A production process, product and application of Honghua Xiaoyao tablets

Abstract

This invention provides a production process, product, and application of safflower Xiaoyao tablets, belonging to the field of traditional Chinese medicine preparation technology. The production process of safflower Xiaoyao tablets provided by this invention includes the following steps: S1, extracting volatile oils from Angelica sinensis, Atractylodes macrocephala, and Mentha haplocalyx to obtain a mixture of volatile oils and medicinal residue; S2, mixing the medicinal residue obtained in step S1 with Paeonia lactiflora, Poria cocos, safflower, Gleditsia sinensis thorns, Bupleurum chinense leaves, and Glycyrrhiza uralensis, adding water and decocting, filtering, and concentrating the filtrate to obtain a thick paste; S3, drying and pulverizing the thick paste obtained in step S2, mixing it with excipients, granulating, mixing it with the volatile oil mixture obtained in step S1, sealing, compressing, and coating to obtain safflower Xiaoyao tablets; wherein, in step S2, the filtration includes sieve filtration and ceramic membrane filtration, and the concentration of the filtrate includes membrane concentration and vacuum concentration. Through improvements to the filtration and filtrate concentration processes, energy consumption is significantly reduced, meeting preparation requirements while reducing production costs.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine preparations and relates to the production process, product and application of safflower Xiaoyao tablets. Background Technology

[0002] Honghua Xiaoyao tablets are a compound traditional Chinese medicine made from the following Chinese medicinal ingredients: Angelica sinensis, Paeonia lactiflora, Atractylodes macrocephala, Poria cocos, Carthamus tinctorius, Gleditsia sinensis thorns, Lophatherum gracile, Bupleurum chinense, Mentha haplocalyx, and Glycyrrhiza uralensis. These small tablets are a liver-soothing and qi-regulating medicine, possessing the effects of soothing the liver, regulating qi, and promoting blood circulation. They are primarily used to treat symptoms such as chest and rib pain, dizziness, loss of appetite, irregular menstruation, breast tenderness, and facial melasma caused by liver qi stagnation.

[0003] Chinese patent application CN109394852A discloses a granulation process for safflower Xiaoyao tablets. The process involves premixing safflower Xiaoyao tablet dry extract powder and corn starch for 5-15 minutes, preparing a soft mass with 60% ethanol, and then granulating the mixture using a 14-18 mesh sieve. The granulated particles, volatile oil, and magnesium stearate are then added to a two-dimensional mixer and mixed for 25-35 minutes. The mixture is then sent for testing, tableted, and coated. This invention reduces the drying and granulation processes, lowering costs. The content of white peony root in safflower Xiaoyao tablets is more than 50% higher than that requiring drying, ensuring no loss of the effective prescription and guaranteeing clinical efficacy.

[0004] Chinese patent application CN109682918A discloses a quality testing method for safflower Xiaoyao tablets. This method newly employs thin-layer chromatography (TLC) for identification of Poria cocos and high-performance liquid chromatography (HPLC) for determination of glycyrrhizin content. This quality control method is more effective for product quality control, exhibiting high precision, sensitivity, and stability.

[0005] Chinese patent application CN102204967A discloses a method for preparing safflower Xiaoyao tablets, comprising the following steps: ① Extracting volatile oils from Angelica sinensis, Atractylodes macrocephala, and Mentha haplocalyx using steam distillation; ② Extracting the residue from the extracted volatile oils along with Paeonia lactiflora, Poria cocos, safflower, Gleditsia sinensis thorns, Bupleurum chinense, and Glycyrrhiza uralensis using water as a solvent and ultrasonically extracting an aqueous extract; ③ Encapsulating the extracted volatile oils with β-cyclodextrin to obtain a volatile oil β-cyclodextrin-infused compound; ④ Adding the aqueous extract obtained in step ② and the volatile oil β-cyclodextrin-infused compound obtained in step ③ to starch, granulating and pressing into tablets, and coating with a film to obtain the final product. This method enables rapid dissolution of the effective components within the medicinal cell without damaging the chemical structure of the effective components, resulting in a high extraction rate. The use of β-cyclodextrin encapsulation technology in the volatile oil addition method effectively increases the retention index of volatile components in the preparation.

