Active component of traditional chinese medicine composition for strengthening spleen and unblocking orifices and preparation method therefor

Abstract

Active components of a traditional Chinese medicine composition for tonifying Qi and consolidating the exterior, strengthening the spleen and unblocking orifices. The traditional Chinese medicine composition is prepared from Astragali radix, Atractylodis macrocephalae rhizoma, Saposhnikoviae radix, Magnoliae flos, Angelicae dahuricae radix, Alpiniae officinarum rhizoma, Notopterygii rhizoma et radix, Moutan cortex, Cicadae periostracum, Mume fructus and Glycyrrhizae radix et rhizoma. The active components of the traditional Chinese medicine composition is composed of a volatile oil inclusion compound extracted from Atractylodis macrocephalae rhizoma, Saposhnikoviae radix, Alpiniae officinarum rhizoma, Notopterygii rhizoma et radix and Magnoliae flos by means of steam distillation; an aqueous extract obtained by means of merging the distilled aqueous solution and a water decoction of Astragali radix, Cicadae periostracum and Glycyrrhizae radix et rhizoma; an alcohol extract of Angelicae dahuricae radix and Mume fructus; and sterilized powder of Moutan cortex. A high-temperature instantaneous sterilization process used on Moutan cortex effectively controls the microbial limit, and has no influence on the overall quality and the content of effective components of the medicine.

Description

Active ingredient of a spleen-strengthening and orifice-opening Chinese medicine composition and preparation method thereof

[0001] This patent application claims priority to Chinese patent application No. CN202410097164.4 filed on January 24, 2024. The disclosure of the prior application is incorporated herein by reference in its entirety. Technical Field

[0002] The present application relates to an active component of a traditional Chinese medicine composition for invigorating qi, strengthening the exterior, invigorating the spleen and opening the orifices, and a preparation method thereof, and belongs to the field of application of Chinese herbal medicines. Background Art

[0003] A traditional Chinese medicine composition for invigorating qi, strengthening exterior, invigorating spleen and clearing orifices is composed of astragalus, atractylodes, siler, magnolia, angelica, galangal, notopterygium wilfordii, peony bark, cicada shell, black plum, liquorice and other traditional Chinese medicines.

[0004] The preparation process of this Chinese medicine composition involves the direct use of raw Chinese medicine powder. Raw Chinese medicine powder is made by crushing Chinese medicinal materials and has a high bacterial content. Therefore, sterilization is a key step in the production process of raw Chinese medicine powder preparations.

[0005] Cobalt-60 (60Co) irradiation is a highly effective and rapid sterilization method. It utilizes high-energy radiation generated by gamma-ray ionization. During the energy transfer process, it produces powerful physical and biological effects, achieving insecticide, sterilization, and inhibition of physiological processes. Its principle is to destroy DNA and RNA in microbial cells, causing them to degrade and lose their ability to synthesize proteins and genetics, thereby killing the cells. Traditional Chinese medicines, due to their complex raw material sources, are susceptible to microbial contamination. This results in some raw powders that are not suitable for high-temperature processing being prone to failing to meet microbial limits. Irradiation sterilization, due to its combined cold treatment, strong penetrating power, simple operation, and continuous operation, is increasingly favored by the traditional pharmaceutical industry.

[0006] During the pilot and clinical stages of this product, 60Co irradiation was used for sterilization. However, due to the simple pre-treatment and high bacterial content of traditional Chinese medicine, the irradiation dose had to be increased to achieve sterilization, sometimes reaching as high as tens of kGy. Sometimes, after irradiation sterilization, the raw powder of the traditional Chinese medicine failed bacterial testing and required re-irradiation, or further irradiation after the finished product was manufactured, which is a cumbersome operation. Furthermore, the applicant found that irradiation (10 kGy) significantly affected the quality of some products (with composition changes exceeding 20%), such as tanshinone IIA in Danshen, chlorogenic acid in Chrysanthemum, ferulic acid in Chuanxiong, and polysaccharides in Poria.

[0007] When applying for production approval for new Chinese medicines, the review center also requires systematic research on 60Co irradiation sterilization, including the types of microorganisms present in the medicinal materials, the level of contamination before and after sterilization, the degree of irradiation condition nonuniformity, changes in indicator components, and the establishment of detection standards for irradiation residues in irradiated samples. In practice, it is difficult to grasp the measurement of irradiation dosage, the cumulative effect of repeated irradiation of raw materials, semi-finished products, and finished products, as well as the follow-up inspection and evaluation after irradiation. Technical issues

