Medicine formula for preventing cerebral infarction and promoting rehabilitation and preparation method thereof

Abstract

The invention discloses a medicine formula for preventing cerebral infarction and promoting rehabilitation and a preparation method thereof, and belongs to the technical field of preparation of medicines for preventing cerebral infarction, the medicine formula comprises the following raw materials by weight: 10-15 parts of flatstem milkvetch seed, 10-15 parts of dodder, 10-15 parts of tortoise plastron, 10-12 parts of red peony root, 6-9 parts of safflower, and 15-30 parts of red sage root. According to the invention, the flatstem milkvetch seed, the semen cuscutae and the tortoise plastron are used for nourishing liver and kidney, replenishing essence and benefiting marrow, so that the traditional Chinese medicine theory that kidney dominates bone marrow generation and brain is marrow sea is met, and brain function decline is improved from the source; meanwhile, the radix salviae miltiorrhizae, the radix paeoniae rubra and the flos carthami have the effects of promoting blood circulation to remove blood stasis, activating meridians to stop pain, effectively improving brain microcirculation, inhibiting platelet aggregation and reducing blood viscosity, and supplement each other to achieve the effects of strengthening the body resistance to eliminate pathogenic factors and treating both symptoms and root causes, so that the traditional Chinese medicine composition can be used for preventing cerebral infarction of high-risk groups and is also suitable for functional recovery in the rehabilitation period after cerebral infarction.

Description

Technical Field

[0001] This invention belongs to the field of drug preparation technology for preventing cerebral infarction, specifically a drug formulation and preparation method for preventing cerebral infarction and promoting rehabilitation. Background Technology

[0002] Cerebral infarction (also known as ischemic stroke) is a serious cardiovascular and cerebrovascular disease caused by impaired blood supply to the brain, leading to local brain tissue ischemia, hypoxia, and necrosis. It is characterized by high incidence, high disability rate, and high recurrence rate. With the increasing aging of the population and changes in lifestyle, the risk of cerebral infarction continues to rise, and it has become one of the major diseases threatening the health of middle-aged and elderly people.

[0003] Traditional Chinese medicine has accumulated rich experience in the prevention and treatment of cerebral infarction, emphasizing a holistic approach of "strengthening the body's resistance and eliminating pathogenic factors" and "treating both the root cause and the symptoms." Traditional Chinese medicine theory holds that "the kidneys govern bones and produce marrow, and the brain is the sea of ​​marrow," indicating a close relationship between declining brain function and deficiency of liver and kidney essence. Furthermore, "prolonged illness affecting the collaterals" and "internal obstruction of blood stasis" are important pathogenesis mechanisms in the development of cerebral infarction. Therefore, if nourishing the liver and kidneys, replenishing essence and marrow, can be organically combined with promoting blood circulation, removing blood stasis, and relieving pain, it is hoped that cerebral blood supply can be improved from the source, promoting the recovery of nerve function and reducing the risk of recurrence.

[0004] However, existing traditional Chinese medicine compound preparations generally suffer from problems such as complex ingredients, non-standard extraction processes, unstable content of active ingredients, and poor clarity, which affect clinical efficacy and patient compliance. In particular, for compound preparations containing animal-derived medicines (such as tortoise shell), if they are decocted with other herbal medicines, precipitation is easily caused by the interaction of proteins, colloids, and other components, which reduces efficacy or affects the quality of the preparation. Summary of the Invention

[0005] The purpose of this invention is to provide a drug formulation and preparation method for preventing cerebral infarction and promoting rehabilitation, so as to solve the problems mentioned in the background art.

[0006] To achieve the above objectives, the present invention provides the following technical solution: a drug formulation for preventing cerebral infarction and promoting rehabilitation and its preparation method, comprising the following raw materials in parts by weight: 10-15 parts of Astragalus complanatus, 10-15 parts of Cuscuta chinensis, 10-15 parts of tortoise shell, 10-12 parts of Paeonia lactiflora, 6-9 parts of Carthamus tinctorius, and 15-30 parts of Salvia miltiorrhiza.

[0007] As a further preferred embodiment of this technical solution, the following raw materials are included in parts by weight: 11 parts of Astragalus complanatus, 11 parts of Cuscuta chinensis, 11 parts of tortoise shell, 10 parts of Paeonia lactiflora, 6 parts of Carthamus tinctorius, and 17 parts of Salvia miltiorrhiza.

