Preparation method of traditional Chinese medicine composition

Abstract

The invention belongs to the technical field of traditional Chinese medicine pharmacy, and provides a preparation method of a traditional Chinese medicine composition, pollen typhae, radix salviae miltiorrhizae, ligusticum wallichii, radix paeoniae rubra, hawthorn, rhizoma alismatis and codonopsis pilosula are extracted with water, the obtained extracting solution and polygonum multiflorum powder obtained by sieving with a 24-80-mesh sieve are combined and uniformly mixed, and the prepared traditional Chinese medicine composition has higher active ingredient content.

Description

Technical Field

[0001] The present invention relates to the pharmaceutical field, and in particular to a process for preparing a traditional Chinese medicine composition. Background Art

[0002] Hyperlipidemia is a condition in which the concentration of plasma lipids exceeds the upper limit of normal. It can be seen in a variety of diseases. According to TCM syndrome differentiation, it is divided into phlegm turbidity and yin suppression syndrome, spleen and kidney yang deficiency syndrome, liver deficiency and yin deficiency syndrome, yin deficiency and yang hyperactivity syndrome, and qi stagnation and blood stasis syndrome. It is mostly caused by the increase of cholesterol, triglycerides, low-density lipoprotein and very low-density protein in the body, and the decrease of high-density lipoprotein, which causes lipid metabolism disorder and increased blood viscosity, directly leading to the formation of hyperlipidemia. Among them, blood stasis syndrome is the most common. Patients have symptoms such as dizziness, chest tightness, chest and flank pain, palpitations, fatigue, Or they are obese, short of breath when moving, with ecchymosis on the edge of the tongue tip, dark purple tongue, and thin and wiry pulse. When the symptoms develop, they may be complicated by cardiovascular and cerebrovascular diseases such as hypertension, coronary heart disease, cerebral thrombosis, and arteriosclerosis. At present, the treatment of hyperlipidemia is mainly based on active prevention and lipid-lowering. Drugs mostly use chemical preparations to dilate blood vessels. However, because the lipid disorder in the patient's body has not been regulated, the symptoms of blood stasis have not disappeared, and blood lipids are prone to repeated increases. Patients cannot achieve both symptomatic and root cause treatment. The development of traditional Chinese medicine for blood stasis caused by hyperlipidemia using traditional Chinese medicine formulas has a wide application market.

[0003] CN113945643A discloses a single-test, multi-evaluation method for hyperlipidemia drugs. This method can be used to detect 10 chemical components in Pushen capsules and anthraquinones in extracts of Codonopsis pilosula, Chuanxiong rhizome, Paeonia lactiflora root, Alisma orientalis, Salvia miltiorrhiza, Crataegus pinnatifida, Pollen Typhae, and Polygonum multiflorum. Among these, emodin-8-O-β-D-glucoside and physcion-8-O-β-D-glucose are the main active ingredients. Furthermore, Polygonum multiflorum contains anthraquinones including stilbene glycoside, emodin, physcion, emodin-8-O-β-D-glucoside, and physcion-8-O-β-D-glucoside.

[0004] CN1317003C discloses a Chinese medicine preparation for treating hyperlipidemia and its preparation process. The raw materials are composed of eight Chinese medicinal materials, including 135 grams of Polygonum multiflorum, 110 grams of Pollen Typhae, 66 grams of Salvia miltiorrhiza, 66 grams of Paeonia lactiflora, 66 grams of Crataegus pinnatifida, 110 grams of Rhizoma Alismatis, and 36 grams of Codonopsis pilosula. The specific preparation process is as follows: first, Polygonum multiflorum is crushed and passed through a 100-mesh sieve to form a fine powder for later use; then, the remaining seven Chinese medicinal materials are decocted twice with 5 times the amount of water each time for 2 hours each time; the decoctions are combined, filtered, and the filtrate is concentrated under reduced pressure to a thick paste with a relative density of 1.30 to 1.32 (60°C) for later use; the fine powder is evenly mixed with the thick paste, dried at a temperature below 80°C, and then crushed and passed through a 100-mesh sieve to form a fine powder; an appropriate amount of ethanol is added to the fine powder to prepare granules, which are then dried, granulated, and divided into 1000 No. 1 capsules to obtain the finished medicine.