[0008] The applicant has developed a traditional Chinese medicine composition for invigorating qi, strengthening the exterior, and strengthening the spleen and opening the orifices. This composition consists of 10-20 parts astragalus, 5-15 parts atractylodes, 5-15 parts siler, 5-15 parts magnolia, 5-15 parts angelica, 5-15 parts galangal, 5-15 parts notopterygium wilfordii, 5-15 parts moutan bark, 5-15 parts cicada slough, 5-15 parts ebony plum, and 4-8 parts liquorice (parts by weight, the same below). The applicant's prior patent 202110966782.4 provides a method for preparing this composition. In this method, the moutan bark is pulverized into a fine powder, sterilized, and set aside. Subsequent research and development revealed numerous problems with the original preparation method. Therefore, the applicant has provided a new preparation method for this composition, as well as the active ingredients obtained by this new preparation method. Technical Solutions

[0009] The applicant provides an active component of a traditional Chinese medicine composition for invigorating qi, strengthening the exterior, and strengthening the spleen and opening the orifices. The traditional Chinese medicine composition comprises 10-20 parts of astragalus, 5-15 parts of atractylodes, 5-15 parts of siler, 5-15 parts of magnolia, 5-15 parts of angelica, 5-15 parts of galangal, 5-15 parts of notopterygium, 5-15 parts of moutan bark, 5-15 parts of cicada slough, 5-15 parts of ebony plum, and 4-8 parts of liquorice. The active component of the traditional Chinese medicine composition is prepared by the following steps:

[0010] A. Crush the Atractylodes macrocephala, Notopterygium wilfordii, and Magnolia flos in the formula; weigh the Atractylodes macrocephala, Saposhnikovia divaricata, Alpinia officinalis, Notopterygium wilfordii, and Magnolia flos according to the prescribed amount, add 6-12 times the amount of water, and extract the volatile oil by steam distillation for 6-10 hours. The volatile oil is collected and included in the solution for later use; the distilled aqueous solution is filtered to obtain a first aqueous extract;

[0011] B. Weigh astragalus, cicada shell, and liquorice according to the prescribed amount, add 9-13 times the amount of water, and boil three times for 1 hour each time. Filter to obtain the second aqueous extract;

[0012] C. combining the first aqueous extract and the second aqueous extract, concentrating under reduced pressure to a relative density of 1.15 to 1.20 to obtain an aqueous extract for later use;

[0013] D. Weigh angelica dahurica and black plum according to the prescribed amount, add 5-8 times the amount of 50-80% ethanol, extract twice, the first time for 2 hours and the second time for 1.5 hours, filter, recover ethanol under reduced pressure, and concentrate under reduced pressure to a relative density of 1.15-1.20 to obtain an alcohol extract, which is set aside;

[0014] E. Crush the peony bark coarsely, sterilize, and grind into fine powder for later use;

[0015] The volatile oil inclusion compound obtained in step A, the water extract obtained in step C, the alcohol extract obtained in step D and the peony bark sterilized powder obtained in step E together constitute the active components of the traditional Chinese medicine composition.

[0016] It should be noted that the description of several times the amount of solvent in this application refers to the mass of the solvent being several times the mass of the raw medicinal materials. If an operation is performed multiple times, then the several times the amount of solvent refers to the amount of solvent added for each operation. The solvents used in this application include water and ethanol. For example, "Weigh astragalus, cicada slough, and licorice according to the prescribed amount, add 9-13 times the amount of water and decoct three times" means that the mass of water added during each decoction is 9-13 times the total mass of the raw medicinal materials astragalus, cicada slough, and licorice, and decoct three times in total.

[0017] In one embodiment, the Chinese medicine composition for invigorating qi, strengthening exterior, invigorating spleen and opening orifices can be composed of 10 parts of astragalus, 15 parts of white atractylodes, 5 parts of siler, 15 parts of magnolia, 5 parts of angelica, 15 parts of galangal, 5 parts of notopterygium, 15 parts of moutan bark, 5 parts of cicada shell, 15 parts of black plum and 4 parts of liquorice.

[0018] In one embodiment, the Chinese medicine composition for invigorating qi, consolidating exterior, strengthening spleen and opening orifices can also be composed of 20 parts of astragalus, 5 parts of white atractylodes, 15 parts of siler, 5 parts of magnolia, 15 parts of angelica, 5 parts of galangal, 15 parts of notopterygium, 5 parts of moutan bark, 15 parts of cicada shell, 5 parts of black plum, and 8 parts of licorice.

[0019] In one embodiment, the Chinese medicine composition for invigorating qi, consolidating exterior, strengthening spleen and opening orifices can also be composed of 10.3 parts of astragalus, 6.85 parts of white atractylodes, 6.85 parts of siler, 6.85 parts of magnolia, 6.85 parts of angelica, 6.85 parts of galangal, 6.85 parts of notopterygium, 6.85 parts of moutan bark, 6.85 parts of cicada shell, 6.85 parts of black plum, and 4.1 parts of licorice.

