Preparation method of pseudo-ginseng extract and application of pseudo-ginseng extract in preparation of traditional Chinese medicine preparation

Abstract

The invention discloses a preparation method of a pseudo-ginseng extract and application of the pseudo-ginseng extract in preparation of a traditional Chinese medicine preparation. Crushing the pseudo-ginseng medicinal material to prepare pseudo-ginseng powder; adding a first ethanol water solution into the pseudo-ginseng powder, carrying out first extraction at room temperature, and carrying out solid-liquid separation to prepare a first extracting solution and first filter residues; adding a second ethanol aqueous solution into the first filter residue, carrying out second extraction at room temperature, and carrying out solid-liquid separation to prepare a second extracting solution and a second filter residue; the first extracting solution and the second extracting solution are combined and filtered, and the pseudo-ginseng extract is prepared. The mass concentration of the ethanol aqueous solution is controlled to be 50-70%, the total time of the extraction process is 8-24 h, and the solid-liquid ratio of the pseudo-ginseng powder to the ethanol aqueous solution is 1 g: (3-8) mL, so that the production cycle is greatly shortened, the cost is reduced, and the method is suitable for industrial production. The prepared pseudo-ginseng extract and / or pseudo-ginseng dregs are / is applied to traditional Chinese medicine preparations to meet the requirement of fingerprint spectrum similarity of the traditional Chinese medicine preparations in Chinese pharmacopoeia.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine preparation technology, specifically to a method for preparing Panax notoginseng extract and its application in the preparation of traditional Chinese medicine preparations. Background Technology

[0002] Panax notoginseng (Burk.) FHChen is a perennial herb belonging to the genus Panax in the family Araliaceae. Saponins are the main active ingredient in Panax notoginseng, primarily used for promoting blood circulation, removing blood stasis, reducing swelling, and relieving pain. It is used in various pharmaceutical preparations, currently mainly for the treatment of cardiovascular and cerebrovascular diseases, such as in various formulations of thrombolytic agents. The extraction of saponins from Panax notoginseng often involves heating and reflux with water or alcohol as solvents, and is widely used in industrial applications and content determination. However, this method has drawbacks such as long extraction time and cumbersome operation. Using traditional extraction processes to prepare a batch of Panax notoginseng extract requires 4-9 days, resulting in an excessively long production cycle, wasting manpower, equipment, and time, and increasing production costs. To shorten the production cycle and control costs, improved extraction processes have yielded extracts with significant differences in active ingredients and reduced quality, making it difficult to meet the quality standards of preparations in the Chinese Pharmacopoeia for use in related pharmaceutical formulations. Furthermore, no optimization for fingerprint similarity has been performed. Summary of the Invention

[0003] Therefore, it is necessary to provide a method that can significantly reduce the processing cycle and cost of Panax notoginseng extract, and the prepared Panax notoginseng extract can meet the quality standards of the Chinese Pharmacopoeia when used in related preparations.

[0004] In a first aspect, this application provides a method for preparing Panax notoginseng extract, comprising the following steps:

[0005] The Panax notoginseng herb is pulverized to prepare Panax notoginseng powder;

[0006] A first aqueous ethanol solution was added to the Panax notoginseng powder, and a first extraction was carried out at room temperature. Solid-liquid separation was performed to prepare a first extract and a first filter residue.

[0007] Add a second aqueous ethanol solution to the first filter residue, perform a second extraction at room temperature, separate the solid and liquid, and prepare a second extract and a second filter residue;

[0008] The first and second extracts were combined and filtered to prepare Panax notoginseng extract;

[0009] The mass concentrations of the first and second aqueous ethanol solutions are each independently 50%-70%;

[0010] The total time for the two extractions is 8-24 hours.

[0011] The ratio of Panax notoginseng powder to the first ethanol aqueous solution and the ratio of Panax notoginseng powder to the second ethanol aqueous solution are each independently 1g:(3-8)mL.

[0012] In some embodiments, the ratio of Panax notoginseng powder to the first ethanol aqueous solution and the ratio of Panax notoginseng powder to the second ethanol aqueous solution are each independently 1g:(4-6)mL.

[0013] In some embodiments, the ratio of Panax notoginseng powder to the first ethanol aqueous solution and the ratio of Panax notoginseng powder to the second ethanol aqueous solution are each independently 1g:(4.8-5.2)mL.

