substantia nigra of the PD mice was measured by high performance liquid chromatography (HPLC). The specific steps were as follows: The mice were decapitated and the brains were taken out. The right midbrain was separated on an ice plate, dried on the surface, weighed and recorded, and stored at -80 °C. When detecting, 80 mg was accurately weighed from each group and added with 490 μL of 0.1 mol / L perchloric acid buffer solution (containing 0.1 mmol / L disodium ethylenediaminetetraacetate (EDTA-Na)) and 10 μL of internal standard solution (DHBA 0.02 g / L). Homogenize in an ice bath and centrifuge at high speed for 30 min (15000 g, 4 °C). The supernatant was centrifuged at 15000 g again at low temperature for 10 min, and 10 μL of the supernatant was taken for injection detection. Mobile phase: 40 mmol / L sodium acetate - 30 mmol / L citric acid buffer solution, containing 0.2 mmol / L EDTA-Na2, 0.4 mmol / L sodium octylsulfonate (B8) and 180 mL / L methanol, adjust the pH to 4.1, use after vacuum filtration and ultrasonic degassing for 15 min. The flow rate of the mobile phase was 0.5 mL / min, the voltage of the reference electrode Ag / AgCl electrochemical detector was +0.8 V, and the results are shown in Table 1. And the first defecation time and the number of defecation grains were observed, and the results are shown in Table 2.

[0050] Table 1 Changes in the levels of dopamine (DA) in the substantia nigra of the operative side of each group (n = 20, ng / L, x±s)

[0051] Group Dopamine (DA) Control group 46.64±5.21 Model group <![CDATA[8.38±1.09 ## > Example 1 group <![CDATA[39.87±4.51 ** >

[0052] (Compared with the control group, ## P < 0.01, compared with the model group * P < 0.05, ** P < 0.01)

[0053] The results showed that: By detecting the level of DA in the substantia nigra of the operative side of the midbrain in the model group by HPLC method, it was found that the dopamine (DA) in the substantia nigra of the model group was significantly decreased, indicating that the modeling was successful. After taking the granule agent in Example 1 group of the present invention, the level of dopamine (DA) in the substantia nigra was significantly higher than that in the model group, indicating that the present invention can increase the content of DA in the striatum, has a certain regulatory effect on the balance of neurotransmitters, and has a certain therapeutic effect on constipation caused by Parkinson's disease.

[0054] Table 2 Effects of each group on defecation of mice

[0055] Group Defecation time (min) Number of defecation pellets (pellets) Control group 25.16±3.98 14.74±2.63 Model group <![CDATA[39.63±4.35 ## > <![CDATA[9.37±1.32 ## > Example 1 group <![CDATA[27.12±3.46 ** > <![CDATA[13.09±2.76 ** >

[0056] (Compared with the control group, ## P < 0.01, compared with the model group * P < 0.05, ** P < 0.01)

[0057] The results showed that: the first defecation time of the model group was longer than that of the control group, and the number of defecation was less. After taking the granules of Example 1 of the present invention, the first defecation time was shortened and the number of defecation was increased, indicating that the present invention can promote defecation and has a certain therapeutic effect on constipation caused by Parkinson's disease.

[0058] Example 5: Clinical experiment

[0059] Diagnostic criteria: Western medicine diagnostic criteria: in line with the "Diagnostic Criteria for Parkinson's Disease in China 2021 Edition"; in line with the Rome IV functional constipation diagnostic criteria published by the Digestive Disease Week (DDW) in the United States in 2016. Traditional Chinese medicine diagnostic criteria: in line with the "Diagnostic and Efficacy Evaluation Criteria for Senile Tremor Syndrome in Traditional Chinese Medicine"; the symptoms of constipation due to liver and kidney yin deficiency are: dry stools, like sheep feces, emaciated body, head shaking and limb tremors, unstable holding of objects, dizziness and tinnitus, flushing of the cheeks, tidal fever and night sweats, soreness and weakness of the waist and knees, red tongue with little coating, and thready and rapid pulse.

