Traditional Chinese medicine composition for treating child cerebral palsy as well as preparation method and application of traditional Chinese medicine composition

Abstract

The invention relates to a traditional Chinese medicine composition for treating child cerebral palsy as well as a preparation method and application thereof, and relates to the technical field of traditional Chinese medicine, the traditional Chinese medicine composition for treating child cerebral palsy comprises the following raw materials in parts by weight: 30-56 parts of aspidopterys obcordata, 25-40 parts of ornithogalum caudatum, 10-18 parts of angelica sinensis, 8-15 parts of mangnolia officinalis and the like. The traditional Chinese medicine composition for treating child cerebral palsy is prepared by taking aspidopterys obcordata and ornithogalum caudatum in a proper proportion as monarch drugs and taking a proper amount of angelica sinensis, mangnolia officinalis, lycopodium clavatum, gordon euryale seed and liquorice as auxiliary materials and combining all the drugs. Animal experiments show that the traditional Chinese medicine composition can relieve symptoms such as low muscle strength and behavior disorder of an animal model of a rat suffering from hypoxia and ischemia cerebral palsy, provides a new and potential clinical treatment means for treating children cerebral palsy, and has wide application and significance.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicines, and in particular to a traditional Chinese medicine composition for treating cerebral palsy in children, and a preparation method and application thereof. Background Art

[0002] Cerebral palsy, or CP for short, is a syndrome caused by brain damage due to various reasons from before birth to early postnatal period, when the brain is not mature. Its core symptoms are movement disorders and abnormal postures, and are often accompanied by sensory, cognitive, communication and behavioral disorders, as well as other functional abnormalities or diseases such as epilepsy. These symptoms severely limit the patient's ability to take care of themselves, and bring heavy economic and psychological burdens to the family and society.

[0003] There are many causes of cerebral palsy, among which neonatal cerebral ischemia and hypoxia caused by perinatal factors such as intrauterine asphyxia, premature birth, and birth trauma is one of the most common causes. The ischemic and hypoxic state will trigger a series of pathophysiological changes, including excitotoxicity, oxidative stress, and increased inflammatory response, which in turn lead to varying degrees of apoptosis of brain neurons and glial cells. Especially when ischemic and hypoxic occur in the hippocampus of the brain, the child's higher neural functions such as learning, cognition, and memory will be seriously affected; if it occurs in the pyramidal system, it will cause movement disorders and abnormal postures in children, forming types such as spastic cerebral palsy.

[0004] At present, there are various treatments for cerebral palsy in children, mainly including physical therapy, drug therapy, surgical treatment and rehabilitation therapy. With the gradual deepening of TCM's understanding of cerebral palsy, the status of TCM in the treatment of cerebral palsy has become increasingly prominent. TCM has the advantages of multiple targets and multiple pathways in the treatment of cerebral palsy, and can achieve the purpose of treating the disease by regulating the overall internal environment of the human body. Clinically, the methods of TCM treatment of cerebral palsy mainly include oral administration of Chinese medicine, acupuncture, massage, external application of Chinese medicine, etc. These methods are safe and have no obvious adverse reactions, and have been widely promoted and used.

[0005] However, although traditional Chinese medicine has shown unique advantages in the treatment of cerebral palsy, there are relatively few reports on effective Chinese herbal compositions for children with cerebral palsy. Summary of the invention

[0006] In order to solve the above problems, the present invention provides a traditional Chinese medicine composition for treating cerebral palsy in children, and a preparation method and application thereof.

[0007] In a first aspect, the present invention provides a traditional Chinese medicine composition for treating cerebral palsy in children, wherein the traditional Chinese medicine composition for treating cerebral palsy in children comprises the following raw materials in parts by weight:

[0008] 30-56 parts of Herba Lycopodii, 25-40 parts of Ornithogalum, 10-18 parts of Angelica sinensis, 8-15 parts of Magnolia officinalis, 7-12 parts of Herba Lycopodii, 3-8 parts of Euryale ferox, and 2-5 parts of Licorice.

[0009] Furthermore, the weight ratio of the Herba Lycopodii and the Herba Ornithogalum is 1.4.

