Preparation method of ginseng, branch and poria cocos oral liquid

Abstract

The invention provides a preparation method of a ginseng, ramulus cinnamomi and poria cocos oral liquid, which comprises the following steps: S1, distilling ramulus cinnamomi and rhizoma zingiberis to obtain a distillate, adding water into the distilled ramulus cinnamomi and rhizoma zingiberis, and decocting to obtain a decoction A; s2, adding water into radix paeoniae alba and rhizoma acori graminei, and decocting twice to obtain a decoction B; s3, adding water into codonopsis pilosula, honey-fried licorice root, poria cocos, processed polygala tenuifolia, fossil fragments and oysters, and decocting twice to obtain a decoction C; s4, mixing the decoction A and the decoction C, concentrating and purifying to obtain clear paste; and S5, mixing the distillate, the clear paste and pharmaceutic adjuvants, filtering, filling and sterilizing to obtain the ginseng, branch and poria cocos oral liquid. According to the method, the radix paeoniae alba and the rhizoma acori graminei are independently decocted, the degradation of thermosensitive components such as paeoniflorin in long-time high-temperature decoction is remarkably reduced on the premise that the yield of clear paste obtained after alcohol precipitation and the total amount of effective components are guaranteed through the independent decoction process, the transfer rate of paeoniflorin and the content stability of a finished product are improved, and the method is more suitable for large-scale production.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine preparation technology, and more specifically to a method for preparing Ginseng, Twig and Poria Oral Liquid. Background Technology

[0002] Alzheimer's disease is a syndrome characterized by acquired intellectual impairment, primarily manifested as cognitive deficits that affect social or occupational functioning. The disease is chronically progressive and involves multiple higher-level neurological functions, including memory, behavior, personality, judgment, attention, visuospatial skills, language, and logical reasoning.

[0003] Ginseng and Ginger Oral Liquid is composed of ten medicinal herbs including Codonopsis pilosula, Paeonia lactiflora, Glycyrrhiza uralensis, Poria cocos, and Polygala tenuifolia. It has the effects of invigorating Qi and warming Yang, resolving phlegm and calming the mind, and is suitable for the treatment of Alzheimer's disease due to insufficient heart Qi. An existing method for preparing a Ginseng and Ginger preparation (authorization announcement number CN105999195B) proposes a preparation that, while capable of producing qualified products in small-scale or laboratory settings, reveals numerous insurmountable process defects and production bottlenecks when scaled up to large-scale industrial production. These defects severely restrict the large-scale and stable production of the product. Specifically, for example, when cinnamon twigs and dried ginger are distilled separately, their material proportion is small, resulting in loose accumulation in the extraction tank, insufficient heating area, slow heating, and low production efficiency; after distillation, it needs to be... Adding all other medicinal materials to the same pot for decoction is cumbersome and does not conform to actual production practices. The heat-sensitive components (such as paeoniflorin) in white peony and acorus are easily degraded during long-term decoction. In large-scale production, the total heating time of the decoction (including heating, decoction, filtration, concentration, and temporary storage) is much longer than in small-scale tests, resulting in a significant decrease in the transfer rate of paeoniflorin, large fluctuations in the content of the finished product, difficulty in controlling the consistency of quality between batches, and affecting the stability of clinical efficacy. The high proportion of mineral medicines such as dragon bone and oyster shell and their low water absorption rate lead to excessive water level and excess decoction during decoction, resulting in energy consumption and subsequent processing burden.

[0004] Therefore, further improvements and development are still needed. Summary of the Invention

[0005] To address the shortcomings of existing technologies and solve the aforementioned problems, a method for preparing Ginseng and Poria Cocos Oral Liquid is proposed, and the following technical solution is provided: A method for preparing Ginseng, Twig and Poria Oral Liquid, the method comprising the following steps: S1. Cinnamon twigs and dried ginger are distilled to obtain distillate. The distilled cinnamon twigs and dried ginger are then boiled with water to obtain decoction A. S2. Boil white peony root and acorus tatarinowii root in water to obtain decoction B; S3. Codonopsis pilosula, prepared licorice root, Poria cocos, prepared Polygala tenuifolia, dragon bone, and oyster shell are decocted in water to obtain decoction C; S4 The above-obtained decoctions A and C are mixed and then concentrated and purified to obtain a clear extract. S5 The distillate, the clear extract, the pharmaceutical excipients, and water are mixed, filtered, filled, and sterilized to obtain Ginseng and Poria Oral Liquid.

[0006] Furthermore, in step S2, before decocting the white peony root and acorus tatarinowii, the white peony root and acorus tatarinowii are first soaked in water. Specifically, the soaking time is 120 minutes.

[0007] Further, the concentration and purification step in step S4 is as follows: after mixing decoction A and decoction D, concentrate to a relative density of 1.06 to 1.08, add ethanol, mix and let stand, take the supernatant, recover the ethanol under reduced pressure and concentrate to a relative density of 1.23 to 1.25 to obtain the clear extract.

[0008] Specifically, the concentration and purification step in step S4 is as follows: after mixing decoction A and decoction D, concentrate to a relative density of 1.06 to 1.08 (measured at 50-80℃), cool, add ethanol to make the alcohol content reach 75%, shake well, let stand, take the supernatant, recover the ethanol under reduced pressure and concentrate to a relative density of 1.23 to 1.25 (measured at 50-80℃) to obtain the clear extract.

[0009] Furthermore, in step S5, the distillate is first mixed with polysorbate, and then mixed with the extract, pharmaceutical excipients and water. The pharmaceutical excipients in step S5 are sodium cyclohexane and sodium benzoate.

[0010] Specifically, step S5 involves first mixing the distillate with polysorbate 80, then taking the clear extract, adding water and stirring, boiling, refrigerating, centrifuging, then adding the above-mentioned distillate, polysorbate 80 mixture, 0.4% sodium clindamylate, and 0.2% sodium benzoate, mixing well, centrifuging, adding water to 1000ml, mixing well, filtering, filling, and sterilizing to obtain Ginseng and Poria Oral Solution.

[0011] Furthermore, in step S1, the amount of water added is (3.5-6) ​​times the total mass of cinnamon twigs and dried ginger, and the decoction time in step S1 is (30-150) min.

[0012] Preferably, the amount of water added in step S1 is (3-6.5) times the total mass of cinnamon twigs and dried ginger, and the decoction time in step S1 is (60-150) min.

[0013] Specifically, in step S1, the amount of water added is 4 times the total mass of cinnamon twigs and dried ginger, and the decoction time in step S1 is 60 minutes.

[0014] Furthermore, in step S2, the white peony root and acorus tatarinowii are decocted twice with water. In the first decoction in step S2, the amount of water added is (6-6.5) times the total mass of the white peony root and acorus tatarinowii, and the first decoction time is (40-150) min. In the second decoction in step S2, the amount of water added is (3.5-4) times the total mass of the white peony root and acorus tatarinowii, and the first decoction time is (10-100) min.

[0015] Specifically, in step S2, the amount of water added for the first decoction is 6 times the total mass of white peony root and acorus tatarinowii, and the first decoction time is 60 minutes; in step S2, the amount of water added for the second decoction is 4 times the total mass of white peony root and acorus tatarinowii, and the first decoction time is 30 minutes.

[0016] Furthermore, in step S3, Codonopsis pilosula, prepared licorice root, Poria cocos, prepared Polygala tenuifolia, dragon bone, and oyster shell are decocted twice with water. In the first decoction in step S3, the amount of water added is (1.5-6.5) times the total mass of Codonopsis pilosula, prepared licorice root, Poria cocos, prepared Polygala tenuifolia, dragon bone, and oyster shell, and the first decoction time is (40-150) min. In step S2, the amount of water added for the second decoction is (1-3.5) times the total mass of Codonopsis pilosula, prepared licorice root, Poria cocos, prepared Polygala tenuifolia, dragon bone, and oyster shell, and the first decoction time is (10-100) min.

[0017] Specifically, in step S3, the amount of water added for the first decoction is three times the total mass of Codonopsis pilosula, prepared licorice root, Poria cocos, prepared Polygala tenuifolia, dragon bone, and oyster shell, and the first decoction time is 60 minutes; in step S2, the amount of water added for the second decoction is twice the total mass of Codonopsis pilosula, prepared licorice root, Poria cocos, prepared Polygala tenuifolia, dragon bone, and oyster shell, and the first decoction time is 30 minutes.

