阅读说明：本技术 一种缺血性中风患者用的中药微生态制剂 (Traditional Chinese medicine microecological preparation for patients with ischemic stroke ) 是由 岳朋 刘国鑫 陈敬杰 石牧 于 2020-06-01 设计创作，主要内容包括：本发明公开了一种缺血性中风患者用的中药微生态制剂,涉及药物制剂技术领域。本发明提供的缺血性中风患者用的中药微生态制剂采用中药复方和益生元组合物配合,利用中药复方辅助改善缺血性中风,而益生元组合物可以调整患者的肠道菌群,拥有良好的肠道菌群进一步有助于改善缺血性中风,从而可用于对缺血性中风疾病的辅助治疗。(The invention discloses a traditional Chinese medicine microecological preparation for patients with ischemic stroke, and relates to the technical field of medicinal preparations. The traditional Chinese medicine microecological preparation for patients with ischemic stroke provided by the invention adopts the matching of the traditional Chinese medicine compound and the prebiotic composition, the traditional Chinese medicine compound is used for assisting in improving the ischemic stroke, and the prebiotic composition can adjust the intestinal flora of the patients, has good intestinal flora and is further beneficial to improving the ischemic stroke, so that the traditional Chinese medicine microecological preparation can be used for assisting in treating ischemic stroke diseases.)

1. A traditional Chinese medicine microecological preparation for patients with ischemic stroke is characterized by comprising a traditional Chinese medicine compound and a prebiotic composition.

2. The microecological preparation of Chinese herbs for ischemic stroke patients according to claim 1, wherein the amount of the Chinese herbal compound is 20-30% by mass of the total system.

3. The herbal micro-ecological formulation for patients with ischemic stroke according to claim 2, wherein the prebiotic composition comprises 70-80% by weight of the total system.

4. The microecological preparation of Chinese herbs for ischemic stroke patients according to claim 3, wherein the Chinese herbs comprise Astragalus membranaceus and Angelica sinensis.

5. The herbal micro-ecological formulation for patients with ischemic stroke according to claim 4, wherein said prebiotic composition comprises fructo-oligosaccharide, trehalose, galacto-oligosaccharide, isomalto-oligosaccharide.

6. The microecological preparation of a chinese medicinal material for patients with ischemic stroke according to claim 5, wherein the astragalus membranaceus is an extract of astragalus membranaceus.

7. The herbal microecological formulation for patients with ischemic stroke according to claim 6, wherein said angelica is an angelica sinensis extract.

8. The Chinese herbal microecological preparation for patients with ischemic stroke according to claim 7, which comprises the following components in percentage by weight:

5 to 20 percent of astragalus extract;

5 to 15 percent of angelica extract;

20% -50% of fructo-oligosaccharide;

5% -10% of trehalose;

5% -10% of galacto-oligosaccharides;

10-30% of isomaltose hypgather.

9. The use of the herbal micro-ecological formulation for ischemic stroke patients as claimed in claim 8 in the preparation of a medicament for treating ischemic stroke diseases.

Technical Field

The invention relates to the technical field of pharmaceutical preparations, in particular to a traditional Chinese medicine microecological preparation for patients with ischemic stroke.

Background

Ischemic stroke, i.e. ischemic stroke, is a common cerebrovascular disease, and ischemic necrosis or brain softening of local tissues of cerebral tissues in a blood supply area is caused by ischemia and hypoxia of the cerebral tissues due to cerebral blood supply disorder, and is manifested as dysfunction of movement, sensation, cognition and the like, thereby bringing great pain to patients and seriously affecting the quality of life. According to statistics, the prevalence rate of ischemic stroke accounts for about 77.8% of all cerebral stroke, the morbidity rate accounts for about 69.6% of all cerebral stroke, and the cerebral apoplexy treatment drug has the characteristics of high incidence, high disability rate, high mortality rate and high recurrence rate.

Numerous studies have shown that gut flora can influence the progression and prognosis of various neurological diseases, including ischemic stroke, by modulating the immune response. Studies have shown that intestinal flora plays an important role in the onset and progression of ischemic stroke, and thus it is possible to treat ischemic stroke by modulating intestinal flora.

