Traditional Chinese medicine composition for treating traumatic brain injury as well as preparation method and application of traditional Chinese medicine composition

Abstract

The invention belongs to the technical field of traditional Chinese medicine compositions, and particularly relates to a traditional Chinese medicine composition for treating traumatic brain injury and a preparation method and application thereof.The traditional Chinese medicine composition is prepared from, by weight, 10-15 parts of rhizoma acori graminei, 8-12 parts of radix scutellariae, 8-12 parts of pollen typhae, 5-7 parts of radix et rhizoma rhei and 5-7 parts of radix notoginseng powder; the effect of treating traumatic brain injury is further improved, and toxic and side effects are reduced.

Description

Technical Field

[0001] The present invention belongs to the technical field of Chinese medicine compositions, and in particular relates to a Chinese medicine composition for treating traumatic brain injury, a preparation method and use thereof. Background Art

[0002] Traumatic brain injury (TBI) is a global health problem. TBI causes a series of inflammatory reactions, neuronal loss, limited brain tissue regeneration, and impaired neurological function, which are the main causes of worsening of the disease. So far, there is a lack of effective treatment for TBI, and clinical treatments such as surgical decompression, drugs, and rehabilitation cannot achieve the purpose of neurological function recovery. Therefore, the development of new drugs to target and inhibit neuronal loss to reduce neurological dysfunction after TBI is of great significance for improving the quality of life of patients and promoting their return to society.

[0003] TBI is a "traumatic encephalopathy" or "brain injury" in traditional Chinese medicine, or "injury syncope" in the "injury internal syndrome" of traumatology. Its main pathogenesis is brain collateral damage, blood overflow outside the vessels, phlegm and blood stasis, brain and intestine disease, and mental malnutrition, resulting in coma. Traditional Chinese medicine has the advantages of a wide range of sources, multiple targets, and multiple pathways, and its medicinal value is increasingly valued.

[0004] Effect of Acorus Root I on Serum GFAP, UCH-L1 and IGF-1 Protein in Patients with Phlegm, Stasis and Heat Syndrome in Acute Phase of Severe Craniocerebral Injury, Chen Yanyi, Zhu Huibin, Yi Min, Dai Xingping, Journal of Traditional Chinese Medicine, Vol. 59, No. 6, March 2018, disclosed Acorus Root I for the treatment of severe craniocerebral injury, which is composed of: Acorus gramineus 12g, Scutellaria baicalensis 10g, Rhubarb 6g, Pollen Typhae 10g, Paeonia suffruticosa 12g, Buffalo Horn 15g, Panax notoginseng powder 6g.

[0005] Clinical study on the treatment of severe craniocerebral injury with Acorus radix Ⅰ combined with Western medicine, Chen Yanyi, Wang Dongsheng, Zhu Huibin, Xu Xia, Dai Xingping, Journal of Chinese Traditional Medicine Information, Volume 24, Issue 6, June 2017, also published Acorus radix Ⅰ, and explained that 10g of earthworm should be added 2 weeks after craniocerebral injury. Acorus radix Ⅰ is the basic formula for awakening in the acute phase of craniocerebral injury. The aromatic Acorus calamus is the main ingredient, which can awaken the mind, remove dampness and eliminate phlegm; it is supplemented with Pollen Typhae and Panax notoginseng powder to promote blood circulation, remove blood stasis, stop bleeding and relieve pain; Paeonia suffruticosa and Buffalo horn both enter the heart meridian, clear away heat and cool blood, and calm the nerves. The whole formula has the functions of awakening the mind, removing blood stasis and stopping bleeding, and clearing heat and purging fire. Summary of the invention

[0006] The technical problem to be solved by the present invention is to provide a Chinese medicine composition for treating traumatic brain injury, a preparation method and use thereof. The present invention further improves the effect of treating traumatic brain injury and reduces toxic and side effects.

[0007] The embodiment of the present invention provides a traditional Chinese medicine composition for treating traumatic brain injury, which is composed of the following traditional Chinese medicine raw materials in weight: 10-15 parts of Acorus calamus, 8-12 parts of Scutellaria baicalensis, 8-12 parts of Pollen Typhae, 5-7 parts of Rhubarb, and 5-7 parts of Panax notoginseng powder.

[0008] Preferably, it is composed of the following Chinese medicinal raw materials in weight: 12 parts of Acorus calamus, 10 parts of Scutellaria baicalensis, 10 parts of Pollen Typhae, 6 parts of Rhubarb, and 6 parts of Panax notoginseng powder.

[0009] The embodiment of the present invention provides a method for preparing the traditional Chinese medicine composition, comprising the following steps: decocting Acorus calamus, Scutellaria baicalensis and Pollen Typhae, filtering to obtain filtrate I and filter residue, adding water and rhubarb to the filter residue and decocting, filtering to obtain filtrate II, mixing filtrate I, filtrate II and Panax notoginseng powder to obtain the traditional Chinese medicine composition.

