CN117959376A - Traditional Chinese medicine composition for treating mild cognitive impairment caused by leukoencephalopathy and preparation method and application thereof - Google Patents
Traditional Chinese medicine composition for treating mild cognitive impairment caused by leukoencephalopathy and preparation method and application thereof Download PDFInfo
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Abstract
The invention relates to a traditional Chinese medicine composition for treating mild cognitive impairment caused by leukoencephalopathy, and a preparation method and application thereof, wherein the traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 3 to 10 parts of pilose asiabell root, 3 to 10 parts of astragalus root, 1 to 5 parts of dried orange peel, 1 to 5 parts of white paeony root, 3 to 10 parts of Chinese angelica, 3 to 10 parts of szechuan lovage rhizome, 3 to 10 parts of dahurian angelica root and 3 to 10 parts of grassleaf sweelflag rhizome. The invention has the advantages that: aiming at the core pathogenesis of the mild cognitive impairment of the white matter lesions, namely 'spleen deficiency and collateral stasis', the invention strengthens the effects of promoting blood circulation, reducing phlegm and dredging collaterals on the basis of strengthening the spleen and strengthening the body resistance, provides a new treatment direction for the mild cognitive impairment caused by the white matter lesions, carries out early and accurate intervention, improves the cognitive impairment of patients, reduces the dementia conversion rate, provides scientific basis for preventing and treating the mild cognitive impairment of the white matter lesions, and provides economic value for reducing social burden.
Description
Technical Field
The invention relates to the technical field of traditional Chinese medicine compositions, in particular to a traditional Chinese medicine composition for treating mild cognitive impairment caused by leukoencephalopathy, and a preparation method and application thereof.
Background
Mild cognitive impairment (mild cognitive impairment, MCI) is an intermediate state between normal aging and dementia, clinically manifested as hypomnesis, decreased executive function, etc. Recent researches show that the prevalence of MCI in people more than or equal to 60 years old in China is 15.4 percent. Related studies have shown that MCI patients develop a 12% annual conversion to dementia and a 72% 5-year conversion, with a dementia incidence of approximately 10 times that of healthy elderly. Thus, early identification and treatment of MCI is a "window of opportunity" to prevent the transition to dementia. White matter lesions (WHITE MATTER lesions, WML) were proposed by Hachinski in 1987 to refer to scattered or diffuse lesions distributed in the subcortical white matter, around the ventricles and in the center of the semi-oval circle, and are characterized by low density shadows on CT, high signals on MRI T2WI and/or Flair sequences, and are one of the important features of small cerebral vascular diseases. Studies have shown that WML is an early marker of brain damage, is associated with an increased risk of MCI and dementia, is considered an early warning signal for reduced cognitive function, and its severity is an independent predictor of reduced cognitive function.
At present, western medicine refers to a diagnosis and treatment scheme of mild cognitive impairment with respect to the prevention and treatment of mild cognitive impairment of leukoencephalopathy, and the treatment scheme is divided into primary prevention, secondary prevention and tertiary prevention. Primary prevention mainly comprises identifying and controlling vascular risk factors such as blood pressure, blood sugar, blood lipid, etc.; secondary prevention is mainly aimed at the etiology of the disease, or symptomatic treatment; three-stage prevention is to delay the illness state as much as possible under the condition that the disease cannot be radically cured. To date, there are many drugs for improving cognitive impairment, including cholinesterase inhibitors, ergot alkaloids, ionic glutamate receptor antagonists, ginkgo leaf preparations, etc., but there is not enough evidence of evidence for the treatment of MCI, and MCI is not inhibited from being converted into dementia, so there is no FDA-approved drug for the treatment of MCI so far. The ginkgo leaf preparation has the effects of promoting blood circulation, removing blood stasis and dredging collaterals, and researches show that the ginkgo leaf preparation can delay the memory decline of MCI patients and improve clinical symptoms, so that the ginkgo leaf preparation is recommended to be used for mild cognitive impairment by the guide (five) for diagnosis and treatment of 2018 Chinese dementia and cognitive impairment.