[0010] Furthermore, the Chinese medicine composition for treating cerebral palsy in children comprises the following raw materials in parts by weight:

[0011] 44.8 parts of Herba Lycopithecidae, 32 parts of Ornithogalum, 15 parts of Radix Angelicae Sinensis, 10 parts of Cortex Magnoliae Officinalis, 9 parts of Herba Lycopodii, 5 parts of Gorgon Fruits, and 3 parts of Radix Glycyrrhizae.

[0012] In a second aspect, the present invention provides a method for preparing the Chinese medicine composition for treating cerebral palsy in children according to any one of the first aspects, the preparation method comprising the following steps:

[0013] The scutellaria baicalensis is crushed and then added into water for a first reflux extraction to obtain a first extract;

[0014] The ornithogalum is crushed and then added into ethanol for a second reflux extraction, and then extracted with petroleum ether to obtain a second extract;

[0015] Adding Chinese Angelica sinensis, Magnolia officinalis, Lycopodiella ciliata, Euryale ferox and Licorice to water for a third reflux extraction to obtain a third extract;

[0016] The first extract, the second extract and the third extract are mixed, crushed and sieved to obtain the traditional Chinese medicine composition.

[0017] Furthermore, the working parameters of the first reflux extraction include: pressure of 14 kPa to 27 kPa, temperature of 58° C. to 70° C., and number of times of 1 to 3 times.

[0018] Furthermore, the working parameters of the second reflux extraction include: pressure is normal pressure, temperature is 88° C. to 92° C., and the number of times is 1 to 3 times.

[0019] Furthermore, the working parameters of the third reflux extraction include: pressure is normal pressure, temperature is 100° C. to 110° C., and the number of times is 1 to 3 times.

[0020] In a third aspect, the present invention provides the use of a traditional Chinese medicine composition for treating cerebral palsy in children as described in any one of the first aspects or a traditional Chinese medicine composition prepared by the preparation method of a traditional Chinese medicine composition for treating cerebral palsy in children as described in any one of the second aspects in the preparation of a drug for treating cerebral palsy in children.

[0021] Furthermore, the dosage form of the drug includes tablets, capsules or granules.

[0022] The above technical solution provided by the embodiment of the present invention has at least the following advantages compared with the prior art:

[0023] The embodiment of the present invention provides a Chinese medicine composition for treating cerebral palsy in children, and its preparation method and application. The present invention uses a suitable proportion of Herba Lycopodii and Dieffenbachia Ornithogalum as the main medicine, and supplements with appropriate amounts of Angelica sinensis, Magnolia officinalis, Herba Lycopodii, Euryale ferox and Licorice, and all the medicines are used together to prepare a Chinese medicine composition for treating cerebral palsy in children. Animal experiments have shown that the Chinese medicine composition can alleviate the symptoms of hypoxia, muscle weakness and behavioral disorders in the ischemic hypoxia cerebral palsy rat model, providing a new and potential clinical treatment method for treating cerebral palsy in children, and has a wide range of uses and significance. Specifically, the relationship between the monarch, minister, assistant and envoy of the Chinese medicine composition provided by the present invention is as follows:

[0024] 1) King of medicines:

[0025] The inverted shield-winged vine has the effects of clearing away heat and detoxifying, promoting blood circulation and removing blood stasis, can improve brain microcirculation, and promote the repair and regeneration of damaged brain tissue; the ornithogalum has the effects of strengthening the heart and promoting diuresis, clearing away heat and detoxifying, which helps to enhance the cardiopulmonary function of children, eliminate toxins in the body, regulate the functions of internal organs, create a good internal environment for the recovery of brain tissue, and help to reduce the inflammatory response and damage of brain tissue. The present invention selects an appropriate proportion of inverted shield-winged vine and ornithogalum as the main medicine, and the two lay the foundation for the efficacy of the entire prescription.