[0005] How to determine the effect of the coarseness of the medicinal materials in the traditional Chinese medicine preparation in CN1317003C on the content of the main active ingredients of Polygonum multiflorum, such as emodin-8-O-β-D-glucoside and physcion-8-O-β-D-glucose, is a problem that needs to be further solved. Summary of the Invention

[0006] The technical problem to be solved by the present invention is to provide a method for reducing the reduction of the main active ingredients of a traditional Chinese medicine preparation containing Polygonum multiflorum, in particular to provide a method for preparing a traditional Chinese medicine preparation with a relatively high content of emodin-8-O-β-D-glucoside and physcion-8-O-β-D-glucose.

[0007] The traditional Chinese medicine composition of the invention is prepared from polygonum multiflorum, pollen cattail, salvia miltiorrhiza, chuanxiong, red peony root, hawthorn, oriental water plantain and codonopsis pilosula as raw materials.

[0008] The method for preparing the traditional Chinese medicine composition of the present invention comprises extracting pollen typhae, salvia miltiorrhiza, chuanxiong rhizome, red peony root, hawthorn, oriental rhizome, and codonopsis pilosula with water, combining the resulting extract with polygonum multiflorum powder and mixing evenly to produce the traditional Chinese medicine composition. In some technical solutions, the polygonum multiflorum powder is obtained by pulverizing the polygonum multiflorum medicinal material and passing it through a 24-80 mesh sieve, further by passing it through a 50-80 mesh sieve, specifically through a 50 mesh, 65 mesh, or 80 mesh sieve; further, the fraction of the polygonum multiflorum powder that can pass through a 100 mesh sieve is ≤50%, and further, the fraction of the polygonum multiflorum powder that can pass through a 100 mesh sieve is ≤20%.

[0009] The extract is concentrated into a thick paste before being combined with the Polygonum multiflorum powder. Preferably, the density of the thick paste is 1.08-1.35 at 50-60°C, preferably 1.10-1.32, and further 1.30-1.32.

[0010] The number of extractions is 1 to 3 times, preferably 2 times; the extraction time is 1 to 3 hours, preferably 2 hours; the extraction temperature is 80 to 100°C, preferably back extraction; the amount of water used for extraction is 3 to 10 times the weight of the medicinal material, preferably 4 to 7 times, and more preferably 5 times.

[0011] The dosage of the Radix Polygoni Multiflori, Pollen Typhae, Salvia Miltiorrhiza, Chuanxiong Rhizome, Red Peony Root, Crataegus Pinellia, Rhizoma Alismatis and Codonopsis Pilosula is as follows: 130-140 parts of Radix Polygoni Multiflori, 105-115 parts of Pollen Typhae, 60-70 parts of Radix Salviae Miltiorrhizae, 60-70 parts of Rhizoma Chuanxiong, 60-70 parts of Red Peony Root, Crataegus Pinellia, 100-120 parts of Rhizoma Alismatis and 30-40 parts of Codonopsis Pilosula. In a preferred embodiment, the dosage of the Radix Polygoni Multiflori, Pollen Typhae, Salvia Miltiorrhiza, Chuanxiong Rhizome, Red Peony Root, Crataegus Pinellia, Rhizoma Alismatis and Codonopsis Pilosula is as follows: 135 parts of Radix Polygoni Multiflori, 110 parts of Pollen Typhae, 66 parts of Radix Salviae Miltiorrhizae, 66 parts of Rhizoma Chuanxiong, 66 parts of Red Peony Root, Crataegus Pinellia, 110 parts of Rhizoma Alismatis and 36 parts of Codonopsis Pilosula.

[0012] The extract and the Polygonum multiflorum powder are combined and mixed, and then dried; preferably, the drying is performed by heating, the drying temperature is 70-85° C., and the drying method is air drying; further, after drying, the powder is crushed, granulated with ethanol, and dried at 70-85° C. after granulation.