Recent studies have found that the occurrence of ischemic stroke can lead to the disruption of intestinal barrier structure and function. In the research, after the brain injury occurs, the remarkable phenomena of mucosa atrophy, epithelial cell shedding, intestinal congestion, edema and the like can be observed. These lesions occur rapidly within at least 3 hours after brain injury occurs and persist for more than 7 days. Severe intestinal barrier disruption will lead to a dysregulated intestinal flora structure and a translocation of the intestinal flora. Recent studies have also shown that the intestinal flora changes significantly after severe stroke.

At present, the clinical or basic research on the correlation between the intestinal flora and the ischemic stroke is less, but the existing evidence suggests that the intestinal flora plays an important role in the onset process of the ischemic stroke: including the effects of the intestinal flora on vascular risk factors and on platelet activation and atherosclerosis.

The research of taking an ischemic stroke patient and a health contrast as research objects and carrying out qualitative analysis on the fecal samples of the ischemic stroke patient and the health contrast by using a high-throughput sequencing platform shows that the ischemic stroke patient has intestinal flora disturbance expressions such as reduction of diversity of intestinal flora, reduction of beneficial bacteria, increase of opportunistic pathogenic bacteria and the like in the acute stage and the convalescent stage; the diversity of intestinal flora is increased in the recovery stage of stroke compared with that in the acute stage.

In view of the large difference between the intestinal flora of patients with ischemic stroke and the intestinal flora of healthy people, from the viewpoint of adjusting the intestinal flora, it is necessary to search for a pharmaceutical preparation for improving ischemic stroke diseases.

Disclosure of Invention

The invention aims to provide a traditional Chinese medicine microecological preparation for patients with ischemic stroke from the viewpoint of adjusting intestinal flora.

In order to solve the above problems, the present invention proposes the following technical solutions:

a Chinese medicinal microecological preparation for patients with ischemic apoplexy comprises Chinese medicinal composition and prebiotic composition.

The further technical scheme is that the traditional Chinese medicine compound accounts for 20-30% of the total mass of the system.

The further technical scheme is that the prebiotic composition accounts for 70-80% of the total system by mass.

The further technical scheme is that the traditional Chinese medicine compound is prepared from astragalus and angelica.

The further technical scheme is that the prebiotic composition comprises fructo-oligosaccharide, trehalose, galacto-oligosaccharide and isomalto-oligosaccharide.

The further technical scheme is that the astragalus membranaceus is an astragalus membranaceus extract.

The further technical scheme is that the angelica is an angelica extract.

The technical scheme is that the traditional Chinese medicine microecological preparation for patients with ischemic stroke comprises the following components in percentage by weight:

5 to 20 percent of astragalus extract;

5 to 15 percent of angelica extract;

20% -50% of fructo-oligosaccharide;

5% -10% of trehalose;

5% -10% of galacto-oligosaccharides;

10-30% of isomaltose hypgather.

The invention also provides application of the traditional Chinese medicine microecological preparation for patients with ischemic stroke in medicines for treating ischemic stroke diseases.

Compared with the prior art, the invention can achieve the following technical effects:

the traditional Chinese medicine microecological preparation for patients with ischemic stroke provided by the invention adopts the matching of the traditional Chinese medicine compound and the prebiotic composition, the traditional Chinese medicine compound is used for assisting in improving the ischemic stroke, and the prebiotic composition can adjust the intestinal flora of the patients, has good intestinal flora and is further beneficial to improving the ischemic stroke, so that the traditional Chinese medicine microecological preparation can be used for assisting in treating ischemic stroke diseases.

In other schemes of the invention, the traditional Chinese medicine compound is monarch drug astragalus and ministerial drug angelica of yang-tonifying five-returning decoction, and the monarch drug astragalus can greatly tonify the deficiency of the original qi and has the functions of tonifying qi and removing blood stasis; the ministerial drug Chinese angelica has the effects of promoting blood circulation and removing blood stasis without damaging the body resistance, and the combination of the ministerial drug Chinese angelica and the ministerial drug Chinese angelica has the effects of promoting blood circulation and removing blood stasis, relieving the disorder of cerebrovascular circulation and promoting the functional recovery of nerve cells.

