Danhong freeze-dried powder injection preparation as well as preparation method and application thereof in neuroprotection
By optimizing the active ingredients and freeze-drying process of Danhong lyophilized powder injection, the stability and shape retention issues of Danhong injection solution were resolved, achieving highly effective neuroprotective effects and safety.
Patent Information
- Application Number
- CN202511364902.8
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2025-09-23
- Publication Date
- 2025-12-16
AI Technical Summary
The existing Danhong injection has poor stability, short shelf life, and causes allergic reactions. Conventional freeze-drying process results in poor formability and serious loss of active ingredients.
High-purity tanshinone and safflower yellow pigment A are used as active ingredients, combined with mannitol as a freeze-drying protectant. Through a two-stage freeze-drying process, the pH value is controlled at 6.5-7.5, the ratio of active ingredients is optimized, and the physical and chemical stability of the formulation is ensured.
It improved the stability and retention rate of active ingredients of Danhong lyophilized powder injection, shortened the reconstitution time, significantly improved the neuroprotective effect, and showed good safety in toxicity tests.
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Figure CN121129935A_ABST
Abstract
Description
Technical Field
[0001] This invention relates to modern pharmaceutical technology for traditional Chinese medicine, specifically to Danhong lyophilized powder injection preparation, its preparation method, and its application in neuroprotection. Background Technology
[0002] Danshen preparations are a classic traditional Chinese medicine compound composed of Salvia miltiorrhiza Bge. and Carthamus tinctorius* L. The traditional dosage form is an injection. It has the effects of promoting blood circulation, removing blood stasis, and clearing the meridians, and is widely used in the clinical treatment of cardiovascular and cerebrovascular diseases such as coronary heart disease and angina pectoris. However, the existing Danshen injection, as an aqueous injection, has the following inherent defects: First, its active ingredients, such as phenolic acids, quinones, and flavonoids, are sensitive to light and heat, and are prone to degradation, precipitation, or darkening of color during storage, resulting in poor stability and a short shelf life; second, the injection solution is large in volume, making it inconvenient to transport and carry; third, there have been occasional reports of adverse reactions such as allergic reactions during clinical use.
[0003] To address the stability issue, existing technologies have attempted to formulate lyophilized powder injections of cinnabar, but conventional lyophilization processes often suffer from the following problems:
[0004] 1. Inaccurate control of process parameters such as pre-freezing temperature, heating program, and vacuum degree leads to shrinkage of product appearance, poor formability, and long remelting time.
[0005] Second, during the drying process, active ingredients such as tanshinone, protocatechuic aldehyde, and hydroxysaffron yellow A are severely lost due to prolonged exposure to specific temperatures, resulting in a decrease in their content.
[0006] The selection and proportioning of excipients in the formulation failed to optimally protect the active ingredients and ensure physical stability. Summary of the Invention
[0007] The purpose of this invention is to provide a lyophilized powder injection formulation of Danshen, its preparation method, and its application in neuroprotection, so as to overcome the shortcomings of poor stability and short shelf life in the prior art.
[0008] To achieve the above objectives, the present invention provides the following technical solution: a lyophilized powder injection of Danshen (Salvia miltiorrhiza), comprising an active ingredient, a lyophilization protectant, and a pH adjuster, wherein the active ingredient is composed of Salvia miltiorrhiza extract and Carthamus tinctorius extract, wherein the weight percentage content of tanshinone in the Salvia miltiorrhiza extract is not less than 80%, and the weight percentage content of hydroxysafflower yellow A in the Carthamus tinctorius extract is not less than 70%, and the contents are determined by high performance liquid chromatography; the lyophilization protectant is selected from one or more of mannitol, sucrose, trehalose, and dextran; and the pH value of the preparation is 6.5 to 7.5.
[0009] Furthermore, the ratio of the tanshinone extract to the safflower extract by weight is 1.5:1 to 2.5:1.
[0010] Furthermore, the freeze-drying protectant is mannitol.
[0011] Furthermore, the weight ratio of mannitol to the total weight of the active ingredients is 0.8:1 to 2:1; the total weight of the active ingredients is the sum of the weights of the tanshinone extract and the safflower extract.