[0013] The Chinese medicine composition contains no less than 0.30 mg·g -1 emodin-8-O-β-D-glucoside and not less than 0.08 mg g -1 The two components of physcion methyl ether-8-O-β-D-glucoside further contain a content of not less than 0.35 mg g -1 emodin-8-O-β-D-glucoside and not less than 0.09 mg g -1 These ingredients are inherent in the medicinal materials themselves and do not include any additional ingredients.

[0014] The present invention also provides a traditional Chinese medicine composition prepared according to the method for preparing the traditional Chinese medicine composition of the present invention. In some embodiments, a traditional Chinese medicine composition is provided, comprising aqueous extracts of Pollen Typhae, Salvia miltiorrhiza, Chuanxiong, Paeonia lactiflora, Crataegus pinnatifida, Alisma orientalis, and Codonopsis pilosula, and Polygonum multiflorum powder, wherein the Polygonum multiflorum powder is obtained by passing through a 24-80 mesh sieve.

[0015] The present invention helps to increase the content of the effective ingredients emodin-8-O-β-D-glucoside and physcion-8-O-β-D-glucoside in the final traditional Chinese medicine preparation composition by controlling the particle size range of Polygonum multiflorum, and further helps to provide a better traditional Chinese medicine preparation.

[0016] The present invention further provides a method for detecting emodin-8-O-β-D-glucoside and physcion-8-O-β-D-glucoside in the traditional Chinese medicine composition, which can effectively separate and detect more than five anthraquinone compounds contained in the traditional Chinese medicine composition at the same time.

[0017] Specifically, the present invention provides a quality control method for an important composition containing extracts of Pollen Typhae, Salvia miltiorrhiza, Chuanxiong, Paeonia lactiflora, Crataegus pinnatifida, Rhizoma Alismatis and Codonopsis pilosula and Polygonum multiflorum, wherein the method is a high performance liquid chromatography method, and the chromatographic conditions are:

[0018] Chromatographic column: reversed phase silica gel bonded phase chromatographic column

[0019] Mobile phase: acetonitrile (A)-0.1% phosphoric acid (B);

[0020] Gradient elution. Elution conditions are shown in Table 1.

[0021] Table 1 Gradient elution conditions

[0022] Time (min) Mobile phase A (%) Mobile phase B (%) 0～20 17→17 83→83 20～30 17→25 83→75 30～45 25→30 75→70 45～55 30→35 70→65 55～65 35→80 65→20 65～75 80→95 20→5

[0023] In some protocols, the chromatographic column was Agilent SB-C18 (250 mm × 4.6 mm, 5.0 μm); the column temperature was 30°C; and the flow rate was 1.0 mL min -1 ; Detection wavelength: 270nm.

[0024] The quality control method includes the preparation of reference solution, specifically, accurately weighing appropriate amounts of physcion-8-O-β-D-glucoside and physcion-8-O-β-D-glucoside reference substances, adding methanol to make the concentrations of 1.10 and 1.09 mg·mL, respectively. -1 Then take appropriate amount of the above reference substances, place them in a 10mL volumetric flask, and add dilute ethanol to make the concentrations of 5.29 and 2.63μg·mL respectively. -1 mixed reference solution.

[0025] The quality control method includes preparing the test solution, specifically taking 1g of the traditional Chinese medicine preparation composition, accurately weighing it, placing it in a 25mL volumetric flask, accurately adding 15mL of 70% ethanol, ultrasonically treating it for 30min, cooling it, and making up the volume to the mark with 70% ethanol. Shaking it well, filtering it through a microporous filter membrane (0.45μm), and taking the filtrate to obtain it.

[0026] The quality control method comprises the following steps: taking a Chinese medicine preparation composition, preparing a test solution, injecting the sample for measurement, recording the peak areas of the test substance in the reference solution and the test solution, and respectively calculating the contents of the components emodin-8-O-β-D-glucoside and physcion-8-O-β-D-glucoside.