[0026] 2) Ministerial drugs:

[0027] Angelica sinensis nourishes blood and regulates menstruation, promotes blood circulation and relieves pain, nourishes nerve and muscle tissue, effectively relieves symptoms of low muscle strength, complements the main drug, enhances the effect of promoting blood circulation and removing blood stasis, and promotes the recovery of brain blood circulation and nerve and muscle function; Magnolia officinalis promotes qi and eliminates accumulation, dries dampness and removes fullness, enhances digestion and absorption capacity, provides sufficient nutritional support for children, and helps the main drug to play a better therapeutic effect; Stretching grass dispels wind and dampness, relaxes muscles and activates collaterals, can relieve muscle spasms and joint stiffness, and promote the recovery of children's motor function. The three play the role of assisting and coordinating the main drug, enhancing the overall efficacy, making the treatment more comprehensive and effective, and conducting comprehensive treatment for the various symptoms of children with cerebral palsy.

[0028] 3) Adjuvant drugs:

[0029] Gorgon fruit can nourish the kidney and consolidate essence, tonify the spleen and stop diarrhea, remove dampness and stop leukorrhea, strengthen the physical fitness and immunity of children, improve disease resistance, provide strong support for long-term treatment, complement each other with the main and auxiliary drugs, and jointly promote the recovery of children; licorice can replenish qi and strengthen the middle, clear away heat and detoxify, and can reconcile various drugs, reduce the side effects of drugs, make the combination more gentle and suitable for children to take, and at the same time enhance the overall efficacy and ensure the safety and effectiveness of the prescription. Both play the role of reconciling the properties of the medicine and enhancing the efficacy of the medicine, making the overall formula more perfect and more suitable for the treatment needs of children with cerebral palsy. DETAILED DESCRIPTION

[0030] In order to make the purpose, technical solution and advantages of the embodiments of the present invention clearer, the technical solution in the embodiments of the present invention will be clearly and completely described below. Obviously, the described embodiments are part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0031] Unless otherwise specified, various raw materials, reagents, instruments and equipment used in the present invention can be purchased from the market or prepared by existing methods.

[0032] In a first aspect, the present invention provides a traditional Chinese medicine composition for treating cerebral palsy in children, wherein the traditional Chinese medicine composition for treating cerebral palsy in children comprises the following raw materials in parts by weight:

[0033] 30-56 parts of Herba Lycopodii, 25-40 parts of Ornithogalum, 10-18 parts of Angelica sinensis, 8-15 parts of Magnolia officinalis, 7-12 parts of Herba Lycopodii, 3-8 parts of Euryale ferox, and 2-5 parts of Licorice.

[0034] The embodiment of the present invention provides a Chinese medicine composition for treating cerebral palsy in children. The present invention uses a suitable proportion of Herba Lycopodii and Dieffenbachia ornithogalum as the main medicine, and is supplemented with appropriate amounts of Angelica sinensis, Magnolia officinalis, Herba Lycopodii, Euryale ferox and Licorice, and the medicines are used together to prepare a Chinese medicine composition for treating cerebral palsy in children. Animal experiments have shown that the Chinese medicine composition can alleviate the symptoms of hypoxia, muscle weakness and behavioral disorders in the ischemic hypoxia cerebral palsy rat model, providing a new and potential clinical treatment method for treating cerebral palsy in children, and has a wide range of uses and significance.

[0035] The Aspidopterys obcordata in the present invention is derived from the dried vine stem of the Malpighiaceae plant Aspidopterys obcordata Hemsl.var.obcordata, which has been formally included in the Yunnan Province Traditional Chinese Medicine Standards - Dai Medicine (2005 edition).

[0036] The ornithogalum in the invention is also known as pearl grass, gourd orchid, and ornithogalum chinense, is sweet in taste, slightly cold in nature, enters the liver and spleen meridians, has the functions of clearing away heat and detoxifying, and dispersing hard masses, and its bulb is selected as the medicinal part.

[0037] The angelica in the present invention is the dried root of Angelica sinensis (Oliv.) Diels of the Umbelliferae family.

[0038] The Magnolia officinalis in the present invention is the dried bark of Magnolia officinalis, which is bitter, pungent and warm in nature and flavor and enters the spleen, stomach, lung and large intestine meridians.

[0039] The stretch grass in the present invention is the dried whole herb of Lycopodiella, a plant of the Lycopodiaceae family, and is also known as lion grass, muscle-relaxing grass, lycopodiella, oxtail grass, large tendon vine, large stretch grass, stemona stretch grass, water bamboo, etc.