[0012] A method for preparing the above-described lyophilized powder injection of Danhong includes the following steps:
[0013] S1. Dissolve the prescribed amount of lyophilized protectant in a portion of water for injection, stir until dissolved to obtain a protectant solution; then add the prescribed amounts of tanshinone extract and safflower extract, stir until completely dissolved, to obtain a drug solution containing active ingredients;
[0014] S2. Adjust the pH of the solution obtained in S1 to 6.5-7.5 using a pH adjuster to obtain a solution with a pH value that meets the requirements.
[0015] S3. Add water for injection to the total volume, stir well, and then filter through a 0.22μm microporous membrane to remove bacteria, thus obtaining a sterile filtrate.
[0016] S4. Aseptically dispense the sterile filtrate obtained in S3 into containers to obtain the dispensed drug solution;
[0017] S5. Pre-freeze the liquid medicine in the container obtained in S4 at -40℃ to -50℃ for 3-5 hours to obtain a pre-frozen solid.
[0018] S6. Under vacuum conditions below 15 Pa, the pre-frozen solid obtained in S5 is subjected to two-stage freeze-drying: in the first stage, the shelf temperature is maintained at -35°C to -40°C and dried for 16-18 hours.
[0019] In the second stage, the shelf temperature is gradually increased to 25°C to 30°C at a heating rate of 2°C to 5°C per hour, and dried for 4-6 hours to obtain the freeze-dried product.
[0020] S7. The freeze-dried product obtained in S6 is sealed by plugging under vacuum or inert gas protection to finally obtain the Danhong freeze-dried powder injection formulation.
[0021] The use of the above-described lyophilized powder for injection in the preparation of a medicament for the prevention and / or treatment of nervous system diseases.
[0022] Furthermore, the neurological disease is selected from cerebral ischemia, cerebral ischemia-reperfusion injury, Alzheimer's disease, or vascular dementia.
[0023] Furthermore, the drug is administered via intravenous injection.
[0024] Compared with the prior art, the Danshen freeze-dried powder injection preparation and its preparation method provided by the present invention, as well as its application in neuroprotection, optimize the content of active ingredients, limiting tanshinone to no less than 80% and hydroxysaffron yellow pigment A to no less than 70%, and use mannitol in a specific weight ratio of 0.8:1 to 2:1 as a freeze-drying protectant. Combined with a two-stage freeze-drying process with precise temperature control, the preparation has excellent physical stability, the product has a full appearance without shrinkage, the reconstitution time is shortened to less than 1 minute, and the retention rate of active ingredients is as high as 97% or more.
[0025] Pharmacodynamic experiments have demonstrated that this formulation has a synergistic effect in neuroprotection, significantly increasing cell survival rate to 86.9%, and reducing LDH release rate and ROS level to 145.2% and 155.3%, respectively, with effects significantly better than single components and physical mixtures.
[0026] Toxicity tests showed that the preparation was safe, with an acute toxicity LD50 that was 50 times greater than the clinical dose, and no toxic reaction was observed at doses up to 10 times the clinical dose in long-term toxicity tests. Blood biochemical indicators were not significantly different from those of the control group.
[0027] Compared with existing technologies, this invention effectively solves the problems of poor stability of Danhong preparations, easy degradation of active ingredients, and unsatisfactory reconstitution effect, providing a safer and more effective drug option for the clinical treatment of neurological diseases such as cerebral ischemia-reperfusion injury and Alzheimer's disease. Attached Figure Description
[0028] To more clearly illustrate the technical solutions in the embodiments of this application or the prior art, the drawings used in the embodiments will be briefly introduced below. Obviously, the drawings described below are only some embodiments recorded in this invention. For those skilled in the art, other drawings can be obtained based on these drawings.
[0029] Figure 1 This is a flowchart illustrating the preparation process of Danhong lyophilized powder injection formulation provided in an embodiment of the present invention.
[0030] Figure 2 This is a comparison chart of detection data for Danhong lyophilized powder injection formulations provided in an embodiment of the present invention;
[0031] Figure 3 This is a line graph showing the effect of different protective agent ratios on product quality, provided in an embodiment of the present invention. Figure 4 A comparative graph of cell protective effects in different groups in a pharmacodynamic experimental study provided in an embodiment of the present invention. Detailed Implementation
[0032] To enable those skilled in the art to better understand the technical solution of the present invention, the present invention will be further described in detail below with reference to the accompanying drawings.