[0027] The sieve numbers described in this application have the definition in the 2020 edition of the Chinese Pharmacopoeia as follows:

[0028] BRIEF DESCRIPTION OF THE DRAWINGS

[0029] Figure 1 : HPLC chart of the preparation composition of 65 mesh Polygonum multiflorum powder;

[0030] Figure 2 : HPLC chart of the preparation composition of 100 mesh Polygonum multiflorum powder;

[0031] Figure 3 : HPLC chart of 65 mesh Polygonum multiflorum powder;

[0032] Figure 4 : HPLC chart of 100 mesh Polygonum multiflorum powder. DETAILED DESCRIPTION

[0033] The present invention is further described below with reference to examples, but these examples are not intended to limit the scope of the present invention.

[0034] The Chinese medicine preparation described in the embodiment, wherein the prescription ratio of the medicinal material formula raw materials is 135 parts of Polygonum multiflorum, 110 parts of Pollen Typhae, 66 parts of Salvia miltiorrhiza, 66 parts of Paeonia lactiflora, 66 parts of Crataegus, 110 parts of Alisma orientalis, and 36 parts of Codonopsis pilosula.

[0035] (1) Preparation of reference Chinese medicine preparations

[0036] According to the method of CN1317003C, 135 grams of Polygonum multiflorum, 110 grams of Pollen Typhae, 66 grams of Salvia miltiorrhiza, 66 grams of Paeonia lactiflora, 66 grams of Crataegus pinnatifida, 110 grams of Rhizoma Alismatis, and 36 grams of Codonopsis pilosula were prepared. The specific preparation process is as follows: first, Polygonum multiflorum was crushed and passed through a 100-mesh sieve to form a powder for later use; then, the remaining seven Chinese medicinal materials were decocted twice with 5 times the amount of water each time, each time for 2 hours; the decoctions were combined, filtered, and the filtrate was concentrated under reduced pressure to a thick paste with a relative density of 1.30 to 1.32 (60° C.) for later use; the powder was evenly mixed with the thick paste, dried at 80° C., and then crushed and passed through a 100-mesh sieve to form a powder; an appropriate amount of ethanol was added to the powder to granulate, dried, and granulated to obtain a Chinese medicine preparation composition, which was divided into 1000 No. 1 capsules to obtain the finished medicine.

[0037] (2) Detection method of active ingredients of Polygonum multiflorum in traditional Chinese medicine preparation composition

[0038] When establishing the research of this method, the test sample used was a Chinese medicine preparation composition prepared according to the method used in the preparation of the reference Chinese medicine preparation.

[0039] 1) Chromatographic conditions

[0040] Referring to the determination method of Polygonum multiflorum in the 2020 edition of the Chinese Pharmacopoeia, the chromatographic conditions are as follows:

[0041] Column: Agilent SB-C 18 (250 mm × 4.6 mm, 5.0 μm); mobile phase: acetonitrile (A)-0.1% phosphoric acid (B); column temperature 30°C; flow rate 1.0 mL min -1 Detection wavelength: 270 nm; gradient elution. Elution conditions are shown in Table 1.

[0042] Table 1 Gradient elution conditions

[0043] Time (min) Mobile phase A (%) Mobile phase B (%) 0～20 17→17 83→83 20～30 17→25 83→75 30～45 25→30 75→70 45～55 30→35 70→65 55～65 35→80 65→20 65～75 80→95 20→5

[0044] 2) Preparation of reference solution

[0045] Accurately weigh appropriate amounts of physcion-8-O-β-D-glucoside and physcion-8-O-β-D-glucoside reference substances and add methanol to make the concentrations 1.10 and 1.09 mg mL, respectively.-1 Then take appropriate amount of the above reference substances, place them in a 10mL volumetric flask, and add dilute ethanol to make the concentrations of 5.29 and 2.63μg·mL respectively. -1 mixed reference solution.