Further, due to the existence of a functionally integrated bidirectional communication system between the brain and the intestinal tract, i.e., the gut brain-axis, the intestinal flora is closely associated with a variety of neurological-related diseases including stroke. The intestinal flora composition of patients with ischemic stroke usually changes relative to that of healthy people. Research proves that the MCAO-induced brain injury can be protected by changing intestinal flora; from the immunization point of view, the essence is that the effect is generated by influencing the content and the proportion of Treg and IL-17+ gamma delta T cells; accumulation of IL-17+ γ δ T cells in the meninges is positively correlated with infarct size, and intestinal T cells migrate to the meninges following ischemic injury to the brain; IL-10 and IL-17 mediate neuroprotection. Therefore, the traditional Chinese medicine microecological preparation for patients with ischemic stroke provided by the invention comprises a prebiotic composition besides a traditional Chinese medicine compound, and the prebiotic composition is used for adjusting the intestinal flora of the patients with ischemic stroke, so that the content and the proportion of Treg and IL-17+ gamma delta T cells are influenced by the change of the intestinal flora, and the treatment of ischemic stroke diseases is assisted.

Still further, in other embodiments of the present invention, the herbal micro-ecological preparation for ischemic stroke patients comprises prebiotic composition comprising fructo-oligosaccharide, trehalose, galacto-oligosaccharide, and isomalto-oligosaccharide. The oligosaccharides belong to sugar molecules which cannot be digested by a human host but only by microbiome, can effectively promote the growth and the propagation of beneficial bacteria in a human body, and are beneficial to establishing a healthy intestinal flora microecosystem.

Detailed Description

The technical solutions in the examples will be clearly and completely described below. It is apparent that the embodiments to be described below are only a part of the embodiments of the present invention, and not all of them. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.

The present invention is directed to the following terms or terms:

treg: regulatory T cells (Regulatory cells) are a subset of T cells that control autoimmune reactivity in vivo.

MCAO, middle cerebral artery occlusion.

IL-17 Interleukin 17 (IL 17) is one of more than 30 interleukins that have been discovered.

γ δ T cells: are a subset of T cells with unique T cell antigen receptors (TCRs) on their surface.

Monarch drug: is a medicine which has main treatment effect aiming at major diseases or major symptoms in a traditional Chinese medicine prescription.

Ministerial drugs: is a medicine which is used for assisting monarch drugs in a traditional Chinese medicine prescription to strengthen the treatment of main diseases or main symptoms or has a treatment effect on accompanying diseases or concurrent symptoms.

The embodiment of the invention provides a traditional Chinese medicine microecological preparation for patients with ischemic stroke, which comprises 20-30% of a traditional Chinese medicine compound and 70-80% of a prebiotic composition by mass.

The traditional Chinese medicine compound is a traditional Chinese medicine formula for treating ischemic stroke diseases. For example, yang-tonifying and five-returning decoction, which is first recorded in Yi Lin correction of Wang Qing ren, is a classic and famous prescription for treating apoplexy due to qi deficiency and blood stasis.

The whole formula consists of 7 medicines, and the monarch medicine astragalus is used for unprocessed four major medicines for tonifying the deficiency of the original qi and playing the role of tonifying qi and removing blood stasis; the ministerial drug uses the angelica and the tail two money to activate blood and remove stasis without damaging the body resistance, and lightly uses the peach kernel, the safflower and the szechuan lovage rhizome and the red paeony root and the earthworm as the assistant and guide to activate blood, remove blood stasis and dredge collaterals.