[0006] However, current technology cannot provide a production process for safflower Xiaoyao tablets that reduces production energy consumption and costs without affecting product quality. Summary of the Invention

[0007] In view of this, and considering that the existing technology cannot provide a production process for safflower Xiaoyao tablets that reduces production energy consumption and costs without affecting product quality, the purpose of this invention is to provide a production process, product, and application of safflower Xiaoyao tablets.

[0008] To achieve the above-mentioned objectives, the present invention provides a production process for safflower Xiaoyao tablets, comprising the following steps:

[0009] S1. Extract volatile oils from Angelica sinensis, Atractylodes macrocephala, and Mentha haplocalyx to obtain a mixture of volatile oils and dregs; S2. Mix the dregs obtained in step S1 with Paeonia lactiflora, Poria cocos, Carthamus tinctorius, Gleditsia sinensis thorns, Bupleurum chinense leaves, and Glycyrrhiza uralensis, add water and decoct, filter, concentrate the filtrate to obtain a thick paste; S3. Dry and pulverize the thick paste obtained in step S2, mix it with excipients, granulate it, mix it with the volatile oil mixture obtained in step S1, seal it, compress it into tablets, and coat it to obtain Safflower Xiaoyao tablets; wherein, in step S2, the filtration includes sieve filtration and ceramic membrane filtration, and the concentrated filtrate includes membrane concentration and vacuum concentration.

[0010] Preferably, in step S2, the screen filtration uses a filter with an 80-120 mesh screen. More preferably, and as an example of the present invention, in step S2, the screen filtration uses a filter with a 100 mesh screen.

[0011] Preferably, in step S2, the reduced pressure concentration uses a double-effect energy-saving concentrator. More preferably, and as an example of the present invention, in step S2, the reduced pressure concentration uses an EJZN-2500 double-effect energy-saving concentrator.

[0012] Preferably, in step S2, the ceramic membrane filtration uses a ceramic membrane filter with a pore size of 5-200 nm, and the membrane concentration uses a reverse osmosis organic membrane concentrator or a nanofiltration organic membrane concentrator.

[0013] More preferably, in step S2, the ceramic membrane filter uses a ceramic membrane filter with a pore size of 5nm, 15nm, 100nm or 200nm.

[0014] More preferably, and as an example of the present invention, in step S2, the ceramic membrane filter uses a ceramic membrane filter with a pore size of 100 nm.

[0015] Preferably, in step S2, the ceramic membrane filter used in the ceramic membrane filtration is made of alumina.

[0016] Preferably, in step S2, the membrane concentration uses a reverse osmosis organic membrane concentrator or a nanofiltration organic membrane concentrator.

[0017] More preferably, and as an example of the present invention, in step S2, the membrane concentration uses a reverse osmosis organic membrane concentrator.

[0018] Preferably, in step S2, the membrane concentrator used for membrane concentration is made of polyamide.

[0019] Preferably, in step S2, the concentrated filtrate includes the following steps: the filtrate is concentrated through a membrane to 5%-30% of its original volume, and then concentrated under reduced pressure at 75-85°C to a relative density of 1.37-1.43.

[0020] More preferably, and as an example of the present invention, the concentrated filtrate includes the following steps: the filtrate is concentrated by membrane to 10%-30% of its original volume, and then concentrated under reduced pressure at 80°C to a relative density of 1.37-1.43.

[0021] Preferably, in step S2, the excipients include a filler and a lubricant. The filler is selected from one or more of dextrin, starch, lactose, lactose monohydrate, and sucrose, and the lubricant is selected from one or more of magnesium stearate, talc, micronized silica gel, and polyvinyl alcohol.

[0022] More preferably, and as an example of the present invention, in step S2, the excipients include a filler and a lubricant, wherein the filler is starch and the lubricant is magnesium stearate.

[0023] Preferably, in step S2, the granulation is performed using a 90%-99% aqueous ethanol solution.

[0024] More preferably, and as an example of the present invention, in step S2, the granulation is performed using a 95% aqueous ethanol solution.

[0025] Preferably, the mass ratio of Angelica sinensis, Atractylodes macrocephala, and Mentha haplocalyx in step S1 to Paeonia lactiflora, Poria cocos, Carthamus tinctorius, Gleditsia sinensis thorns, Bupleurum chinense, and Glycyrrhiza uralensis in step S2 is 20-32:20-32:2-6:20-32:20-32:3-7:6-10:20-32:15-24.