[0046] 3) Preparation of test solution

[0047] Take 1 g of the traditional Chinese medicine preparation composition prepared in the preparation of the reference traditional Chinese medicine preparation, accurately weigh it, place it in a 25 mL volumetric flask, accurately add 15 mL of 70% ethanol, ultrasonically treat it for 30 minutes, let it cool, and dilute it to the scale with 70% ethanol. Shake well, filter it through a microporous filter membrane (0.45 μm), and take the filtrate to obtain it.

[0048] 4) Preparation of negative sample solution

[0049] Take 1 g of the negative sample lacking Polygonum multiflorum, weigh accurately, and prepare it according to the test sample method under 2.4 to obtain the negative sample solution.

[0050] 5) Content determination

[0051] Take the traditional Chinese medicine preparation composition, prepare the test solution, inject the sample for measurement, record the peak area of ​​the test substance in the reference solution and the test solution, and calculate the content of physcion-8-O-β-D-glucoside and physcion methyl ether-8-O-β-D-glucoside components (peak time is about 40min and 48min), respectively.

[0052] 6) Methodological investigation

[0053] The results of linear relationship investigation showed that with the injection concentration as the abscissa (X) and the peak area as the ordinate (Y), the regression equation of emodin-8-O-β-D-glucoside was: y = 0.5554x-0.1071, r = 0.9997; the regression equation of physcion-8-O-β-D-glucoside was: y = 0.572x-0.0469, r = 0.9998, indicating that the peak area of ​​emodin-8-O-β-D-glucoside was 1.32-11.03 μg·mL -1 In the range of physcion-8-O-β-D-glucoside, the range was 0.66~5.47μg·mL -1 Within the specified range, there is a good linear relationship between the injection concentration and the peak area.

[0054] The results of the instrument precision test showed that the RSD values ​​of the peak areas of each component were less than 1%, indicating that the precision of the instrument was good.

[0055] In the stability test, the test solution of the Chinese medicine preparation composition was injected into the liquid chromatograph at 0, 3, 6, 9, 12, 24, 48, and 60 hours, 10 μL each time, and the sample was injected and measured. The RSD value of the peak area was calculated. The results showed that the RSD value of the peak area of ​​each component in the test solution within 60 hours was less than 3%, indicating that the solution had good stability.

[0056] Repeatability study: 1g of the same batch of Chinese medicine preparation was prepared in 7 replicates to prepare the test solution. 10μL of the sample was injected for determination and the content was calculated. The results showed that the average content of emodin-8-O-β-D-glucoside was 0.1466mg·g -1 The average content of physcion-8-O-β-D-glucoside was 0.0358 mg·g- 1 The RSD values ​​of the contents of each component were all less than 1%, and the repeatability of this method was good.

[0057] To investigate the recovery rate of sample addition, 0.5 g of the Chinese medicine preparation composition was taken, 6 portions were prepared in parallel, accurately weighed, and placed in a volumetric flask. An appropriate amount of the reference solution was added at a ratio of 1:1 (equivalent to a 100% concentration level) to prepare a sample recovery rate test solution. After sampling and determination, the average recovery rate and RSD value of each component were calculated. The results showed that the average recoveries of emodin-8-O-β-D-glucoside and emodin methyl ether-8-O-β-D-glucoside were 107.56% and 102.78%, respectively, and the RSD values ​​were 0.41% and 1.38%, respectively, further illustrating that the determination method has good accuracy.

[0058] In the investigation of intermediate precision, 6 portions of 1 g of the Chinese medicine preparation composition were taken in parallel, accurately weighed, and placed in a volumetric flask to prepare the test solution, with two portions as a group. The RSD values ​​of the peak area of ​​the preparation under different operators, different instruments and different chromatographic columns were examined. The results showed that in the intermediate precision test, the RSD values ​​of the content of each component were less than 5% through tests on different operators, different instruments and different chromatographic columns, indicating that this determination method has good applicability.