[0020] In one embodiment, the Chinese medicine composition for invigorating qi, consolidating exterior, strengthening spleen and opening orifices can also be composed of 15 parts of astragalus, 10 parts of white atractylodes, 10 parts of siler, 10 parts of magnolia, 10 parts of angelica, 10 parts of galangal, 10 parts of notopterygium, 10 parts of moutan bark, 10 parts of cicada shell, 10 parts of black plum, and 6 parts of licorice.

[0021] The active components prepared from the traditional Chinese medicine composition described in the present application can be further prepared into capsules, tablets, granules or pills.

[0022] The preparation process of the active ingredient into tablets is as follows:

[0023] A. Crush the Atractylodes macrocephala, Notopterygium wilfordii, and Magnolia flos in the formula; weigh the Atractylodes macrocephala, Saposhnikovia divaricata, Alpinia officinalis, Notopterygium wilfordii, and Magnolia flos according to the prescribed amount, add 6-12 times the amount of water, and extract the volatile oil by steam distillation for 6-10 hours. The volatile oil is collected and included in the solution for later use; the distilled aqueous solution is filtered to obtain a first aqueous extract;

[0024] B. Weigh astragalus, cicada shell, and liquorice according to the prescribed amount, add 9-13 times the amount of water, and boil three times for 1 hour each time. Filter to obtain the second aqueous extract;

[0025] C. combining the first aqueous extract and the second aqueous extract, concentrating under reduced pressure to a relative density of 1.15 to 1.20 to obtain an aqueous extract for later use;

[0026] D. Weigh angelica dahurica and black plum according to the prescribed amount, add 5-8 times the amount of 50-80% ethanol, extract twice, the first time for 2 hours and the second time for 1.5 hours, filter, recover ethanol under reduced pressure, and concentrate under reduced pressure to a relative density of 1.15-1.20 to obtain an alcohol extract, which is set aside;

[0027] E. Crush the peony bark coarsely, sterilize, and grind into fine powder for later use;

[0028] F is made by using peony bark fine powder as the base material, granulating, sizing and tableting according to conventional technology.

[0029] The preferred preparation process for the active ingredient to be made into tablets is:

[0030] A. Crush the Atractylodes macrocephala and Notopterygium wilfordii in the formula, and crush and shell the Magnolia buds; weigh the Atractylodes macrocephala, Saposhnikovia divaricata, Alpinia officinalis, Notopterygium wilfordii, and Magnolia buds according to the prescribed amount, add 8-10 times the amount of water, and extract the volatile oil by steam distillation for 8 hours. The volatile oil is collected and included in the solution for later use; the distilled aqueous solution is filtered to obtain the first aqueous extract;

[0031] B. Weigh astragalus, cicada shell, and liquorice according to the prescribed amount, add 10-12 times the amount of water, and boil three times for 1 hour each time. Filter to obtain the second aqueous extract;

[0032] C. combining the first aqueous extract and the second aqueous extract, concentrating under reduced pressure to a relative density of 1.15 to 1.20 to obtain an aqueous extract for later use;

[0033] D. Weigh angelica dahurica and black plum according to the prescribed amount, add 6-7 times the amount of 60-70% ethanol, extract twice, the first time for 2 hours and the second time for 1.5 hours, filter, recover ethanol by vacuum concentration, and concentrate under reduced pressure to a relative density of 1.15-1.20 to obtain an alcohol extract, which is set aside;

[0034] E. Crush the peony bark coarsely, sterilize, and grind into fine powder for later use;

[0035] F is made by using peony bark fine powder as the base material, granulating, sizing and tableting according to conventional technology.

[0036] The active component of the traditional Chinese medicine composition provided by the applicant comprises the following steps: coarsely crushing the peony bark, sterilizing the peony bark by a high-temperature instantaneous sterilization process, and then pulverizing the peony bark into fine powder.

[0037] The high-temperature instantaneous sterilization temperature is 170-180 degrees Celsius and the time is 5-10 seconds.

[0038] The greatest contribution of this application to the prior art is the improvement of the sterilization process of Paeonia suffruticosa Andrews.

[0039] During the preparation process of the active components of the Chinese medicine composition, since the paeonol contained in the peony bark is a heat-sensitive component, it cannot be used as medicine in the form of extraction. It needs to be crushed into fine powder in the preparation and then used as the original Chinese medicine powder. Therefore, the microbial limit must comply with regulations.

[0040] Because the microbial limits in Moutan Bark Powder failed to meet quality control requirements, sterilization was required. Prior to the start of clinical trials, Moutan Bark Powder was sterilized using 60Co irradiation, with an irradiation dose not exceeding 3 kGy. However, irradiation sterilization is subject to numerous uncertainties, as described in the background article. Therefore, the applicant urgently sought a better alternative to irradiation for sterilizing the product.