[0018] Due to the adoption of the above technical solutions, the beneficial technical effects of the present invention are as follows: 1. In this application, white peony root and acorus tatarinowii are decocted separately. The separate decoction process, while ensuring the yield of clear extract after alcohol precipitation and the total amount of effective ingredients, significantly reduces the degradation of heat-sensitive components such as paeoniflorin during long-term high-temperature decoction, improves the transfer rate of paeoniflorin and the stability of the finished product content, and is more suitable for large-scale production.

[0019] 2. In this application, the cinnamon twigs and dried ginger residue after distillation are decocted separately. Decoction separately is more in line with the routine operation of large-scale production. It solves the problems of uneven heating and slow temperature rise caused by the small proportion of medicinal materials and loose stacking in the original process, and significantly improves production efficiency and process controllability.

[0020] 3. This application optimizes the parameters of water addition and decoction time through systematic research. The optimized process ensures the yield of clear extract after alcohol precipitation, the amount of dry extract and the total amount of effective components (cinnamic acid, paeoniflorin and ammonium glycyrrhizate), while significantly reducing the total amount of decoction, reducing the energy consumption of subsequent concentration, shortening the production cycle, and avoiding problems such as fine fragmentation of medicinal materials and difficulty in filtration caused by excessive decoction time. Attached Figure Description

[0021] Figure 1 The chromatographic fingerprints of the samples from Examples 1 and 4 are shown. Figure 2 The chromatographic fingerprints of the samples from Example 1 and Comparative Example 1 are shown. Figure 3 The chromatographic fingerprint of the clear extract after alcohol precipitation in Experiment Example 1; Figure 4 The chromatographic fingerprint of the clear extract after alcohol precipitation in Experiment Example 6; Figure 5 The chromatographic fingerprint of the clear extract after alcohol precipitation in Experiment Example 9 is shown. Detailed Implementation

[0022] To enable those skilled in the art to better understand the technical solutions of the present invention, the technical solutions of the present invention will be clearly and completely described below in conjunction with the embodiments of the present invention. Based on the embodiments in this application, other similar embodiments obtained by those skilled in the art without creative effort should all fall within the scope of protection of this application.

[0023] A method for preparing Ginseng, Twig and Poria Oral Liquid, the method comprising the following steps: S1. Cinnamon twigs and dried ginger are distilled to obtain distillate. The distilled cinnamon twigs and dried ginger are then boiled with water to obtain decoction A. S2. Boil white peony root and acorus tatarinowii root in water twice to obtain decoction B; S3. Codonopsis pilosula, prepared licorice root, Poria cocos, prepared Polygala tenuifolia, dragon bone, and oyster shell are decocted twice with water to obtain decoction C; S4 The above-obtained decoctions A and C are mixed and then concentrated and purified to obtain a clear extract. S5 distillate, extract, pharmaceutical excipients, and water are mixed, filtered, filled, and sterilized to obtain Ginseng and Poria Oral Solution.

[0024] This application involves decocting white peony root and acorus tatarinowii rhizome separately. This separate decoction process, while ensuring the yield of the clear extract after alcohol precipitation and the total amount of active ingredients, significantly reduces the degradation of heat-sensitive components such as paeoniflorin during prolonged high-temperature decoction, improves the transfer rate of paeoniflorin and the stability of the finished product content, and is more suitable for large-scale production. The distilled cinnamon twig and dried ginger residue are also decocted separately. This separate decoction is more in line with conventional large-scale production operations and solves problems such as uneven heating and slow temperature rise caused by the small proportion of medicinal materials and loose stacking in the original process, significantly improving production efficiency and process controllability. This application optimizes the water addition and decoction time parameters through systematic research. The optimized process, while ensuring the yield of the clear extract after alcohol precipitation, the amount of dry extract, and the total amount of active ingredients (cinnamic acid, paeoniflorin, and ammonium glycyrrhizate), significantly reduces the total amount of decoction, lowers the energy consumption for subsequent concentration, shortens the production cycle, and avoids problems such as fragmented medicinal materials and difficult filtration caused by excessively long decoction times.

[0025] In step S2, before decocting white peony root and acorus tatarinowii, soak them in water. Specifically, the soaking time is 120 minutes. This pre-soaking method allows water-soluble components to be extracted more easily during the decoction process.

[0026] Example 1 The raw material dosage in this embodiment is the dosage of one prescription: Codonopsis pilosula 750g, Cinnamomum cassia 500g, Paeonia lactiflora 500g, Glycyrrhiza uralensis (processed) 500g, Poria cocos 750g, Zingiber officinale (dried) 500g, Polygala tenuifolia (processed) 450g, Acorus tatarinowii 500g, Os draconis 1500g, Ostrea gigas 1500g.

[0027] S1. Cinnamon twigs and dried ginger are distilled to obtain distillate. The distilled cinnamon twigs and dried ginger are then added to 4 times the amount of water and decocted for 60 minutes to obtain decoction A. S2. Add water to white peony root and acorus tatarinowii and decoct twice. For the first decoction, add 6 times the amount of water, soak for 120 minutes, and decoct for 60 minutes. For the second decoction, add 4 times the amount of water and decoct for 30 minutes to obtain decoction B. S3. Codonopsis pilosula, prepared licorice root, Poria cocos, prepared Polygala tenuifolia, dragon bone, and oyster shell are decocted twice with water. The first time, 3 times the amount of water is added and the decoction is decocted for 60 minutes. The second time, 2 times the amount of water is added and the decoction is decocted for 30 minutes to obtain decoction C. S4. Mix decoction A and decoction C and concentrate to a relative density of 1.06-1.08 (measured at 50℃). Cool, add ethanol to make the alcohol content reach 75%, shake well, let stand, take the supernatant, recover the ethanol under reduced pressure and concentrate to a relative density of 1.23-1.25 (measured at 80℃) to obtain the clear extract.

[0028] S5 Take the clear extract, add an appropriate amount of water and stir well, boil, refrigerate, centrifuge, then add the above distillate (first mix thoroughly with an appropriate amount of polysorbate 80), 0.4% sodium cyclohexane, and 0.2% sodium benzoate, mix well, centrifuge, add water to 1000ml, mix well, filter, fill, sterilize, and you will get Ginseng and Poria Oral Liquid.

[0029] Example 2 The raw material dosage in this embodiment is the dosage of one prescription: Codonopsis pilosula 750g, Cinnamomum cassia 500g, Paeonia lactiflora 500g, Glycyrrhiza uralensis (processed) 500g, Poria cocos 750g, Zingiber officinale (dried) 500g, Polygala tenuifolia (processed) 450g, Acorus tatarinowii 500g, Os draconis 1500g, Ostrea gigas 1500g.

[0030] S1. Cinnamon twigs and dried ginger are distilled to obtain distillate. The distilled cinnamon twigs and dried ginger are then added to 3 times the amount of water and decocted for 30 minutes to obtain decoction A. S2. Add water to white peony root and acorus tatarinowii and decoct twice. For the first decoction, add 6 times the amount of water, soak for 120 minutes, and decoct for 40 minutes. For the second decoction, add 3.5 times the amount of water and decoct for 10 minutes to obtain decoction B. S3. Codonopsis pilosula, prepared licorice root, Poria cocos, prepared Polygala tenuifolia, dragon bone, and oyster shell are decocted twice with water. The first time, 1.5 times the amount of water is added and the decoction is decocted for 40 minutes. The second time, 1 times the amount of water is added and the decoction is decocted for 10 minutes to obtain decoction C. S4 After mixing decoction A and decoction C, concentrate to a relative density of 1.06-1.08 (measured at 50℃), cool, add ethanol to make the alcohol content reach 75%, shake well, let stand, take the supernatant, recover the ethanol under reduced pressure and concentrate to a relative density of 1.23-1.25 (measured at 80℃) to obtain clear extract; S5 Take the clear extract, add an appropriate amount of water and stir well, boil, refrigerate, centrifuge, then add the above distillate (first mix thoroughly with an appropriate amount of polysorbate 80), 0.4% sodium cyclohexane, and 0.2% sodium benzoate, mix well, centrifuge, add water to 1000ml, mix well, filter, fill, sterilize, and you will get Ginseng and Poria Oral Liquid.