[0010] Preferably, when Acorus calamus, Scutellaria baicalensis and Pollen Typhae are decocted, the amount of water added is 7-10 times the total volume of Acorus calamus, Scutellaria baicalensis and Pollen Typhae.

[0011] Preferably, the Chinese medicinal materials are soaked before decocting.

[0012] Preferably, when Acorus calamus, Scutellaria baicalensis and Pollen Typhae are decocted, the amount of water added is 8 times the total volume of Acorus calamus, Scutellaria baicalensis and Pollen Typhae, and the decocting time is 30 min.

[0013] Preferably, when the filter residue is boiled with water and rhubarb, the amount of water added is 6 times the total volume of Acorus calamus, Scutellaria baicalensis and Pollen Typhae.

[0014] Preferably, when the filter residue is added with water and rhubarb for decocting, the decocting time is 10-20 minutes.

[0015] An embodiment of the present invention provides a use of the traditional Chinese medicine composition, wherein the traditional Chinese medicine composition is used to prepare a medicine for treating traumatic brain injury.

[0016] The invention has the beneficial effects that the invention uses the aromatic Acorus calamus as the main ingredient, and the "Shennong's Herbal Classic" records that the ingredient "opens the heart orifices, nourishes the five internal organs, unblocks the nine orifices, brightens the eyes and ears, and makes sounds". Because the ingredient has the effects of refreshing the mind and improving intelligence, removing dampness and harmonizing the stomach, and opening the orifices and removing phlegm, the ingredient is widely used in clinical practice for improving intelligence and refreshing the brain, etc.; the bitter and cold-natured Scutellaria baicalensis is the auxiliary ingredient, which can remove dampness and remove phlegm, clear away heat and purge fire; the Rhubarb is the auxiliary ingredient, which can remove blood stasis and promote bowel movement, bring forth something new out of the old, and treat the brain and intestines together; Pollen Typhae and Panax Notoginseng are the auxiliary ingredients, which can promote blood circulation, remove blood stasis, and stop bleeding; the whole formula can play the functions of treating the brain and intestines together, opening the orifices and refreshing the mind, removing blood stasis and stopping bleeding, and clearing heat and purging fire, and has a good therapeutic effect on promoting the awakening of comatose patients with brain trauma and the recovery of neurological function.

[0017] The present invention can treat TBI more specifically by streamlining the ingredients and removing peony bark and buffalo horn, especially for awakening and neurological recovery of comatose patients with brain trauma. The present invention reduces potential adverse reactions, improves patient tolerance, and improves medication experience. The present invention makes the medication regimen simpler, reduces the complexity of medication for patients, reduces medical costs, and can be more conveniently promoted. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] Figure 1 HE staining images of brain tissues of mice in each group.

[0019] Figure 2 The bar graph shows the mNSS scores of mice in each group on the 14th day.

[0020] Figure 3 The mNSS scores of mice in each group at different times are shown in Figure 2. DETAILED DESCRIPTION

[0021] Example 1

[0022] A traditional Chinese medicine composition for treating traumatic brain injury is prepared from the following traditional Chinese medicine raw materials by weight: 12g of Acorus tatarinowii, 10g of Scutellaria baicalensis, 10g of Pollen Typhae, 6g of Rhubarb, and 6g of Notoginseng powder.

[0023] Cooking method:

[0024] 1) Soak the slices of Acorus calamus, Scutellaria baicalensis, Pollen Typhae and Rhubarb in distilled water for 30 min;

[0025] 2) Add 8 times the volume of water of the total weight of Acorus calamus, Scutellaria baicalensis and Pollen Typhae, decoct Acorus calamus and Scutellaria baicalensis, and wrap the decoction Pollen Typhae with double gauze, continue to decoct for 30 minutes after boiling, and collect the filtrate I and the residue;

[0026] 3) Add 6 times the volume of distilled water to submerge the residue, continue to boil for 10 minutes, then add rhubarb and boil for 10 minutes to obtain filtrate II;

[0027] 4) Mix the filtrate I and the filtrate II, and add the decocted medicinal decoction to the notoginseng powder to obtain a Chinese medicine composition.

[0028] Comparative Example 1

[0029] A traditional Chinese medicine composition for treating traumatic brain injury is prepared from the following traditional Chinese medicine raw materials by weight: 12g of Acorus tatarinowii, 10g of Scutellaria baicalensis, 10g of Pollen Typhae, 6g of Rhubarb, 12g of Paeonia suffruticosa, 15g of Buffalo Horn, and 6g of Panax notoginseng powder.