[0059] For the durability investigation, 6 portions of 1.0 g of the Chinese medicine preparation composition were accurately weighed to prepare the test solution, with two portions as a group. The RSD values ​​of the peak areas of the preparations at different flow rates, different column temperatures, and different detection wavelengths were examined. The results showed that during the durability investigation, the RSD values ​​of the contents of emodin-8-O-β-D-glucoside and emodin methyl ether-8-O-β-D-glucoside were all less than 3%.

[0060] (3) Detection method of active ingredients of the medicinal material Polygonum multiflorum

[0061] 1) Chromatographic conditions

[0062] The same as the detection method of the active ingredients of Polygonum multiflorum in the aforementioned traditional Chinese medicine preparation.

[0063] 2) Preparation of reference solution

[0064] The same as the detection method of the active ingredients of Polygonum multiflorum in the aforementioned traditional Chinese medicine preparation.

[0065] 3) Preparation of test solution

[0066] Take 0.5 g of Polygonum multiflorum powder, accurately weigh it, place it in a 25 mL volumetric flask, accurately add 15 mL of 70% ethanol, ultrasonically treat it for 30 minutes, let it cool, dilute to the scale with 70% ethanol, shake well, filter it through a microporous filter membrane (0.45 μm), and take the filtrate to obtain the product.

[0067] 4) Content determination

[0068] Take the Polygonum multiflorum powder to be measured respectively, prepare the test solution according to the above method, inject and measure according to the above chromatographic conditions, and calculate the contents of physcion-8-O-β-D-glucoside and physcion methyl ether-8-O-β-D-glucoside respectively.

[0069] 5) Methodological investigation

[0070] The same method as the detection method of the active ingredients of Polygonum multiflorum in the aforementioned traditional Chinese medicine preparations confirmed that the present method had a good linear relationship between the injection concentration and the peak area, instrument precision, stability, repeatability, sample recovery rate, intermediate precision, and durability.

[0071] (4) Effects of different particle sizes of Polygonum multiflorum on the content of components in traditional Chinese medicine preparations

[0072] 1) Preparation of thick paste

[0073] In addition to Polygonum multiflorum, the traditional Chinese medicine prescription includes 110 grams of Pollen Typhae, 66 grams of Salvia miltiorrhiza, 66 grams of Paeonia lactiflora, 66 grams of Crataegus pinnatifida, 110 grams of Alisma orientalis, and 36 grams of Codonopsis pilosula. Add 5 times the amount of water, reflux extraction twice, each time for two hours, combine the extracts, filter, and decompress the filtrate to a thick paste with a relative density of 1.30-1.32 (60°C) for later use.

[0074] 2) Preparation of Polygonum multiflorum powder with different particle sizes

[0075] An appropriate amount of Polygonum multiflorum medicinal material is taken, crushed, and sieved using a No. 4 (65 mesh) and a No. 6 (100 mesh) pharmacopoeia sieve. Samples of each pharmacopoeia sieve are weighed, sealed, and stored to prepare 65-mesh Polygonum multiflorum powder and 100-mesh Polygonum multiflorum powder, respectively, for later use. The 65-mesh Polygonum multiflorum powder can completely pass through the No. 4 sieve and is mixed with 20% of powder that can pass through the No. 6 sieve; the 100-mesh Polygonum multiflorum powder is powder that completely passes through the No. 6 sieve.

[0076] 3) Preparation of Chinese medicine composition samples

[0077] About 15 g of Polygonum multiflorum powder, respectively passed through 65-mesh and 100-mesh sieves, were added, the Polygonum multiflorum powder was mixed with the thick paste in a ratio of 1:1, stirred evenly, dried in a forced air drying oven at 80°C, crushed, passed through a 100-mesh sieve, granulated with ethanol, dried in a forced air drying oven at 80°C, crushed, and passed through an 80-mesh sieve to obtain a sample of a traditional Chinese medicine preparation composition. The results are shown in Table 2.