[0060] Included cases: 100 patients were collected from outpatient cases, who met the diagnostic criteria of advanced Parkinson's disease and functional constipation at the same time. Parkinson's disease lasted for one year, and the age was 60 - 80 years old. They were given routine Parkinson's drugs for treatment, divided into a control group and a drug administration group. The control group took lactulose oral solution (national drug approval number H20093523, produced by Hunan Kelun Pharmaceutical Co., Ltd.), with an initial dose of 30 mL, once a day, orally before breakfast. After 3 weeks of medication, the defecation situation of the patients was evaluated, and a maintenance dose of 10 - 25 mL was given, and individualized dose adjustment was carried out according to the clinical symptoms and adverse reactions of the patients, with a treatment course of 3 weeks. The drug administration group was given the granules prepared in Example 1 of the present invention, and the daily dosage was: 20 g of Rehmannia glutinosa, 15 g of Lycium barbarum, 10 g of Schisandra chinensis, 20 g of Eclipta prostrata, 15 g of Uncaria rhynchophylla, 20 g of Gardenia jasminoides, 15 g of Asparagus cochinchinensis, 7 g of Fritillaria cirrhosa, 25 g of Astragalus membranaceus, 20 g of Codonopsis pilosula, 20 g of Polygonatum odoratum, 15 g of Schisandra chinensis, 20 g of Panax ginseng, 15 g of Poria cocos, 25 g of Dioscorea opposita, 15 g of Prunus davidiana, 10 g of Prunus persica, 12 g of Armeniaca vulgaris, 20 g of Angelica sinensis, 10 g of Salvia miltiorrhiza, three times a day, with a treatment course of 3 weeks.

[0061] Observation indicators: Score before and after treatment according to the Chronic Constipation Severity Score Scale (CSS). Calculate the efficacy index according to the Nimodipine method. The formula is as follows: Efficacy index = [(CSS score before treatment - CSS score after treatment) / CSS score before treatment] × 100%. Marked effect: efficacy index ≥ 70%; Effective: 30% ≤ efficacy index < 70%; Ineffective: efficacy index < 30%. The results are shown in Table 3.

[0062] Table 3 Clinical Observation Table

[0063] Group Marked effect Effective Ineffective Effective rate (%) Control group 27 17 6 88 Drug administration group 19 19 12 76

[0064] Comparison of clinical efficacy: The total effective rate of the observation group was 88%, and that of the control group was 76%. The difference was statistically significant (P < 0.05), indicating that the present invention has a good therapeutic effect on constipation caused by liver and kidney yin deficiency in Parkinson's disease.

[0065] Although the embodiments of the present invention have been shown and described, it will be understood by those of ordinary skill in the art that various changes, modifications, substitutions, and variations can be made to these embodiments without departing from the principles and spirit of the present invention. The scope of the present invention is defined by the appended claims and their equivalents.

Claims

1. A Chinese medicine composition for treating constipation, characterized in that: The invention is prepared by extracting the following traditional Chinese medicines in parts by weight: 15-25 parts of Rehmannia root, 10-20 parts of Lycium barbarum, 8-12 parts of Schisandra chinensis, 15-25 parts of Ecliptae herba, 10-20 parts of Uncaria rhynchophylla, 15-25 parts of Gardenia jasminoides, 12-18 parts of Asparagus cochinchinensis, 5-9 parts of Fritillaria cirrhosa, 20-30 parts of Astragalus membranaceus, 15-25 parts of Codonopsis pilosula, 18-22 parts of Polygonatum odoratum, 10-20 parts of Schisandra chinensis, 15-25 parts of Ginseng, 12-18 parts of Poria cocos, 20-30 parts of Dioscorea opposita, 10-20 parts of Prunus mume seeds, 8-12 parts of Peach kernel, 10-14 parts of Apricot kernel, 15-25 parts of Angelica sinensis and 8-12 parts of Salvia miltiorrhiza.

2. The Chinese medicine composition for treating constipation according to claim 1, characterized in that: The invention is prepared by extracting the following traditional Chinese medicines in parts by weight: 20 parts of Rehmannia glutinosa, 15 parts of Lycium barbarum, 10 parts of Schisandra chinensis, 20 parts of Ecliptae, 15 parts of Uncaria rhynchophylla, 20 parts of Gardenia jasminoides, 15 parts of Asparagus cochinchinensis, 7 parts of Fritillaria cirrhosa, 25 parts of Astragalus membranaceus, 20 parts of Codonopsis pilosula, 20 parts of Polygonatum odoratum, 15 parts of Schisandra chinensis, 20 parts of Ginseng, 15 parts of Poria cocos, 25 parts of Dioscorea opposita, 15 parts of Prunus mume seeds, 10 parts of Persica sesamoides, 12 parts of Apricot kernel, 20 parts of Angelica sinensis, and 10 parts of Salvia miltiorrhiza.