[0031] Example 3 The raw material dosage in this embodiment is the dosage of one prescription: Codonopsis pilosula 750g, Cinnamomum cassia 500g, Paeonia lactiflora 500g, Glycyrrhiza uralensis (processed) 500g, Poria cocos 750g, Zingiber officinale (dried) 500g, Polygala tenuifolia (processed) 450g, Acorus tatarinowii 500g, Os draconis 1500g, Ostrea gigas 1500g.

[0032] S1. Cinnamon twigs and dried ginger are distilled to obtain distillate. The distilled cinnamon twigs and dried ginger are then added to 6.5 times the amount of water and decocted for 150 minutes to obtain decoction A. S2. Add water to white peony root and acorus tatarinowii and decoct twice. For the first decoction, add 6.5 times the amount of water, soak for 120 minutes, and decoct for 150 minutes. For the second decoction, add 4 times the amount of water and decoct for 100 minutes to obtain decoction B. S3. Codonopsis pilosula, prepared licorice root, Poria cocos, prepared Polygala tenuifolia, dragon bone, and oyster shell were decocted twice with water. The first time, 6.5 times the amount of water was added and the decoction was decocted for 150 minutes. The second time, 3.5 times the amount of water was added and the decoction was decocted for 100 minutes to obtain decoction C. S4 After mixing decoction A and decoction C, concentrate to a relative density of 1.06-1.08 (measured at 50℃), cool, add ethanol to make the alcohol content reach 75%, shake well, let stand, take the supernatant, recover the ethanol under reduced pressure and concentrate to a relative density of 1.23-1.25 (measured at 80℃) to obtain clear extract; S5 Take the clear extract, add an appropriate amount of water and stir well, boil, refrigerate, centrifuge, then add the above distillate (first mix thoroughly with an appropriate amount of polysorbate 80), 0.4% sodium cyclohexane, and 0.2% sodium benzoate, mix well, centrifuge, add water to 1000ml, mix well, filter, fill, sterilize, and you will get Ginseng and Poria Oral Liquid.

[0033] Each of the above Examples 1-3 was tested in parallel three times to test the yield of the clear extract, the amount of dry extract, and the total amount of cinnamic acid, paeoniflorin, and glycyrrhizic acid ammonium in the decoction and the clear extract after alcohol precipitation. The results are shown in Table 1 below.

[0034] Table 1. Component test results of Examples 1-3 Example 4 In this embodiment, 15 times the amount of raw materials (Codonopsis pilosula 11.25kg, Cinnamomum cassia 7.5kg, Paeonia lactiflora 7.5kg, Glycyrrhiza uralensis 7.5kg, Poria cocos 11.25kg, Zingiber officinale 7.5kg, Polygala tenuifolia 6.75g, Acorus tatarinowii 7.5kg, Os draconis 22.5kg, Ostrea gigas 22.5kg) were used to prepare three batches of Shenzhiling oral liquid pilot products to verify the feasibility of process changes and product quality stability. The experimental data collected are shown in Table 2 below.

[0035] The process flow is as follows: S1. Cinnamon twigs and dried ginger are distilled to obtain distillate. The distilled cinnamon twigs and dried ginger are then added to 4 times the amount of water and decocted for 60 minutes to obtain decoction A. S2. Add water to white peony root and acorus tatarinowii and decoct twice. For the first decoction, add 6 times the amount of water, soak for 120 minutes, and decoct for 60 minutes. For the second decoction, add 4 times the amount of water and decoct for 30 minutes to obtain decoction B. S3. Codonopsis pilosula, prepared licorice root, Poria cocos, prepared Polygala tenuifolia, dragon bone, and oyster shell are decocted twice with water. The first time, 3 times the amount of water is added and the decoction is decocted for 60 minutes. The second time, 2 times the amount of water is added and the decoction is decocted for 30 minutes to obtain decoction C. S4 After mixing decoction A and decoction C, concentrate to a relative density of 1.06-1.08 (measured at 50℃), cool, add ethanol to make the alcohol content reach 75%, shake well, let stand, take the supernatant, recover the ethanol under reduced pressure and concentrate to a relative density of 1.23-1.25 (measured at 80℃) to obtain clear extract; S5 Take the clear extract, add an appropriate amount of water and stir well, boil, refrigerate, centrifuge, then add the above distillate (first mix thoroughly with an appropriate amount of polysorbate 80), 0.4% sodium cyclohexane, and 0.2% sodium benzoate, mix well, centrifuge, add water to 1000ml, mix well, filter, fill, sterilize, and you will get Ginseng and Poria Oral Liquid.

[0036] Table 2 Test data of pilot-scale sample of Ginseng and Poria oral liquid in Example 4 The results showed that the process change did not significantly alter the medicinal material basis. Pilot production proceeded smoothly and efficiently, preliminarily demonstrating the feasibility of the modified process and providing data support for further large-scale production. Three batches of samples from Examples 1 and 4 were taken and compared using the similarity evaluation system for chromatographic fingerprints of traditional Chinese medicine. The similarity is shown in Table 3, and the comparison chart is shown below. Figure 1 (In the figure, S1-S3 are samples of Example 1; S4-S6 are samples of Example 4; and S7 is a mixed control).

[0037] Table 3. Fingerprint similarity of Shenzhiling Oral Liquid According to the similarity evaluation system for chromatographic fingerprints of traditional Chinese medicine, the similarity of the samples was all above 0.95, indicating that the process change did not cause a significant change in the medicinal material basis. Therefore, this application complies with routine large-scale production operations and the process can be scaled up.

[0038] Comparative Example 1 This comparative example adopts the technical solution of CN105999195B in the prior art, and the specific solution is as follows: The raw materials used in this comparative example are: Codonopsis pilosula 750g, Cinnamomum cassia 500g, Paeonia lactiflora 500g, Glycyrrhiza uralensis (processed) 500g, Poria cocos 750g, Zingiber officinale (dried) 500g, Polygala tenuifolia (processed) 450g, Acorus tatarinowii 500g, Os draconis 1500g, and Ostrea gigas 1500g.

[0039] Cinnamon twigs and dried ginger were steam distilled, and the distillate was collected and set aside. The distilled cinnamon twigs, dried ginger, and their aqueous solution were then decocted twice with the remaining eight ingredients, including Codonopsis pilosula. The first decoction was made with 6.5 times the amount of water and decocted for 150 minutes. The second decoction was made with 3.5 times the amount of water and decocted for 100 minutes. The decoctions were combined, filtered, and the filtrate was concentrated to a relative density of 1.08-1.10 (50℃). After cooling, ethanol was added to bring the alcohol content to 75%. The mixture was stirred, allowed to stand, filtered, and the ethanol was recovered under reduced pressure and concentrated to a clear extract with a relative density of 1.22-1.24 (80℃). The clear extract was mixed with an appropriate amount of aspartame (dissolved in hot water), cooled, and then the above distillate, 0.15% peppermint oil, and 0.2% sodium benzoate were added. The mixture was stirred, and water was added to 1000 ml. The mixture was stirred, filtered, and bottled to obtain the final product.

[0040] Three batches of samples were prepared for both Comparative Example 1 and Example 1. The samples were compared using the similarity evaluation system for chromatographic fingerprints of traditional Chinese medicine. The similarity scores are shown in Table 4, and the comparison chart is shown below. Figure 2 (S1-S3 are samples of Comparative Example 1, S4-S6 are samples of Example 1, and S7 is a mixed control).

[0041] Table 4. Fingerprint similarity between Comparative Example 1 and Example 1 samples According to the similarity evaluation system of chromatographic fingerprint of traditional Chinese medicine, the similarity between Example 1 and Comparative Example 1 is above 0.95, indicating that the change in decoction process did not cause a significant change in the medicinal material basis.

[0042] Comparative Example 2 This comparative example is a test conducted on the existing technology CN105999195B during mass production.

[0043] The raw materials used in this comparative example are: Codonopsis pilosula 11.25kg, Cinnamomum cassia twig 7.5kg, Paeonia lactiflora 7.5kg, Glycyrrhiza uralensis (processed) 7.5kg, Poria cocos 11.25kg, Zingiber officinale (dried) 7.5kg, Polygala tenuifolia (processed) 6.75g, Acorus tatarinowii 7.5kg, Os draconis 22.5kg, and Ostrea gigas 22.5kg.