[0078] Table 2 Investigation of samples of different particle sizes of Polygonum multiflorum powder preparations

[0079]

[0080]

[0081] 4) Determination of the content of Polygonum multiflorum powder of different particle sizes and its preparation composition

[0082] Take 0.5 g each of the Polygonum multiflorum powder passed through 65-mesh and 100-mesh sieves under item 2), accurately weigh them, and determine the content according to the method under "Detection method of active ingredients in the medicinal material Polygonum multiflorum".

[0083] Take 1 g of each sample of the preparation composition prepared by mixing the Polygonum multiflorum powder passed through 65 mesh and 100 mesh sieves under item 3), accurately weigh them, and determine the content according to the method under "Detection method of active ingredients of Polygonum multiflorum in traditional Chinese medicine preparation compositions".

[0084] The results are shown in Table 3 and Appendix Figure 1-4 .

[0085] Table 3 Content of ingredients in samples of Polygonum multiflorum powder preparations with different particle sizes (mg·g -1 )

[0086]

[0087] The experimental results show that the use of Polygonum multiflorum powder with a larger particle size passing through a 65-mesh sieve can help increase the content of effective chemical components in traditional Chinese medicine preparations, while powder with too small a particle size is not conducive to increasing the content of effective chemical components.

[0088] The present invention controls the particle size of Polygonum multiflorum powder, significantly reduces the decomposition of heat-sensitive anthraquinone glycosides in the subsequent drying and granulation process, and ensures that the content of emodin-8-O-β-D-glucoside in the final preparation is ≥0.35 mg·g -1 , Physcion methyl ether-8-O-β-D-glucoside ≥ 0.09 mg·g -1 , which is more than 40% higher than the 100 mesh process.

[0089] (5) Preparation of the Chinese medicine preparation of the present invention

[0090] Take 135 grams of Polygonum multiflorum, 110 grams of Pollen Typhae, 66 grams of Salvia miltiorrhiza, 66 grams of Paeonia lactiflora, 66 grams of Crataegus pinnatifida, 110 grams of Rhizoma Alismatis, and 36 grams of Codonopsis pilosula. The specific preparation process is as follows: first, grind Polygonum multiflorum through a 65-mesh sieve to form a powder for later use; then take the remaining seven Chinese medicinal materials, add 5 times the amount of water each time, and decoct twice for 2 hours each time; combine the decoctions, filter, and concentrate the filtrate under reduced pressure to a thick paste with a relative density of 1.30 to 1.32 (60° C.) for later use; mix the powdered medicine and the thick paste evenly, dry at 80° C., grind, and pass through a 100-mesh sieve to form a powder; add an appropriate amount of ethanol to the powder to granulate, dry, and reconstitute the granules to prepare a Chinese medicine preparation composition, which is then divided into 1000 No. 1 capsules to obtain the finished medicine.

Claims

1. A method for preparing a Chinese medicine composition, characterized in that: Pollen typhae, salvia miltiorrhiza, chuanxiong, red peony root, hawthorn, oriental rhizome and codonopsis pilosula are extracted with water, and the obtained extract is combined and mixed with polygonum multiflorum powder to prepare a traditional Chinese medicine composition, wherein the polygonum multiflorum powder is obtained by passing through a 24-80 mesh sieve.

2. The preparation method according to claim 1, characterized in that The Polygonum multiflorum powder is obtained by grinding the Polygonum multiflorum medicinal material and then passing it through a 50-80 mesh sieve, specifically through a 50 mesh, 65 mesh, and 80 mesh sieve; further, the powder of the Polygonum multiflorum powder that can pass through a 100 mesh sieve is ≤50%, and the powder of the Polygonum multiflorum powder that can pass through a 100 mesh sieve is ≤20%.

3. The preparation method according to claim 1, characterized in that The dosage of Polygonum multiflorum, Pollen Typhae, Salvia miltiorrhiza, Chuanxiong, Red Peony Root, Crataegus pinnatifida, Alisma orientalis and Codonopsis pilosula is as follows: 130-140 parts of Polygonum multiflorum, 105-115 parts of Pollen Typhae, 60-70 parts of Salvia miltiorrhiza, 60-70 parts of Chuanxiong, 60-70 parts of Red Peony Root, 60-70 parts of Crataegus pinnatifida, 100-120 parts of Alisma orientalis and 30-40 parts of Codonopsis pilosula.