[0033] Example 1:
[0034] The Danshen lyophilized powder for injection comprises an active ingredient, a lyophilization protectant, and a pH adjuster. The active ingredient consists of tanshinone extract and safflower extract. The tanshinone extract contains no less than 80% by weight, and the safflower extract contains no less than 70% by weight. The contents of both are determined by high performance liquid chromatography. The lyophilization protectant is selected from one or more of mannitol, sucrose, trehalose, and dextran. The pH of the preparation is 6.5 to 7.5.
[0035] The synergistic effect of high-purity tanshinone from tanshinone extract and high-purity hydroxysaffron yellow A from safflower extract exerts cardiovascular and neuroprotective effects. Tanshinone is mainly responsible for anti-oxidation, improving microcirculation and anti-platelet aggregation, while hydroxysaffron yellow A is mainly responsible for anti-inflammation and anti-thrombosis. The combination of the two achieves multi-target therapy.
[0036] Lyophilization protectants form a stable amorphous glassy matrix during the freeze-drying process, which encapsulates and fixes the active ingredient molecules, preventing ice crystal formation and oxidative denaturation. This ensures that the drug maintains its physical and chemical stability in a dehydrated state for a long time, making it easy to store and transport.
[0037] pH adjusters maintain the system within the physiological pH range of 6.5-7.5, which minimizes tissue irritation and pain during injection and provides a stable chemical environment for active ingredients, especially pH-sensitive phenolic acids, inhibiting their hydrolysis or degradation, thereby ensuring the safety and efficacy of the formulation.
[0038] The ratio of Salvia miltiorrhiza extract to Carthamus tinctorius extract by weight is 1.5:1 to 2.5:1.
[0039] The weight ratio of tanshinone extract to safflower extract ranges from 1.5:1 to 2.5:1. This specific ratio is the optimal synergistic ratio verified by a large number of pharmacological experiments. At this ratio, the potent antioxidant and vasodilatory effects of tanshinone and the anti-inflammatory and neuroprotective effects of hydroxysafflower yellow pigment A achieve a superimposed or even enhanced effect, realizing the optimal balance in pharmacodynamics. If the ratio is too low, the dominant effect of tanshinone will be insufficient, affecting the efficacy. If the ratio is too high, the safflower extract will be relatively insufficient, and the inflammatory response will not be able to be fully inhibited. This ratio ensures the synergistic pharmacological effects of the two extracts in vivo, and is a combination of multi-stage interventions for complex pathological processes such as cerebral ischemia.
[0040] The freeze-drying protectant is mannitol.
[0041] Mannitol, as an excellent crystalline excipient, can crystallize completely during freeze-drying to form a robust skeletal structure. This structure can support the shape of the product in the early stage of drying to prevent collapse, and provide a large number of moisture escape channels in the later stage, greatly improving drying efficiency.
[0042] Mannitol preferentially crystallizes when frozen, thus "isolating" the remaining amorphous active ingredient molecules within its crystal network. This provides physical protection for heat-sensitive tanshinone and hydroxysaffron yellow A, preventing damage to their structure from freezing stress or drying heating.
[0043] In addition, mannitol itself is stable, non-reducing, does not react with active ingredients, and the freeze-dried cakes made from it have a full and white appearance and a very fast reconstitution speed.
[0044] The weight ratio of mannitol to the total weight of active ingredients is 0.8:1 to 2:1; the total weight of active ingredients is the sum of the weights of tanshinone extract and safflower extract.
[0045] The ratio of mannitol to the total weight of the active ingredient is between 0.8:1 and 2:1. If the mannitol ratio is less than 0.8:1, the crystal skeleton will not have sufficient support and will easily collapse, shrink or melt during the drying process, resulting in substandard product appearance, excessive residual moisture and poor stability. If the mannitol ratio exceeds 2:1, the proportion of excipients in the unit dose will be too large, requiring an increase in injection volume or dosage, which will cause inconvenience to clinical use and may also affect the reconstitution rate.
[0046] With this optimized ratio, mannitol can provide sufficient structural support to ensure the smooth progress of the freeze-drying process and the product's appearance, while avoiding excessive dilution of the active ingredients, thus ensuring that the final formulation has low residual moisture, good physical strength, and chemical stability during storage.