[0014] In some embodiments, the time for the first extraction and the second extraction is each 4h-12h independently.

[0015] In some embodiments, the total time for the two extractions is 16h-18h; and / or, the time for the first extraction and the second extraction is each 8h-9h independently.

[0016] In some embodiments, the room temperature is 15°C-30°C; and / or the extraction process is immersion extraction; and / or the particle size of the Panax notoginseng powder is 65 mesh-100 mesh.

[0017] In some embodiments, the second filter residue is dried to prepare Panax notoginseng residue.

[0018] Secondly, this application also provides a method for preparing a traditional Chinese medicine preparation, wherein the components of the traditional Chinese medicine preparation include Panax notoginseng extract, and the Panax notoginseng extract includes the method for preparing Panax notoginseng extract provided in the first aspect;

[0019] Optionally, the ingredients of the traditional Chinese medicine preparation may also include Panax notoginseng residue, and the preparation method of the Panax notoginseng residue includes the preparation method of Panax notoginseng extract provided in the first aspect.

[0020] In some embodiments, the traditional Chinese medicine preparation includes a thrombolytic preparation;

[0021] Optionally, the thrombolytic preparation includes one or more of thrombolytic tablets, thrombolytic capsules, thrombolytic granules, and compound thrombolytic capsules.

[0022] In some embodiments, the traditional Chinese medicine preparation is Compound XueShuanTong Capsules, which are composed of Panax notoginseng extract, Panax notoginseng residue, Astragalus membranaceus extract, Salvia miltiorrhiza extract and Scrophularia ningpoensis extract.

[0023] The preparation method of the compound thrombolytic capsules includes: mixing Panax notoginseng extract, Panax notoginseng residue, Astragalus membranaceus extract, Salvia miltiorrhiza extract and Scrophularia ningpoensis extract.

[0024] Compared with traditional technologies, the beneficial effects of the technical solution in this application include:

[0025] This application provides a preparation process for Panax notoginseng extract, which involves two extractions using 50%-70% ethanol aqueous solution at room temperature. The total extraction time is controlled to be 8-24 hours, and the material-to-liquid ratio is 1g:(3-8)mL, yielding both Panax notoginseng extract and Panax notoginseng residue. This application achieves a synergistic effect by controlling the mass concentration and amount of extraction solvent while shortening the extraction time, significantly reducing the production cycle and cost of Panax notoginseng extract. Furthermore, the prepared Panax notoginseng extract and / or Panax notoginseng residue meet the fingerprint similarity requirements for extracts in traditional Chinese medicine preparations as stipulated in the Chinese Pharmacopoeia. Attached Figure Description

[0026] Figure 1 The fingerprint spectrum is that of the Panax notoginseng extract prepared in Example 1 of this application.

[0027] Figure 2 The fingerprints are shown for Compound XueShuanTong Capsules (B) prepared using Panax notoginseng extract and Panax notoginseng residue prepared in Example 1 of this application, and for commercially available Compound XueShuanTong Capsules (A). Detailed Implementation

[0028] To facilitate understanding of this application, a more complete description will be provided below with reference to the accompanying drawings. Preferred embodiments of this application are shown in the drawings. However, this application can be implemented in many different forms and is not limited to the embodiments described herein. Rather, these embodiments are provided to provide a thorough and complete understanding of the disclosure of this application.

[0029] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs. The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the application.

[0030] As used herein, "optional," "optional," and "optional" refer to either "with" or "without" parallel options. If multiple "optional" entries appear in a technical solution, each "optional" entry is independent unless otherwise specified and there are no contradictions or mutual constraints. The term "and / or" as used herein includes any and all combinations of one or more related listed items. Unless otherwise specified, "multiple," "multiple," etc., as used herein refer to a quantity greater than 2 or equal to 2; for example, "one or more" indicates one, two, or more than two. In open-ended technical features or solutions described herein using words such as "containing," "including," and "comprising," unless otherwise specified, additional members beyond the listed members are not excluded. This can be considered as providing both a closed-ended feature or solution consisting of the listed members and an open-ended feature or solution that includes additional members beyond the listed members.

