A preparation method of Gukang capsule medicine

Abstract

The invention discloses a preparation method of Gukang capsule. The method comprises the following steps: S1, according to the formula, Panax notoginseng is measured, crushed into fine powder, and Panax notoginseng fine powder is obtained, and it is standby; S2, according to the formula, banana root, Oxalis, Psoralea corylifolia, Dipsacus asper are measured, and the feed liquid mass volume ratio is 1:8-12, 50% ethanol solution is added and refluxed and extracted twice, each time 1-1.5h, and the extraction temperature is 60-70℃, filtered, and filtrate is recovered ethanol, and the extract with a relative density of 1.25-1.30 when the pressure is reduced and concentrated to 60℃, is dried under reduced pressure, crushed into fine powder, and dry paste powder is obtained; S3, the obtained Panax notoginseng fine powder and dry paste fine powder are mixed, and then appropriate amount of starch is added to adjust the total amount to 400g, and capsules are loaded, and 1000 are made, that is, obtained. The preparation method is simple, the filtering time is short, the paste collection rate is ideal, and the determination of the content of the effective ingredient of Psoralea corylifolia meets the current quality standard, and the stability is good.

Description

Technical Field

[0001] The invention relates to the field of medicine, and in particular to a method for preparing a Gukang capsule medicine. Background Art

[0002] Gukang Capsule is a product of Guizhou Weikang Zifan Pharmaceutical Co., Ltd. It has the functions of nourishing liver and kidney, strengthening tendons and bones, unblocking meridians and relieving pain. It is clinically used for fractures, osteoarthritis and osteoporosis.

[0003] The current quality standard of Gukang Capsule is WS-10464 (ZD-0464)-2005-2012Z, and the prescription is: 600g of banana root, 400g of Oxalis, 600g of Psoralea corylifolia, 300g of Dipsacus asper, and 150g of Panax notoginseng; the preparation process is: of the above five flavors, 30g of banana root and Panax notoginseng are crushed into fine powder respectively. The remaining banana root and the other three flavors such as Psoralea corylifolia are decocted with water for three times, each time for 1 hour, the decoction is combined, filtered, and the filtrate is concentrated to a thick paste with a relative density of 1.31-1.35 (60°C), the above fine powder is added, mixed, dried, and an appropriate amount of starch is added to adjust the total amount to 400g, crushed into fine powder, mixed, and filled into capsules to make 1000 capsules.

[0004] The current production process of the applicant is carried out in accordance with the prescription and preparation process included in the above-mentioned current quality standards. However, the following problems exist in the actual production process: 1. It is difficult to filter the decoction, which takes nearly 1 hour and is time-consuming and inefficient; 2. Using water as a solvent, the paste recovery rate is low, resulting in low utilization efficiency of raw materials. 3. The original production process requires taking 30g of banana root separately, grinding it into powder and adding it to the extract to mix, so as to increase the active ingredients of banana root in the extract, resulting in an increase in production processes; and because banana root contains more fiber components, it is more difficult to grind into powder, and the production efficiency is low. Therefore, it is necessary to improve the problems of the existing production process.

[0005] In response to the above problems, the team of the present invention has conducted a large number of small-scale and pilot-scale process exploration tests and found that the main source of filtration difficulties in the water decoction extraction process lies in the banana root medicinal material. Not only is the extract of banana root low in water decoction extraction, but the water extract is also difficult to filter. In response to this, the present invention improves the original extraction method and solves the problems of difficult and time-consuming water decoction filtration, low extract and paste yield in water decoction extraction, and low raw material utilization. Summary of the invention

[0006] The purpose of the present invention is to provide a method for preparing Gukang capsule medicine. On the basis of retaining the existing process of "Sanqi powder", the water decoction extraction part is improved to 50% ethanol reflux extraction, which not only solves the problem of difficult water decoction extraction and filtration, but also improves the paste recovery rate and raw material utilization rate, and reduces the production process of separate powdering of banana roots.