[0040] The gorgon fruit of the present invention is also called chicken head rice, which is the dried mature seed kernel of the gorgon fruit of the Nymphaeaceae plant, has sweet and astringent taste, is neutral in nature, and enters the spleen and kidney meridians.

[0041] The liquorice in the present invention is a perennial herb of the genus Glycyrrhiza of the Leguminosae family, and its root is selected as medicine.

[0042] In some specific embodiments, the weight ratio of the Herba Lycopodii and the Herba Ornithogalum is 1.4. The present invention has found through further research that when the weight ratio of the Herba Lycopodii and the Herba Ornithogalum is 1.4, the therapeutic effect of the obtained Chinese medicine composition is better.

[0043] In some specific embodiments, the Chinese medicine composition for treating cerebral palsy in children comprises the following raw materials in parts by weight:

[0044] 44.8 parts of Herba Lycopithecidae, 32 parts of Ornithogalum, 15 parts of Radix Angelicae Sinensis, 10 parts of Cortex Magnoliae Officinalis, 9 parts of Herba Lycopodii, 5 parts of Euryale Fructus and 3 parts of Radix Glycyrrhizae.

[0045] In a second aspect, based on the same inventive concept, the present invention provides a method for preparing the Chinese medicine composition for treating cerebral palsy in children as described in any one of the first aspects, the preparation method comprising the following steps:

[0046] The scutellaria baicalensis is crushed and then added into water for a first reflux extraction to obtain a first extract;

[0047] The ornithogalum is crushed and then added into ethanol for a second reflux extraction, and then extracted with petroleum ether to obtain a second extract;

[0048] Adding Chinese Angelica sinensis, Magnolia officinalis, Lycopodiella ciliata, Euryale ferox and Licorice to water for a third reflux extraction to obtain a third extract;

[0049] The first extract, the second extract and the third extract are mixed, crushed and sieved to obtain the traditional Chinese medicine composition.

[0050] The preparation method of the traditional Chinese medicine composition for treating cerebral palsy in children provided by the present invention is simple to operate, does not require additional specific equipment, and is suitable for industrial mass production; at the same time, the preparation method is realized based on the traditional Chinese medicine composition for treating cerebral palsy in children as described in any one of the first aspects, and therefore has at least the beneficial effects of the traditional Chinese medicine composition for treating cerebral palsy in children as described in any one of the first aspects, which will not be repeated here.

[0051] In some specific embodiments, the working parameters of the first reflux extraction include: pressure of 14 kPa to 27 kPa, preferably 20 kPa; temperature of 58° C. to 70° C., preferably 65° C., and the number of times is 1 to 3 times.

[0052] In some specific embodiments, the working parameters of the second reflux extraction include: pressure is normal pressure, temperature is 88° C. to 92° C., preferably 90° C.; the number of times is 1 to 3 times.

[0053] In some specific embodiments, the working parameters of the third reflux extraction include: pressure is normal pressure, temperature is 100° C. to 110° C., preferably 105° C.; the number of times is 1 to 3 times.

[0054] In a third aspect, the present invention provides the use of a traditional Chinese medicine composition for treating cerebral palsy in children as described in any one of the first aspects or a traditional Chinese medicine composition prepared by the preparation method of a traditional Chinese medicine composition for treating cerebral palsy in children as described in any one of the second aspects in the preparation of a drug for treating cerebral palsy in children.

[0055] In some specific embodiments, the dosage form of the drug includes tablets, capsules or granules.

[0056] It should be noted that the components and raw materials involved in the traditional Chinese medicine composition for treating cerebral palsy in children and its preparation method and application provided in the embodiments of the present invention, unless otherwise specified or specified, can be directly commercially available products or homemade using existing public preparation methods; at the same time, the steps and parameters involved, unless otherwise specified or specified, can be carried out according to existing traditional Chinese medicine processing technology or directly using existing equipment, and the present invention document will not describe them one by one.

[0057] The present invention will be further described below in conjunction with specific examples. It should be understood that these examples are intended only to illustrate the present invention and are not intended to limit the scope of the present invention. The experimental methods in the following examples that do not specify specific conditions are usually measured according to national standards. If there is no corresponding national standard, then the conditions recommended by the manufacturer are followed.