[0026] More preferably, and as an example of the present invention, the mass ratio of Angelica sinensis, Atractylodes macrocephala, and Mentha haplocalyx in step S1 to Paeonia lactiflora, Poria cocos, Carthamus tinctorius, Gleditsia sinensis thorns, Bupleurum chinense, and Glycyrrhiza uralensis in step S2 is 26:26:4:26:26:5:8:26:19.5.

[0027] On the other hand, the present invention provides a safflower Xiaoyao tablet, which is produced using the production process described in the claims.

[0028] Furthermore, this invention provides the application of the above-mentioned production process in the production of safflower Xiaoyao tablets.

[0029] Compared with the prior art, the present invention has the following beneficial effects:

[0030] Based on the existing production process of safflower Xiaoyao tablets, this invention improves the filtration and concentration steps by modifying the process. Under the premise that the product quality is not significantly different from that of the existing process, it effectively improves the filtration effect and reduces the energy consumption and cost of the entire production process of safflower Xiaoyao tablets. Detailed Implementation

[0031] Terminology and Declarations of this Invention:

[0032] 1. Articles “a,” “a kind,” and “the”: These include plural objects unless otherwise explicitly specified as a single (kind) object.

[0033] 2. Numerical Range: Unless otherwise expressly stated, all ranges or ratios disclosed herein shall be construed as including any and all subranges or subratios contained herein. For example, a stated range or ratio of 1 to 30 shall be considered to be included between the minimum value of 1 and the maximum value of 30, and includes any subranges or subratios, integers, decimals, or subranges or subratios consisting of integers or decimals, including endpoints.

[0034] The following non-limiting embodiments are intended to enable those skilled in the art to gain a more comprehensive understanding of the present invention, but do not limit the invention in any way. The following description is merely an exemplary illustration of the scope of protection of the present invention, and those skilled in the art can make various changes and modifications to the invention based on the disclosed content, which should also fall within the scope of protection of the present invention.

[0035] The present invention will be further described below by way of specific embodiments. Unless otherwise specified, all chemical reagents used in the embodiments of the present invention were obtained through conventional commercial means. Unless otherwise specified, all contents mentioned below are mass contents. Unless otherwise specified, it is understood that the process was carried out at room temperature.

[0036] Example 1

[0037] An optimized production process for safflower Xiaoyao tablets.

[0038] The following nine herbs were prepared: Angelica sinensis (260 parts by weight), Paeonia lactiflora (260 parts by weight), Atractylodes macrocephala (260 parts by weight), Poria cocos (260 parts by weight), Carthamus tinctorius (50 parts by weight), Gleditsia sinensis (80 parts by weight), Bupleurum chinense (260 parts by weight), Mentha haplocalyx (40 parts by weight), and Glycyrrhiza uralensis (195 parts by weight). Except for Angelica sinensis, Atractylodes macrocephala, and Mentha haplocalyx, whose volatile oils were extracted by steam distillation and reserved, the dregs were decocted twice with the remaining six herbs (including Paeonia lactiflora) for two hours each time. The decoction was then filtered in stages: first through a double filter with a 100-mesh sieve (Φ230×750DN50), and then through a JSMST-MF100-23-2 ceramic membrane filter (100nm pore size) at a capacity of 2000kg / h. The filtrates were combined and concentrated to a thick paste with a relative density of 1.37-1.43 (50℃). The specific concentration process involves using a 2000 kg / h JSMST-RO-8040-12 reverse osmosis organic membrane concentrator to concentrate the volume to 10% of its original volume, followed by further concentration using a 2500 kg / h EJZN-2500 dual-effect energy-saving concentrator.

[0039] Dry, pulverize, add appropriate amounts of starch and magnesium stearate, mix well, granulate with 95% ethanol, spray in the above volatile oil, seal for 12 hours, compress into tablets (when each of the above 1 part by weight is 1g, 1000 tablets can be compressed), and coat with film to obtain the final product.

[0040] Example 2

[0041] Compared to Example 1, the 100nm ceramic film was replaced with a 5nm ceramic film, and all other aspects remained the same.

[0042] Example 3

[0043] Compared to Example 1, the 100nm ceramic film was replaced with a 15nm ceramic film, and all other aspects remained the same.

[0044] Example 4

[0045] Compared to Example 1, the 100nm ceramic film was replaced with a 200nm ceramic film, and all other aspects remained the same.

[0046] Example 5

[0047] Compared to Example 1, the reverse osmosis organic membrane was replaced with a nanofiltration organic membrane, but everything else remained the same.