[0008] As a further preferred embodiment of this technical solution, the following steps are included:

[0009] S1: Clean and select the following herbs: Astragalus complanatus, Cuscuta chinensis, Paeonia lactiflora, Carthamus tinctorius, and Salvia miltiorrhiza, remove impurities, dry them for later use, and process the tortoise shell into small pieces before processing it separately.

[0010] S2: Decoction of tortoise shell alone: ​​Take tortoise shell and add 8 times the amount of water, bring to a boil over high heat, then simmer over low heat for 2 hours. Filter out the liquid. Add 6 times the amount of water to the dregs and decoct for 1 hour. Combine the two filtrates and concentrate to a relative density of about 1.10. At the same time, mix Astragalus complanatus, Cuscuta chinensis, Paeonia lactiflora, Carthamus tinctorius, and Salvia miltiorrhiza, add 10 times the amount of water and soak for 30 minutes. Decoction for 1.5 hours. Filter out the liquid. Add 8 times the amount of water to the dregs and decoct for 1 hour. Combine the two filtrates and concentrate to a relative density of about 1.15.

[0011] S3: Combine the tortoise shell concentrate with other medicinal material concentrates, stir evenly, and optionally add an appropriate amount of ethanol and let stand for 24 hours to remove some tannins and impurities, recover the ethanol, and obtain a clear medicinal solution.

[0012] S4: Spray dry the drug solution to obtain dry extract powder, add appropriate amount of dextrin, lactose and other excipients, mix evenly, make soft material with 70% ethanol, sieve and granulate, dry at below 60℃, granulate, sieve to obtain finished granules;

[0013] S5: Packaged in 5g bags, sealed with aluminum foil composite film, and subject to quality inspection in all aspects of the medicine;

[0014] As a further preferred embodiment of this technical solution: the concentration of ethanol added when the tortoise shell concentrate is combined with other medicinal material concentrates is 60%;

[0015] As a further preferred embodiment of this technical solution: the filter hole diameter for sieving and granulating the 70% ethanol-based soft material is 16 mesh, and the filter hole diameter range for sieving the dried granules is 18-60 mesh.

[0016] As a further preferred embodiment of this technical solution, the drug quality inspection aspects include appearance, moisture content, solubility, microbial limits, and content determination.

[0017] Compared with the prior art, the beneficial effects of the present invention are:

[0018] 1. In this invention, by using Astragalus complanatus, Cuscuta chinensis, and tortoise shell to nourish the liver and kidneys, replenish essence and marrow, it conforms to the traditional Chinese medicine theory that "the kidneys govern bones and produce marrow, and the brain is the sea of ​​marrow," thus improving brain function decline from the source. At the same time, it is combined with Salvia miltiorrhiza, Paeonia lactiflora, and Carthamus tinctorius to promote blood circulation, remove blood stasis, unblock collaterals and relieve pain, effectively improving cerebral microcirculation, inhibiting platelet aggregation, and reducing blood viscosity. The two complement each other to achieve "strengthening the body's resistance and eliminating pathogens, treating both the symptoms and the root cause," which can be used for the prevention of cerebral infarction in high-risk groups and is also suitable for functional recovery during the rehabilitation period after cerebral infarction.

[0019] 2. In this invention, by using an extraction process that involves decocting tortoise shell separately from other medicinal materials and then combining the decoctions, the full dissolution of the gelatinous components in the tortoise shell is ensured, while avoiding precipitation or chemical reactions that may occur when decocting with other medicinal materials. The ethanol precipitation (60% ethanol) effectively removes impurities such as tannins and proteins, improving the clarity and stability of the preparation. Finally, the preparation is made into granules with good solubility, high bioavailability, and convenient for long-term use. Attached Figure Description

[0020] Figure 1 This is a flowchart of a drug formulation for preventing cerebral infarction and promoting rehabilitation, and its preparation method, according to the present invention. Detailed Implementation

[0021] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0022] Example 1:

[0023] Please see Figure 1 As shown, the present invention provides a technical solution: a drug formula for preventing cerebral infarction and promoting rehabilitation and its preparation method, comprising the following raw materials in parts by weight: 10-15 parts of Astragalus complanatus, 10-15 parts of Cuscuta chinensis, 10-15 parts of tortoise shell, 10-12 parts of Paeonia lactiflora, 6-9 parts of Carthamus tinctorius, and 15-30 parts of Salvia miltiorrhiza.