[0031] In this application, the terms "first aspect," "second aspect," "third aspect," "fourth aspect," etc., are used for descriptive purposes only and should not be construed as indicating or implying relative importance or quantity, nor should they be construed as implicitly indicating the importance or quantity of the indicated technical features. Moreover, "first," "second," "third," "fourth," etc., serve only as a non-exhaustive enumeration and should be understood not to constitute a closed limitation on quantity.

[0032] Unless otherwise specified, all embodiments and optional embodiments of this application can be combined to form new technical solutions.

[0033] The extraction of saponins from Panax notoginseng typically involves heating and reflux with water or alcohol as solvents, and is widely used in industrial applications and content determination. However, this method suffers from drawbacks such as long extraction times or cumbersome procedures. This application aims to provide a preparation method that can significantly reduce the production cycle of Panax notoginseng extract, while ensuring that the prepared extract meets the quality standards for relevant preparations in the Chinese Pharmacopoeia.

[0034] In a first aspect, this application provides a method for preparing Panax notoginseng extract, comprising the following steps:

[0035] The Panax notoginseng herb is pulverized to prepare Panax notoginseng powder;

[0036] A first aqueous ethanol solution was added to the Panax notoginseng powder, and a first extraction was carried out at room temperature. Solid-liquid separation was performed to prepare a first extract and a first filter residue.

[0037] Add a second aqueous ethanol solution to the first filter residue, perform a second extraction at room temperature, separate the solid and liquid, and prepare a second extract and a second filter residue;

[0038] The first and second extracts were combined and filtered to prepare Panax notoginseng extract;

[0039] The mass concentrations of the first and second aqueous ethanol solutions are each independently 50%-70%;

[0040] The total time for the two extractions is 8-24 hours.

[0041] The ratio of Panax notoginseng powder to the first ethanol aqueous solution and the ratio of Panax notoginseng powder to the second ethanol aqueous solution are each independently 1g:(3-8)mL.

[0042] This application optimizes the amount of extraction solvent added and the immersion extraction time simultaneously. By reducing the amount of extraction solvent added and shortening the extraction time, a synergistic effect is achieved, enabling the simultaneous preparation of Panax notoginseng extract and Panax notoginseng residue within one day (24 hours). The Panax notoginseng extract and Panax notoginseng residue can then be used in the preparation of traditional Chinese medicine preparations, which can meet the fingerprint spectrum similarity requirements of traditional Chinese medicine preparations in the Chinese Pharmacopoeia. At the same time, it can significantly save the product manufacturing time, simplify the process, shorten the production cycle, significantly improve production efficiency, and effectively reduce costs.

[0043] In some embodiments, the material-to-liquid ratio of Panax notoginseng powder to the first ethanol aqueous solution and the material-to-liquid ratio of Panax notoginseng powder to the second ethanol aqueous solution are each independently 1g:(3-8)mL, including but not limited to 1g:3mL, 1g:4mL, 1g:5mL, 1g:6mL, 1g:7mL, 1g:8mL, or any of the foregoing ranges and values ​​within those ranges. Further, the material-to-liquid ratio of Panax notoginseng powder to the first ethanol aqueous solution and the material-to-liquid ratio of Panax notoginseng powder to the second ethanol aqueous solution are each independently 1g:(4-6)mL, including but not limited to 1g:4mL, 1g:4.2mL, 1g:4.4mL, 1g:4.5mL, 1g:4.6mL, 1g:4.8mL, 1g:5mL, 1g:5.2mL, 1g:5.4mL, 1g:5.5mL, 1g:5.6mL, 1g:5.8mL, 1g:6mL, or any of the foregoing ranges and values ​​within those ranges. Furthermore, the ratio of Panax notoginseng powder to the first ethanol aqueous solution and the ratio of Panax notoginseng powder to the second ethanol aqueous solution are each independently 1g:(4.8-5.2)mL, including but not limited to 1g:4.8mL, 1g:4.9mL, 1g:5mL, 1g:5.1mL, 1g:5.2mL or any of the foregoing ranges and values ​​within those ranges.

[0044] In some embodiments, the time for the first extraction and the second extraction is each independently 4h-12h, including but not limited to 4h, 5h, 6h, 7h, 8h, 9h, 10h, 11h, 12h or any of the foregoing ranges and values ​​within that range.