[0041] Paeonol, a major component of peony bark, has antibacterial, analgesic, and sedative properties. To ensure consistent efficacy while maintaining drug quality and hygiene, an optimal sterilization method is crucial. Prior art indicates that paeonol is heat-sensitive and volatile, volatilizing at temperatures of 48-49 degrees Celsius and reducing its efficacy. During autoclaving, high temperatures cause some paeonol to volatilize, reducing its content. Therefore, prior art suggests that high temperatures should be avoided when sterilizing traditional Chinese medicines containing paeonol.

[0042] The applicant conducted extensive research on sterilization methods for peony bark. Using paeonol content and microbial limits as evaluation indicators, they compared pulsed light sterilization and high-temperature instantaneous sterilization. Based on the test results, they determined that high-temperature instantaneous sterilization should be used for peony bark slices. This process had no significant impact on the quality of the peony bark slices, and the microbial limits met regulatory requirements. High-temperature instantaneous sterilization can be used to control the microbial content of peony bark slices at the source, eliminating the need for irradiation sterilization of peony bark powder. Beneficial effects

[0043] The present application provides an active ingredient of a traditional Chinese medicine composition for invigorating qi, strengthening the exterior, strengthening the spleen and opening the orifices. During the preparation process, the active ingredient is processed by first coarsely crushing the peony bark, which is directly used as a traditional Chinese medicine raw powder, and then sterilizing it with a high-temperature instantaneous sterilization process, and then crushing it into a fine powder. High-temperature instantaneous sterilization technology has the advantages of energy saving and high efficiency, safety and reliability, and maximizing the preservation of the natural and effective properties of the raw materials. The present application uses paeonol content and microbial limit as evaluation indicators, and adopts a high-temperature instantaneous sterilization process to sterilize the coarsely crushed peony bark. The sterilization effect is good. The microbial limit in the peony bark after sterilization meets the regulations, and the effect on the paeonol content is small. Modes for Carrying Out the Invention

[0044] Test example

[0045] The research contents of the sterilization process of Paeonia suffruticosa are as follows:

[0046] Test Example 1: Research on Pulsed Light Sterilization Process

[0047] Pulsed intense light sterilization technology is a new generation of cold sterilization technology currently launched. It is a physical cold sterilization method that is pollution-free, has fast sterilization speed and high energy efficiency. Therefore, the feasibility of pulsed intense light sterilization process has been studied.

[0048] Test method: Take two batches of peony bark and use microbial count as an indicator to examine the changes in microbial count before and after sterilization of the material.

[0049] Test results: The test results are shown in Table 1.

[0050] Table 1 Pulse light sterilization test results

[0051]

[0052] Note: Batch Z200501-1 is the coarsely crushed pieces of M200327-1.

[0053] It can be seen from the test data that pulsed light sterilization technology has a certain sterilization effect on aerobic bacteria, but the sterilization effect is not ideal, and the effect on mold and bile-resistant Gram-negative bacteria is poor. The reason may be related to the structure of peony bark. Pulsed light sterilization has a better sterilization effect on the surface that can be irradiated by light. After the wood core of peony bark is removed, the shape is curled and hollow. The coarsely crushed particles and slices have places that cannot be irradiated by the light source, so the sterilization effect is poor. Therefore, pulsed light sterilization technology is no longer considered for sterilization.

[0054] Research on high temperature instantaneous sterilization process

[0055] High-temperature instantaneous sterilization is a physical sterilization technology that uses pure "superheated steam" (saturated steam) as the sterilization medium. Because "superheated steam" has good penetrability, rapid sterilization, safety, and reliability, high-temperature instantaneous sterilization technology is energy-efficient, safe, reliable, and economical, while also preserving the natural and effective properties of the raw materials to the greatest extent possible. Based on these factors, the high-temperature instantaneous sterilization process of Paeonia suffruticosa was studied.

[0056] Test Example 2: Small-scale study on high-temperature instantaneous sterilization

[0057] Test method: According to the characteristics of instantaneous sterilization equipment, microbial count and paeonol content were used as indicators to conduct a comprehensive investigation on material particle size, sterilization temperature and sterilization time.

[0058] Test results: The results are shown in Table 2.

[0059] Table 2 High temperature instantaneous sterilization test results

[0060]

[0061] Note: Samples 1 to 8 are samples of peony bark slices from batch Z191225-1 crushed into fine powder, and samples 17 to 24 are samples of peony bark slices from batch Z191225-1. The paeonol content of the above samples before sterilization is 2.8%; samples 9 to 16 are samples of coarsely crushed peony bark medicinal materials from batch M200327-1. The paeonol content before sterilization is 1.7%.

