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CN-121987757-A - Formula for improving thrombolytic capability of human body, preparation method and application thereof

CN121987757ACN 121987757 ACN121987757 ACN 121987757ACN-121987757-A

Abstract

The invention provides a formula for improving thrombolysis capability of a human body, a preparation method and application thereof, wherein the formula comprises, by weight, 5-30 parts of earthworm protein, 30-120 parts of sea buckthorn total flavone extract, 50-150 parts of silymarin extract, 20-80 parts of maltodextrin and 15-60 parts of pregelatinized starch, the earthworm protein activates a fibrinolysis system to promote t-PA to release and dissolve thrombus, the ratio of PGI 2 /TXA 2 of sea buckthorn total flavone to inhibit platelet aggregation and reduce blood fat, silymarin protects liver function and enhances LDL-C metabolism and clearance, and the three cooperate to form a thrombolysis-anti-thrombus-metabolism regulation three-dimensional intervention system, and the preparation adopts a whole-course low-temperature mixing direct tabletting process, so that the invention is safe and efficient.

Inventors

  • ZHANG FENG

Assignees

  • 南京东马生物科技有限公司

Dates

Publication Date
20260508
Application Date
20260325

Claims (10)

  1. 1. The formula for improving the thrombolytic capacity of a human body is characterized by comprising, by weight, 5-30 parts of earthworm protein, 30-120 parts of sea buckthorn total flavone extract, 50-150 parts of silymarin extract, 20-80 parts of maltodextrin and 15-60 parts of pregelatinized starch, wherein the content of fibrin dissolution system activator protein in the earthworm protein is not less than 15% of the total protein mass, the content of total flavone in the sea buckthorn total flavone extract is not less than 60%, and the content of silybin in the silymarin extract is not less than 50%.
  2. 2. The formula of claim 1, wherein the components comprise, by weight, 8-15 parts of earthworm protein, 50-90 parts of sea buckthorn total flavone extract, 80-120 parts of silymarin extract, 35-60 parts of maltodextrin and 25-45 parts of pregelatinized starch.
  3. 3. The formula of claim 1, wherein the molecular weight range of the fibrinolytic system activating protein in the earthworm protein is 20-35 kDa, and the earthworm protein is obtained by low-temperature water extraction, enzymolysis, ultrafiltration separation and freeze drying of a fresh living body of Eisenia foetida or Eisenia gensenensis, wherein the protein purity is not lower than 85%.
  4. 4. The formulation of claim 1, wherein the total flavonoids of seabuckthorn extract comprises isorhamnetin, quercetin, myricetin and kaempferol, and the total content of four aglycone compounds is more than 40% of the total flavonoids.
  5. 5. The formulation of claim 1, wherein the formulation is in the form of a tablet having a tablet weight of 400-600 mg.
  6. 6. A method for preparing the formula according to any one of claims 1-5 is characterized by comprising the following steps of firstly uniformly mixing silymarin extract and pregelatinized starch at 25+/-5 ℃ and stirring for 3-8 min, secondly adding sea buckthorn total flavonoid extract and maltodextrin into the mixture obtained in the first step and stirring for 8-15 min at 25+/-5 ℃, thirdly adding earthworm protein into the mixture obtained in the second step and stirring for 12-20 min at a low speed at 20+/-3 ℃, fourthly, sieving the material obtained in the third step with a 16-24-mesh sieve, uniformly mixing and directly tabletting to form.
  7. 7. The method according to claim 6, wherein the tablet compression pressure in the fourth step is 5-15 kn, the hardness of the obtained tablet is 45-90 n, and the disintegration time is not more than 35min.
  8. 8. The method of claim 6, wherein the rotation speed of low-speed stirring in the third step is 5-15 r/min, and the earthworm protein is subjected to pre-cooling treatment at 4 ℃ for not less than 30min before being added.
  9. 9. The method of claim 6, wherein the material in step four is directly tableted without a granulation step.
  10. 10. The use of the formulation according to any one of claims 1 to 5 for the preparation of functional or health food for increasing the activity of the fibrinolytic system in humans.