[0007] In order to achieve the purpose of the present invention, the present invention adopts the following technical solutions and steps:

[0008] A method for preparing a Gukang capsule medicine, the medicine prescription is: 600g of banana root, 400g of oxalis, 600g of psoralea corylifolia, 300g of dipsacus root, and 150g of Panax notoginseng, the method comprising the following steps:

[0009] S1, taking Panax notoginseng according to the formula, crushing it into fine powder, and obtaining Panax notoginseng fine powder for later use;

[0010] S2, taking banana root, Oxalis, Psoralea corylifolia, and Dipsacus as per the formula, adding ethanol solution to reflux and extract twice, each time for 1-2 hours, at an extraction temperature of 60-80°C, filtering, recovering ethanol from the filtrate, concentrating under reduced pressure to an extract with a relative density of 1.25-1.30 at 60°C, drying under reduced pressure, and crushing into fine powder to obtain dry paste powder;

[0011] S3, mix the Panax notoginseng fine powder and dry paste powder obtained in the above steps, add appropriate amount of starch to adjust the total amount to 400g, put into capsules, and make 1000 capsules.

[0012] Preferably, the preparation method of the Gukang capsule medicine of the present invention comprises the following steps:

[0013] S1, taking Panax notoginseng according to the formula, crushing it into fine powder, and obtaining Panax notoginseng fine powder for later use;

[0014] S2, taking banana root, Oxalis, Psoralea corylifolia, and Dipsacus as per the formula, adding ethanol solution for reflux extraction twice, each time for 1-1.5h, the extraction temperature is 60-70°C, filtering, recovering ethanol from the filtrate, concentrating under reduced pressure to an extract with a relative density of 1.25-1.30 at 60°C, drying under reduced pressure, and crushing into fine powder to obtain dry paste powder;

[0015] S3, mix the Panax notoginseng fine powder and the dry paste fine powder obtained in the above steps, add appropriate amount of starch to adjust the total amount to 400g, put into capsules, and make 1000 capsules.

[0016] Preferably, the preparation method of the Gukang capsule medicine of the present invention comprises the following steps:

[0017] S1, taking Panax notoginseng according to the formula, crushing it into fine powder, and obtaining Panax notoginseng fine powder for later use;

[0018] S2, taking banana root, Oxalis, Psoralea corylifolia, and Dipsacus as per the formula, adding ethanol solution at a material-liquid mass volume ratio of 1:10, reflux extraction twice, each time for 1.5 hours, the extraction temperature is 70°C, filtering, recovering ethanol from the filtrate, concentrating under reduced pressure to an extract with a relative density of 1.25-1.30 at 60°C, drying under reduced pressure, and crushing into fine powder to obtain dry paste powder;

[0019] S3, mix the Panax notoginseng fine powder and the dry paste fine powder obtained in the above steps, add appropriate amount of starch to adjust the total amount to 400g, put into capsules, and make 1000 capsules.

[0020] Preferably, the ethanol solution of the present invention is 40-60% ethanol.

[0021] Further preferably, the ethanol solution of the present invention is 40-50% ethanol.

[0022] More preferably, the ethanol solution of the present invention is 50% ethanol.

[0023] Preferably, the reduced pressure drying conditions of the present invention are: vacuum degree 0.7-0.9Mpa, temperature 55-60°C.

[0024] Further preferably, the reduced pressure drying conditions of the present invention are: vacuum degree 0.8-0.9Mpa, temperature 60°C.

[0025] Preferably, the fine powder of the present invention is sieved through 80-100 mesh.

[0026] Further preferably, the fine powder of the present invention is sieved through a 100-mesh sieve.

[0027] Beneficial effects of the present invention:

[0028] 1. The method of the present invention significantly increases the paste recovery rate from 15.62% in the current production process to 21.28%, thereby solving the problems of low paste recovery rate and low raw material utilization rate in the current production process.

[0029] 2. The filtration process of the present invention is shorter, from 50-55 minutes of filtration in the current production process to 20-25 minutes of filtration in the present method, which is more than doubled, with significant effects and improved production efficiency.