[0047] Example 2:
[0048] Please see Figure 1 A method for preparing lyophilized powder injection of Danshen includes the following steps:
[0049] S1. Dissolve the prescribed amount of lyophilized protectant in a portion of water for injection, stir until dissolved to obtain a protectant solution; then add the prescribed amounts of tanshinone extract and safflower extract, stir until completely dissolved, to obtain a drug solution containing active ingredients;
[0050] S2. Adjust the pH of the solution obtained in S1 to 6.5-7.5 using a pH adjuster to obtain a solution with a pH value that meets the requirements.
[0051] S3. Add water for injection to the total volume, stir well, and then filter through a 0.22μm microporous membrane to remove bacteria, thus obtaining a sterile filtrate.
[0052] S4. Aseptically dispense the sterile filtrate obtained in S3 into containers to obtain the dispensed drug solution;
[0053] S5. Pre-freeze the liquid medicine in the container obtained in S4 at -40℃ to -50℃ for 3-5 hours to obtain a pre-frozen solid.
[0054] S6. Under vacuum conditions below 15 Pa, the pre-frozen solid obtained in S5 is subjected to two-stage freeze-drying: in the first stage, the shelf temperature is maintained at -35°C to -40°C and dried for 16-18 hours.
[0055] In the second stage, the shelf temperature is gradually increased to 25°C to 30°C at a heating rate of 2°C to 5°C per hour, and dried for 4-6 hours to obtain the freeze-dried product.
[0056] S7. The freeze-dried product obtained in S6 is sealed by plugging under vacuum or inert gas protection to finally obtain the Danhong freeze-dried powder injection formulation.
[0057] Dissolving the freeze-drying protectant first provides a uniform carrier solution, and then adding the extract can avoid excessively high local concentrations or clumping, and promote dissolution.
[0058] Adjusting the pH to 6.5-7.5 provides the most stable chemical environment for subsequent filtration, sterilization and freeze-drying. 0.22μm microporous membrane filtration ensures the sterility of the drug solution. Deep cryogenic pre-freezing at -40℃ to -50℃ aims to allow the drug solution to quickly pass through the maximum ice crystal formation zone, forming fine ice crystals, thereby minimizing physical damage to macromolecular structures and amorphous regions.
[0059] The first stage of the two-stage freeze-drying removes most of the free water without melting the ice crystals. The second stage effectively removes bound water without damaging the product structure and activity by slowly raising the temperature, so that the final residual moisture meets the qualified standard.
[0060] A pressure stopper under vacuum or inert gas protection prevents the antioxidant active pharmaceutical ingredients from coming into contact with oxygen and becoming ineffective, thus ensuring the long-term stability of the product.
[0061] Example 3:
[0062] This embodiment provides a technical solution based on Embodiment 1 or Embodiment 2: the application of a Danhong lyophilized powder injection formulation in the preparation of a drug for the prevention and / or treatment of nervous system diseases.
[0063] Based on the pharmacological properties of the active ingredients tanshinone and hydroxysaffron yellow A, they can synergistically act on multiple pathological aspects of neurological diseases. Tanshinone, through its powerful antioxidant capacity, scavenges excess free radicals produced in the brain, reduces oxidative stress damage to neurons, and increases blood oxygen supply to ischemic areas by improving cerebral microcirculation. Hydroxysaffron yellow A, on the other hand, effectively inhibits the cascade reaction of neuroinflammatory reactions by suppressing excessive activation of microglia and the release of downstream inflammatory factors (such as TNF-α and IL-1β). It can also inhibit thrombus formation and improve blood flow. The two work synergistically to protect the integrity of the blood-brain barrier, reduce neuronal apoptosis, and promote the repair of nerve function, thereby achieving preventive and therapeutic effects on neurological diseases such as cerebral ischemia and Alzheimer's disease through multiple pathways and multiple targets.
[0064] Neurological disorders are selected from cerebral ischemia, cerebral ischemia-reperfusion injury, Alzheimer's disease, or vascular dementia.
[0065] For cerebral ischemia and reperfusion injury, this preparation restores blood flow by dilating cerebral blood vessels and inhibiting platelet aggregation and thrombus formation. At the same time, it counteracts the oxidative stress and inflammatory response that occurs after reperfusion through antioxidant and anti-inflammatory effects, thereby reducing secondary damage. For Alzheimer's disease, its components can inhibit β-amyloid (Aβ)-induced neurotoxicity and tau protein hyperphosphorylation, and improve brain energy metabolism and cholinergic system function. For vascular dementia, it mainly improves cognitive function by improving cerebral vascular function, protecting vascular endothelium and neuronal cells, and enhancing brain tissue tolerance to ischemia and hypoxia.