[0062] It can be seen from the test results that all 24 samples achieved good sterilization effects after sterilization, but the content of paeonol in fine powder decreased significantly after sterilization, while sterilization had no obvious effect on the content of paeonol in moutan bark slices and coarsely crushed moutan bark. Considering that the coarse crushing process is relatively simple, the medicinal materials were processed using the coarse crushing process; the sterilization effect was better when the sterilization temperature was between 170 and 180°C and the sterilization time was 5 to 10 seconds, and the sterilization effect at 165°C was worse than other sterilization temperatures. Therefore, a high-temperature instantaneous sterilization process was proposed to sterilize moutan bark, and the sterilization parameters were: sterilization temperature 175±5°C, sterilization time 5 to 10 seconds.

[0063] Test Example 3: High-temperature instantaneous sterilization pilot study

[0064] Three batches of pilot tests were conducted on peony bark according to the selected sterilization process. The test results are shown in Table 3.

[0065] Table 3 Results of pilot test on sterilization of peony bark

[0066]

[0067] The test results show that the microbial limits in moutan bark meet the regulations using the selected high-temperature instantaneous sterilization process, sterilization has little effect on the paeonol content, and test items such as moisture and identification also meet the regulations. This indicates that the high-temperature instantaneous sterilization process can be used to sterilize moutan bark.

[0068] Process Summary

[0069] After investigation of the sterilization process and pilot process verification of this product, the preparation process of this product was determined as follows: take the medicinal material of Paeonia suffruticosa murica, remove impurities mixed in the raw materials, clean it, coarsely crush it to less than 5mm, and then sterilize it at high temperature instantaneously (sterilization conditions: 175℃±5℃, 5-10 seconds).

[0070] Example:

[0071] Example 1:

[0072] Astragalus 100g, Atractylodes 150g, Saposhnikovia 50g, Magnolia 150g, Angelica dahurica 50g, Alpinia officinalis 150g, Notopterygium wilfordii 50g, Paeonia suffruticosa 150g, Cicada slough 50g, Plum 150g, Licorice root 40g

[0073] A. Crush the Atractylodes macrocephala and Notopterygium wilfordii in the formula, and crush and shell the Magnolia buds; weigh the Atractylodes macrocephala, Saposhnikovia divaricata, Alpinia officinalis, Notopterygium wilfordii, and Magnolia buds according to the prescribed amount, add 8 times the amount of water, and extract the volatile oil by steam distillation for 8 hours. The volatile oil is collected and included in the solution for later use; the distilled aqueous solution is filtered to obtain the first aqueous extract;

[0074] B. Weigh astragalus, cicada shell, and liquorice according to the prescribed amount, add 11 times the amount of water, and boil three times for 1 hour each time. Filter to obtain the second aqueous extract;

[0075] C. combining the first aqueous extract and the second aqueous extract, concentrating under reduced pressure to a relative density of 1.15 to 1.20 to obtain an aqueous extract for later use;

[0076] D. Weigh angelica dahurica and black plum according to the prescribed amount, add 6 times the amount of 60% ethanol, extract twice, each time for 1.5 hours, filter, recover ethanol by vacuum concentration, and concentrate under reduced pressure to a relative density of 1.15-1.20, and set aside;

[0077] E. Crush the peony bark coarsely, sterilize it at 170 degrees Celsius for 5 seconds, crush the sterilized coarse powder to obtain fine powder, and set aside;

[0078] F is made by using peony bark fine powder as the base material, granulating, sizing and tableting according to conventional technology.

[0079] Finished product inspection: microbial limit total aerobic bacteria (cfu / g) <100

[0080] Total number of molds and yeasts (cfu / g) <100

[0081] Escherichia coli (1g) not detected

[0082] Bile-resistant Gram-negative bacteria (1g) were not detected

[0083] Salmonella (10g) not detected

[0084] Paeonol content (%) 2.5

[0085] Example 2:

[0086] Astragalus 200g, Atractylodes macrocephala 50g, Saposhnikovia divaricata 150g, Magnolia officinalis 50g, Angelica dahurica 150g, Alpinia officinalis 50g, Notopterygium incisum 150g, Paeonia suffruticosa 50g, Cicada slough 150g, Plum 50g, Licorice root 80g

[0087] A. Crush the Atractylodes macrocephala and Notopterygium wilfordii in the formula, and crush and shell the Magnolia buds; weigh the Atractylodes macrocephala, Saposhnikovia divaricata, Alpinia officinalis, Notopterygium wilfordii, and Magnolia buds according to the prescribed amount, add 10 times the amount of water, and extract the volatile oil by steam distillation for 8 hours. The volatile oil is collected and included in the solution for later use; the distilled aqueous solution is filtered to obtain the first aqueous extract;

[0088] B. Weigh astragalus, cicada shell, and liquorice according to the prescribed amount, add 12 times the amount of water, and boil three times for 1 hour each time. Filter to obtain the second aqueous extract;