[0044] The preparation process is the same as in Comparative Example 1: Cinnamon twigs and dried ginger are steam distilled, and the distillate is collected and set aside. The distilled cinnamon twigs, dried ginger, and aqueous solution are decocted twice with the remaining eight ingredients, including Codonopsis pilosula. The first decoction is made with 6.5 times the amount of water and decocted for 150 minutes. The second decoction is made with 3.5 times the amount of water and decocted for 100 minutes. The decoctions are combined, filtered, and the filtrate is concentrated to a relative density of 1.08-1.10 (50℃). After cooling, ethanol is added to make the alcohol content reach 75%. The mixture is stirred, allowed to stand, filtered, and the ethanol is recovered under reduced pressure and concentrated to a clear extract with a relative density of 1.22-1.24 (80℃). The clear extract is mixed with an appropriate amount of aspartame (dissolved in hot water), cooled, and then the above distillate, 0.15% peppermint oil, and 0.2% sodium benzoate are added. The mixture is stirred, water is added to 1000ml, stirred, filtered, and bottled to obtain the final product.

[0045] The ointment obtained in Comparative Example 2 was tested, and the experimental data are shown in Table 5 below.

[0046] Table 5. Comparative Example 2 and Example 4: Ointment Component Data In Comparative Example 2, white peony root and acorus tatarinowii were decocted twice for 250 minutes (150 minutes and 100 minutes). Including the time to boil, the herbs were heated for over 300 minutes. Paeoniflorin in white peony root is heat-sensitive, and prolonged heating affects its content. Table 6 shows that the paeoniflorin content in Comparative Example 2 was lower than that in Example 4, which also involved large-scale production. To reduce the thermal degradation of paeoniflorin, this application decocts white peony root and acorus tatarinowii separately from other herbs such as codonopsis, optimizing the heating process and shortening the high-temperature exposure time in key stages. Acorus tatarinowii also contains some heat-sensitive substances and is not suitable for excessive heat treatment. Decoction with the same quantity and similar texture of acorus tatarinowii as white peony root effectively shortens the actual heating time of heat-sensitive components. Furthermore, pre-soaking before decoction makes it easier to extract water-soluble components during the decoction process.

[0047] Furthermore, in Example 2, the process of "decocting the distilled cinnamon twigs, dried ginger, and their aqueous solution twice with the remaining eight herbs, including Codonopsis pilosula," involves first decocting the cinnamon twigs and dried ginger with water to collect the distillate, and then adding the remaining eight herbs, including Codonopsis pilosula, to the extraction tank containing the distilled cinnamon twigs, dried ginger, and their aqueous solution, and then decocting again with water. While this operation is easy to perform in small-scale production such as in a laboratory setting, it presents difficulties in actual large-scale production. Because cinnamon twigs and dried ginger account for only 13.4% of all the herbs in the decoction, the material is at the bottom of the extraction tank during the decoction process, occupying only one-tenth of the tank's volume. This results in a small heating area, slow heating time, and low production efficiency. Moreover, adding the other eight herbs to the distilled residue and decoction for further decoction does not conform to standard production practices.

[0048] Comparative Example 3 The only difference from Example 1 is that the soaking process was not used in step S2 of this comparative example. The resulting extract was tested, and the experimental data are shown in Table 6 below.

[0049] Table 6 Comparative Example 3: Ingredient Data of the Cleansing Paste If white peony root and acorus tatarinowii are not soaked before decoction, the content of paeoniflorin in the extract will decrease significantly.

[0050] Experimental Example 1 This experimental example studies the decoction process of distilled cinnamon twigs and dried ginger residues. Each experiment was repeated in triplicate. The raw materials used in this experimental example were: Codonopsis pilosula 750g, cinnamon twigs 500g, white peony root 500g, prepared licorice root 500g, Poria cocos 750g, dried ginger 500g, prepared Polygala tenuifolia 450g, Acorus tatarinowii 500g, dragon bone 1500g, and oyster shell 1500g.

[0051] Experimental Example 1-1 Process: Cinnamon twigs, dried ginger residue, and eight other herbs, including Codonopsis pilosula, are decocted twice.

[0052] The above ten ingredients are steam distilled. Cinnamon twigs and dried ginger are steam distilled, and the distillate is collected for later use. The distilled cinnamon twigs, dried ginger and aqueous solution are added to the remaining eight ingredients, including Codonopsis pilosula, and decocted twice. The first decoction is made with 6.5 times the amount of water and decocted for 150 minutes. The second decoction is made with 3.5 times the amount of water and decocted for 100 minutes. The decoctions are combined, filtered, and the filtrate is concentrated to a relative density of 1.08-1.10 (50℃). The filtrate is cooled, and ethanol is added to make the alcohol content reach 75%. The mixture is stirred, allowed to stand, filtered, and the ethanol is recovered under reduced pressure and concentrated to a clear extract with a relative density of 1.22-1.24 (80℃).

[0053] Process in Experimental Example 1-2: Cinnamon twigs and dried ginger residue were decocted separately twice.

[0054] The above ten ingredients are prepared as follows: Cinnamon twigs and dried ginger are steam distilled, and an appropriate amount of distillate is collected for later use. The decoction is filtered and set aside. The distilled cinnamon twigs and dried ginger are then decocted twice with water. The first time, 6.5 times the amount of water is added, and the decoction is decocted for 150 minutes. The second time, 3.5 times the amount of water is added, and the decoction is decocted for 100 minutes. The decoction is filtered and set aside. The remaining eight ingredients, including Codonopsis pilosula, are decocted twice with water. The first time, 6.5 times the amount of water is added, and the decoction is decocted for 150 minutes. The second time, 3.5 times the amount of water is added, and the decoction is decocted for 100 minutes. The decoction is filtered and set aside. The combined filtrates are concentrated to a relative density of 1.08-1.10 (50℃), cooled, and ethanol is added to achieve an alcohol content of 75%. The mixture is stirred well, allowed to stand, filtered, and the ethanol is recovered from the filtrate under reduced pressure and concentrated to a clear extract with a relative density of 1.22-1.24 (80℃).

[0055] Two types of ginseng, twig and poria oral liquid were prepared by alcohol precipitation and the resulting dry extracts were calculated and the quantities were recorded. The contents of the corresponding decoction and alcohol-precipitated extracts were determined, and the data were recorded and analyzed.

[0056] Detection methods and contents: Detection of the clear extract after alcohol precipitation: density (measured with a densitometer); Determination of cinnamic acid and paeoniflorin content: Take appropriate amounts of the decoction and the clear extract after alcohol precipitation, and test and record the results according to the determination method of cinnamic acid and paeoniflorin content under the draft quality standard of Shenzhiling Oral Liquid; Fingerprint spectrum determination method: Take an appropriate amount of the clear extract after alcohol precipitation and perform the determination according to the fingerprint spectrum method.

[0057] Comparing the data and test results of two different decoction processes (three parallel groups each) for Ginseng and Ginger Oral Liquid, one involving the separate decoction of cinnamon twig and dried ginger residue, and the other involving decoction of cinnamon twig and dried ginger residue combined with other herbs, the results showed that the amounts of clear and dry extracts after alcohol precipitation were basically the same for both processes; the total amounts of cinnamic acid and paeoniflorin in the decoction and clear extract obtained from the two processes were not significantly different. Fingerprint analysis showed that the similarity of the six batches of clear extract samples after alcohol precipitation was all above 0.95. Detailed data are shown in Table 7. Figure 3 (S1-S3 are the clear extract after alcohol precipitation in Experiment 1-1, S4-S6 are the clear extract after alcohol precipitation in Experiment 1-2, and S7 is the mixed control).

[0058] Table 7. Summary of fingerprint similarity of the ginseng, twig and ling oral liquid after alcohol precipitation and clearing. According to the similarity evaluation system for chromatographic fingerprints of traditional Chinese medicine, the similarity of the six batches of ethanol-precipitated extract samples was all above 0.95, indicating that this process change did not cause a significant change in the medicinal material basis. Changing the process from decocting the distilled cinnamon twig and dried ginger residue together with eight other herbs, including Codonopsis pilosula, twice, to decocting the distilled cinnamon twig and dried ginger residue separately twice with water, did not cause a significant change in the medicinal material basis; the results were essentially the same. Therefore, the process of decocting the distilled cinnamon twig and dried ginger residue separately is feasible.