[0030] Cooking method:

[0031] 1) Soak the pieces of Acorus calamus, Scutellaria baicalensis, Pollen Typhae, Paeonia suffruticosa, Horn of buffalo and Rhubarb in distilled water for 30 min;

[0032] 2) Add 8 times the total volume of Acorus calamus, Scutellaria baicalensis, Pollen Typhae, Paeonia suffruticosa, and Buffalo horn in water, decoct Acorus calamus, Scutellaria baicalensis, Pollen Typhae, and Buffalo horn, and wrap the decoction with double-layer gauze. Continue to decoct for 30 minutes after boiling, and collect the filtrate I and the residue;

[0033] 3) Add 6 times the volume of distilled water to submerge the residue, continue to boil for 10 minutes, then add rhubarb and boil for 10 minutes to obtain filtrate II;

[0034] 4) Mix the filtrate I and the filtrate II, and add the decocted medicinal decoction to the notoginseng powder to obtain a Chinese medicine composition.

[0035] Example 2

[0036] Animal Testing:

[0037] Grouping and modeling: Adult male C57BL / 6 mice, weighing 20-25 g, were used for experimental research after one week of adaptive feeding. 24 mice were randomly selected by random number table method and divided into 4 groups: sham operation group, model group, Example 1 group, and Comparative Example 1 group, with 6 mice in each group.

[0038] The TBI mouse model was established by controlled cortical injury. The steps were as follows: 2% sodium pentobarbital 60 mg / kg was injected intraperitoneally for anesthesia at room temperature. After successful anesthesia, the scalp was incised under sterile conditions to expose the right parietal bone. A circular bone window with a diameter of 3 mm was drilled 2 mm from the midpoint of the sagittal suture of the skull to expose the dura mater. The impact parameters were set as follows: the impact depth was 1.0 mm, the impact speed was 3.0 m / s, and the contact time was 100 ms. The scalp was sutured after the bone slice was repositioned.

[0039] Test method:

[0040] HE staining was used to observe the brain injury area of ​​TBI mice.

[0041] mNSS neurological function scores were performed before modeling and 1, 3, 7, and 14 days after modeling, ranging from 0 to 18 (normal score is 0 and maximum defect score is 18).

[0042] Results: The brain injury area increased after TBI, while the brain injury area of ​​the Example 1 group was significantly reduced after treatment ( Figure 1 ).

[0043] After TBI modeling, the mNSS neurological function scores of mice in each group increased; the mNSS neurological function scores of mice in the Example 1 group after treatment improved ( Figure 2-3 ).

[0044] 3. Clinical application:

[0045] Methods: 70 patients with severe craniocerebral injury were enrolled and randomly divided into a Chinese medicine group of 35 cases and a control group of 35 cases. The control group was given basic Western medicine treatment, and the Chinese medicine group was given the drug of Example 1 on the basis of the above basic Western medicine treatment, 1 dose per day, 2 times through nasogastric tube feeding or oral administration. The treatment lasted for 14 days. One month after treatment, the clinical efficacy, prognosis and adverse drug reactions of the two groups were compared.

[0046] Both groups received basic Western medicine treatment. Basic Western medicine treatment includes: oxygen inhalation, intracranial pressure reduction, nerve nutrition, anti-infection, nutritional support, hyperbaric oxygen, maintenance of water and electrolyte balance and other conventional treatments for severe craniocerebral injury. The general treatment methods are:

[0047] ① For patients with mild dyspnea, nasal cannula oxygen inhalation is given, for patients with severe dyspnea, mask oxygen inhalation is given, and patients with airway obstruction are given tracheotomy to ensure the airway is unobstructed; ② Dehydration and intracranial pressure reduction: mannitol injection, 125 ml each time, intravenous drip, once a day or every other day; or glycerol fructose, 250 ml each time, intravenous drip, once or twice a day; ③ Treatment for nerve nutrition, scavenging oxygen free radicals, and improving cerebral circulation: 30 mg of edaravone injection, diluted in 100 ml of normal saline, intravenous drip, twice a day; ④ Nutritional support and maintenance of internal environment stability treatment, including the use of compound amino acids, fat emulsions, and supplementation of sodium, potassium, and chloride; ⑤ Anti-infection treatment; ⑥ Prevention and treatment of complications; ⑦ Stop using phenytoin sodium and barbiturates; ⑧ Hyperbaric oxygen therapy, once a day, 1 hour each time. Continuous treatment for 14 days.