Disclosure of Invention
The invention aims to overcome at least one of the defects in the prior art and provide a traditional Chinese medicine composition for treating mild cognitive impairment caused by leukoencephalopathy, and a preparation method and application thereof.
The aim of the invention can be achieved by the following technical scheme:
The invention aims at providing a traditional Chinese medicine composition for treating mild cognitive impairment caused by leukoencephalopathy, which is prepared from the following raw materials in parts by weight: 3 to 10 parts of pilose asiabell root, 3 to 10 parts of astragalus root, 1 to 5 parts of dried orange peel, 1 to 5 parts of white paeony root, 3 to 10 parts of Chinese angelica, 3 to 10 parts of szechuan lovage rhizome, 3 to 10 parts of dahurian angelica root and 3 to 10 parts of grassleaf sweelflag rhizome.
Further, the traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 5 to 7 parts of pilose asiabell root, 5 to 7 parts of astragalus root, 2 to 4 parts of dried orange peel, 2 to 4 parts of white paeony root, 5 to 7 parts of Chinese angelica, 5 to 7 parts of szechuan lovage rhizome, 5 to 7 parts of dahurian angelica root and 5 to 7 parts of grassleaf sweelflag rhizome. Further, the traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 6 parts of radix codonopsis, 6 parts of astragalus, 3 parts of dried orange peel, 3 parts of white peony root, 6 parts of Chinese angelica, 6 parts of szechuan lovage rhizome, 6 parts of dahurian angelica root and 6 parts of grassleaf sweelflag rhizome.
Further, the traditional Chinese medicine preparation is prepared into clinically acceptable pharmaceutical preparations according to a conventional preparation method of traditional Chinese medicines.
Further, the traditional Chinese medicine composition is one of decoction, tablets, capsules, granules, mixture, oral liquid or syrup. Further, the traditional Chinese medicine composition is in the form of decoction or granules.
The second purpose of the invention is to use the traditional Chinese medicine composition in preparing medicines for treating mild cognitive impairment caused by leukoencephalopathy.
The invention also aims at a medicine for treating mild cognitive impairment caused by leukoencephalopathy, which is characterized by being prepared by decocting any one of the traditional Chinese medicine compositions in water.
Further, the preparation method comprises the following steps: weighing radix codonopsis pilosulae, radix astragali, dried orange peel, white paeony root, chinese angelica, szechuan lovage rhizome, dahurian angelica root and grassleaf sweelflag rhizome according to the formula, adding 100-300 ml of water for boiling for 10-30 min for the first time, and adding 100-300 ml of water for boiling for 10-30 min for the second time; filtering, and collecting filtrate to obtain the final product.
Further, adding water for 200min for the first time, and boiling for 20min; adding water for 200min for the second time, and decocting for 20min.
And (3) square solution: radix codonopsis pilosulae and radix astragali are used as monarch drugs for replenishing qi and strengthening spleen; the Chinese angelica root has the effects of nourishing blood, strengthening spleen, activating blood, promoting qi and activating blood circulation of the szechuan lovage rhizome, and the dahurian angelica root has the effects of dispelling wind, inducing resuscitation, eliminating phlegm, inducing resuscitation, tranquilizing mind and improving intelligence and is taken as a ministerial drug; dried orange peel, pericarpium citri reticulatae regulates qi, strengthens spleen and eliminates phlegm, and radix paeoniae alba, has effects of softening liver, nourishing yin and tonifying spleen, and is used as an adjuvant drug. The medicines are compatible, and together play the roles of strengthening spleen, tonifying qi, ascending and clearing heat, promoting blood circulation, removing obstruction in channels and inducing resuscitation.
The invention has the advantages that: the invention strengthens the effects of activating blood, resolving phlegm and dredging collaterals on the basis of strengthening spleen and strengthening body resistance, provides a new treatment direction for mild cognitive dysfunction caused by leukoencephalopathy, performs early and accurate intervention, reduces cognitive dysfunction of patients, reduces dementia incidence and provides economic value for reducing social burden.