[0059] Experiment Example 2 This experiment investigated the number of times the dregs of cinnamon twig and dried ginger were decocted separately. Each experiment was repeated three times. The raw materials used in this experiment were: Codonopsis pilosula 750g, cinnamon twig 500g, white peony root 500g, prepared licorice root 500g, Poria cocos 750g, dried ginger 500g, prepared Polygala tenuifolia 450g, Acorus tatarinowii 500g, dragon bone 1500g, and oyster shell 1500g.

[0060] Experimental Example 2-1 Process: After distillation, the dregs of cinnamon twigs and dried ginger are decocted twice.

[0061] The above ten ingredients are prepared as follows: Cinnamon twigs and dried ginger are steam distilled, and an appropriate amount of distillate is collected for later use. The decoction is filtered and set aside. The distilled cinnamon twigs and dried ginger are then decocted twice with water. The first time, 6.5 times the amount of water is added, and the decoction is decocted for 150 minutes. The second time, 3.5 times the amount of water is added, and the decoction is decocted for 100 minutes. The decoction is filtered and set aside. The remaining eight ingredients, including Codonopsis pilosula, are decocted twice with water. The first time, 6.5 times the amount of water is added, and the decoction is decocted for 150 minutes. The second time, 3.5 times the amount of water is added, and the decoction is decocted for 100 minutes. The decoction is filtered and set aside. The combined filtrates are concentrated to a relative density of 1.08-1.10 (50℃), cooled, and ethanol is added to achieve an alcohol content of 75%. The mixture is stirred well, allowed to stand, filtered, and the ethanol is recovered from the filtrate under reduced pressure and concentrated to a clear extract with a relative density of 1.22-1.24 (80℃).

[0062] Experimental Example 2-2 Process: After distillation, the dregs of cinnamon twigs and dried ginger are decocted once.

[0063] The above ten ingredients are prepared by steam distillation of cinnamon twigs and dried ginger. A suitable amount of distillate is collected and set aside. The decoction is filtered and set aside. The distilled cinnamon twigs and dried ginger are then decocted with 6.5 times their volume of water for 150 minutes. The decoction is filtered and set aside. The remaining eight ingredients, including codonopsis, are decocted twice. The first time, 6.5 times the volume of water is added and the decoction is decocted for 150 minutes. The second time, 3.5 times the volume of water is added and the decoction is decocted for 100 minutes. The decoctions are filtered and set aside. The combined filtrates are concentrated to a relative density of 1.08-1.10 (50℃), cooled, and ethanol is added to achieve an alcohol content of 75%. The mixture is stirred, allowed to stand, filtered, and the ethanol is recovered under reduced pressure and concentrated to a clear extract with a relative density of 1.22-1.24 (80℃).

[0064] Two types of ginseng, twig and poria oral liquid were prepared by alcohol precipitation and the resulting dry extracts were calculated and the quantities were recorded. The contents of the corresponding decoction and alcohol-precipitated extracts were determined, and the data were recorded and analyzed. The data are shown in Table 8.

[0065] Table 8. Comparison of research results on different decoction times for distilled cinnamon twigs and dried ginger. Experimental results showed that changing the method of decocting cinnamon twigs and dried ginger after distillation to a single decoction did not cause a significant change in their content; the content remained essentially the same before and after the change. Therefore, it is feasible to decoct the cinnamon twig and dried ginger residue separately once after distillation.

[0066] Experimental Example 3 This experiment investigated the decoction time of cinnamon twig and dried ginger residue after decocting them separately. Each experiment was repeated in triplicate. The raw materials used in this experiment were: Codonopsis pilosula 750g, cinnamon twig 500g, white peony root 500g, prepared licorice root 500g, Poria cocos 750g, dried ginger 500g, prepared Polygala tenuifolia 450g, Acorus tatarinowii 500g, dragon bone 1500g, and oyster shell 1500g.

[0067] Experimental Procedure: Study on different decoction times for cinnamon twig and dried ginger residue after distillation. The above ten herbs were steam distilled. A suitable amount of distillate was collected and set aside. The decoction was filtered and set aside. The distilled cinnamon twig and dried ginger were then added to 6.5 times the amount of water and decocted for ①150 minutes ②120 minutes ③90 minutes ④60 minutes ⑤30 minutes respectively. The remaining eight herbs, including Codonopsis pilosula, were decocted twice. The first time, 6.5 times the amount of water was added and decocted for 150 minutes; the second time, 3.5 times the amount of water was added and decocted for 100 minutes. The decoctions were filtered and set aside. The combined filtrates were concentrated to a relative density of 1.08-1.10 (50℃), cooled, and ethanol was added to achieve an alcohol content of 75%. The mixture was stirred, allowed to stand, filtered, and the ethanol was recovered under reduced pressure and concentrated to a clear extract with a relative density of 1.22-1.24 (80℃).

[0068] Distilled cinnamon twigs and dried ginger were decocted for different times: ①150 minutes ②120 minutes ③90 minutes ④60 minutes ⑤30 minutes. Five ginseng-twig-and-poria oral liquid extracts were prepared, purified by alcohol precipitation, and converted to dry extracts. The quantities were recorded. The contents of the corresponding decoctions and purified extracts were determined, and the data were recorded and analyzed. The data are shown in Table 9.

[0069] Table 9 Comparison of research results on different decoction times of cinnamon twig and dried ginger residue (n=3) Comparing the process data and test data of the second decoction of cinnamon twigs and dried ginger after distillation of Shenzhiling oral liquid using five different decoction times (three parallel groups each), the results showed that the amount of clear and dry extract obtained after alcohol precipitation was the lowest when the cinnamon twig and dried ginger residue was decocted for 30 minutes after distillation, and the total amount of cinnamic acid in the clear extract was also the lowest. For the other four decoction times (①150 minutes ②120 minutes ③90 minutes ④60 minutes), there were no significant differences in the amount of clear and dry extract obtained after alcohol precipitation, or the total amount of cinnamic acid in the clear extract. To save energy, reduce consumption, and improve production efficiency, the optimal decoction time for cinnamon twig and dried ginger residue is 60 minutes.

[0070] Experiment Example 4 This experiment investigated the amount of water added when decocting the dregs of cinnamon twig and dried ginger separately. Each experiment was repeated three times. The raw materials used in this experiment were: Codonopsis pilosula 750g, cinnamon twig 500g, white peony root 500g, prepared licorice root 500g, Poria cocos 750g, dried ginger 500g, prepared Polygala tenuifolia 450g, Acorus tatarinowii 500g, dragon bone 1500g, and oyster shell 1500g.

[0071] Experimental Procedure: An experimental study on the decoction of cinnamon twigs and dried ginger residues after distillation with different amounts of water. The above ten herbs were steam distilled. A suitable amount of distillate was collected and set aside. The decoction was filtered and set aside. The distilled cinnamon twigs and dried ginger were then added to water at the following ratios: ① 6.5 times, ② 5 times, ③ 4 times, ④ 3 times, respectively, and decocted for 60 minutes. The remaining eight herbs, including Codonopsis pilosula, were decocted twice. The first time, 6.5 times the amount of water was added, and the decoction was decocted for 150 minutes. The second time, 3.5 times the amount of water was added, and the decoction was decocted for 100 minutes. The decoctions were filtered and set aside. The combined filtrates were concentrated to a relative density of 1.08-1.10 (50℃), cooled, and ethanol was added to achieve an alcohol content of 75%. The mixture was stirred, allowed to stand, filtered, and the ethanol was recovered under reduced pressure and concentrated to a clear extract with a relative density of 1.22-1.24 (80℃).

[0072] After distillation, cinnamon twigs and dried ginger were decocted with different amounts of water (① 6.5 times ② 5 times ③ 4 times ④ 3 times) to prepare four different amounts of ginseng, twig and ginger oral liquid. The precipitated extract was then converted to dry extract and the quantities were recorded. The contents of the corresponding decoction and the precipitated extract were determined and the contents of cinnamic acid and paeoniflorin were recorded and analyzed. The data are shown in Table 10.

[0073] Table 10 Comparison of research results on different amounts of water added when decocting cinnamon twig and dried ginger residue (n=3) Comparing the process data and test data of cinnamon twig and dried ginger after distillation of Shenzhiling oral liquid using four different water additions (three parallel groups each), the results showed that adding three times the amount of water to the cinnamon twig and dried ginger residue after distillation resulted in the lowest amount of clear and dry extract after alcohol precipitation, and the lowest total amount of cinnamic acid in the clear extract. For the other three decoction times (① 6.5 times ② 5 times ③ 4 times), there were no significant differences in the amount of clear and dry extract after alcohol precipitation, or the total amount of cinnamic acid in the clear extract. To save energy, reduce consumption, and improve production efficiency, the optimal method is to add four times the amount of water when decocting the cinnamon twig and dried ginger residue.