[0058] Example 1

[0059] This example provides a Chinese medicine composition for treating cerebral palsy in children. The Chinese medicine composition for treating cerebral palsy in children comprises the following raw materials in parts by weight:

[0060] 44.8 parts of Herba Lycopithecidae, 32 parts of Ornithogalum, 15 parts of Radix Angelicae Sinensis, 10 parts of Cortex Magnoliae Officinalis, 9 parts of Herba Lycopodii, 5 parts of Gorgon Fruits, and 3 parts of Radix Glycyrrhizae.

[0061] The preparation method of the above-mentioned Chinese medicine composition for treating cerebral palsy in children comprises the following steps:

[0062] The first water extracts are combined, concentrated under reduced pressure, and dried to a constant weight to obtain a first extract;

[0063] The ornithogalum is crushed and then added to anhydrous ethanol for a second reflux extraction, wherein the weight ratio of the ornithogalum to the anhydrous ethanol is 1:10, the pressure of the second reflux extraction is normal pressure, the temperature of the second reflux extraction is 90° C., and the number of the second reflux extraction is 2 times; the obtained ethanol extracts are combined, concentrated under reduced pressure, and dried to obtain an ornithogalum alcohol extract; the ornithogalum alcohol extract is suspended in water and then extracted with petroleum ether for 3 times, the obtained petroleum ether phases are combined, concentrated under reduced pressure, and dried to constant weight to obtain a second extract;

[0064] Adding Chinese angelica, Magnolia officinalis, Herba Lycopodii, Euryale ferox and Licorice to water for a third reflux extraction, wherein the weight ratio of the total weight of the Chinese angelica, Magnolia officinalis, Herba Lycopodii, Euryale ferox and Licorice to the weight of the water is 1:10, the pressure of the third reflux extraction is normal pressure, the temperature of the third reflux extraction is 105° C., and the number of times of the third reflux extraction is 2 times; combining the obtained second water extracts, concentrating under reduced pressure, and drying to constant weight to obtain a third extract;

[0065] The first extract, the second extract and the third extract are mixed, crushed and passed through a 100-mesh sieve to obtain the traditional Chinese medicine composition.

[0066] Example 2

[0067] This example provides a Chinese medicine composition for treating cerebral palsy in children. The Chinese medicine composition for treating cerebral palsy in children comprises the following raw materials in parts by weight:

[0068] 30 parts of Herba Lycopithecidae, 25 parts of Ornithogalum, 10 parts of Radix Angelicae Sinensis, 8 parts of Cortex Magnoliae, 7 parts of Herba Lycopodii, 3 parts of Gorgon Fruits, and 2 parts of Radix Glycyrrhizae.

[0069] The preparation method of the above-mentioned Chinese medicine composition for treating cerebral palsy in children comprises the following steps:

[0070] The first water extracts are combined, concentrated under reduced pressure, and dried to a constant weight to obtain a first extract;

[0071] The ornithogalum is crushed and then added to anhydrous ethanol for a second reflux extraction, wherein the weight ratio of the ornithogalum to the anhydrous ethanol is 1:10, the pressure of the second reflux extraction is normal pressure, the temperature of the second reflux extraction is 90° C., and the number of the second reflux extraction is 2 times; the obtained ethanol extracts are combined, concentrated under reduced pressure, and dried to obtain an ornithogalum alcohol extract; the ornithogalum alcohol extract is suspended in water and then extracted with petroleum ether for 3 times, the obtained petroleum ether phases are combined, concentrated under reduced pressure, and dried to constant weight to obtain a second extract;

[0072] Adding Chinese angelica, Magnolia officinalis, Herba Lycopodii, Euryale ferox and Licorice to water for a third reflux extraction, wherein the weight ratio of the total weight of the Chinese angelica, Magnolia officinalis, Herba Lycopodii, Euryale ferox and Licorice to the weight of the water is 1:10, the pressure of the third reflux extraction is normal pressure, the temperature of the third reflux extraction is 105° C., and the number of times of the third reflux extraction is 2 times; combining the obtained second water extracts, concentrating under reduced pressure, and drying to constant weight to obtain a third extract;

[0073] The first extract, the second extract and the third extract are mixed, crushed and passed through a 100-mesh sieve to obtain the traditional Chinese medicine composition.