Detailed Description
The following describes in detail the examples of the present invention, which are implemented on the premise of the technical solution of the present invention, and detailed embodiments and specific operation procedures are given, but the scope of protection of the present invention is not limited to the following examples.
EXAMPLE 1 Chinese medicinal composition formulation
3 Parts of radix codonopsis, 3 parts of astragalus, 1 part of dried orange peel, 1 part of white peony root, 3 parts of Chinese angelica, 3 parts of szechuan lovage rhizome, 3 parts of dahurian angelica root and 3 parts of grassleaf sweelflag rhizome.
Example 2 Chinese medicinal composition formulation
4 Parts of radix codonopsis, 4 parts of astragalus, 2 parts of dried orange peel, 2 parts of white peony root, 4 parts of angelica, 4 parts of szechuan lovage rhizome, 4 parts of angelica dahurica and 4 parts of grassleaf sweelflag rhizome.
EXAMPLE 3 Chinese medicinal composition formulation
5 Parts of codonopsis pilosula, 5 parts of astragalus, 3 parts of dried orange peel, 3 parts of white paeony root, 5 parts of Chinese angelica, 5 parts of szechuan lovage rhizome, 5 parts of dahurian angelica root and 5 parts of grassleaf sweelflag rhizome.
EXAMPLE 4 Chinese medicinal composition formulation
6 Parts of radix codonopsis, 6 parts of astragalus, 4 parts of dried orange peel, 4 parts of white peony root, 6 parts of Chinese angelica, 6 parts of szechuan lovage rhizome, 6 parts of dahurian angelica root and 6 parts of grassleaf sweelflag rhizome.
EXAMPLE 5 Chinese medicinal composition formulation
7 Parts of radix codonopsis, 7 parts of astragalus, 5 parts of dried orange peel, 5 parts of white peony root, 7 parts of angelica, 7 parts of szechuan lovage rhizome, 7 parts of angelica dahurica and 7 parts of grassleaf sweelflag rhizome.
EXAMPLE 6 Chinese medicinal composition formulation
8 Parts of radix codonopsis, 8 parts of astragalus, 5 parts of dried orange peel, 5 parts of white peony root, 8 parts of Chinese angelica, 8 parts of szechuan lovage rhizome, 8 parts of dahurian angelica root and 8 parts of grassleaf sweelflag rhizome.
EXAMPLE 7 Chinese medicinal composition formulation
9 Parts of codonopsis pilosula, 9 parts of astragalus, 5 parts of dried orange peel, 5 parts of white paeony root, 9 parts of Chinese angelica, 9 parts of szechuan lovage rhizome, 9 parts of dahurian angelica root and 9 parts of grassleaf sweelflag rhizome.
EXAMPLE 8 Chinese medicinal composition formulation
10 Parts of codonopsis pilosula, 10 parts of astragalus, 5 parts of dried orange peel, 5 parts of white paeony root, 10 parts of Chinese angelica, 10 parts of szechuan lovage rhizome, 10 parts of dahurian angelica root and 10 parts of grassleaf sweelflag rhizome.
Example 9 Chinese medicinal composition formulation
6 Parts of radix codonopsis, 6 parts of astragalus, 3 parts of dried orange peel, 3 parts of white peony root, 6 parts of Chinese angelica, 6 parts of szechuan lovage rhizome, 6 parts of dahurian angelica root and 6 parts of grassleaf sweelflag rhizome.
Example 10 preparation of decoction of Chinese medicinal composition
Taking the traditional Chinese medicine composition in any one of embodiments 1-9, adding 200ml of water, boiling for 20 minutes, filtering, and obtaining a filtrate.