[0030] 3. The optimal process parameters of the method of the present invention, i.e., using 50% ethanol as the extraction solvent, a solid-liquid ratio of 1:10, an extraction time of 1.5 h, and an extraction temperature of 70°C, are obtained by orthogonal test optimization. After pilot process verification, it is measured that: the average paste yield is 21.28%, the psoralen content is 0.50 mg / grain, and the isopsoralen content is 0.43 mg / grain. The calculated RSDs all meet the requirements, indicating that the process is stable, reasonable and feasible, and the quality meets the requirements of the national drug standards for Gukang Capsules, and can be used as the optimal extraction process for this prescription. DETAILED DESCRIPTION

[0031] The present invention is described in detail below with reference to specific embodiments.

[0032] Example 1

[0033] S1, take 150g of Panax notoginseng according to the formula, crush it into fine powder, and obtain Panax notoginseng fine powder (passing 100 mesh), and set aside;

[0034] S2, according to the formula, take 600g of banana root, 400g of oxalis, 600g of psoralea corylifolia, and 300g of Dipsacus asper, according to the mass volume ratio of the material to the liquid of 1:10, add 50% ethanol solution to reflux and extract twice, each time for 1.5h, the extraction temperature is 70°C, filter, recover ethanol from the filtrate, and concentrate under reduced pressure to an extract with a relative density of 1.25-1.30 at 60°C, dry under reduced pressure (vacuum degree 0.8-0.9Mpa, temperature 60°C), and grind into fine powder (over 100 mesh) to obtain dry paste powder;

[0035] S3, mix the Panax notoginseng fine powder and the dry paste fine powder obtained in the above steps, add appropriate amount of starch to adjust the total amount to 400g, put into capsules, and make 1000 capsules.

[0036] Example 2

[0037] S1, take 150g of Panax notoginseng according to the formula, grind it into fine powder, and obtain Panax notoginseng fine powder (passing 80 mesh), and set aside;

[0038] S2, according to the formula, 600g of banana root, 400g of oxalis, 600g of psoralea corylifolia, and 300g of Dipsacus asper were taken, and the mass volume ratio of the material to the liquid was 1:8, and 40% ethanol solution was added for reflux extraction twice, each time for 1h, and the extraction temperature was 60°C, filtered, and the filtrate was ethanol recovered, and the extract was concentrated under reduced pressure to a relative density of 1.25-1.30 at 60°C, and dried under reduced pressure (vacuum degree 0.8-0.9Mpa, temperature 60°C), and crushed into fine powder (passing 80 mesh) to obtain dry paste powder;

[0039] S3, mix the Panax notoginseng fine powder and the dry paste fine powder obtained in the above steps, add appropriate amount of starch to adjust the total amount to 400g, put into capsules, and make 1000 capsules.

[0040] Example 3

[0041] S1, take 150g of Panax notoginseng according to the formula, crush it into fine powder, and obtain Panax notoginseng fine powder (passing 100 mesh), and set aside;

[0042] S2, according to the formula, 600g of banana root, 400g of oxalis, 600g of psoralea corylifolia, and 300g of Dipsacus asper were taken, and the mass volume ratio of the material to the liquid was 1:12, and 60% ethanol solution was added for reflux extraction twice, each time for 2h, and the extraction temperature was 80°C, filtered, and the filtrate was ethanol recovered, and the extract was concentrated under reduced pressure to a relative density of 1.25-1.30 at 60°C, and dried under reduced pressure (vacuum degree 0.8-0.9Mpa, temperature 60°C), and crushed into fine powder (over 100 mesh) to obtain dry paste powder;

[0043] S3, mix the Panax notoginseng fine powder and the dry paste fine powder obtained in the above steps, add appropriate amount of starch to adjust the total amount to 400g, put into capsules, and make 1000 capsules.

[0044] Example 4

[0045] S1, take 150g of Panax notoginseng according to the formula, crush it into fine powder, and obtain Panax notoginseng fine powder (passing 100 mesh), and set aside;

[0046] S2, according to the formula, 600g of banana root, 400g of oxalis, 600g of psoralea corylifolia, and 300g of Dipsacus asper were taken, and the mass volume ratio of the material to the liquid was 1:6, and 40% ethanol solution was added for reflux extraction twice, each time for 1h, and the extraction temperature was 60°C, filtered, and the filtrate was ethanol recovered, and the extract was concentrated under reduced pressure to a relative density of 1.25-1.30 at 60°C, and dried under reduced pressure (vacuum degree 0.8-0.9Mpa, temperature 60°C), and crushed into fine powder (over 100 mesh) to obtain dry paste powder;

[0047] S3, mix the Panax notoginseng fine powder and the dry paste fine powder obtained in the above steps, add appropriate amount of starch to adjust the total amount to 400g, put into capsules, and make 1000 capsules.