4. The preparation method according to claim 1, characterized in that The dosage of Polygonum multiflorum, Pollen Typhae, Salvia miltiorrhiza, Chuanxiong, Red Peony Root, Crataegus pinnatifida, Alisma orientalis and Codonopsis pilosula is as follows: 135 parts of Polygonum multiflorum, 110 parts of Pollen Typhae, 66 parts of Salvia miltiorrhiza, 66 parts of Chuanxiong, Red Peony Root, 66 parts of Crataegus pinnatifida, 110 parts of Alisma orientalis and 36 parts of Codonopsis pilosula.

5. The preparation method according to claim 1, characterized in that The extract is concentrated into a thick paste before being combined with the Polygonum multiflorum powder. Preferably, the density of the thick paste is 1.08-1.35 at 50-60°C, preferably 1.10-1.32, and further 1.30-1.

32.

6. The preparation method according to claim 1, characterized in that The number of extractions is 1 to 3 times, preferably 2 times; the extraction time is 1 to 3 hours, preferably 2 hours; the extraction temperature is 80 to 100° C., preferably back extraction; the amount of water used for extraction is 3 to 10 times the weight of the medicinal material, preferably 4 to 7 times, and more preferably 5 times.

7. The preparation method according to claim 1, characterized in that The extract and the Polygonum multiflorum powder are combined and mixed, and then dried; preferably, the drying is carried out by heating at a temperature of 70-85° C. and by air drying; further, the drying is followed by pulverization, ethanol granulation, and drying at 70-85° C. after granulation.

8. The preparation method according to claim 1, characterized in that The Chinese medicine composition contains no less than 0.30 mg·g -1 emodin-8-O-β-D-glucoside and not less than 0.08 mg g -1 The two components of physcion methyl ether-8-O-β-D-glucoside further contain a content of not less than 0.35 mg g -1 emodin-8-O-β-D-glucoside and not less than 0.09 mg g -1 Physcion methyl ether-8-O-β-D-glucoside; the above-mentioned component is possessed by the medicinal material itself.

9. The preparation method according to claim 8, characterized in that The contents of the emodin-8-O-β-D-glucoside and physcion-8-O-β-D-glucoside were detected by high performance liquid chromatography (HPLC) under the following chromatographic conditions: Chromatographic column: C18 reverse phase silica gel bonded phase column Mobile phase: acetonitrile (A)-0.1% phosphoric acid (B); Gradient elution, elution conditions are: Column temperature 30°C; flow rate 1.0 mL min -1 ; Detection wavelength: 270nm; The reference solution was prepared as follows: appropriate amounts of physcion-8-O-β-D-glucoside and physcion-8-O-β-D-glucoside reference substances were weighed and methanol was added to make the concentrations 1.10 and 1.09 mg mL, respectively. -1 Then take appropriate amount of the above reference substances, place them in a 10mL volumetric flask, and add dilute ethanol to make the concentrations of 5.29 and 2.63μg·mL respectively. -1 Mixed reference solution; The test solution was prepared as follows: 1 g of the Chinese medicine preparation composition prepared in the preparation of the reference Chinese medicine preparation was accurately weighed and placed in a 25 mL volumetric flask. 15 mL of 70% ethanol was accurately added and ultrasonically treated for 30 min. The solution was cooled and diluted to the mark with 70% ethanol. The solution was shaken and filtered to obtain the filtrate.

10. A Chinese medicine composition comprising water extracts of Pollen Typhae, Salvia miltiorrhiza, Ligusticum chuanxiong, Paeonia lactiflora, Crataegus pinnatifida, Rhizoma Alismatis and Codonopsis pilosula and Polygonum multiflorum powder, characterized in that: The Polygonum multiflorum powder is obtained by passing through a 24-80 mesh sieve.

11. The Chinese medicine composition according to claim 10, prepared according to the method according to claims 1 to 8.

Images