EXAMPLE 11 preparation of Chinese medicinal composition granules
Taking the traditional Chinese medicine composition in any one of embodiments 1 to 9, and preprocessing the medicinal materials which are qualified in detection; extracting the processed medicinal materials and decoction pieces according to a required process to obtain an extracting solution; concentrating the filtrate under reduced pressure until the specific gravity of the extract is the concentration requirement to obtain fluid extract; sieving the clear paste, performing spray drying, and collecting powder at proper time to obtain an intermediate; sieving the intermediate, mixing for 30 minutes to make the intermediate uniform; granulating above mixture by dry method to obtain 12-40 mesh granule. The granules were packed into aluminum foil sachets (4 sachets per dose) at 5 g/sachet using a blank aluminum foil pouch spray-printed package.
Example 12 clinical trials of Chinese medicinal composition for treating Mild cognitive impairment caused by leukoencephalopathy (1) comparison of two groups of baseline data
Comparing the baseline data of two groups of patients, the difference of the baseline data including gender, age, risk factors and the like of the two groups is found to have no statistical significance (P > 0.05).
Table 1 comparison of general data for two groups of patients
Note that: * White matter severity grade of 1 patient with deficiency, n=6
(2) Therapeutic method
Control group of this example: the simulator of the prescription for promoting the lift and inducing resuscitation is added with ginkgo leaf. The simulator for the Shangqing resuscitator consists of maltodextrin, lemon yellow pigment, sunset yellow pigment, caramel pigment, lactose, bittering agent and citric acid, and has the same shape, color and taste as the Shangqing resuscitator. The dosage form is granule, and the administration method is oral administration, one patch per day, two bags per day, and two times of oral administration in the morning and evening for 3 months. Ginkgo leaf tablet comprises folium Ginkgo extract, wherein each tablet contains total flavonol glycoside 19.2mg, terpene lactone 4.8mg, which is supplied by Shanghai Xin Yi Bai Lida Limited company, and is qualified by drug inspection, and Chinese medicinal standard Z20027954. The administration method comprises oral administration, 1 tablet/time, 3 times/day, and 3 months respectively in the morning, in the middle and in the evening.
Treatment group of this example: the granule for improving the clarity and inducing resuscitation and the ginkgo leaf simulator are added. The traditional Chinese medicine composition of the embodiment 9 is prepared by weighing 6g of codonopsis pilosula, 6g of astragalus, 3g of dried orange peel, 3g of white paeony root, 6g of Chinese angelica, 6g of szechuan lovage rhizome, 6g of dahurian angelica root and 6g of grassleaf sweelflag rhizome according to the formula ratio, and preparing into traditional Chinese medicine granules by the method of the reference embodiment 11, wherein the traditional Chinese medicine granules are orally taken twice a day in the morning and evening, and the continuous taking for 3 months is a treatment course. The ginkgo leaf analog is prepared from pregelatinized starch, lactose, 30% ethanol, carboxymethyl starch sodium and magnesium stearate, and has the same shape, color and taste as those of ginkgo leaf. Is provided by Shanghai Yi Baidada Limited company, and is qualified by drug inspection. The administration method comprises oral administration, 1 tablet/time, 3 times/day, and 3 months respectively in the morning, in the middle and in the evening.
(3) Comparison of two sets of correlation scales at the time of group entry
The control group was found to have a higher GAD-7 score than the treatment group, with a statistical difference (P < 0.05) when compared to the two patient-related scales. Other differences in scale scores including spleen deficiency syndrome scores, MMSE, moCA, PHQ-9, BI, etc. were not statistically significant (P > 0.05).
Table 2 comparison of two sets of patient related scales
(4) Comparison of the related scales of two groups of patients after treatment
Comparing the relevant scales of the two groups of patients after 3 months of treatment, the results among the groups show that the BI score of the treatment group after 3 months of treatment is significantly higher than that of the control group, and the difference has statistical significance (P < 0.05), which indicates that the daily life activity of the patients in the treatment group after treatment is better. The comparative differences of other related scales have no statistical significance (P > 0.05).