[0024] Further: Includes the following raw materials by weight: 11 parts of Astragalus complanatus, 11 parts of Cuscuta chinensis, 11 parts of tortoise shell, 10 parts of Paeonia lactiflora, 6 parts of Carthamus tinctorius, and 17 parts of Salvia miltiorrhiza.

[0025] Experiment feedback:

[0026] The customized formula consists of 11 parts of Astragalus complanatus, 11 parts of Cuscuta chinensis, 11 parts of tortoise shell, 10 parts of Paeonia lactiflora, 6 parts of Carthamus tinctorius, and 17 parts of Salvia miltiorrhiza.

[0027] Prepared according to a fixed preparation process;

[0028] Experimental conclusions: The obtained granules were brownish-yellow in color, had good solubility, and no charred residue; the tanshinone IIA content was 0.82 mg / g, which met the quality standard; animal model experiments showed that continuous administration for 4 weeks could significantly improve the neurological function score of rats with cerebral ischemia (P<0.05) and reduce plasma viscosity, suggesting that this formula has good blood-activating and collateral-clearing and neuroprotective effects, and is suitable for the prevention and early rehabilitation of cerebral infarction.

[0029] Example 2:

[0030] A drug formulation for preventing cerebral infarction and promoting rehabilitation, and its preparation method, comprising the following raw materials in parts by weight: 10-15 parts of Astragalus complanatus, 10-15 parts of Cuscuta chinensis, 10-15 parts of tortoise shell, 10-12 parts of Paeonia lactiflora, 6-9 parts of Carthamus tinctorius, and 15-30 parts of Salvia miltiorrhiza.

[0031] Further: Includes the following raw materials by weight: 12 parts of Astragalus complanatus, 12 parts of Cuscuta chinensis, 12 parts of tortoise shell, 11 parts of Paeonia lactiflora, 7 parts of Carthamus tinctorius, and 20 parts of Salvia miltiorrhiza.

[0032] Experiment feedback:

[0033] The customized formula consists of 12 parts of Astragalus complanatus, 12 parts of Cuscuta chinensis, 12 parts of tortoise shell, 11 parts of Paeonia lactiflora, 7 parts of Carthamus tinctorius, and 20 parts of Salvia miltiorrhiza.

[0034] Prepared according to a fixed preparation process;

[0035] Experimental conclusions: The finished product granules have good flowability, and the content determination shows that tanshinone IIA has increased to 1.05 mg / g; in the in vitro antiplatelet aggregation experiment, the drug solution of this example has an inhibition rate of 68.3% against ADP-induced platelet aggregation, which is better than Example 1 (59.7%). Preclinical observation shows that this formulation is more effective in improving limb movement disorders and is suitable for patients with blood stasis and collateral obstruction syndrome in the recovery period of cerebral infarction.

[0036] Example 3:

[0037] A drug formulation for preventing cerebral infarction and promoting rehabilitation, and its preparation method, comprising the following raw materials in parts by weight: 10-15 parts of Astragalus complanatus, 10-15 parts of Cuscuta chinensis, 10-15 parts of tortoise shell, 10-12 parts of Paeonia lactiflora, 6-9 parts of Carthamus tinctorius, and 15-30 parts of Salvia miltiorrhiza.

[0038] Further: Includes the following raw materials by weight: 14 parts of Astragalus complanatus, 15 parts of Cuscuta chinensis, 14 parts of tortoise shell, 12 parts of Paeonia lactiflora, 8 parts of Carthamus tinctorius, and 25 parts of Salvia miltiorrhiza.

[0039] Experiment feedback:

[0040] The customized formula consists of 14 parts of Astragalus complanatus, 15 parts of Cuscuta chinensis, 14 parts of tortoise shell, 12 parts of Paeonia lactiflora, 8 parts of Carthamus tinctorius, and 25 parts of Salvia miltiorrhiza.

[0041] Prepared according to a fixed preparation process;

[0042] Experimental conclusions: All quality inspection indicators of the granules were qualified, with the highest content of effective ingredients (tanshinone IIA reached 1.31 mg / g, paeoniflorin 0.68 mg / g); no abnormalities in liver and kidney function were observed in the long-term toxicity test (90 days of continuous administration to rats); in elderly rabbits with arteriosclerosis model, this formula can significantly reduce carotid intima-media thickness and blood lipid levels (TC and LDL-C decreased P<0.01), indicating that under the dual mechanism of "tonifying the kidney and replenishing essence + promoting blood circulation and removing blood stasis", it has a stronger intervention effect on high-risk factors of cerebral infarction (such as arteriosclerosis and hyperlipidemia), and is suitable for long-term prevention and conditioning of elderly people, those with chronic illness and physical weakness and blood stasis syndrome.