[0074] Experimental Example 5 This experiment investigated the thermal degradation of paeoniflorin. The herbal solution was stored at different temperatures for 17 hours, and the degradation rate of paeoniflorin is shown in Table 11 below.

[0075] Table 11 Effect of temperature on the degradation rate of paeoniflorin During large-scale extraction, we found that the transfer rate of paeoniflorin in white peony root was lower than that in the small-scale test. Specifically, the transfer rate of paeoniflorin in each stage of the small-scale test was relatively high, and the finished product content met requirements. However, the transfer rate in large-scale production was lower than in the small-scale test, making it difficult to guarantee the finished product content. Research and analysis revealed that paeoniflorin is a heat-sensitive substance, and its content decreases with increasing temperature and heating time. The key differences lie in the significant variations in decoction boiling time, filtration time, concentration time, and storage temperature and time between large-scale and small-scale / pilot-scale tests. The high-temperature exposure time of paeoniflorin was significantly longer in large-scale production than in the small-scale test.

[0076] Experimental Example 6 This experiment investigated the decoction of white peony root and acorus tatarinowii rhizome alone. Each experiment was repeated three times. The raw materials used in this experiment were: Codonopsis pilosula 750g, Cinnamomum cassia twig 500g, white peony root 500g, prepared licorice root 500g, Poria cocos 750g, dried ginger 500g, prepared Polygala tenuifolia root 450g, acorus tatarinowii rhizome 500g, dragon bone 1500g, and oyster shell 1500g.

[0077] Process of Experiment 6-1: White peony root, acorus tatarinowii, and the other six herbs, including codonopsis pilosula, are decocted together. The above ten ingredients are used as follows: Cinnamon twigs and dried ginger are steam distilled, and an appropriate amount of distillate is collected for later use. The decoction is filtered and set aside. The distilled cinnamon twigs and dried ginger are then decocted with 4 times the amount of water for 60 minutes. The remaining eight ingredients, including Codonopsis pilosula, are decocted twice with water. The first time, 6.5 times the amount of water is added, and the decoction is decocted for 150 minutes. The second time, 3.5 times the amount of water is added, and the decoction is decocted for 100 minutes. The decoctions are filtered and set aside. The combined liquids are concentrated to a relative density of 1.08-1.10 (50℃), cooled, and ethanol is added to achieve an alcohol content of 75%. The mixture is stirred well, allowed to stand, filtered, and the filtrate is reduced under reduced pressure to recover the ethanol and concentrated to a clear extract with a relative density of 1.22-1.24 (80℃).

[0078] Experimental Example 6-2 Process: White peony root and acorus tatarinowii were decocted separately. The above ten ingredients are prepared as follows: Cinnamon twigs and dried ginger are steam distilled, and an appropriate amount of distillate is collected for later use. The decoction is filtered and set aside. The distilled cinnamon twigs and dried ginger are then decocted with 4 times the amount of water for 60 minutes. White peony root and acorus tatarinowii are decocted twice with water. The first time, 6.5 times the amount of water is added, and the decoction is decocted for 150 minutes. The second time, 3.5 times the amount of water is added, and the decoction is decocted for 100 minutes. The decoction is filtered and set aside. The remaining six ingredients, including codonopsis pilosula, are decocted twice with water. The first time, 6.5 times the amount of water is added, and the decoction is decocted for 150 minutes. The second time, 3.5 times the amount of water is added, and the decoction is decocted for 100 minutes. The decoction is filtered. The above three filtrates are concentrated to a relative density of 1.08-1.10 (50℃), cooled, and ethanol is added to achieve an alcohol content of 75%. The mixture is stirred, allowed to stand, filtered, and the ethanol is recovered from the filtrate under reduced pressure and concentrated to a clear extract with a relative density of 1.22-1.24 (80℃).

[0079] Two different processes were used to prepare the ginseng, twig, and poria oral liquid, which was then purified by alcohol precipitation and converted to dry extract. The quantities were recorded. The corresponding decoction and purified extract were taken to determine the contents of cinnamic acid and paeoniflorin, and the data were recorded and analyzed. The data are shown in Tables 12-13.

[0080] Table 12 Comparison of Results of Different Production Processes for Decoction of White Peony Root and Acorus Root (n=3) Table 13 Summary of fingerprint similarity of the ginseng, twig and poria oral liquid after alcohol precipitation in Experiment Example 6 The results showed that the amounts of clear and dry extracts after alcohol precipitation were basically the same for both processes; the total amounts of cinnamic acid and paeoniflorin in the decoction and clear extract obtained from the two processes were not significantly different. Fingerprint analysis showed that the similarity of the six batches of clear extract samples after alcohol precipitation was all above 0.95, indicating that the process change did not cause a significant alteration to the medicinal material basis. Therefore, the separate decoction process for white peony root and acorus tatarinowii in Shenzhiling oral liquid is feasible. Detailed results are shown in Tables 13-14. Figure 4 (S1-S3 are the clear extract after alcohol precipitation in Experiment 6-1, S4-S6 are the clear extract after alcohol precipitation in Experiment 6-2, and S7 is a mixed control).

[0081] Experimental Example 7 This experiment investigated the decoction time of white peony root and acorus tatarinowii rhizome alone. Each experiment was repeated three times. The raw materials used in this experiment were: Codonopsis pilosula 750g, Cinnamomum cassia twig 500g, white peony root 500g, prepared licorice root 500g, Poria cocos 750g, dried ginger 500g, prepared Polygala tenuifolia root 450g, acorus tatarinowii rhizome 500g, dragon bone 1500g, and oyster shell 1500g.

[0082] Experimental Procedure: Study on the decoction time of white peony root and acorus tatarinowii rhizome alone. The above ten herbs were used. Cinnamon twig and dried ginger were steam distilled, and an appropriate amount of distillate was collected for later use. The decoction was filtered and set aside. The distilled cinnamon twig and dried ginger were then added to 4 times the amount of water and decocted for 60 minutes. White peony root and acorus tatarinowii rhizome were decocted twice with water. The first time, 6.5 times the amount of water was added, and the second time, 3.5 times the amount of water was added. The decoction times were ① 150 minutes, 100 minutes ② 120 minutes, 90 minutes ③ 100 minutes, 70 minutes ④ 80 minutes, 50 minutes ⑤ 60 minutes, 30 minutes ⑥ 40 minutes, 10 minutes. The decoctions were filtered and set aside. The remaining six herbs, including codonopsis pilosula, were decocted twice with water. The first time, 6.5 times the amount of water was added, and the decoction was decocted for 150 minutes. The second time, 3.5 times the amount of water was added, and the decoction was decocted for 100 minutes. The decoctions were filtered and set aside. The above three filtrates were concentrated to a relative density of 1.08-1.10 (50℃), cooled, and ethanol was added to make the alcohol content reach 75%. The mixture was stirred, allowed to stand, filtered, and the ethanol was recovered from the filtrate under reduced pressure and concentrated to a clear paste with a relative density of 1.22-1.24 (80℃).

[0083] White peony root and acorus tatarinowii were decocted for different times (①250 minutes ②210 minutes ③170 minutes ④130 minutes ⑤90 minutes ⑥50 minutes) to prepare ginseng, twig and poria oral liquid. After alcohol precipitation, the clear extract was obtained and converted to dry extract, and the quantities were recorded. The contents of the corresponding decoction and alcohol-precipitated clear extract were determined, and the data were recorded and analyzed. The data are shown in Table 14.

[0084] Table 14 Comparison of research results on different decoction times for white peony root and acorus tatarinowii (n=3) Comparing the process data and test data of decocting white peony root and acorus tatarinowii with six different decoction times (three parallel groups each), the results showed that the total amount of paeoniflorin in the decoction and the clear extract after alcohol precipitation was significantly reduced in the sixth group (40 minutes and 10 minutes). In the other five groups, there was no significant difference in the total amount of paeoniflorin in the decoction and the clear extract after alcohol precipitation, nor was there a significant difference in the amount of clear extract and dry extract after alcohol precipitation. To save energy, reduce consumption, and improve production efficiency, the optimal decoction time for white peony root and acorus tatarinowii residue is 60 minutes and 30 minutes, respectively. Specific data are shown in Table 15.