[0045] In some embodiments, the total time for the two extractions is 16h-18h, including but not limited to 16h, 17h, 18h, or any range formed by both of the foregoing and values ​​within that range. Further, the times for the first and second extractions are each independently 8h-9h, including but not limited to 8h, 8.1h, 8.2h, 8.3h, 8.4h, 8.5h, 8.6h, 8.7h, 8.8h, 8.9h, 9h, or any range formed by both of the foregoing and values ​​within that range.

[0046] In some embodiments, both the first extraction and the second extraction processes are performed at room temperature, which is 15°C to 30°C, including but not limited to 15°C, 18°C, 20°C, 22°C, 25°C, 28°C, 30°C or any combination thereof and values ​​within that range.

[0047] In some embodiments, the extraction process is immersion extraction.

[0048] In some embodiments, the particle size of Panax notoginseng powder is 65-100 mesh, including but not limited to 65 mesh, 70 mesh, 75 mesh, 80 mesh, 85 mesh, 90 mesh, 95 mesh, 100 mesh or any combination thereof and values ​​within that range.

[0049] In some embodiments, the filtered residue is dried to prepare Panax notoginseng residue.

[0050] For example, the preparation method of Panax notoginseng extract provided in this application includes: the material-liquid ratio of Panax notoginseng powder to the first ethanol aqueous solution and the material-liquid ratio of Panax notoginseng powder to the second ethanol aqueous solution are each independently 1g:(4-6)mL, and the first extraction and the second extraction time are each independently 4h-12h.

[0051] For example, the preparation method of Panax notoginseng extract provided in this application includes: the material-to-liquid ratio of Panax notoginseng powder to the first ethanol aqueous solution and the material-to-liquid ratio of Panax notoginseng powder to the second ethanol aqueous solution are each independently 1g:(4.8-5.2)mL, the first extraction and the second extraction times are each independently 8h-9h, and the mass concentrations of the first ethanol aqueous solution and the second ethanol aqueous solution are each independently 50%.

[0052] Secondly, this application also provides a method for preparing a traditional Chinese medicine preparation, wherein the components of the traditional Chinese medicine preparation include Panax notoginseng extract, and the method for preparing the Panax notoginseng extract includes the method for preparing the Panax notoginseng extract provided in the first aspect.

[0053] In some embodiments, the traditional Chinese medicine preparation further includes Panax notoginseng residue, and the preparation method of the Panax notoginseng residue includes the preparation method of the Panax notoginseng extract provided in the first aspect.

[0054] In some embodiments, the traditional Chinese medicine preparation includes a thrombolytic preparation. As a non-limiting example, the thrombolytic preparation includes one or more of thrombolytic tablets, thrombolytic capsules, thrombolytic granules, and compound thrombolytic capsules.

[0055] In some embodiments, the thrombolytic preparation is compound thrombolytic capsules, which are oral traditional Chinese medicine preparations with the effects of promoting blood circulation, removing blood stasis, and nourishing qi and yin. Clinically, it is often used for retinal vein occlusion with blood stasis and qi and yin deficiency, manifested as decreased vision or visual abnormalities, fundus hemorrhage, fatigue, dry throat, and dry mouth; and for stable exertional angina pectoris with blood stasis and qi and yin deficiency, manifested as chest tightness, chest pain, palpitations, shortness of breath, fatigue, irritability, and dry mouth. It has significant clinical efficacy, but the current preparation process of compound thrombolytic capsules is time-consuming and inefficient, resulting in a waste of manpower, equipment, and time, and increasing manufacturing costs. Therefore, the preparation method of Panax notoginseng extract of this application for the production of compound thrombolytic capsules can significantly shorten its production cycle, improve efficiency, and at the same time ensure the quality and clinical efficacy of compound thrombolytic capsules.

[0056] In some embodiments, the compound thrombolytic capsules are composed of 250g Panax notoginseng, 80g Astragalus membranaceus, 50g Salvia miltiorrhiza and 80g Scrophularia ningpoensis.

[0057] In some embodiments, the preparation method of the compound thrombolytic capsule is the same as that described in the Chinese Pharmacopoeia, specifically including: mixing Panax notoginseng extract, Panax notoginseng residue, Astragalus membranaceus extract, Salvia miltiorrhiza extract and Scrophularia ningpoensis extract to prepare the capsule.