[0074] Example 3

[0075] This example provides a Chinese medicine composition for treating cerebral palsy in children. The Chinese medicine composition for treating cerebral palsy in children comprises the following raw materials in parts by weight:

[0076] 56 parts of Herba Lycopithecidae, 40 parts of Ornithogalum, 18 parts of Radix Angelicae Sinensis, 15 parts of Cortex Magnoliae, 12 parts of Herba Lycopodii, 8 parts of Gorgon Fruits, and 5 parts of Radix Glycyrrhizae.

[0077] The preparation method of the above-mentioned Chinese medicine composition for treating cerebral palsy in children comprises the following steps:

[0078] The first water extracts are combined, concentrated under reduced pressure, and dried to a constant weight to obtain a first extract;

[0079] The ornithogalum is crushed and then added to anhydrous ethanol for a second reflux extraction, wherein the weight ratio of the ornithogalum to the anhydrous ethanol is 1:10, the pressure of the second reflux extraction is normal pressure, the temperature of the second reflux extraction is 90° C., and the number of the second reflux extraction is 2 times; the obtained ethanol extracts are combined, concentrated under reduced pressure, and dried to obtain an ornithogalum alcohol extract; the ornithogalum alcohol extract is suspended in water and then extracted with petroleum ether for 3 times, the obtained petroleum ether phases are combined, concentrated under reduced pressure, and dried to constant weight to obtain a second extract;

[0080] Adding Chinese angelica, Magnolia officinalis, Herba Lycopodii, Euryale ferox and Licorice to water for a third reflux extraction, wherein the weight ratio of the total weight of the Chinese angelica, Magnolia officinalis, Herba Lycopodii, Euryale ferox and Licorice to the weight of the water is 1:10, the pressure of the third reflux extraction is normal pressure, the temperature of the third reflux extraction is 105° C., and the number of times of the third reflux extraction is 2 times; combining the obtained second water extracts, concentrating under reduced pressure, and drying to constant weight to obtain a third extract;

[0081] The first extract, the second extract and the third extract are mixed, crushed and passed through a 100-mesh sieve to obtain the traditional Chinese medicine composition.

[0082] Comparative Example 1

[0083] This example provides a traditional Chinese medicine composition for treating cerebral palsy in children and a preparation method thereof, which is different from Example 1 only in that the Herba Plantaginis is replaced with Herba Plantaginis; the remaining steps and parameters are the same.

[0084] Comparative Example 2

[0085] This example provides a Chinese medicine composition for treating cerebral palsy in children and a preparation method thereof, which is different from Example 1 only in that Ornithogalum ornithogalum is replaced with Forsythia suspensa; the remaining steps and parameters are the same.

[0086] Comparative Example 3

[0087] This example provides a Chinese medicine composition for treating cerebral palsy in children and a preparation method thereof. The only difference from Example 1 is that the weight portions of the Herba Lycopodii are adjusted to 25 parts and the weight portions of the Herba Ornithogalum are adjusted to 51.8 parts; the remaining steps and parameters are the same.

[0088] Test Case

[0089] In this example, a neonatal rat hypoxic-ischemic cerebral palsy model was prepared with reference to the classic Rice-Vannucci model method, and the intervention effect of the Chinese medicine composition samples for treating cerebral palsy in children obtained in Example 13 and Comparative Example 13 was tested.

[0090] The test method is as follows:

[0091] 1) Experimental animals and grouping: 10 14-week gestational SD rats were selected and raised in an SPF environment. After giving birth, several 7-day-old (P7) SD rats were selected as experimental animals, regardless of gender. The young rats were randomly divided into 8 groups, including 1 blank control group (no modeling, given saline), 1 model control group (modeling, given saline), and 6 drug intervention groups (modeling, given Chinese medicine composition samples), with 10 rats in each group.