[0085] Experimental Example 8 This experiment investigated the amount of water to add when decocting white peony root and acorus tatarinowii rhizome separately. Each experiment was repeated three times. The raw materials used in this experiment were: Codonopsis pilosula 750g, Cinnamomum cassia twig 500g, white peony root 500g, prepared licorice root 500g, Poria cocos 750g, dried ginger 500g, prepared Polygala tenuifolia 450g, acorus tatarinowii rhizome 500g, dragon bone 1500g, and oyster shell 1500g.

[0086] Example 8-1 Process: For the above ten ingredients, cinnamon twigs and dried ginger are steam distilled, and an appropriate amount of distillate is collected for later use. The decoction is filtered and set aside. The distilled cinnamon twigs and dried ginger are then added to 4 times the amount of water and decocted for 60 minutes. White peony root and acorus tatarinowii are decocted twice with water. The first time, 6.5 times the amount of water is added, and the mixture is soaked for 120 minutes and decocted for 60 minutes. The second time, 3.5 times the amount of water is added, and the mixture is decocted for 30 minutes. The decoction is filtered and set aside. The remaining six ingredients, including codonopsis pilosula, are decocted twice with water. The first time, 6.5 times the amount of water is added, and the mixture is decocted for 150 minutes. The second time, 3.5 times the amount of water is added, and the mixture is decocted for 100 minutes. The decoction is filtered. The above three filtrates are concentrated to a relative density of 1.08-1.10 (50℃), cooled, and ethanol is added to achieve an alcohol content of 75%. The mixture is stirred, allowed to stand, filtered, and the ethanol is recovered under reduced pressure and concentrated to a clear extract with a relative density of 1.22-1.24 (80℃).

[0087] Process of Experiment 8-2: For the above ten ingredients, cinnamon twigs and dried ginger are steam distilled, and an appropriate amount of distillate is collected for later use. The decoction is filtered and set aside. The distilled cinnamon twigs and dried ginger are then added to 4 times the amount of water and decocted for 60 minutes. White peony root and acorus tatarinowii are decocted twice with water. The first time, 6 times the amount of water is added, the mixture is soaked for 120 minutes, and decocted for 60 minutes. The second time, 4 times the amount of water is added, and the mixture is decocted for 30 minutes. The decoction is filtered and set aside. The remaining six ingredients, including codonopsis pilosula, are decocted twice with water. The first time, 6.5 times the amount of water is added, and the mixture is decocted for 150 minutes. The second time, 3.5 times the amount of water is added, and the mixture is decocted for 100 minutes. The decoction is filtered. The above three filtrates are concentrated to a relative density of 1.08-1.10 (50℃), cooled, and ethanol is added to achieve an alcohol content of 75%. The mixture is stirred, allowed to stand, filtered, and the ethanol is recovered from the filtrate under reduced pressure and concentrated to a clear extract with a relative density of 1.22-1.24 (80℃).

[0088] White peony root and acorus tatarinowii were decocted with different amounts of water (① 6.5 times, 3.5 times ② 6 times, 4 times) to prepare two ginseng, twig and lingzhi oral liquids. The precipitated extracts were then converted to dry extracts and the quantities were recorded. The contents of the corresponding decoctions and precipitated extracts were determined and the contents of cinnamic acid and paeoniflorin were recorded and analyzed. The data are shown in Table 15.

[0089] Table 15 Comparison of Research Results on Different Amounts of Water Added for Decoction of White Peony and Acorus tatarinowii (n=3) Comparing the process data and test data of different decoction and water addition of ginseng, twig and ling (Shenzhiling) oral administration of white peony root and acorus tatarinowii, the results showed that there was no significant difference in the amount of clear extract and dry extract after alcohol precipitation, or the total amount of cinnamic acid and paeoniflorin in the clear extract after alcohol precipitation, obtained by different water addition processes.

[0090] Experimental Example 9 This experiment investigated the amount of water to add when decocting six herbs: Codonopsis pilosula, prepared licorice root, Poria cocos, prepared Polygala tenuifolia, dragon bone, and oyster shell. Each experiment was repeated three times. The raw materials used in this experiment were: Codonopsis pilosula 750g, Cinnamomum cassia 500g, Paeonia lactiflora 500g, prepared licorice root 500g, Poria cocos 750g, dried ginger 500g, prepared Polygala tenuifolia 450g, Acorus tatarinowii 500g, dragon bone 1500g, and oyster shell 1500g.

[0091] Experimental Procedure: Study on the amount of water added for the decoction of the remaining six herbs, including Codonopsis pilosula. The above ten herbs were used as follows: Cinnamomum cassia and Zingiber officinale were steam distilled, and an appropriate amount of distillate was collected for later use. The decoction was filtered and set aside. The distilled Cinnamomum cassia and Zingiber officinale were then added to 4 times the amount of water and decocted for 60 minutes. Paeonia lactiflora and Acorus tatarinowii were decocted twice. The first time, 6 times the amount of water was added, and the herbs were soaked for 120 minutes and decocted for 60 minutes. The second time, 4 times the amount of water was added and the herbs were decocted for 30 minutes. The decoction was filtered and set aside. The remaining six herbs, including Codonopsis pilosula, were decocted twice with water added at the following amounts: ① 6.5 times, 3.5 times; ② 5 times, 2.5 times; ③ 3 times, 2 times; ④ 1.5 times, 1 time. The first decoction was 150 minutes, and the second decoction was 100 minutes. The decoction was filtered. The above three filtrates were concentrated to a relative density of 1.08-1.10 (50℃), cooled, and ethanol was added to make the alcohol content reach 75%. The mixture was stirred, allowed to stand, filtered, and the ethanol was recovered from the filtrate under reduced pressure and concentrated to a clear paste with a relative density of 1.22-1.24 (80℃).

[0092] Six herbs, including Codonopsis pilosula, were decocted with different amounts of water (① 6.5 times, 3.5 times ② 5 times, 2.5 times ③ 3 times, 2 times ④ 1.5 times, 1 time) to prepare four different amounts of ginseng, twig and poria oral liquid. After alcohol precipitation, the clear extract was calculated and the quantity was recorded. The corresponding decoction and alcohol-precipitated clear extract were taken to determine the contents of cinnamic acid, paeoniflorin and glycyrrhizic acid ammonium. The data were recorded and analyzed. The data are shown in Tables 16-17.

[0093] Table 16 Comparison of Production Process Investigation Results for Six Herbs Including Codonopsis pilosula Table 17 Summary of fingerprint similarity of the purifying extract after alcohol precipitation of Shenzhiling oral liquid Comparing the process data and test data of decoction of six herbs including Codonopsis pilosula and Ginseng Zhiling Oral Liquid using four different water addition amounts (three parallel groups each), the results showed that the fourth group (1.5 times and 1 times the water addition) yielded the least amount of clear extract and dry extract after alcohol precipitation, as well as the least amount of total ammonium glycyrrhizate, significantly less than the other three groups. There were no significant differences in the total amounts of cinnamic acid, paeoniflorin, and ammonium glycyrrhizate in the decoction and clear extract after alcohol precipitation in the other three groups, nor were there significant differences in the amount of clear extract and dry extract after alcohol precipitation. Fingerprint analysis showed that the similarity of the nine batches of clear extract samples after alcohol precipitation was above 0.95. To save energy, reduce consumption, and improve production efficiency, the optimal water addition amounts for the decoction of the six herbs including Codonopsis pilosula were selected as 3 times and 2 times. Detailed results are shown in Tables 17-18. Figure 5 (S1-S3 are clear extracts diluted with 6.5 times and 3.5 times water, respectively; S4-S6 are clear extracts diluted with 5 times and 2.5 times water, respectively; S7-S9 are clear extracts diluted with 3 times and 2 times water, respectively; S10 is a mixed reference standard).

[0094] Experimental Example 10 This experiment investigated the decoction time of six herbs: Codonopsis pilosula, prepared licorice root, Poria cocos, prepared Polygala tenuifolia, dragon bone, and oyster shell. Each experiment was repeated in triplicate. The raw materials used in this experiment were: Codonopsis pilosula 750g, Cinnamomum cassia 500g, Paeonia lactiflora 500g, prepared licorice root 500g, Poria cocos 750g, dried ginger 500g, prepared Polygala tenuifolia 450g, Acorus tatarinowii 500g, dragon bone 1500g, and oyster shell 1500g.