[0089] C. combining the first aqueous extract and the second aqueous extract, concentrating under reduced pressure to a relative density of 1.15 to 1.20 to obtain an aqueous extract for later use;

[0090] D. Weigh angelica dahurica and black plum according to the prescribed amount, add 7 times the amount of 70% ethanol, extract twice, the first time for 2 hours, the second time for 1.5 hours, filter, recover ethanol by vacuum concentration, and concentrate under reduced pressure to a relative density of 1.15-1.20, and set aside;

[0091] E. Crush the peony bark coarsely, sterilize it at 180 degrees Celsius for 10 seconds, crush the sterilized coarse powder to obtain fine powder, and set aside;

[0092] F is made by using peony bark fine powder as the base material, granulating according to conventional technology, wholeing the granules and filling them into capsules.

[0093] Finished product inspection: microbial limit total aerobic bacteria (cfu / g) <100

[0094] Total number of molds and yeasts (cfu / g) <100

[0095] Escherichia coli (1g) not detected

[0096] Bile-resistant Gram-negative bacteria (1g) were not detected

[0097] Salmonella (10g) not detected

[0098] Paeonol content (%) 2.7

[0099] Example 3:

[0100] Astragalus 103g, Atractylodes macrocephala 68.5g, Saposhnikovia divaricata 68.5g, Magnolia officinalis 68.5g, Angelica dahurica 68.5g, Alpinia officinalis 68.5g, Notopterygium incisum 68.5g, Paeonia suffruticosa 68.5g, Cicada slough 68.5g, Plum ebony root 68.5g, Licorice root 41g

[0101] A. Crush the Atractylodes macrocephala and Notopterygium wilfordii in the formula, and crush and shell the Magnolia buds; weigh the Atractylodes macrocephala, Saposhnikovia divaricata, Alpinia officinalis, Notopterygium wilfordii, and Magnolia buds according to the prescribed amount, add 8 times the amount of water, and extract the volatile oil by steam distillation for 8 hours. The volatile oil is collected and included in the solution for later use; the distilled aqueous solution is filtered to obtain the first aqueous extract;

[0102] B. Weigh astragalus, cicada shell, and liquorice according to the prescribed amount, add 11 times the amount of water, and boil three times for 1 hour each time. Filter to obtain the second aqueous extract;

[0103] C. combining the first aqueous extract and the second aqueous extract, concentrating under reduced pressure to a relative density of 1.15 to 1.20 to obtain an aqueous extract for later use;

[0104] D. Weigh angelica dahurica and black plum according to the prescribed amount, add 6 times the amount of 60% ethanol, extract twice, the first time for 2 hours, the second time for 1.5 hours, filter, recover ethanol by vacuum concentration, and concentrate under reduced pressure to a relative density of 1.15-1.20, and set aside;

[0105] E. Crush the peony bark coarsely, sterilize it at 175 degrees for 10 seconds, and then crush it to obtain fine powder for later use;

[0106] F is made by using peony bark fine powder as the base material, granulating, sizing and tableting according to conventional technology.

[0107] Finished product inspection: microbial limit total aerobic bacteria (cfu / g) <100

[0108] Total number of molds and yeasts (cfu / g) <100

[0109] Escherichia coli (1g) not detected

[0110] Bile-resistant Gram-negative bacteria (1g) were not detected

[0111] Salmonella (10g) not detected

[0112] Paeonol content (%) 2.7

[0113] Example 4:

[0114] Astragalus 150g, Atractylodes 100g, Saposhnikovia 100g, Magnolia 100g, Angelica dahurica 100g, Alpinia officinalis 100g, Notopterygium wilfordii 100g, Paeonia suffruticosa 100g, Cicada slough 100g, Plum 100g, Licorice 60g

[0115] A. Crush the Atractylodes macrocephala and Notopterygium wilfordii in the formula, and crush and shell the Magnolia buds; weigh the Atractylodes macrocephala, Saposhnikovia divaricata, Alpinia officinalis, Notopterygium wilfordii, and Magnolia buds according to the prescribed amount, add 10 times the amount of water, and extract the volatile oil by steam distillation for 8 hours. The volatile oil is collected and included in the solution for later use; the distilled aqueous solution is filtered to obtain the first aqueous extract;

[0116] B. Weigh astragalus, cicada shell, and liquorice according to the prescription amount, add 10 times the amount of water and boil three times, each time for 1 hour, filter, and obtain the second water extract;

[0117] C. combining the first aqueous extract and the second aqueous extract, concentrating under reduced pressure to a relative density of 1.15 to 1.20 to obtain an aqueous extract for later use;

[0118] D. Weigh angelica dahurica and black plum according to the prescribed amount, add 6 times the amount of 60% ethanol, extract twice, the first time for 2 hours, the second time for 1.5 hours, filter, recover ethanol by vacuum concentration, and concentrate under reduced pressure to a relative density of 1.15-1.20, and set aside;

[0119] E. Crush the peony bark coarsely, sterilize it at 180 degrees Celsius for 5 seconds, and then crush it to obtain fine powder for later use;

[0120] F uses peony bark fine powder as the base material, granulates according to conventional technology, and granules are obtained.