[0092] 2) Modeling method: 7-day-old SD rats were anesthetized by isoflurane inhalation under sterile conditions, fixed on the operating table, and maintained at a low dose of anesthesia (induction anesthesia concentration was 3.0% by volume, and maintenance anesthesia concentration was 1.5% by volume). The skin was disinfected, a midline incision was made in the neck, the left common carotid artery was isolated, and the blood vessels were cut after double ligation. The skin was sutured and the local skin was rinsed with penicillin injection to prevent infection. After 1 hour of resuscitation, the pups were placed in a sealed hypoxia box, and a mixed gas of 92% nitrogen and 8% oxygen was introduced. After 2.5 hours of hypoxia, they were taken out and returned to the mother's cage to continue breastfeeding. The pups in the control group were only anesthetized, midline incision was made in the neck, and the left common carotid artery was exposed and sutured, without ligation of the left common carotid artery and hypoxia treatment. A heating pad and a water bath were used to keep the pups' body temperature constant during the operation. After surgery, the success of the model construction was determined based on behavioral observations.

[0093] 3) Model identification and neurobehavioral testing Behavioral testing was performed 24 hours after modeling to determine whether the model was successful. The main test items were: suspension test and tilt board test; among them, suspension test: let the 7-day-old rats grab a horizontal wooden stick (diameter 0.1cm) with their front legs, leave the table 45cm, and record the time when the rats fall. Scoring criteria: 1 point, ≤10s; 2 points, 10s-<30s; 3 points, 30s-<2min; 4 points, 2-5min; 5 points, >5min. Test the muscle strength of the rats' voluntary motor function limbs. In the suspension test, the scores of the experimental group animals were lower than the mean of the control group-1.96 times the standard deviation, which was defined as abnormal; tilt board test: 7-day-old rats were placed head down on a 45° inclined plane, and the time for the rats to twist their bodies and turn to an angle of 135° with the original head direction was recorded, calculated in seconds. Test the balance ability of rats. In the tilt board test, the scores of the experimental group animals were higher than the mean of the control group+1.96 times the standard deviation, which was defined as abnormal. Among the SD rats identified with cerebral palsy, rats with hypoxia-ischemia cerebral palsy model that also had abnormalities in the suspension test and the tilt plate test in behavioral evaluation were selected for subsequent experiments.

[0094] 4) Administration: 24 hours after the modeling, the drug was administered by intragastric administration on the day when the model was determined to be successful. The drug administration intervention group was given 5 g / (kg·d) of the Chinese medicine composition for treating cerebral palsy in children obtained in Examples 1 to 3 and Comparative Examples 1 to 3, respectively. The blank control group and the model control group were given an equal volume of normal saline, once a day, for 7 consecutive days.

[0095] 5) Neurobehavioral testing: 7 days after administration, the rats in each group were subjected to suspension test and tilt board test again to detect the changes in neurobehavior.

[0096] 6) Data statistics and records: SPSS 27.0 software was used to process the data, and the data were expressed as mean ± standard deviation. The test results were statistically analyzed, as shown in Tables 1 and 2.

[0097] Table 1 Neurobehavioral test results - suspension test

[0098]

[0099] Table 2 Neurobehavioral test results - tilt board test

[0100]

[0101]

[0102] It can be seen from Tables 1 and 2 that compared with the model control group, the suspension test score of the group treated with the Chinese medicine composition provided by the embodiment of the present invention was significantly increased and the tilt board test time was significantly reduced, indicating that the Chinese medicine composition provided by the embodiment of the present invention can alleviate the symptoms of hypoxia, muscle weakness, behavioral disorders and the like in the ischemic hypoxia cerebral palsy rat model, and the intervention treatment effect is better than that of the control group.

[0103] In summary, the embodiment of the present invention provides a Chinese medicine composition for treating cerebral palsy in children, and its preparation method and application. The present invention uses a suitable proportion of Herba Lycopodii and Dieffenbachia ornithogalum as the main medicine, and is supplemented with appropriate amounts of Angelica sinensis, Magnolia officinalis, Herba Lycopodii, Euryale ferox and Licorice, and all the medicines are used together to prepare a Chinese medicine composition for treating cerebral palsy in children. Animal experiments have shown that the Chinese medicine composition can alleviate the symptoms of hypoxia, muscle weakness and behavioral disorders in the ischemic hypoxia cerebral palsy rat model, providing a new and potential clinical treatment method for treating cerebral palsy in children, and has a wide range of uses and significance.