[0095] Experimental Procedure: For the above ten ingredients, cinnamon twigs and dried ginger are steam distilled, and an appropriate amount of distillate is collected for later use. The decoction is filtered and set aside. The distilled cinnamon twigs and dried ginger are then added to 4 times the amount of water and decocted for 60 minutes. White peony root and acorus tatarinowii are decocted twice. The first time, 6 times the amount of water is added, and the herbs are soaked for 120 minutes and decocted for 60 minutes. The second time, 4 times the amount of water is added, and the herbs are decocted for 30 minutes. The decoction is filtered and set aside. The remaining six ingredients, including codonopsis pilosula, are decocted twice. The first time, 6.5 times the amount of water is added, and the second time, 3.5 times the amount of water is added. The decoction times are: ① 150 minutes, 100 minutes ② 120 minutes, 90 minutes ③ 100 minutes, 70 minutes ④ 80 minutes, 50 minutes ⑤ 60 minutes, 30 minutes ⑥ 40 minutes, 10 minutes. The decoction is filtered. The above three filtrates were concentrated to a relative density of 1.08-1.10 (50℃), cooled, and ethanol was added to make the alcohol content reach 75%. The mixture was stirred, allowed to stand, filtered, and the ethanol was recovered from the filtrate under reduced pressure and concentrated to a clear paste with a relative density of 1.22-1.24 (80℃).

[0096] Six herbs, including Codonopsis pilosula, were decocted for different times (①250 minutes ②210 minutes ③170 minutes ④130 minutes ⑤90 minutes ⑥50 minutes) to prepare six groups of ginseng, twig, and poria oral liquids after alcohol precipitation and conversion to dry extracts. The quantities were recorded. The contents of the corresponding decoctions and alcohol-precipitated extracts were determined, including cinnamic acid, paeoniflorin, and ammonium glycyrrhizate. The data were recorded and analyzed. The data are shown in Table 18.

[0097] Table 18 Comparison of research results on different decoction times of six herbs including Codonopsis pilosula (n=3) Comparing the process data and test data of six different decoction times for the six herbs including Codonopsis pilosula in the Shenzhiling oral liquid, the results showed that the sixth group (40 minutes and 10 minutes) yielded the least amount of clear extract and dry extract after alcohol precipitation, as well as the least amount of ammonium glycyrrhizate, significantly less than the other five groups. There were no significant differences in the total amounts of cinnamic acid, paeoniflorin, and ammonium glycyrrhizate in the decoction and clear extract after alcohol precipitation among the other five groups, nor were there significant differences in the amount of clear extract and dry extract after alcohol precipitation. To save energy, reduce consumption, and improve production efficiency, the decoction time for the six herbs including Codonopsis pilosula was selected as 60 minutes and 30 minutes.

[0098] In summary, based on Experiments 1-10, the decoction process for Shenzhiling Oral Liquid is modified as follows: Cinnamon twigs and dried ginger are steam distilled, and an appropriate amount of distillate is collected for later use. The decoction is filtered and set aside. The distilled cinnamon twigs and dried ginger are then mixed with 4 times the amount of water and decocted for 60 minutes. White peony root and acorus tatarinowii are decocted twice with water. The first time, 6 times the amount of water is added, the herbs are soaked for 120 minutes, and decocted for 60 minutes. The second time, 4 times the amount of water is added, and the herbs are decocted for 30 minutes. The decoction is filtered and set aside. The remaining six herbs, including codonopsis pilosula, are decocted twice with water. The first time, 3 times the amount of water is added, and the herbs are decocted for 60 minutes. The second time, 2 times the amount of water is added, and the herbs are decocted for 30 minutes. The decoction is filtered.

[0099] Furthermore, it should be understood that although this specification describes embodiments, not every embodiment contains only one independent technical solution. This narrative style is merely for clarity. Those skilled in the art should consider the specification as a whole, and the technical solutions in each embodiment can also be appropriately combined to form other embodiments that can be understood by those skilled in the art.

Claims

1. A method for preparing a ginseng, twig, and poria oral liquid, characterized in that, The preparation method includes the following steps: S1. Cinnamon twigs and dried ginger are distilled to obtain distillate. The distilled cinnamon twigs and dried ginger are then boiled with water to obtain decoction A. S2. Boil white peony root and acorus tatarinowii root in water to obtain decoction B; S3. Codonopsis pilosula, prepared licorice root, Poria cocos, prepared Polygala tenuifolia, dragon bone, and oyster shell are decocted in water to obtain decoction C; S4 The above-obtained decoctions A and C are mixed and then concentrated and purified to obtain a clear extract. S5 The distillate, the clear extract, and the pharmaceutical excipients are mixed, filtered, filled, and sterilized to obtain Ginseng and Poria Oral Liquid.

2. The preparation method of Shenzhiling oral liquid according to claim 1, characterized in that, Before decocting the white peony root and acorus tatarinowii in step S2, soak the white peony root and acorus tatarinowii in water.

3. The preparation method of Shenzhiling oral liquid according to claim 1, characterized in that, The concentration and purification step in step S4 is as follows: after mixing decoction A and decoction D, concentrate to a relative density of 1.06 to 1.08, add ethanol, mix and let stand, take the supernatant, recover the ethanol under reduced pressure and concentrate to a relative density of 1.23 to 1.25 to obtain the clear extract.

4. The preparation method of Ginseng and Poria Cocos Oral Liquid according to claim 1, wherein in step S5, the extract is first mixed with water, and then mixed with pharmaceutical excipients and distillate, wherein the pharmaceutical excipients in step S5 are sodium cyclohexane and sodium benzoate.

5. The preparation method of Ginseng, Twig and Poria Oral Solution according to claim 1, characterized in that, In step S1, the amount of water added is 3-6.5 times the total mass of cinnamon twigs and dried ginger, and the decoction time in step S1 is 30-150 minutes.

6. The preparation method of Ginseng, Twig and Poria Oral Liquid according to claim 5, characterized in that, In step S1, the amount of water added is 4 times the total mass of cinnamon twigs and dried ginger, and the decoction time in step S1 is 60 minutes.

7. The preparation method of Ginseng, Twig and Poria Oral Liquid according to claim 1, characterized in that, In step S2, white peony root and acorus tatarinowii are decocted twice with water. In the first decoction in step S2, the amount of water added is 6-6.5 times the total mass of white peony root and acorus tatarinowii, and the first decoction time is 40-150 minutes. In the second decoction in step S2, the amount of water added is 3.5-4 times the total mass of white peony root and acorus tatarinowii, and the first decoction time is 10-100 minutes.

8. The preparation method of Shenzhiling oral liquid according to claim 7, characterized in that, In step S2, the amount of water added for the first decoction is 6 times the total mass of white peony root and acorus tatarinowii, and the first decoction time is 60 minutes; in step S2, the amount of water added for the second decoction is 4 times the total mass of white peony root and acorus tatarinowii, and the first decoction time is 30 minutes.

9. The preparation method of Shenzhiling oral liquid according to claim 1, characterized in that, In step S3, Codonopsis pilosula, prepared licorice root, Poria cocos, prepared Polygala tenuifolia, dragon bone, and oyster shell are decocted twice with water. In the first decoction in step S3, the amount of water added is 1.5-6.5 times the total mass of Codonopsis pilosula, prepared licorice root, Poria cocos, prepared Polygala tenuifolia, dragon bone, and oyster shell, and the first decoction time is 40-150 minutes. In step S2, the amount of water added for the second decoction is 1-3.5 times the total mass of Codonopsis pilosula, prepared licorice root, Poria cocos, prepared Polygala tenuifolia, dragon bone, and oyster shell, and the first decoction time is 10-100 minutes.

10. The method for preparing Ginseng, Twig, and Poria Oral Liquid according to claim 9, characterized in that, In step S3, the amount of water added for the first decoction is three times the total mass of Codonopsis pilosula, prepared licorice root, Poria cocos, prepared Polygala tenuifolia, dragon bone, and oyster shell, and the first decoction time is 60 minutes; in step S2, the amount of water added for the second decoction is twice the total mass of Codonopsis pilosula, prepared licorice root, Poria cocos, prepared Polygala tenuifolia, dragon bone, and oyster shell, and the first decoction time is 30 minutes.

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