[0121] Finished product inspection: microbial limit total aerobic bacteria (cfu / g) <100

[0122] Total number of molds and yeasts (cfu / g) <100

[0123] Escherichia coli (1g) not detected

[0124] Bile-resistant Gram-negative bacteria (1g) were not detected

[0125] Salmonella (10g) not detected

[0126] Paeonol content (%) 2.7

[0127] The above description is only a preferred embodiment of the present application and is not intended to limit the present application. Any modifications, equivalent replacements or improvements made within the spirit and principles of the present application should be included in the scope of protection of the present application.

Claims

1. The active components of a traditional Chinese medicine composition for replenishing qi and strengthening the superficies, invigorating the spleen and dredging the orifices. The traditional Chinese medicine composition consists of 10 - 20 parts of Astragalus membranaceus, 5 - 15 parts of Atractylodes macrocephala, 5 - 15 parts of Saposhnikovia divaricata, 5 - 15 parts of Magnolia officinalis var. biloba, 5 - 15 parts of Angelica dahurica, 5 - 15 parts of Alpinia officinarum, 5 - 15 parts of Notopterygium incisum, 5 - 15 parts of Paeonia suffruticosa, 5 - 15 parts of Cryptotympana pustulata, 5 - 15 parts of Prunus mume, and 4 - 8 parts of Glycyrrhiza uralensis. The active components of the traditional Chinese medicine composition are prepared by the following steps: A. Coarsely crush Atractylodes macrocephala and Notopterygium incisum in the formula, and coarsely crush Magnolia officinalis var. biloba. Weigh Atractylodes macrocephala, Saposhnikovia divaricata, Alpinia officinarum, Notopterygium incisum, and Magnolia officinalis var. biloba according to the prescription amount, add 6 - 12 times the amount of water, extract the volatile oil by steam distillation for 6 - 10 hours, collect the volatile oil, and reserve it after inclusion; filter the aqueous solution after distillation to obtain the first water extract for reserve; B. Weigh Astragalus membranaceus, Cryptotympana pustulata, and Glycyrrhiza uralensis according to the prescription amount, decoct with 9 - 13 times the amount of water three times, each time for 1 hour, filter to obtain the second water extract; C. Combine the first water extract and the second water extract, concentrate under reduced pressure to a relative density of 1.15 - 1.20 to obtain a water extract paste for reserve; D. Weigh Angelica dahurica and Prunus mume according to the prescription amount, add 5 - 8 times the amount of 50 - 80% ethanol, extract twice, the first time for 2 hours and the second time for 1.5 hours, filter, recover the ethanol from the extract under reduced pressure, and concentrate under reduced pressure to a relative density of 1.15 - 1.20 to obtain an ethanol extract paste for reserve; E. Coarsely crush Paeonia suffruticosa, sterilize it, and pulverize it into fine powder for reserve; The volatile oil inclusion obtained in step A, the water extract paste obtained in step C, the ethanol extract paste obtained in step D, and the sterilized powder of Paeonia suffruticosa obtained in step E together constitute the active components of the traditional Chinese medicine composition.

2. The active component according to claim 1, characterized in that: In step E, high - temperature short - time sterilization process is used to sterilize Paeonia suffruticosa.

3. The active component according to claim 2, wherein: The temperature of high - temperature short - time sterilization is 170 - 180 °C, and the time is 5 - 10 seconds.

4. The active component according to claim 1, wherein: The traditional Chinese medicine composition consists of the following raw materials in parts by weight: 10 parts of Astragalus membranaceus, 15 parts of Atractylodes macrocephala, 5 parts of Saposhnikovia divaricata, 15 parts of Magnolia officinalis var. biloba, 5 parts of Angelica dahurica, 15 parts of Alpinia officinarum, 5 parts of Notopterygium incisum, 15 parts of Paeonia suffruticosa, 5 parts of Cryptotympana pustulata, 15 parts of Prunus mume, and 4 parts of Glycyrrhiza uralensis.

5. The active component according to claim 1, characterized in that: The traditional Chinese medicine composition consists of the following raw materials in parts by weight: 20 parts of Astragalus membranaceus, 5 parts of Atractylodes macrocephala, 15 parts of Saposhnikovia divaricata, 5 parts of Magnolia officinalis var. biloba, 15 parts of Angelica dahurica, 5 parts of Alpinia officinarum, 15 parts of Notopterygium incisum, 5 parts of Paeonia suffruticosa, 15 parts of Cryptotympana pustulata, 5 parts of Prunus mume, and 8 parts of Glycyrrhiza uralensis.