[0104] Various embodiments of the present invention may be presented in the form of a range; it should be understood that the description in the form of a range is only for convenience and brevity, and should not be understood as a rigid limitation on the scope of the present invention; therefore, the range description should be considered to have specifically disclosed all possible sub-ranges and single numerical values ​​within the range. For example, the range description from 1 to 6 should be considered to have specifically disclosed sub-ranges, such as from 1 to 3, from 1 to 4, from 1 to 5, from 2 to 4, from 2 to 6, from 3 to 6, etc., as well as single numbers within the range, such as 1, 2, 3, 4, 5 and 6, which apply regardless of the range. In addition, whenever a numerical range is indicated herein, it is meant to include any cited number (fractional or integer) within the indicated range.

[0105] The foregoing is merely a specific embodiment of the present invention, which enables those skilled in the art to understand or implement the present invention. Various modifications to these embodiments will be apparent to those skilled in the art, and the general principles defined herein may be implemented in other embodiments without departing from the spirit or scope of the present invention. Therefore, the present invention will not be limited to the embodiments shown herein, but rather to the widest scope consistent with the principles and novel features claimed herein.

Claims

1. A Chinese medicine composition for treating cerebral palsy in children, characterized in that: The Chinese medicine composition for treating cerebral palsy in children comprises the following raw materials in parts by weight: fall 30-56 parts of Herba Cynanchifoliae, 25-40 parts of Ornithogalum, 10-18 parts of Angelica sinensis, 8-15 parts of Magnolia officinalis, 7-12 parts of Herba Lycopodii, 3-8 parts of Euryale ferox, and 2-5 parts of Licorice.

2. The Chinese medicine composition for treating cerebral palsy in children according to claim 1, characterized in that: The weight ratio of the Herba Lycopodii and the Herba Ornithogalum is 1.

4.

3. The Chinese medicine composition for treating cerebral palsy in children according to claim 1, characterized in that: The Chinese medicine composition for treating cerebral palsy in children comprises the following raw materials in parts by weight: fall 44.8 parts of Herba Cynanchii, 32 parts of Ornithogalum, 15 parts of Radix Angelicae Sinensis, 10 parts of Cortex Magnoliae, 9 parts of Herba Lycopodii, 5 parts of Euryale ferox, and 3 parts of Radix Glycyrrhizae.

4. A method for preparing the Chinese medicine composition for treating cerebral palsy in children according to any one of claims 1 to 3, characterized in that: The preparation method comprises the following steps: The scutellaria baicalensis is crushed and then added into water for a first reflux extraction to obtain a first extract; The ornithogalum is crushed and then added into ethanol for a second reflux extraction, and then extracted with petroleum ether to obtain a second extract; Adding Chinese Angelica sinensis, Magnolia officinalis, Lycopodiella ciliata, Euryale ferox and Licorice to water for a third reflux extraction to obtain a third extract; The first extract, the second extract and the third extract are mixed, crushed and sieved to obtain the traditional Chinese medicine composition.

5. The method for preparing the Chinese medicine composition for treating cerebral palsy in children according to claim 4, characterized in that: The working parameters of the first reflux extraction include: pressure of 14 kPa to 27 kPa, temperature of 58° C. to 70° C., and number of times of 1 to 3 times.

6. The method for preparing the Chinese medicine composition for treating cerebral palsy in children according to claim 4, characterized in that: The working parameters of the second reflux extraction include: pressure is normal pressure, temperature is 88° C. to 92° C., and the number of times is 1 to 3 times.

7. The method for preparing the Chinese medicine composition for treating cerebral palsy in children according to claim 4, characterized in that: The working parameters of the third reflux extraction include: pressure is normal pressure, temperature is 100° C. to 110° C., and the number of times is 1 to 3 times.

8. Use of a Chinese medicine composition for treating cerebral palsy in children as claimed in any one of claims 1 to 3 or a Chinese medicine composition prepared by the method for preparing a Chinese medicine composition for treating cerebral palsy in children as claimed in any one of claims 4 to 7 in preparing a medicine for treating cerebral palsy in children.

9. The use according to claim 8, characterized in that: The dosage form of the drug includes tablets, capsules or granules.

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