[0048] Example 6

[0049] Compared to Example 1, the organic membrane was concentrated to 30% of its original volume, with all other aspects remaining the same.

[0050] Example 7

[0051] Compared to Example 1, the organic membrane was concentrated to 5% of its original volume, with all other aspects remaining the same.

[0052] Comparative Example 1

[0053] A production process for safflower Xiaoyao tablets. Compared with Example 1, ceramic membrane filtration and membrane concentration are omitted, while the rest are the same.

[0054] Angelica sinensis 260 parts by weight, Paeonia lactiflora 260 parts by weight, Atractylodes macrocephala 260 parts by weight, Poria cocos 260 parts by weight, Carthamus tinctorius 50 parts by weight, Gleditsia sinensis thorns 80 parts by weight, Bupleurum chinense leaves 260 parts by weight, Mentha haplocalyx 40 parts by weight, Glycyrrhiza uralensis 195 parts by weight. The above nine herbs are used to extract volatile oils from Angelica sinensis, Atractylodes macrocephala, and Mentha haplocalyx by steam distillation. The volatile oils are reserved. The residue is decocted twice with the remaining six herbs, including Paeonia lactiflora, for 2 hours each time.

[0055] The solution was filtered through a double filter with a 100-mesh sieve (Φ230×750DN50). The filtrates were combined and concentrated to a thick paste with a relative density of 1.37-1.43 (50℃). The concentration process was carried out using an EJZN-2500 double-effect energy-saving concentrator with a capacity of 2500 kg / h.

[0056] Dry, pulverize, add appropriate amounts of starch and magnesium stearate, mix well, granulate with 95% ethanol, spray in the above volatile oil, seal for 12 hours, compress into tablets (when each of the above 1 part by weight is 1g, 1000 tablets can be compressed), and coat with film to obtain the final product.

[0057] Comparative Example 2

[0058] Safflower Xiaoyao tablets were prepared according to the preparation method provided in Example 1 of patent CN117045711A.

[0059] Comparative Example 3

[0060] A production process for safflower Xiaoyao tablets. Compared with Example 1, membrane concentration is omitted, but all other processes are the same.

[0061] The following nine herbs were prepared: Angelica sinensis (260 parts by weight), Paeonia lactiflora (260 parts by weight), Atractylodes macrocephala (260 parts by weight), Poria cocos (260 parts by weight), Carthamus tinctorius (50 parts by weight), Gleditsia sinensis (80 parts by weight), Bupleurum chinense (260 parts by weight), Mentha haplocalyx (40 parts by weight), and Glycyrrhiza uralensis (195 parts by weight). Except for Angelica sinensis, Atractylodes macrocephala, and Mentha haplocalyx, whose volatile oils were extracted by steam distillation and reserved, the dregs were decocted twice with the remaining six herbs (including Paeonia lactiflora) for two hours each time. The decoction was then filtered in stages: first through a double filter with a 100-mesh sieve (Φ230×750DN50), and then through a JSMST-MF100-23-2 ceramic membrane filter (100nm pore size) at a capacity of 2000kg / h. The filtrates were combined and concentrated to a thick paste with a relative density of 1.37-1.43 (50℃). The concentration process involves using an EJZN-2500 dual-effect energy-saving concentrator with a capacity of 2500 kg / h.

[0062] Dry, pulverize, add appropriate amounts of starch and magnesium stearate, mix well, granulate with 95% ethanol, spray in the above volatile oil, seal for 12 hours, compress into tablets (when each of the above 1 part by weight is 1g, 1000 tablets can be compressed), and coat with film to obtain the final product.

[0063] Comparative Example 4

[0064] A production process for safflower Xiaoyao tablets. Compared with Example 1, the reduced pressure concentration is omitted, and all other processes are the same.