[0058] In some embodiments, pharmaceutical excipients are added during the preparation of the compound thrombolytic capsules. Exemplarily, the pharmaceutical excipients include one or more of talc, starch, and microcrystalline cellulose.

[0059] It should be noted that experimental methods in the following embodiments of this application, unless otherwise specified, are generally performed under conventional conditions or as recommended by the manufacturer. All raw materials used in the embodiments are commercially available products, or can be prepared by those skilled in the art using known methods.

[0060] Example 1

[0061] Take 25g of Panax notoginseng herb and grind it into medium powder (65-100 mesh). Add 5 times the amount of 125g of 50wt% ethanol aqueous solution and extract at room temperature for 8 hours. Filter and recover the filtrate. Add another 5 times the amount of 125g of 50wt% ethanol aqueous solution to the residue and extract again at room temperature for 8 hours. Filter and recover the filtrate. Combine the two recovered filtrates and concentrate them under reduced pressure using a rotary evaporator to obtain Panax notoginseng extract, which is then refrigerated. Dry the filter residue at 60℃ to obtain Panax notoginseng residue, which is then stored.

[0062] Example 2

[0063] Take 25g of Panax notoginseng herb and grind it into medium powder (65-100 mesh). Add 100g (4 times the amount of 50wt%) ethanol aqueous solution and extract at room temperature for 9 hours. Filter and recover the filtrate. Add 100g (4 times the amount of 50wt%) ethanol aqueous solution to the residue and extract again at room temperature for 9 hours. Filter and recover the filtrate. Combine the two recovered filtrates and concentrate them under reduced pressure using a rotary evaporator to obtain Panax notoginseng extract, which is then refrigerated. Dry the filter residue at 60℃ to obtain Panax notoginseng residue, which is then stored.

[0064] Example 3

[0065] Take 25g of Panax notoginseng herb and grind it into medium powder (65-100 mesh). Add 150g (6 times the amount of the extract) of 50wt% ethanol aqueous solution and extract at room temperature for 8 hours. Filter and collect the filtrate. Add 150g (6 times the amount of the extract) of 50wt% ethanol aqueous solution to the residue and extract again at room temperature for 8 hours. Filter and collect the filtrate. Combine the two collected filtrates and concentrate them under reduced pressure using a rotary evaporator to obtain Panax notoginseng extract, which is then refrigerated. Dry the filter residue at 60℃ to obtain Panax notoginseng residue, which is then stored.

[0066] Example 4

[0067] Take 300g of Panax notoginseng herb and grind it into medium powder (65-100 mesh). Add 5 times the amount of 1500g of 50wt% ethanol aqueous solution and extract at room temperature for 8 hours. Filter and recover the filtrate. Add another 5 times the amount of 1500g of 50wt% ethanol aqueous solution to the residue and extract again at room temperature for 8 hours. Filter and recover the filtrate. Combine the two recovered filtrates and concentrate them under reduced pressure using a rotary evaporator to obtain Panax notoginseng extract, which is then refrigerated. Dry the filter residue at 60℃ to obtain Panax notoginseng residue, which is then stored.

[0068] Example 5

[0069] Take 25g of Panax notoginseng herb and grind it into medium powder (65-100 mesh). Add 5 times the amount of 125g of 60wt% ethanol aqueous solution and extract at room temperature for 8 hours. Filter and collect the filtrate. Add 5 times the amount of 125g of 60wt% ethanol aqueous solution to the residue and extract again at room temperature for 8 hours. Filter and collect the filtrate. Combine the two collected filtrates and concentrate them under reduced pressure using a rotary evaporator to obtain Panax notoginseng extract, which is then refrigerated. Dry the filter residue at 60℃ to obtain Panax notoginseng residue, which is then stored.

[0070] Example 6

[0071] Take 25g of Panax notoginseng herb and grind it into medium powder (65-100 mesh). Add 5 times the amount of 125g of 70wt% ethanol aqueous solution and extract at room temperature for 8 hours. Filter and recover the filtrate. Add 5 times the amount of 125g of 70wt% ethanol aqueous solution to the residue and extract again at room temperature for 8 hours. Filter and recover the filtrate. Combine the two recovered filtrates and concentrate them under reduced pressure using a rotary evaporator to obtain Panax notoginseng extract, which is then refrigerated. Dry the filter residue at 60℃ to obtain Panax notoginseng residue, which is then stored.