Meanwhile, the comparison before and after treatment shows that compared with the comparison before treatment, the effect degree of traditional Chinese medicine syndrome on life, moCA total score and PHQ-9 difference of the patients in the treatment group after 3 months of treatment have statistical significance (P < 0.05), and the effect degree of traditional Chinese medicine syndrome on life, cognitive function and depression state are obviously improved after the patients in the treatment group intervene for 3 months; after 3 months of control patient intervention, the GAD-7 score was significantly reduced compared to that before treatment, the difference being statistically significant (P < 0.05).
Table 3 inter-group comparison of two groups of patient related scales after 3 months of treatment
Note that: # compared to pre-treatment, differences were statistically significant (P < 0.05); * Group-to-group comparison, differences were statistically significant (P < 0.05)
The above description is only a preferred embodiment of the present invention, and is not intended to limit the invention in any way, and any person skilled in the art may make modifications or alterations to the disclosed technical content to the equivalent embodiments. However, any simple modification, equivalent variation and variation of the above embodiments according to the technical substance of the present invention still fall within the protection scope of the technical solution of the present invention.
Claims (10)
1. The traditional Chinese medicine composition for treating mild cognitive impairment caused by leukoencephalopathy is characterized by being prepared from the following raw materials in parts by weight:
3 to 10 parts of pilose asiabell root, 3 to 10 parts of astragalus root, 1 to 5 parts of dried orange peel, 1 to 5 parts of white paeony root, 3 to 10 parts of Chinese angelica, 3 to 10 parts of szechuan lovage rhizome, 3 to 10 parts of dahurian angelica root and 3 to 10 parts of grassleaf sweelflag rhizome.
2. The traditional Chinese medicine composition for treating mild cognitive impairment caused by leukoencephalopathy according to claim 1, which is characterized by being prepared from the following raw materials in parts by weight:
5 to 7 parts of pilose asiabell root, 5 to 7 parts of astragalus root, 2 to 4 parts of dried orange peel, 2 to 4 parts of white paeony root, 5 to 7 parts of Chinese angelica, 5 to 7 parts of szechuan lovage rhizome, 5 to 7 parts of dahurian angelica root and 5 to 7 parts of grassleaf sweelflag rhizome.
3. The traditional Chinese medicine composition for treating mild cognitive impairment caused by leukoencephalopathy according to claim 2, which is characterized by being prepared from the following raw materials in parts by weight:
6 parts of radix codonopsis, 6 parts of astragalus, 3 parts of dried orange peel, 3 parts of white peony root, 6 parts of Chinese angelica, 6 parts of szechuan lovage rhizome, 6 parts of dahurian angelica root and 6 parts of grassleaf sweelflag rhizome.
4. The traditional Chinese medicine composition for treating mild cognitive impairment caused by leukoencephalopathy according to claim 3, which is prepared into clinically acceptable pharmaceutical preparations according to a conventional preparation method of traditional Chinese medicines.
5. The traditional Chinese medicine composition for treating mild cognitive impairment caused by white matter lesions, according to claim 4, wherein the traditional Chinese medicine composition is in a form of decoction or granule.
6. Use of a Chinese medicinal composition according to any one of claims 1-3 for the preparation of a medicament for treating mild cognitive impairment caused by leukoencephalopathy.
7. A medicament for treating mild cognitive impairment caused by white matter lesions, which is prepared by decocting the traditional Chinese medicine composition according to any one of claims 1-3 in water.
8. A medicament for treating mild cognitive impairment caused by white matter lesions as defined in claim 7, comprising the following preparation method:
Weighing radix codonopsis pilosulae, radix astragali, dried orange peel, white paeony root, chinese angelica, szechuan lovage rhizome, dahurian angelica root and grassleaf sweelflag rhizome according to the formula, adding 100-300 ml of water for boiling for 10-30min for the first time, and adding 100-300 ml of water for boiling for 10-30min for the second time; filtering, and collecting filtrate to obtain the final product.
9. The medicament for treating mild cognitive impairment caused by white matter lesions of claim 8, wherein the first water addition is for 200min and the decoction is for 20min.
10. The medicament for treating mild cognitive impairment caused by white matter lesions of claim 8, wherein the second addition of water is for 200min and the decoction is for 20min.
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