[0048] Example 5

[0049] S1, take 150g of Panax notoginseng according to the formula, crush it into fine powder, and obtain Panax notoginseng fine powder (passing 100 mesh), and set aside;

[0050] S2, according to the formula, take 600g of banana root, 400g of oxalis, 600g of psoralea corylifolia, and 300g of Dipsacus asper, according to the mass volume ratio of the material to the liquid of 1:14, add 60% ethanol solution to reflux and extract twice, each time for 1.5h, the extraction temperature is 60°C, filter, recover ethanol from the filtrate, and concentrate under reduced pressure to an extract with a relative density of 1.25-1.30 at 60°C, dry under reduced pressure (vacuum degree 0.8-0.9Mpa, temperature 60°C), and grind into fine powder (over 100 mesh) to obtain dry paste powder;

[0051] S3, mix the Panax notoginseng fine powder and the dry paste fine powder obtained in the above steps, add appropriate amount of starch to adjust the total amount to 400g, put into capsules, and make 1000 capsules.

[0052] Example 6

[0053] S1, take 150g of Panax notoginseng according to the formula, crush it into fine powder, and obtain Panax notoginseng fine powder (passing 100 mesh), and set aside;

[0054] S2, according to the formula, take 600g of banana root, 400g of oxalis, 600g of psoralea corylifolia, and 300g of Dipsacus asper, according to the mass volume ratio of the material to the liquid of 1:10, add 60% ethanol solution to reflux and extract twice, each time for 1.5h, the extraction temperature is 60°C, filter, recover ethanol from the filtrate, concentrate under reduced pressure to an extract with a relative density of 1.25-1.30 at 60°C, dry under reduced pressure (vacuum degree 0.8-0.9Mpa, temperature 60°C), and grind into fine powder (pass 80 mesh) to obtain dry paste powder;

[0055] S3, mix the Panax notoginseng fine powder and the dry paste fine powder obtained in the above steps, add appropriate amount of starch to adjust the total amount to 400g, put into capsules, and make 1000 capsules.

[0056] Example 7

[0057] S1, take 150g of Panax notoginseng according to the formula, grind it into fine powder, and obtain Panax notoginseng fine powder (passing 80 mesh), and set aside;

[0058] S2, according to the formula, 600g of banana root, 400g of oxalis, 600g of psoralea corylifolia, and 300g of Dipsacus asper were taken, and the mass volume ratio of the material to the liquid was 1:7, and 45% ethanol solution was added for reflux extraction twice, each time for 1.5h, and the extraction temperature was 60°C, filtered, and the filtrate was ethanol recovered, and the extract was concentrated under reduced pressure to a relative density of 1.25-1.30 at 60°C, and dried under reduced pressure (vacuum degree 0.7-0.8Mpa, temperature 60°C), and crushed into fine powder (passing 80 mesh) to obtain dry paste powder;

[0059] S3, mix the Panax notoginseng fine powder and the dry paste fine powder obtained in the above steps, add appropriate amount of starch to adjust the total amount to 400g, put into capsules, and make 1000 capsules.

[0060] Example 8

[0061] S1, take 150g of Panax notoginseng according to the formula, crush it into fine powder, and obtain Panax notoginseng fine powder (passing 100 mesh), and set aside;

[0062] S2, according to the formula, 600g of banana root, 400g of oxalis, 600g of psoralea corylifolia, and 300g of Dipsacus asper were taken, and the mass volume ratio of the material to the liquid was 1:9, and 55% ethanol solution was added for reflux extraction twice, each time for 1h, and the extraction temperature was 60°C, filtered, and the filtrate was ethanol recovered, and the extract was concentrated under reduced pressure to a relative density of 1.25-1.30 at 60°C, and dried under reduced pressure (vacuum degree 0.8-0.9Mpa, temperature 60°C), and crushed into fine powder (over 100 mesh) to obtain dry paste powder;

[0063] S3, mix the Panax notoginseng fine powder and the dry paste fine powder obtained in the above steps, add appropriate amount of starch to adjust the total amount to 400g, put into capsules, and make 1000 capsules.