[0066] The drug is administered via intravenous injection.
[0067] Intravenous injection allows high-purity active ingredients to enter the systemic circulation directly and rapidly, avoiding the first-pass effect and gastrointestinal degradation that may occur with oral administration. This results in extremely high bioavailability. For acute neurological conditions such as acute cerebral infarction, intravenous injection can rapidly achieve and maintain effective blood drug concentrations, enabling the drug to cross the blood-brain barrier in a timely manner and exert its antioxidant, anti-inflammatory, microcirculation-improving, and neuroprotective effects in brain tissue. This buys valuable time for the rescue of neurons in the ischemic penumbra. This route of administration ensures rapid onset of drug action and accurate and controllable dosage, making it particularly suitable for the treatment of critically ill patients in a hospital setting.
[0068] Example 4:
[0069] Please see Figure 2 The prescription is based on the preparation of 1000 bottles:
[0070] 60g of Salvia miltiorrhiza extract, 40g of Carthamus tinctorius extract, and 100g of mannitol were selected and added to 2000mL with water for injection. The content of tanshinone in Salvia miltiorrhiza extract was 82.5%, and the content of hydroxysafflower yellow A in Carthamus tinctorius extract was 73.2%. The contents of both were determined by high performance liquid chromatography.
[0071] The preparation method includes the following steps: 1600 mL of water for injection is added to a mixing tank, with the water temperature controlled at 25 degrees Celsius. Mannitol is added first under stirring, and after stirring to dissolve, tanshinone extract and safflower extract are added sequentially, and stirring is continued until completely dissolved. The pH is adjusted to 6.8 with 0.1 M sodium hydroxide solution, and stirring is maintained for 15 minutes. Water for injection is added to 2000 mL, and the mixture is stirred evenly. The mixture is then filtered through 0.45 μm and 0.22 μm microporous membranes for sterilization. Under aseptic conditions, the mixture is dispensed into vials, 2.0 mL per vial, and pre-frozen: frozen at -45 degrees Celsius for 4 hours; freeze-dry: first stage vacuum drying at -35 degrees Celsius for 18 hours, second stage drying at a rate of 5 degrees Celsius per hour to 30 degrees Celsius for 6 hours; vacuum stoppering and sealing with aluminum caps.
[0072] Example 5:
[0073] Please see Figure 3 Comparative study of different proportions of freeze-drying protectants
[0074] Five experimental groups were set up: experimental group 1 (100g of active ingredient and 80g of mannitol), experimental group 2 (100g of active ingredient and 100g of mannitol), experimental group 3 (100g of active ingredient and 200g of mannitol), comparative group (100g of active ingredient and 40g of mannitol), and control group (100g of active ingredient and no protectant).
[0075] Example 6:
[0076] Please see Figure 4 Pharmacodynamic experimental studies
[0077] A hydrogen peroxide-induced oxidative damage model was established using the PC12 cell line. The groups included a blank control group, a model group, a Danshen extract group (50 μg / mL), a Safflower extract group (50 μg / mL), a physical mixture group (Danshen 25 μg / mL + Safflower 25 μg / mL), and the preparation group of this invention (Danshen 25 μg / mL + Safflower 25 μg / mL). The cell protective effects of each group were compared (x±s, n=6).
[0078] Example 7:
[0079] Drug toxicity test
[0080] Acute toxicity test: Fifty healthy ICR mice were randomly divided into 5 groups and intravenously injected with physiological saline and Danhong lyophilized powder injection solution equivalent to 10, 20, 40 and 80 times the clinical dose, respectively.
[0081] The results of the acute toxicity test are shown in Table 1:
[0082] Dosage group Number of animals (individuals) Number of deaths (animals) Abnormal reaction situation Blank control group 10 0 No abnormalities 10 times the clinical dose 10 0 No abnormalities 20 times the clinical dose 10 0 No abnormalities 40 times the clinical dose 10 0 1 short-term activity reduction 80 times the clinical dose 10 1 Two animals experienced brief respiratory distress, and one died later.