[0048] Patient inclusion criteria were:

[0049] (1) Meet the relevant diagnostic criteria in the document "Wang Zhongcheng Neurosurgery", with a coma time of 12 hours or more, impaired consciousness or even re-coma; (2) Diagnose head trauma through imaging examination (including MRI, head CT, etc.), such as extensive skull fracture, extensive cerebral contusion and laceration, brain stem injury or intracranial hematoma; (3) Remain in a coma after surgical treatment within the acute phase of craniocerebral injury (2 weeks); (4) Glasgow Coma Scale (GCS) score of 8 or less at admission; (5) Have obvious positive neurological signs; (6) Show obvious changes in body temperature, respiration, blood pressure and pulse; (7) Aged 18 to 70 years; (8) Survival period in hospital > 3 days; (9) Explain the patient's condition and treatment method to the patient's family before treatment, and obtain the family's consent.

[0050] Exclusion criteria were: (1) severe dysfunction of the heart, liver, kidney, etc.; (2) presence of malignant tumors or blood system diseases; (3) presence of severe infection; (4) paraplegia caused by high spinal cord injury; (5) severe irreversible damage to the brainstem that affects basic vital signs such as breathing.

[0051] Results: One month after treatment, the effective rate of the Chinese medicine group was 74.29% (26 / 35), and that of the control group was 71.43% (25 / 35), with a significant difference between the two groups (P=0.04). The GOS score of the Chinese medicine group after treatment was 3.23±0.49, and that of the control group was 2.97±0.45, with a significant difference between the two groups (t=5.76, P=0.03). The incidence rates of liver dysfunction, renal dysfunction, and rash in the Chinese medicine group were 17.14%, 8.57%, and 11.43%, respectively. The incidence rates of liver dysfunction, renal dysfunction, and rash in the control group were 11.43%, 8.57%, and 5.71%, respectively. There was no significant difference between the two groups (P>0.05).

[0052] Conclusion: The drug in Example 1 can improve the clinical efficacy of TBI patients and improve the prognosis of patients, and has no increased adverse reactions compared with the control group.

[0053] A person skilled in the art should understand that the discussion of any of the above embodiments is merely illustrative and is not intended to imply that the scope of protection of the present application is limited to these examples. In line with the concept of the present application, the technical features in the above embodiments or different embodiments may be combined, the steps may be implemented in any order, and there are many other variations of different aspects of one or more embodiments of the present application as described above, which are not provided in detail for the sake of simplicity.

[0054] One or more embodiments of the present application are intended to cover all such substitutions, modifications and variations that fall within the broad scope of the present application. Therefore, any omissions, modifications, equivalent substitutions, improvements, etc. made within the spirit and principles of one or more embodiments of the present application should be included in the protection scope of the present application.

Claims

1. A Chinese medicine composition for treating traumatic brain injury, characterized in that: The invention is composed of the following Chinese medicinal raw materials in weight: 10-15 parts of Acorus calamus, 8-12 parts of Scutellaria baicalensis, 8-12 parts of Pollen Typhae, 5-7 parts of Rhubarb and 5-7 parts of Notoginseng powder.

2. The Chinese medicine composition according to claim 1, characterized in that: The invention is composed of the following Chinese medicinal raw materials in weight: 12 parts of Acorus calamus, 10 parts of Scutellaria baicalensis, 10 parts of Pollen Typhae, 6 parts of Rhubarb and 6 parts of Panax notoginseng powder.

3. A method for preparing the Chinese medicine composition according to claim 1 or 2, characterized in that: The method comprises the following steps: decocting Acorus calamus, Scutellaria baicalensis and Pollen Typhae, filtering to obtain filtrate I and filter residue, adding water and rhubarb to the filter residue and decocting, filtering to obtain filtrate II, mixing filtrate I, filtrate II and Panax notoginseng powder to obtain a traditional Chinese medicine composition.

4. The preparation method according to claim 3, characterized in that: When decocting Acorus calamus, Scutellaria baicalensis and Pollen Typhae, the amount of water added is 7-10 times the total volume of Acorus calamus, Scutellaria baicalensis and Pollen Typhae.

5. The preparation method according to claim 3, characterized in that: Before decocting, soak the Chinese medicinal materials first.

6. The preparation method according to claim 4, characterized in that: When decocting Acorus calamus, Scutellaria baicalensis and Pollen Typhae, the amount of water added is 8 times the total volume of Acorus calamus, Scutellaria baicalensis and Pollen Typhae, and the decocting time is 30 minutes.

7. The preparation method according to claim 3, characterized in that: When the filter residue is boiled with water and rhubarb, the amount of water added is 6 times the total volume of Acorus calamus, Scutellaria baicalensis and Pollen Typhae.

8. The method for preparing the Chinese medicine composition according to claim 7, characterized in that: When the filter residue is added with water and rhubarb for decocting, the decocting time is 10-20 minutes.

9. A use of the Chinese medicine composition as claimed in claim 1 or 2, characterized in that: The traditional Chinese medicine composition is used for preparing medicine for treating traumatic brain injury.

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