[0072] Example 7

[0073] Take 25g of Panax notoginseng herb and grind it into medium powder (65-100 mesh). Add 125g of 50wt% ethanol aqueous solution (5 times the amount of the extract) and extract at room temperature for 4 hours. Filter and collect the filtrate. Add another 125g of 50wt% ethanol aqueous solution (5 times the amount of the extract) to the residue and extract at room temperature for another 12 hours. Filter and collect the filtrate. Combine the two filtrates and concentrate them under reduced pressure using a rotary evaporator to obtain Panax notoginseng extract, which is then refrigerated. Dry the filter residue at 60℃ to obtain Panax notoginseng residue, which is then stored.

[0074] Example 8

[0075] Take 25g of Panax notoginseng herb and grind it into medium powder (65-100 mesh). Add 75g (3 times the amount of 50wt%) ethanol aqueous solution and extract at room temperature for 8 hours. Filter and recover the filtrate. Add 75g (3 times the amount of 50wt%) ethanol aqueous solution to the residue and extract again at room temperature for 8 hours. Filter and recover the filtrate. Combine the two recovered filtrates and concentrate them under reduced pressure using a rotary evaporator to obtain Panax notoginseng extract, which is then refrigerated. Dry the filter residue at 60℃ to obtain Panax notoginseng residue, which is then stored.

[0076] Example 9

[0077] Take 25g of Panax notoginseng herb and grind it into medium powder (65-100 mesh). Add 200g of 50wt% ethanol aqueous solution (8 times the amount of the extract) and extract at room temperature for 8 hours. Filter and recover the filtrate. Add another 200g of 50wt% ethanol aqueous solution (8 times the amount of the extract) to the residue and extract again at room temperature for 8 hours. Filter and recover the filtrate. Combine the two recovered filtrates and concentrate them under reduced pressure using a rotary evaporator to obtain Panax notoginseng extract, which is then refrigerated. Dry the filter residue at 60℃ to obtain Panax notoginseng residue, which is then stored.

[0078] Comparative Example 1

[0079] Take 25g of Panax notoginseng and grind it into a fine powder (100-180 mesh). Add 10 times its volume (250mL) of 50wt% ethanol aqueous solution and soak at room temperature for 5 days. Filter and collect the filtrate. Add 8 times its volume (200mL) of 50wt% ethanol aqueous solution to the resulting residue and soak at room temperature for 2 days. Filter and collect the filtrate. Combine the two collected filtrates and concentrate them under reduced pressure using a rotary evaporator to obtain Panax notoginseng extract. Dry the residue at 60℃ to obtain Panax notoginseng residue, which is then stored.

[0080] Comparative Example 2

[0081] Take 25g of Panax notoginseng herb and grind it into medium powder (65-100 mesh). Add 25mL of 55wt% ethanol aqueous solution, and simmer in a sealed container at 45℃ for 5 hours. Filter and collect the filtrate. Add another 25mL of 55wt% ethanol aqueous solution to the resulting residue and simmer in a sealed container at 45℃ for 5 hours. Filter and collect the filtrate. Combine the two collected filtrates and concentrate them under reduced pressure using a rotary evaporator to obtain Panax notoginseng extract, which is then refrigerated. Dry the filter residue at 60℃ to obtain Panax notoginseng residue, which is then stored.

[0082] Comparative Example 3

[0083] Take 25g of Panax notoginseng herb and grind it into medium powder (65-100 mesh). Add 5 times the amount of 125g of 50wt% ethanol aqueous solution and extract at room temperature for 4 hours. Filter and collect the filtrate. Add another 5 times the amount of 125g of 50wt% ethanol aqueous solution to the residue and extract again at room temperature for 3 hours. Filter and collect the filtrate. Combine the two collected filtrates and concentrate them under reduced pressure using a rotary evaporator to obtain Panax notoginseng extract, which is then refrigerated. Dry the filter residue at 60℃ to obtain Panax notoginseng residue, which is then stored.

[0084] Comparative Example 4

[0085] Take 25g of Panax notoginseng herb and grind it into medium powder (65-100 mesh). Add twice the amount of 50g of 50wt% ethanol aqueous solution and extract at room temperature for 8 hours. Filter and collect the filtrate. Add twice the amount of 50g of 50wt% ethanol aqueous solution to the residue and extract again at room temperature for 8 hours. Filter and collect the filtrate. Combine the two collected filtrates and concentrate them under reduced pressure using a rotary evaporator to obtain Panax notoginseng extract, which is then refrigerated. Dry the filter residue at 60℃ to obtain Panax notoginseng residue, which is then stored.