[0043] The selected medicinal materials are all commonly used Chinese medicines in clinical practice, with mild medicinal properties and no obvious toxic side effects. They have undergone standardized quality inspections, including heavy metal, pesticide residue, microbial limits and content determination, to ensure product safety and reliability. They are especially suitable for secondary prevention of cerebral infarction and continuous intervention during the rehabilitation period in middle-aged and elderly people.

[0044] Although embodiments of the invention have been shown and described, it will be understood by those skilled in the art that various changes, modifications, substitutions and alterations can be made to these embodiments without departing from the principles and spirit of the invention, the scope of which is defined by the appended claims and their equivalents.

Claims

1. A pharmaceutical formulation for preventing cerebral infarction and promoting rehabilitation, and its preparation method, characterized in that, The ingredients include the following parts by weight: 10-15 parts of Astragalus complanatus, 10-15 parts of Cuscuta chinensis, 10-15 parts of tortoise shell, 10-12 parts of Paeonia lactiflora, 6-9 parts of Carthamus tinctorius, and 15-30 parts of Salvia miltiorrhiza.

2. The drug formulation for preventing cerebral infarction and promoting rehabilitation, and its preparation method, as described in claim 1, are characterized in that: The ingredients include the following ingredients by weight: 11 parts of Astragalus complanatus, 11 parts of Cuscuta chinensis, 11 parts of tortoise shell, 10 parts of Paeonia lactiflora, 6 parts of Carthamus tinctorius, and 17 parts of Salvia miltiorrhiza.

3. The drug formulation for preventing cerebral infarction and promoting rehabilitation, and its preparation method, as described in claim 2, are characterized in that: Includes the following steps: S1: Clean and select the following herbs: Astragalus complanatus, Cuscuta chinensis, Paeonia lactiflora, Carthamus tinctorius, and Salvia miltiorrhiza, remove impurities, dry them for later use, and process the tortoise shell into small pieces before processing it separately. S2: Decoction of tortoise shell alone: ​​Take tortoise shell and add 8 times the amount of water, bring to a boil over high heat, then simmer over low heat for 2 hours. Filter out the liquid. Add 6 times the amount of water to the dregs and decoct for 1 hour. Combine the two filtrates and concentrate to a relative density of about 1.

10. At the same time, mix Astragalus complanatus, Cuscuta chinensis, Paeonia lactiflora, Carthamus tinctorius, and Salvia miltiorrhiza, add 10 times the amount of water and soak for 30 minutes. Decoction for 1.5 hours. Filter out the liquid. Add 8 times the amount of water to the dregs and decoct for 1 hour. Combine the two filtrates and concentrate to a relative density of about 1.

15. S3: Combine the tortoise shell concentrate with other medicinal material concentrates, stir evenly, and optionally add an appropriate amount of ethanol and let stand for 24 hours to remove some tannins and impurities, recover the ethanol, and obtain a clear medicinal solution. S4: Spray dry the drug solution to obtain dry extract powder, add appropriate amount of dextrin, lactose and other excipients, mix evenly, make soft material with 70% ethanol, sieve and granulate, dry at below 60℃, granulate, sieve to obtain finished granules; S5: Packaged in 5g bags, sealed with aluminum foil composite film, and subject to quality inspection in all aspects of the medicine.

4. The drug formulation for preventing cerebral infarction and promoting rehabilitation, and its preparation method, as described in claim 3, are characterized in that: The concentration of ethanol added when the tortoise shell concentrate is combined with other medicinal material concentrates is 60%.

5. A pharmaceutical formulation for preventing cerebral infarction and promoting rehabilitation, and its preparation method, as described in claim 4, characterized in that: The 70% ethanol-based soft material is granulated using a sieve with a filter pore diameter of 16 mesh, while the granulated material after drying is sieved with a filter pore diameter ranging from 18 to 60 mesh.

6. The drug formulation for preventing cerebral infarction and promoting rehabilitation, and its preparation method, as described in claim 5, are characterized in that: The drug quality inspection includes appearance, moisture content, solubility, microbial limits, and content determination.

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