[0064] Example 9

[0065] S1, take 150g of Panax notoginseng according to the formula, crush it into fine powder, and obtain Panax notoginseng fine powder (passing 100 mesh), and set aside;

[0066] S2, according to the formula, 600g of banana root, 400g of oxalis, 600g of psoralea corylifolia, and 300g of Dipsacus asper were taken, and the mass volume ratio of the material to the liquid was 1:11, and 45% ethanol solution was added for reflux extraction twice, each time for 1.5h, and the extraction temperature was 60°C, filtered, and the filtrate was ethanol recovered, and the extract was concentrated under reduced pressure to a relative density of 1.25-1.30 at 60°C, and dried under reduced pressure (vacuum degree 0.8-0.9Mpa, temperature 60°C), and crushed into fine powder (over 100 mesh) to obtain dry paste powder;

[0067] S3, mix the Panax notoginseng fine powder and the dry paste fine powder obtained in the above steps, add appropriate amount of starch to adjust the total amount to 400g, put into capsules, and make 1000 capsules.

[0068] Example 10

[0069] S1, take 150g of Panax notoginseng according to the formula, crush it into fine powder, and obtain Panax notoginseng fine powder (passing 100 mesh), and set aside;

[0070] S2, according to the formula, 600g of banana root, 400g of oxalis, 600g of psoralea corylifolia, and 300g of Dipsacus asper were taken, and the mass volume ratio of the material to the liquid was 1:10, and 50% ethanol solution was added for reflux extraction twice, each time for 2h, and the extraction temperature was 60°C, filtered, and the filtrate was ethanol recovered, and the extract was concentrated under reduced pressure to a relative density of 1.25-1.30 at 60°C, and dried under reduced pressure (vacuum degree 0.7-0.8Mpa, temperature 60°C), and crushed into fine powder (over 80 mesh) to obtain dry paste powder;

[0071] S3, mix the Panax notoginseng fine powder and the dry paste fine powder obtained in the above steps, add appropriate amount of starch to adjust the total amount to 400g, put into capsules, and make 1000 capsules.

[0072] Embodiment 11

[0073] S1, take 150g of Panax notoginseng according to the formula, crush it into fine powder, and obtain Panax notoginseng fine powder (passing 100 mesh), and set aside;

[0074] S2, according to the formula, take 600g of banana root, 400g of oxalis, 600g of psoralea corylifolia, and 300g of Dipsacus asper, according to the mass volume ratio of the material to the liquid of 1:10, add 40% ethanol solution to reflux and extract twice, each time for 1.5h, the extraction temperature is 80°C, filter, recover ethanol from the filtrate, and concentrate under reduced pressure to an extract with a relative density of 1.25-1.30 at 60°C, dry under reduced pressure (vacuum degree 0.8-0.9Mpa, temperature 60°C), and grind into fine powder (over 100 mesh) to obtain dry paste powder;

[0075] S3, mix the Panax notoginseng fine powder and the dry paste fine powder obtained in the above steps, add appropriate amount of starch to adjust the total amount to 400g, put into capsules, and make 1000 capsules.

[0076] Example 12

[0077] S1, take 150g of Panax notoginseng according to the formula, crush it into fine powder, and obtain Panax notoginseng fine powder (passing 100 mesh), and set aside;

[0078] S2, according to the formula, 600g of banana root, 400g of oxalis, 600g of psoralea corylifolia, and 300g of Dipsacus asper were taken, and the mass volume ratio of the material to the liquid was 1:10, and 50% ethanol solution was added for reflux extraction twice, each time for 2h, and the extraction temperature was 60°C, filtered, and the filtrate was ethanol recovered, and the extract was concentrated under reduced pressure to a relative density of 1.25-1.30 at 60°C, and dried under reduced pressure (vacuum degree 0.8-0.9Mpa, temperature 60°C), and crushed into fine powder (over 100 mesh) to obtain dry paste powder;

[0079] S3, mix the Panax notoginseng fine powder and the dry paste fine powder obtained in the above steps, add appropriate amount of starch to adjust the total amount to 400g, put into capsules, and make 1000 capsules.