[0086] Experimental Example 1

[0087] Using the Panax notoginseng extract and Panax notoginseng residue prepared in the aforementioned examples, this application example takes Compound XueShuanTong Capsules as an example. The preparation method is as follows: According to the preparation method requirements of Compound XueShuanTong Capsules in the Chinese Pharmacopoeia, the three medicinal materials, Salvia miltiorrhiza, Scrophularia ningpoensis, and Astragalus membranaceus, are extracted twice by heating and refluxing with 50% ethanol. The extract is filtered, the filtrates are combined, concentrated under reduced pressure, and then mixed with the Panax notoginseng extract and Panax notoginseng residue prepared in the aforementioned examples. Then, an appropriate amount of starch and talc are added, mixed evenly, dried, pulverized, and filled into gelatin empty capsule shells, with each capsule containing 0.5g, to obtain Compound XueShuanTong Capsules.

[0088] Fingerprint analysis

[0089] The fingerprint analysis was performed on the Panax notoginseng extract of Example 1 and the prepared compound thrombolytic capsules. The fingerprint analysis was conducted using HPLC, and the specific conditions and parameters are as follows:

[0090] Preparation of the reference standard: Take 10 commercially available compound thrombolytic capsules, remove the capsule shells, grind them into a fine powder, calculate the average capsule weight, accurately weigh 0.5g of the contents (equivalent to one capsule), place them in a stoppered conical flask, accurately add 25ml of 80% methanol, seal tightly, weigh, sonicate (power 300W, frequency 45kHz) for 1 hour, cool, weigh again, replenish the lost weight with 80% methanol, shake well, filter, and take the filtrate to obtain the reference standard solution.

[0091] Preparation of the test sample: Take 10 capsules of the compound thrombolytic capsules prepared in the examples and comparative examples, remove the capsule shells, grind them into a fine powder, calculate the average capsule weight, accurately weigh 0.5g of the contents (equivalent to one capsule), place them in a stoppered conical flask, accurately add 25mL of 80% methanol, seal tightly, weigh, sonicate (power 300W, frequency 45kHz) for 1 hour, cool, weigh again, replenish the lost weight with 80% methanol, shake well, filter, and take the filtrate to obtain the test sample solution.

[0092] Chromatographic column: The column is packed with octadecylsilane-bonded silica gel (Thermo ODS Hypersil C18, column length 250 mm, column inner diameter 4.6 mm, particle size 5 μm).

[0093] Mobile phase: Acetonitrile is mobile phase A, and an aqueous solution containing 0.1 wt% phosphoric acid is mobile phase B.

[0094] Elution procedure: Perform gradient elution according to the procedure specified in Table 1.

[0095] Table 1: Elution Procedure

[0096]

[0097] The fingerprint spectra obtained by the above fingerprint spectra determination method were compared with the fingerprint spectra of the reference standard, and the results are shown in Table 2.

[0098] Table 2: Similarity of fingerprint chromatograms between Compound Thrombolytic Capsules and the reference standard

[0099]

[0100]

[0101] The fingerprint spectrum of the Compound XueShuanTong Capsules prepared in this application has a similarity of more than 0.9 with the fingerprint spectrum of the Panax notoginseng-derived component in Compound XueShuanTong Capsules in the Chinese Pharmacopoeia, which meets the requirements of the Chinese Pharmacopoeia. The fingerprint spectrum of the Panax notoginseng extract prepared in Example 1 of this application is attached. Figure 1 As shown. Further, a comparison of the fingerprint spectra of the compound thrombolytic capsules prepared using Example 1 of this application and commercially available compound thrombolytic capsules is shown in the appendix. Figure 2 The fingerprint similarity between the two was 0.95, which meets the requirements of the Chinese Pharmacopoeia.