[0065] The following nine herbs were prepared: Angelica sinensis (260 parts by weight), Paeonia lactiflora (260 parts by weight), Atractylodes macrocephala (260 parts by weight), Poria cocos (260 parts by weight), Carthamus tinctorius (50 parts by weight), Gleditsia sinensis (80 parts by weight), Bupleurum chinense (260 parts by weight), Mentha haplocalyx (40 parts by weight), and Glycyrrhiza uralensis (195 parts by weight). Except for Angelica sinensis, Atractylodes macrocephala, and Mentha haplocalyx, whose volatile oils were extracted by steam distillation and reserved, the dregs were decocted twice with the remaining six herbs (including Paeonia lactiflora) for two hours each time. The decoction was then filtered in stages: first through a double filter with a 100-mesh sieve (Φ230×750DN50), and then through a JSMST-MF100-23-2 ceramic membrane filter (100nm pore size) at a capacity of 2000kg / h. The filtrates were combined and concentrated to a thick paste with a relative density of 1.37-1.43 (50℃). The concentration process involves using a 2000 kg / h JSMST-RO-8040-12 reverse osmosis organic membrane concentrator.

[0066] Dry, pulverize, add appropriate amounts of starch and magnesium stearate, mix well, granulate with 95% ethanol, spray in the above volatile oil, seal for 12 hours, compress into tablets (when each of the above 1 part by weight is 1g, 1000 tablets can be compressed), and coat with film to obtain the final product.

[0067] Comparative Example 5

[0068] A production process for safflower Xiaoyao tablets. Compared with Example 1, the ceramic membrane filtration is omitted, but all other processes are the same.

[0069] The following nine herbs were prepared: Angelica sinensis (260 parts by weight), Paeonia lactiflora (260 parts by weight), Atractylodes macrocephala (260 parts by weight), Poria cocos (260 parts by weight), Carthamus tinctorius (50 parts by weight), Gleditsia sinensis (80 parts by weight), Bupleurum chinense (260 parts by weight), Mentha haplocalyx (40 parts by weight), and Glycyrrhiza uralensis (195 parts by weight). Except for Angelica sinensis, Atractylodes macrocephala, and Mentha haplocalyx, whose volatile oils were extracted by steam distillation and reserved, the dregs were decocted twice with the remaining six herbs (including Paeonia lactiflora) for two hours each time. The decoction was then filtered through a double filter with a 100-mesh sieve (Φ230×750DN50). The filtrates were combined and concentrated to a thick paste with a relative density of 1.37-1.43 (50℃). The concentration process involved using a JSMST-RO-8040-12 reverse osmosis organic membrane concentrator at a capacity of 2000 kg / h to concentrate the paste to 10% of its original volume, followed by further concentration using an EJZN-2500 double-effect energy-saving concentrator at a capacity of 2500 kg / h.

[0070] Dry, pulverize, add appropriate amounts of starch and magnesium stearate, mix well, granulate with 95% ethanol, spray in the above volatile oil, seal for 12 hours, compress into tablets (when each of the above 1 part by weight is 1g, 1000 tablets can be compressed), and coat with film to obtain the final product.

[0071] Comparative Example 6

[0072] A production process for safflower Xiaoyao tablets. Compared with Example 1, the sieve filtration is omitted, but all other processes are the same.

[0073] The following nine herbs were prepared: Angelica sinensis (260 parts by weight), Paeonia lactiflora (260 parts by weight), Atractylodes macrocephala (260 parts by weight), Poria cocos (260 parts by weight), Carthamus tinctorius (50 parts by weight), Gleditsia sinensis (80 parts by weight), Bupleurum chinense (260 parts by weight), Mentha haplocalyx (40 parts by weight), and Glycyrrhiza uralensis (195 parts by weight). Except for Angelica sinensis, Atractylodes macrocephala, and Mentha haplocalyx, whose volatile oils were extracted by steam distillation and reserved, the dregs were decocted twice with the remaining six herbs (including Paeonia lactiflora) for two hours each time. The decoction was then filtered through a JSMST-MF100-23-2 ceramic membrane filter (100nm pore size) at a capacity of 2000 kg / h. The filtrates were combined and concentrated to a thick paste with a relative density of 1.37-1.43 (50℃). The specific concentration process involves using a 2000 kg / h JSMST-RO-8040-12 reverse osmosis organic membrane concentrator to concentrate the volume to 10% of its original volume, followed by further concentration using a 2500 kg / h EJZN-2500 dual-effect energy-saving concentrator.

[0074] Dry, pulverize, add appropriate amounts of starch and magnesium stearate, mix well, granulate with 95% ethanol, spray in the above volatile oil, seal for 12 hours, compress into tablets (when each of the above 1 part by weight is 1g, 1000 tablets can be compressed), and coat with film to obtain the final product.

[0075] In Examples 1-7 and Comparative Examples 1-6, the ceramic membrane filters used were all made of alumina, and the organic membrane concentrators used were all made of polyamide.