[0083] Table 1
[0084] Long-term toxicity test: 80 SD rats were divided into 4 groups (blank control, clinically equivalent dose, 5 times the clinical dose, and 10 times the clinical dose) and administered the drug continuously for 30 days;
[0085] Changes in blood biochemical parameters during long-term toxicity testing (x±s, n=20), data are shown in Table 2;
[0086] Group ALT(U / L) AST(U / L) BUN (mmol / L) Cr (μmol / L) Blank control group 35.2±4.8 89.5±10.2 6.2±0.8 45.3±5.2 Clinical equivalent dose group 36.8±5.1 91.2±11.3 6.5±0.9 46.1±5.7 5 times clinical dose group 38.5±5.3 93.7±12.1 6.8±1.0 47.8±6.2 10 times clinical dose group 40.2±5.9 96.4±13.5 7.1±1.2 49.2±6.8
[0087] Table 2
[0088] The foregoing has only described certain exemplary embodiments of the present invention by way of illustration. Undoubtedly, those skilled in the art can modify the described embodiments in various ways without departing from the spirit and scope of the present invention. Therefore, the foregoing drawings and descriptions are illustrative in nature and should not be construed as limiting the scope of protection of the claims of the present invention.
Claims
1. A lyophilized powder injection of Danhong, characterized in that, The formulation includes an active ingredient, a lyophilization protectant, and a pH adjuster. The active ingredient is composed of tanshinone extract and safflower extract. The tanshinone extract contains at least 80% tanshinone by weight, and the safflower extract contains at least 70% hydroxysafflower yellow A by weight. The contents of these contents are determined by high performance liquid chromatography. The lyophilization protectant is selected from one or more of mannitol, sucrose, trehalose, and dextran. The pH of the formulation is 6.5 to 7.
5.
2. The lyophilized powder injection of Danhong according to claim 1, characterized in that, The ratio of the salvia miltiorrhiza extract to the safflower extract by weight is 1.5:1 to 2.5:
1.
3. The lyophilized powder injection formulation of Danhong according to claim 1, characterized in that, The freeze-drying protectant is mannitol.
4. The lyophilized powder injection of Danhong according to claim 3, characterized in that, The weight ratio of mannitol to the total weight of the active ingredients is 0.8:1 to 2:1; the total weight of the active ingredients is the sum of the weights of the tanshinone extract and the safflower extract.
5. A method for preparing the lyophilized powder injection of Danhong as described in any one of claims 1-4, characterized in that, Includes the following steps: S1. Dissolve the prescribed amount of lyophilized protectant in a portion of water for injection, stir until dissolved to obtain a protectant solution; then add the prescribed amounts of tanshinone extract and safflower extract, stir until completely dissolved, to obtain a drug solution containing active ingredients; S2. Adjust the pH of the solution obtained in S1 to 6.5-7.5 using a pH adjuster to obtain a solution with a pH value that meets the requirements. S3. Add water for injection to the total volume, stir well, and then filter through a 0.22μm microporous membrane to remove bacteria, thus obtaining a sterile filtrate. S4. Aseptically dispense the sterile filtrate obtained in S3 into containers to obtain the dispensed drug solution; S5. Pre-freeze the liquid medicine in the container obtained in S4 at -40℃ to -50℃ for 3-5 hours to obtain a pre-frozen solid. S6. Under vacuum conditions below 15 Pa, the pre-frozen solid obtained in S5 is subjected to two-stage freeze-drying: in the first stage, the shelf temperature is maintained at -35°C to -40°C and dried for 16-18 hours. In the second stage, the shelf temperature is gradually increased to 25°C to 30°C at a heating rate of 2°C to 5°C per hour, and dried for 4-6 hours to obtain the freeze-dried product. S7. The freeze-dried product obtained in S6 is sealed by plugging under vacuum or inert gas protection to finally obtain the Danhong freeze-dried powder injection formulation.
6. The use of the lyophilized powder for injection of Danshen as described in any one of claims 1-4 in the preparation of a medicament for the prevention and / or treatment of nervous system diseases.
7. The application of the lyophilized powder injection of Danshen according to claim 6 in neuroprotection, characterized in that, The neurological diseases mentioned are selected from cerebral ischemia, cerebral ischemia-reperfusion injury, Alzheimer's disease, or vascular dementia.
8. The application of the lyophilized powder injection of Danshen according to claim 6 in neuroprotection, characterized in that, The drug is administered via intravenous injection.