The action mechanism of the yang-tonifying and blood stasis-reducing decoction for treating stroke (ischemic stroke) caused by qi stagnation and blood stasis is as follows: the yang-tonifying and five-returning decoction has the effects of directly regulating the proportion balance of prostacyclin PGI2 and thromboxane TXA2, inhibiting lipid peroxidation and improving the activity of antioxidant enzyme, thereby indirectly protecting vascular endothelial cells, reducing the synthesis and release of plasma endothelin ET, relieving the disorder of cerebral vascular circulation, promoting the functional recovery of nerve cells and achieving the effect of treating ischemic stroke.

In one embodiment, the traditional Chinese medicine microecological preparation for patients with ischemic stroke provided by the invention comprises a traditional Chinese medicine compound comprising monarch drug astragalus and ministerial drug angelica of yang-tonifying five-returning decoction, wherein the monarch drug astragalus can greatly tonify deficiency of vital energy, and has the effects of tonifying qi and removing blood stasis; the ministerial drug Chinese angelica has the effects of promoting blood circulation and removing blood stasis without damaging the body resistance, and the combination of the ministerial drug Chinese angelica and the ministerial drug Chinese angelica has the effects of promoting blood circulation and removing blood stasis, relieving the disorder of cerebrovascular circulation and promoting the functional recovery of nerve cells.

Further, due to the existence of a functionally integrated bidirectional communication system between the brain and the intestinal tract, i.e., the gut brain-axis, the intestinal flora is closely associated with a variety of neurological-related diseases including stroke. The intestinal flora composition of patients with ischemic stroke usually changes relative to that of healthy people. Research proves that the MCAO-induced brain injury can be protected by changing intestinal flora; from the immunization point of view, the essence is that the effect is generated by influencing the content and the proportion of Treg and IL-17+ gamma delta T cells; accumulation of IL-17+ γ δ T cells in the meninges is positively correlated with infarct size, and intestinal T cells migrate to the meninges following ischemic injury to the brain; IL-10 and IL-17 mediate neuroprotection. Therefore, the traditional Chinese medicine microecological preparation for patients with ischemic stroke provided by the invention comprises a prebiotic composition besides a traditional Chinese medicine compound, and the prebiotic composition is used for adjusting the intestinal flora of the patients with ischemic stroke, so that the content and the proportion of Treg and IL-17+ gamma delta T cells are influenced by the change of the intestinal flora, and the treatment of ischemic stroke diseases is assisted.

Still further, in other embodiments of the present invention, the herbal micro-ecological preparation for ischemic stroke patients comprises prebiotic composition comprising fructo-oligosaccharide, trehalose, galacto-oligosaccharide, isomalto-oligosaccharide. The oligosaccharides belong to sugar molecules which cannot be digested by a human host but only by microbiome, can effectively promote the growth and the propagation of beneficial bacteria in a human body, and are beneficial to establishing a healthy intestinal flora microecosystem.

In one embodiment, the traditional Chinese medicine microecological preparation for patients with ischemic stroke provided by the invention comprises the following components in percentage by weight:

5 to 20 percent of astragalus extract;

5 to 15 percent of angelica extract;

20% -50% of fructo-oligosaccharide;

5% -10% of trehalose;

5% -10% of galacto-oligosaccharides;

10-30% of isomaltose hypgather.

The following table 1 shows the contents (mass percentages) of the respective components in the specific examples.

TABLE 1

The traditional Chinese medicine microecological preparation for the patients with ischemic stroke provided by the embodiment of the invention is provided for the patients with ischemic stroke to take, the diversity of intestinal flora of the patients is obviously improved, and simultaneously, both plasma endothelin and lipid peroxide in the bodies of the patients are reduced. Therefore, the traditional Chinese medicine microecological preparation for patients with ischemic stroke provided by the invention can be used for assisting in the treatment of ischemic stroke.

In the above embodiments, the descriptions of the respective embodiments have respective emphasis, and for parts that are not described in detail in a certain embodiment, reference may be made to related descriptions of other embodiments.

While the invention has been described with reference to specific embodiments thereof, it will be understood by those skilled in the art that various changes in form and details may be made therein without departing from the spirit and scope of the invention as defined by the appended claims. Therefore, the protection scope of the present invention shall be subject to the protection scope of the claims.