[0076] Comparative Example 7

[0077] A production process for safflower Xiaoyao tablets. The process is the same as in Example 1, except that the ceramic membrane is replaced with a silicon carbide ceramic membrane.

[0078] Comparative Example 8

[0079] A production process for safflower Xiaoyao tablets. Compared with Example 1, the organic membrane is replaced with an organic membrane made of polyvinylidene fluoride, and all other aspects are the same.

[0080] Example 1

[0081] Energy cost accounting

[0082] The same amount (10 kg) of safflower Xiaoyao tablets were produced using the production methods of Examples 1-7 and Comparative Examples 1-8. The energy consumption cost and proportions are shown in Table 1.

[0083] Table 1

[0084]

[0085] It is evident that the energy consumption cost of producing the same weight of safflower Xiaoyao tablets using the production methods of each embodiment is lower than that of producing safflower Xiaoyao tablets using the production methods provided in each comparative example. It should be noted that in Comparative Example 5, concentration was performed using an organic membrane concentration method with reduced pressure, but ceramic membrane filtration was not used. Since organic membrane concentration requires the turbidity of the concentrate to be low to a certain range, without ceramic membrane filtration, the turbidity of the concentrate cannot meet the requirements for organic membrane concentration, the organic membrane concentration process cannot proceed normally, and the process cannot continue continuously.

[0086] Example 2

[0087] Characterization methods for Honghua Xiaoyao tablets.

[0088] 1. Determination of the content of multiple components.

[0089] 1.1 Measurement conditions and analytical methods

[0090] Chromatographic conditions and system suitability: Octadecylsilane-bonded silica gel was used as the packing material; acetonitrile was used as mobile phase A and 0.1% phosphoric acid was used as mobile phase B, and gradient elution was performed according to the specifications in Table 2; the detection wavelength was 230 nm; the flow rate was 1.0 mL / min and the column temperature was 30 °C.

[0091] Table 2

[0092] Time (minutes) Mobile phase A (%) Mobile phase B (%) 0 15 85 15 14 86 20 17 83 25 35 65 45 50 50 50 15 85 53 15 85

[0093] Preparation of reference solution: Take appropriate amounts of paeoniflorin lactone, paeoniflorin and glycyrrhizic acid ammonium reference standards, accurately weigh them, add methanol to prepare a mixed solution containing 50 μg of paeoniflorin lactone, paeoniflorin and glycyrrhizic acid ammonium per 1 mL.

[0094] Preparation of test solution: Take 20 tablets of this product, remove the film coating, grind finely, accurately weigh 0.25g of the powder and place it in a stoppered conical flask, add 30mL of ether, sonicate (90W, 59KHz) for 5 minutes, filter, evaporate the solvent from the residue and filter paper, place it in a stoppered conical flask, accurately add 25mL of methanol, stopper tightly, weigh, sonicate (90W, 59KHz) for 25 minutes, cool, weigh again, replenish the lost weight with methanol, shake well, and collect the filtrate to obtain the test solution.

[0095] Assay: Accurately pipette 10 μL each of the reference solution and the test solution into the liquid chromatograph and determine the result.

[0096] Using the above method, the concentrations of paeoniflorin lactone, paeoniflorin, and ammonium glycyrrhizate in the safflower Xiaoyao tablets prepared in Examples 1-7 and Comparative Examples 1-8 were detected, and the average value was taken after five repeated measurements. The results are shown in Table 3.

[0097] Table 3

[0098]

[0099]