[0080] In order to prove the feasibility and beneficial effects of the present invention, research tests were conducted, and some of the tests are excerpted as follows:

[0081] 1. Investigation on the preparation process of Gukang Capsules

[0082] The current production process of Gukang Capsules:

[0083] Prescription: 600g banana root, 400g oxalis, 600g psoralea corylifolia, 300g dipsacus root, 150g Panax notoginseng;

[0084] Preparation process: For the above five ingredients, take 30g of banana root and Panax notoginseng and grind them into fine powder respectively. Add water to the remaining banana root and the other three ingredients such as Psoralea corylifolia and boil them three times, each time for 1 hour. Combine the decoctions, filter, and concentrate the filtrate to a thick paste with a relative density of 1.31-1.35 (60℃). Add the above fine powder, mix well, dry, add appropriate amount of starch to adjust the total amount to 400g, grind into fine powder, mix well, put into capsules, and make 1000 capsules.

[0085] According to the current production process, the following problems exist in the actual production process: 1. It is difficult to filter the decoction, which takes nearly 1 hour; 2. The actual paste recovery rate is low, less than 20%, which is not ideal, resulting in low utilization efficiency of raw materials.

[0086] After a long period of small-scale and pilot tests, it was found that the main source of filtration difficulties lies in the banana root medicinal material. The banana root medicinal material not only has a low extract in water decoction extraction, but its water extract is also difficult to filter. In response to this, the present invention team has improved the current water decoction extraction process.

[0087] 1. Selection of extraction method

[0088] The present invention selects to adopt three methods for comparison in the early stage, respectively as follows:

[0089] Method 1: Decoction and extraction

[0090] The extraction parameters were set as follows: water was used as the extraction solvent, the solid-liquid ratio was 1:8, and the extraction was performed twice, each time for 1 hour.

[0091] Method 2: Reflux Extraction

[0092] The extraction parameters were set as follows: 50% ethanol as the extraction solvent, a solid-liquid ratio of 1:8, and extraction twice, each for 1 hour.

[0093] Method 3: Ultrasonic extraction

[0094] The extraction parameters were set as follows: 50% ethanol as the extraction solvent, a solid-liquid ratio of 1:8, and extraction twice, each for 1 hour.

[0095] Results: The recovery rate of water decoction extraction method was 15.62%, the recovery rate of ethanol reflux extraction method was 21.03%, and the recovery rate of ethanol ultrasonic extraction method was 14.38%; the ethanol reflux extraction and filtration took 20-25 minutes to complete; the water decoction extraction and filtration took 50-55 minutes; and the ethanol ultrasonic extraction and filtration took about 40 minutes.

[0096] Therefore, the present invention selects the ethanol reflux extraction method and adopts orthogonal test to carry out optimization investigation.

[0097] 2. Extraction method optimization study

[0098] 2.1 Orthogonal experiment to optimize the extraction process

[0099] The ethanol concentration, solid-liquid ratio, extraction time and extraction temperature were selected as factors, the recovery rate, psoralen and isopsoralen content were selected as experimental optimization indicators, and orthogonal experiments were designed to determine the reasonable extraction process. The factor levels are shown in Table 1, and the orthogonal experimental scheme and result calculation are shown in Table 2. The determination of psoralen and isopsoralen content was carried out in accordance with the current quality collection standard.