[0102] Compared with the method of Comparative Example 1, the preparation method of Panax notoginseng extract provided in this application not only meets the fingerprint requirements of the Chinese Pharmacopoeia in terms of product quality but also significantly reduces manufacturing time. The Panax notoginseng extract prepared by the warm boiling extraction method in Comparative Example 2 and its compound XueShuanTong capsules do not meet the requirements of the Chinese Pharmacopoeia. Compared with Comparative Examples 3-4, the similarity is higher; reducing the ethanol-water solution and shortening the soaking extraction time will lead to a decrease in the extraction effect of Panax notoginseng, thus failing to meet the requirements of the Chinese Pharmacopoeia.

[0103] The technical features of the above embodiments can be combined in any way. For the sake of brevity, not all possible combinations of the technical features in the above embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0104] The embodiments described above are merely illustrative of several implementations of the present invention, and while the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the invention patent. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of the present invention, and these all fall within the protection scope of the present invention. Therefore, the protection scope of this invention patent should be determined by the appended claims.

Claims

1. A method for preparing Panax notoginseng extract, characterized in that, Includes the following steps: The Panax notoginseng herb is pulverized to prepare Panax notoginseng powder; A first aqueous ethanol solution was added to the Panax notoginseng powder, and a first extraction was carried out at room temperature. Solid-liquid separation was performed to prepare a first extract and a first filter residue. Add a second aqueous ethanol solution to the first filter residue, perform a second extraction at room temperature, separate the solid and liquid, and prepare a second extract and a second filter residue; The first and second extracts were combined and filtered to prepare Panax notoginseng extract; The mass concentrations of the first and second aqueous ethanol solutions are each independently 50%-70%; The total time for the two extractions is 8-24 hours. The ratio of Panax notoginseng powder to the first ethanol aqueous solution and the ratio of Panax notoginseng powder to the second ethanol aqueous solution are each independently 1g:(3-8)mL.

2. The method for preparing Panax notoginseng extract according to claim 1, characterized in that, The ratio of Panax notoginseng powder to the first ethanol aqueous solution and the ratio of Panax notoginseng powder to the second ethanol aqueous solution are each independently 1g:(4-6)mL.

3. The method for preparing Panax notoginseng extract according to claim 2, characterized in that, The ratio of Panax notoginseng powder to the first ethanol aqueous solution and the ratio of Panax notoginseng powder to the second ethanol aqueous solution are each independently 1g:(4.8-5.2)mL.

4. The method for preparing Panax notoginseng extract according to claim 1, characterized in that, The first and second extractions each take 4-12 hours independently.

5. The method for preparing Panax notoginseng extract according to claim 4, characterized in that, The total extraction time is 16-18 hours; and / or, the extraction time for the first and second extractions is 8-9 hours each independently.

6. The method for preparing Panax notoginseng extract according to claim 1, characterized in that, The room temperature is 15℃-30℃; and / or, the first and second extractions are immersion extractions; and / or, the particle size of the Panax notoginseng powder is 65 mesh-100 mesh.

7. The method for preparing Panax notoginseng extract according to any one of claims 1 to 6, characterized in that, The second filter residue is dried to prepare Panax notoginseng residue.

8. A method for preparing a traditional Chinese medicine preparation, characterized in that, The traditional Chinese medicine preparation comprises Panax notoginseng extract, and the preparation method of Panax notoginseng extract comprises the preparation method of Panax notoginseng extract according to any one of claims 1 to 6; Optionally, the ingredients of the traditional Chinese medicine preparation may also include Panax notoginseng residue, and the preparation method of the Panax notoginseng residue includes the preparation method of the Panax notoginseng extract according to claim 7.

9. The method for preparing the traditional Chinese medicine preparation according to claim 8, characterized in that, The traditional Chinese medicine preparations include thrombolytic preparations; Optionally, the thrombolytic preparation includes one or more of thrombolytic tablets, thrombolytic capsules, thrombolytic granules, and compound thrombolytic capsules.

10. The method for preparing the traditional Chinese medicine preparation according to claim 9, characterized in that, The thrombolytic preparation is a compound thrombolytic capsule, which is composed of Panax notoginseng extract, Panax notoginseng residue, Astragalus membranaceus extract, Salvia miltiorrhiza extract and Scrophularia ningpoensis extract. The preparation method of the compound thrombolytic capsules includes: mixing Panax notoginseng extract, Panax notoginseng residue, Astragalus membranaceus extract, Salvia miltiorrhiza extract and Scrophularia ningpoensis extract.

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