[0100] The safflower Xiaoyao tablets produced by the production processes provided in Examples 1-7 had paeoniflorin lactone, paeoniflorin, and glycyrrhizic acid contents ranging from 4.00-4.12 mg / g, 6.33-6.80 mg / g, and 5.35-5.69 mg / g, respectively. It is particularly noteworthy that Comparative Example 1, compared to the examples, did not employ ceramic membrane filtration and membrane concentration. The safflower Xiaoyao tablets produced in Comparative Example 1 contained paeoniflorin lactone, paeoniflorin, and glycyrrhizic acid contents of 4.03 mg / g, 6.58 mg / g, and 5.47 mg / g, respectively, levels comparable to the examples. However, due to the significantly higher energy consumption cost of Comparative Example 1 compared to the examples, the examples represent a significant technological advancement over Comparative Example 1. Comparative Example 2 prepared safflower Xiaoyao tablets using existing technology. In Comparative Example 2, the contents of paeoniflorin lactone, paeoniflorin, and ammonium glycyrrhizate in the safflower Xiaoyao tablets were 4.23 mg / g, 6.85 mg / g, and 5.62 mg / g, respectively. The contents of paeoniflorin lactone and paeoniflorin were slightly higher than those in the examples, while the content of ammonium glycyrrhizate was comparable to that in the examples. However, the relative energy consumption cost of Comparative Example 2 was 1.58, while the relative energy consumption cost of Examples 1-7 was 0.57-0.77. Calculations show that the energy consumption cost of Comparative Example 2 was 2.05-2.77 times that of Examples 1-7, and its energy consumption reduction was significantly greater than the increase in the contents of paeoniflorin lactone and paeoniflorin in the safflower Xiaoyao tablets prepared in Comparative Example 2. It is evident that the examples achieved significant technical progress compared to Comparative Example 2.

[0101] In summary, considering the energy consumption cost and the results of multi-component content determination, the preparation process provided by the various embodiments of the present invention can significantly reduce the production energy consumption cost by improving the filtration and concentration process steps while maintaining the contents of paeoniflorin lactone, paeoniflorin, and ammonium glycyrrhizate within a certain range, thereby significantly reducing the overall process cost.

[0102] Finally, it should be noted that the above content is only used to illustrate the technical solution of the present invention, and is not intended to limit the scope of protection of the present invention. Simple modifications or equivalent substitutions made by those skilled in the art to the technical solution of the present invention do not depart from the essence and scope of the technical solution of the present invention.

Claims

1. A production process for safflower Xiaoyao tablets, characterized in that, Includes the following steps: S1. Extract volatile oils from Angelica sinensis, Atractylodes macrocephala, and Mentha haplocalyx to obtain a mixture of volatile oils and medicinal residue; S2. Mix the dregs obtained in step S1 with white peony root, poria cocos, safflower, soapberry thorn, bamboo leaf, bupleurum and licorice, add water and decoct, filter, concentrate the filtrate through a membrane to 10% of the original volume, and then concentrate under reduced pressure at 80℃ to a relative density of 1.37-1.43 to obtain a thick paste. S3. Dry and pulverize the thick paste obtained in step S2, mix it with excipients, granulate it, mix it with the volatile oil mixture obtained in step S1, seal it, compress it into tablets, and coat it to obtain safflower Xiaoyao tablets. In step S2, the filtration is screen filtration and ceramic membrane filtration, and the concentrated filtrate is membrane concentration and vacuum concentration. In step S2, the ceramic membrane filtration uses a ceramic membrane filter with a pore size of 100 nm, and the membrane concentration uses a reverse osmosis organic membrane concentrator. The ceramic membrane filter used in the ceramic membrane filtration is made of alumina; the membrane concentrator used in the membrane concentration is made of polyamide.

2. The production process according to claim 1, characterized in that, In step S2, the excipients include fillers and lubricants. The fillers are selected from one or more of dextrin, starch, lactose, lactose monohydrate, and sucrose. The lubricants are selected from one or more of magnesium stearate, talc, micronized silica gel, and polyvinyl alcohol.

3. The production process according to claim 1, characterized in that, In step S2, the granulation is performed using a 90%-99% aqueous ethanol solution.

4. The production process according to claim 1, characterized in that, The mass ratio of Angelica sinensis, Atractylodes macrocephala, and Mentha haplocalyx in step S1 to Paeonia lactiflora, Poria cocos, Carthamus tinctorius, Gleditsia sinensis thorns, Bupleurum chinense, and Glycyrrhiza uralensis in step S2 is 20-32:20-32:2-6:20-32:20-32:3-7:6-10:20-32:15-24.

5. The production process according to claim 4, characterized in that, The mass ratio of Angelica sinensis, Atractylodes macrocephala, and Mentha haplocalyx in step S1 to Paeonia lactiflora, Poria cocos, Carthamus tinctorius, Gleditsia sinensis thorns, Bupleurum chinense, and Glycyrrhiza uralensis in step S2 is 26:26:4:26:26:5:8:26:19.

5.

6. A safflower herbal tablet, characterized in that, It is produced using the production process described in any one of claims 1-5.

7. The application of the production process according to any one of claims 1-5 in the production of safflower Xiaoyao tablets.

Images