[0100] Table 1 Experimental factor level table

[0101] level AEthanol concentration / % B material-liquid ratio (g / ml) C extraction time / h D Extraction temperature / ℃ 1 40％ 1:8 1 60 2 50％ 1:10 1.5 70 3 60％ 1:12 2 80

[0102] Table 2 Orthogonal test design and results

[0103]

[0104]

[0105] Table 3 Results of variance analysis of paste yield

[0106] factor Sum of Squares of Deviations Degrees of Freedom F Ratio F-number A 27.057 2 3.730 4.460 B 0.969 2 0.134 4.460 C 0.140 2 0.019 4.460 D 0.849 2 0.117 4.460 error 29.02 8

[0107] Table 4 Results of variance analysis of psoralen content

[0108] factor Sum of Squares of Deviations Degrees of Freedom F Ratio F-number A 0.012 2 3.692 4.460 B 0.000 2 0.000 4.460 C 0.000 2 0.000 4.460 D 0.001 2 0.308 4.460 error 0.01 8

[0109] Table 5 Results of variance analysis of isopsoralen content

[0110] factor Sum of Squares of Deviations Degrees of Freedom F Ratio F-number A 0.019 2 3.455 4.460 B 0.001 2 0.182 4.460 C 0.001 2 0.182 4.460 D 0.001 2 0.182 4.460 error 0.02 8

[0111] From the orthogonal test results table 2, we can see that

[0112] 1) The influence of each factor on the paste yield is A>B>D>C, and A2>A3>A1, B3>B2>B1, C1>C3>C2, D2>D1>D3. Among them, the ethanol concentration (A) has a greater influence on the paste yield, and the other factors have little influence on it, which is not significant. The optimal process parameters are A2B2C1D2;

[0113] 2) The influence of each factor on the content of psoralen is A>D>C>B, and A2>A3>A1, B2>B1>B3, C1>C3>C2, D2>D3>D1. Among them, the ethanol concentration (A) has a greater influence on the content of psoralen, and the other factors have a small and insignificant influence on it. Taking the content of psoralen as an indicator, the optimal process parameters are A2B2C1D2;

[0114] 3) The influence of each factor on the content of isopsoralen is A>B>D>C, and A2>A3>A1, B3>B1>B2, C3>C2=C1, D2>D3>D1, among which ethanol concentration (A) has a greater influence on the content of isopsoralen, and other factors have little influence on it, which is not significant. Taking the content of isopsoralen as an indicator, the optimal process parameters are A2B3C3D2;

[0115] Taking into account the comprehensive cost saving perspective, the optimal process parameters finally selected were A2B2C2D2, that is, 50% ethanol as the extraction solvent, a solid-liquid ratio of 1:10, an extraction time of 1.5h, and an extraction temperature of 70℃.

[0116] 2.2 Verification of optimal extraction process parameters

[0117] Three batches of pilot tests were carried out according to the optimal extraction process selected above. The specific method is as follows:

[0118] Step 1: Take 150g of Panax notoginseng according to the formula, crush it into fine powder, pass it through a 100-mesh sieve, and obtain Panax notoginseng fine powder for later use;

[0119] Step 2, according to the formula, 600g of banana root, 400g of Oxalis sorrel, 600g of Psoralea corylifolia, and 300g of Dipsacus asper are taken, and the mass volume ratio of the material to the liquid is 1:10 (g / ml), and 50% ethanol solution is added for reflux extraction twice, each time for 1.5h, and the extraction temperature is 70°C, filtered, and the filtrate is used to recover ethanol, and the extract with a relative density of 1.25-1.30 at 60°C is concentrated under reduced pressure (vacuum degree 0.8-0.9Mpa, temperature 60°C) is dried under reduced pressure (vacuum degree 0.8-0.9Mpa, temperature 60°C), crushed into fine powder, passed through a 100-mesh sieve, and a dry paste powder is obtained for standby use;

[0120] Step three, mix the above-mentioned Panax notoginseng fine powder and dry paste powder, then add appropriate amount of starch to adjust the total amount to 400g, put into capsules, and make 1000 capsules.

[0121] The average extract yield was 21.28%, the psoralen content was 0.50 mg / tablet, and the isopsoralen content was 0.43 mg / tablet. The calculated RSDs all met the requirements, indicating that the process was stable, reasonable, and feasible, and could be used as the optimal extraction process for this prescription. See Table 5.