6. The active component according to claim 1, characterized in that: The traditional Chinese medicine composition consists of the following raw materials in parts by weight: 10.3 parts of Astragalus membranaceus, 6.85 parts of Atractylodes macrocephala, 6.85 parts of Saposhnikovia divaricata, 6.85 parts of Magnolia officinalis var. biloba, 6.85 parts of Angelica dahurica, 6.85 parts of Alpinia officinarum, 6.85 parts of Notopterygium incisum, 6.85 parts of Paeonia suffruticosa, 6.85 parts of Cryptotympana pustulata, 6.85 parts of Prunus mume, and 4.1 parts of Glycyrrhiza uralensis.

7. The active component according to claim 1, wherein: The traditional Chinese medicine composition consists of the following raw materials in parts by weight: 15 parts of Astragalus membranaceus, 10 parts of Atractylodes macrocephala, 10 parts of Saposhnikovia divaricata, 10 parts of Magnolia officinalis var. biloba, 10 parts of Angelica dahurica, 10 parts of Alpinia officinarum, 10 parts of Notopterygium incisum, 10 parts of Paeonia suffruticosa, 10 parts of Cryptotympana pustulata, 10 parts of Prunus mume, and 6 parts of Glycyrrhiza uralensis.

8. The active component according to claim 1, characterized in that: The active components can be further prepared into capsules, tablets, granules or pills.

9. The active component according to claim 8, characterized in that: The preparation process of the tablets made from the active components is as follows: Coarsely crush Atractylodes macrocephala and Notopterygium incisum in the formula, and coarsely crush Magnolia liliflora; Weigh Atractylodes macrocephala, Saposhnikovia divaricata, Alpinia officinarum, Notopterygium incisum, and Magnolia liliflora according to the prescription amount, add 6 - 12 times the amount of water, and extract the volatile oil by steam distillation for 6 - 10 hours. Collect the volatile oil, and reserve it after inclusion; Filter the aqueous solution after distillation to obtain the first water extract; Weigh Astragalus membranaceus, Cryptotympana pustulata, and Glycyrrhiza uralensis according to the prescription amount, decoct with 9 - 13 times the amount of water for three times, each time for 1 hour, filter to obtain the second water extract; Combine the first water extract and the second water extract, and concentrate under reduced pressure to a relative density of 1.15 - 1.20 to obtain a water extract paste for standby; Weigh Angelica dahurica and Prunus mume according to the prescription amount, add 5 - 8 times the amount of 50 - 80% ethanol, extract twice, the first time for 2 hours and the second time for 1.5 hours, filter, recover the ethanol from the extract under reduced pressure, and concentrate under reduced pressure to a relative density of 1.15 - 1.20 to obtain an ethanol extract paste for standby; Coarsely crush Paeonia suffruticosa, sterilize it, and pulverize it into fine powder for standby; Using the fine powder of Paeonia suffruticosa as the base material, granulate, size the granules, and press tablets to obtain the product.

10. The active component according to claim 9, characterized in that: The preparation process of the tablets made from the active ingredient is as follows: Coarsely crush Atractylodes macrocephala and Notopterygium incisum in the formula, and coarsely crush and break the shell of Magnolia liliflora; Weigh Atractylodes macrocephala, Saposhnikovia divaricata, Alpinia officinarum, Notopterygium incisum, and Magnolia liliflora according to the prescription amount, add 8 - 10 times the amount of water, and extract the volatile oil by steam distillation for 8 hours. Collect the volatile oil, and reserve it after inclusion; Filter the aqueous solution after distillation to obtain the first water extract; Weigh Astragalus membranaceus, Cryptotympana pustulata, and Glycyrrhiza uralensis according to the prescription amount, decoct with 10 - 12 times the amount of water for three times, each time for 1 hour, filter to obtain the second water extract; Combine the first water extract and the second water extract, and concentrate under reduced pressure to a relative density of 1.15 - 1.20 to obtain a water extract paste for standby; Weigh Angelica dahurica and Prunus mume according to the prescription amount, add 6 - 7 times the amount of 60 - 70% ethanol, extract twice, the first time for 2 hours and the second time for 1.5 hours, filter, recover the ethanol from the extract under reduced pressure, and concentrate under reduced pressure to a relative density of 1.15 - 1.20 to obtain an ethanol extract paste for standby; Coarsely crush Paeonia suffruticosa, sterilize it, and pulverize it into fine powder for standby; Using the fine powder of Paeonia suffruticosa as the base material, granulate, size the granules, and press tablets to obtain the product.

Images