Description

Formula for improving thrombolytic capability of human body, preparation method and application thereof Technical Field The invention belongs to the technical field of natural pharmaceutical compositions, and particularly relates to a formula for improving the thrombolytic capacity of a human body, a preparation method and application thereof. Background Cardiovascular and cerebrovascular diseases are the most deadly disease type worldwide, and their central pathological mechanisms are intravascular thrombosis and microcirculation disturbance. The thrombotic process involves three key links of activation of the coagulation cascade, abnormal aggregation of platelets and low function of the fibrinolytic system. Under normal physiological conditions, the human endogenous plasmin system converts plasminogen to plasmin via tissue plasminogen activator (t-PA), which in turn degrades the fibrin clot to maintain vascular patency. However, with age, metabolic disturbance and vascular endothelial injury aggravated, the release capacity of t-PA is significantly reduced, and the activity of plasmatic plasminogen activator inhibitor-1 (PAI-1) is abnormally increased, resulting in imbalance of plasmatic system function and a great impairment of thrombus clearance. It is counted that the direct causes of ischemic stroke and acute myocardial infarction are closely related to intra-arterial thrombosis or shedding embolism. Epidemiological studies show that hyperlipidemia, hypertension and diabetes are three independent risk factors for thrombosis, the prevalence of the three metabolic diseases is continuously rising, and the prevention and control situation of the thrombosis related diseases is increasingly severe. Microcirculation disturbance is a common pathological basis for various chronic diseases, and is also closely related to the formation of micro-thrombosis in micro-blood vessels and vascular endothelial injury. Therefore, starting from improving the thrombolytic capacity of the human body, a natural functional formula which is safe, mild and can be used for a long time is developed, and the composition has important public health significance for primary prevention and secondary prevention of cardiovascular and cerebrovascular diseases. The thrombolytic drugs used clinically at present mainly comprise urokinase, streptokinase, recombinant tissue plasminogen activator (rt-PA) and the like, and although the drugs can directly dissolve thrombus, the drugs have the limitations of high bleeding risk, narrow treatment time window, high price, strict medical monitoring and the like, and are not suitable for being used as a means for long-term prevention and chronic thrombus management. In the traditional Chinese medicine field, the formulas for promoting blood circulation and removing blood stasis such as Xuefu Zhuyu decoction, buyang Huanwu decoction and the like have long application history, but most of the formulas lack modern pharmacological mechanism explanation and accurate quality control standards, have complex formulas and ambiguous interaction among all components, and are difficult to meet the requirements of modern medicine registration and approval. In recent years, functional composition research based on natural active proteins and plant extracts has received a great deal of attention. Lumbricus protein is an active protein mixture extracted from Lumbricus body, and has been studied to confirm its pharmacological activity of promoting fibrinolysis and improving microcirculation. However, the existing earthworm protein products have the problems of large batch-to-batch quality fluctuation, undefined active ingredients, slow individual use, and the like. In the published patent literature, CN116270984A discloses a vascular embolism improving composition containing earthworm protein peptide, but the composition depends on traditional Chinese medicine extracts (angelica sinensis, ligusticum wallichii and the like) for promoting blood circulation to remove blood stasis as auxiliary components, and does not relate to the effect of flavonoid compounds on platelet aggregation inhibition and blood lipid metabolism regulation. CN115607657a discloses a composition of nattokinase and earthworm protein peptide, but the scheme only involves superposition of direct plasmin activity, lacks intervention on thrombus formation upstream nodes (dyslipidemia, vascular endothelial injury, platelet overactivation), and cannot realize synergistic effects of preventing thrombus from being regenerated and promoting thrombus dissolution. Therefore, how to design a safe and effective natural composition capable of comprehensively improving the thrombolysis capability of a human body through a multi-target synergistic mechanism, which not only can activate an endogenous fibrinolytic system, but also can inhibit upstream factors of thrombus formation, is a technical problem to be solved in the field. From the pharmacological analysis,