[0122] Table 5 Verification results of optimal extraction process parameters

[0123]

[0124] Although the present invention has been described in detail above by means of general description, specific implementation methods and experiments, it is obvious to those skilled in the art that some modifications or improvements can be made to the present invention. Therefore, these modifications or improvements made without departing from the spirit of the present invention all fall within the scope of protection claimed by the present invention.

Claims

1. A method for preparing a Gukang capsule drug, the drug prescription is: 600g of banana root, 400g of oxalis, 600g of psoralea corylifolia, 300g of Dipsacus asper, and 150g of Panax notoginseng, characterized in that: The method comprises the following steps: S1, taking Panax notoginseng according to the formula, crushing it into fine powder, and obtaining Panax notoginseng fine powder for later use; S2, taking banana root, Oxalis, Psoralea corylifolia, and Dipsacus as per the formula, adding ethanol solution to reflux and extract twice, each time for 1-2 hours, at an extraction temperature of 60-80°C, filtering, recovering ethanol from the filtrate, concentrating under reduced pressure to an extract with a relative density of 1.25-1.30 at 60°C, drying under reduced pressure, and crushing into fine powder to obtain dry paste powder; S3, mix the Panax notoginseng fine powder and dry paste powder obtained in the above steps, add appropriate amount of starch to adjust the total amount to 400g, put into capsules, and make 1000 capsules.

2. The method for preparing the Gukang capsule drug according to claim 1, characterized in that: The method comprises the following steps: S1, taking Panax notoginseng according to the formula, crushing it into fine powder, and obtaining Panax notoginseng fine powder for later use; S2, taking banana root, Oxalis, Psoralea corylifolia, and Dipsacus as per the formula, adding ethanol solution for reflux extraction twice, each time for 1-1.5h, the extraction temperature is 60-70°C, filtering, recovering ethanol from the filtrate, concentrating under reduced pressure to an extract with a relative density of 1.25-1.30 at 60°C, drying under reduced pressure, and crushing into fine powder to obtain dry paste powder; S3, mix the Panax notoginseng fine powder and the dry paste fine powder obtained in the above steps, add appropriate amount of starch to adjust the total amount to 400g, put into capsules, and make 1000 capsules.

3. The method for preparing the Gukang capsule medicine according to claim 2, characterized in that: The method comprises the following steps: S1, taking Panax notoginseng according to the formula, crushing it into fine powder, and obtaining Panax notoginseng fine powder for later use; S2, taking banana root, Oxalis, Psoralea corylifolia, and Dipsacus as per the formula, adding ethanol solution at a material-liquid mass volume ratio of 1:10, reflux extraction twice, each time for 1.5 hours, the extraction temperature is 70°C, filtering, recovering ethanol from the filtrate, concentrating under reduced pressure to an extract with a relative density of 1.25-1.30 at 60°C, drying under reduced pressure, and crushing into fine powder to obtain dry paste powder; S3, mix the Panax notoginseng fine powder and the dry paste fine powder obtained in the above steps, add appropriate amount of starch to adjust the total amount to 400g, put into capsules, and make 1000 capsules.

4. The method for preparing the Gukang capsule drug according to any one of claims 1 to 3, characterized in that: The ethanol solution is 40-60% ethanol.

5. The method for preparing the Gukang capsule medicine according to claim 4, characterized in that: The ethanol solution is 40-50% ethanol.

6. The method for preparing the Gukang capsule drug according to claim 5, characterized in that: The ethanol solution is 50% ethanol.

7. The method for preparing the Gukang capsule drug according to any one of claims 1 to 3, characterized in that: The reduced pressure drying conditions are: vacuum degree 0.7-0.9Mpa, temperature 55-60°C.

8. The method for preparing the Gukang capsule medicine according to claim 7, characterized in that: The reduced pressure drying conditions are: vacuum degree 0.8-0.9Mpa, temperature 60°C.

9. The method for preparing the Gukang capsule drug according to any one of claims 1 to 3, characterized in that: The fine powder is sieved through 80-100 mesh.

10. The method for preparing the Gukang capsule medicine according to claim 9, characterized in that: The fine powder is sieved through a 100-mesh sieve.

Images