3. The Chinese medicine composition for treating constipation according to claim 1, characterized in that: The invention is prepared by extracting the following traditional Chinese medicines in parts by weight: 15 parts of Rehmannia glutinosa, 20 parts of Lycium barbarum, 8 parts of Schisandra chinensis, 25 parts of Ecliptae, 10 parts of Uncaria rhynchophylla, 25 parts of Gardenia jasminoides, 12 parts of Asparagus cochinchinensis, 9 parts of Fritillaria cirrhosa, 20 parts of Astragalus membranaceus, 25 parts of Codonopsis pilosula, 18 parts of Polygonatum odoratum, 20 parts of Schisandra chinensis, 15 parts of Ginseng, 18 parts of Poria cocos, 20 parts of Dioscorea opposita, 20 parts of Prunus mume seeds, 8 parts of Persica rapa, 14 parts of Apricot kernel, 15 parts of Angelica sinensis and 12 parts of Salvia miltiorrhiza.

4. The Chinese medicine composition for treating constipation according to claim 1, characterized in that: The invention is prepared by extracting the following traditional Chinese medicines in parts by weight: 25 parts of Rehmannia glutinosa, 10 parts of Lycium barbarum, 12 parts of Schisandra chinensis, 15 parts of Ecliptae, 20 parts of Uncaria rhynchophylla, 15 parts of Gardenia jasminoides, 18 parts of Asparagus cochinchinensis, 5 parts of Fritillaria cirrhosa, 30 parts of Astragalus membranaceus, 15 parts of Codonopsis pilosula, 22 parts of Polygonatum odoratum, 10 parts of Schisandra chinensis, 25 parts of Ginseng, 12 parts of Poria cocos, 30 parts of Dioscorea opposita, 10 parts of Prunus mume seeds, 12 parts of Persica juncea, 10 parts of Apricot kernel, 25 parts of Angelica sinensis, and 8 parts of Salvia miltiorrhiza.

5. The Chinese medicine composition for treating constipation according to claim 1, characterized in that: The preparation method comprises the following steps: (1) 6 times the weight of the above-mentioned Schisandra chinensis, Prunus mume, peach kernel, apricot kernel, Chinese angelica, and Salvia miltiorrhiza were heated and refluxed at 80° C. for 2 times, each time for 3 hours, filtered, and the filtrate was concentrated under reduced pressure at a pressure of 2.5 kPa and a temperature of 60° C. for 10 hours to obtain a thick paste with a relative density of 1.35-1.38 at 60° C., vacuum dried, and the obtained dry extract was crushed and passed through an 80-mesh sieve to obtain a powder I for later use; (2) boiling the residues of step (1) and other medicinal materials except Fritillaria cirrhosa three times with water, boiling for 3 hours with water 12 times the weight of the medicinal materials for the first time, boiling for 2 hours with water 10 times the weight of the medicinal materials for the second time, and boiling for 1.5 hours with water 8 times the weight of the medicinal materials for the third time; filtering the extract, concentrating the filtrate under reduced pressure at a pressure of 2.5 kPa and a temperature of 80° C. for 12 hours to obtain a thick paste with a relative density of 1.35-1.38 at 60° C., vacuum drying, and crushing the obtained dry extract through an 80-mesh sieve to obtain powder II for standby use; (3) grinding the Fritillaria cirrhosa into fine powder, passing through an 80-mesh sieve, and mixing the powder I prepared in step (1) and the powder II prepared in step (2) uniformly for later use; (4) The fine powder of the mixture obtained in step (3) is made into a soft material, granulated using a 20-mesh screen in a granulator, dried in a drying chamber at 60° C. for 2 hours, and granulated through a 20-mesh screen to prepare a preparation.

6. The Chinese medicine composition for treating constipation according to claim 1, characterized in that: The preparation is one of tablets, granules or capsules.

7. Use of the Chinese medicinal composition for treating constipation as claimed in claim 1 in preparing a drug for constipation caused by Parkinson's disease.

8. Use of the Chinese medicinal composition for treating constipation as claimed in claim 1 in the preparation of a drug for reducing the content of dopamine in the substantia nigra.

9. Use of the Chinese medicinal composition for treating constipation as claimed in claim 1 in preparing a drug for constipation caused by Parkinson's disease, characterized in that: The constipation syndrome caused by Parkinson's disease is mainly liver and kidney yin deficiency, spleen and kidney yang deficiency, and qi and blood deficiency.