Chaihuang oral liquid and preparation process thereof
By improving the preparation process of Chaihuang oral liquid, technical means such as packaging and flocculating condensation are used to solve the problem of precipitation during the storage process of Chaihuang oral solution, and the effect of antiviral and liver protection is improved.
Patent Information
- Application Number
- CN202411512656.1
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2024-10-28
- Publication Date
- 2025-01-28
AI Technical Summary
Chaihuang oral liquid is prone to precipitation during long-term storage, affecting stability, and at the same time, its antiviral and liver protection effects are insufficient.
Use water -lift acid sinking method to extract scutelinins and mix with sodium sodium sodium sodium, combined with the water vapor distillation method to extract the trachaer volatile oil and combine it with the hydroxybalbbele, and the gel and the gel and the gum Activated carbon flocculation and alcohol sinking process extract Chaihu concentrated liquid, finally adjust the pH value and add sweet chrysantheonoside as a sweetener.
It significantly improves the stability of Chaihuang oral liquid, avoids the phenomenon of precipitation in long -term storage, and at the same time enhances its antiviral effect and liver protection.
Smart Images
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Abstract
Description
Technical Field
[0001] The invention belongs to the technical field of drug preparation and relates to Chaihuang oral liquid and a preparation process thereof. Background Art
[0002] The information disclosed in this background technology section is only intended to enhance the understanding of the overall background of the invention, and should not necessarily be regarded as an admission or any form of suggestion that the information constitutes the prior art already known to a person skilled in the art.
[0003] The main ingredients of Chaihuang oral liquid are bupleurum and scutellaria. In the formula, bupleurum is bitter, pungent and slightly cold, and it is light and clear and ascending, and it is clear and unblocked. It enters the liver and gallbladder meridians, and is good at dispersing the evil of the half exterior and half interior, and dispersing the heat of the Wei division. It is the main drug; scutellaria has a cold air and bitter taste, clears the upper and purges the lower, and goes to the exterior and interior. It can clear lung heat, purge heart fire, remove phlegm and turbidity, treat toxicity, and relieve superficial heat. It is the ministerial drug. "Ben Jing Shu Zheng" says that "scutellaria cooperates with bupleurum to clear the heat of the qi division." Therefore, the two drugs are used together to relieve fever, soothe the liver and relieve depression, clear heat and dry dampness, purge fire and detoxify. Clinical studies have shown that this medicine has a good antipyretic effect and has a good therapeutic effect on cold Wei Qi syndrome. Modern pharmacological studies have shown that bupleurum has obvious antipyretic, analgesic and antitussive effects on the central nervous system, has a wide range of anti-inflammatory and anti-cold virus effects, and has the effect of enhancing the body's immunity. Scutellaria baicalensis has antipyretic and analgesic effects, has a broad antibacterial spectrum against Staphylococcus, Nephila, Pneumococcus, etc., and also has an inhibitory effect on influenza virus.
[0004] Pharmacological research on Chaihuang oral liquid shows that it has fast fever-reducing and strong cooling effect, has obvious inhibitory effect on influenza A and B viruses, protects the liver and promotes bile secretion, and has obvious anti-inflammatory and antibacterial effects, especially for children with acute upper respiratory tract infection caused by viruses and bacteria.
[0005] During long-term storage, Chaihuang oral liquid will precipitate. Studies have shown that the precipitate is mostly baicalin, which has clinical effects such as anti-inflammatory and antipyretic, and is the active ingredient in Chaihuang oral liquid. Therefore, it is necessary to develop a process to prevent Chaihuang oral liquid from precipitating during storage. Summary of the invention
[0006] In order to overcome the deficiencies in the prior art, the object of the present invention is to provide a Chaihuang oral liquid and a preparation process thereof. The Chaihuang oral liquid prepared by the preparation process provided by the present invention has higher stability during storage and can be stored for a long time without precipitation. At the same time, the Chaihuang oral liquid prepared by the process has better antiviral effect than the original process and has a stronger protective effect on the liver than the original process.
[0007] In order to achieve the above object, the technical solution of the present invention is:
[0008] In a first aspect, a preparation process of Chaihuang oral liquid comprises the following steps:
[0009] The baicalin was extracted from Scutellaria baicalensis by water extraction and acid precipitation, and the precipitate after extraction was mixed with sodium sulfobutyl beta-cyclodextrin to obtain the Scutellaria baicalensis inclusion complex.
[0010] Bupleurum volatile oil, Bupleurum aqueous solution and Bupleurum residue were obtained by steam distillation.
[0011] Mixing and including the bupleurum volatile oil with hydroxypropyl beta-cyclodextrin to obtain a bupleurum volatile oil inclusion compound;
[0012] The bupleurum aqueous solution and the bupleurum residue are boiled and extracted, gelatin and activated carbon are added for flocculation, and then alcohol precipitation is performed, and the supernatant after alcohol precipitation is concentrated to obtain a bupleurum concentrate;
[0013] The scutellaria baicalensis inclusion compound is added to the bupleurum concentrated solution to adjust the pH value to 5.0-6.5, water is added for refrigeration, and then the bupleurum volatile oil inclusion compound is added, auxiliary materials are added after filtering, and water is added to obtain the product.
[0014] Firstly, baicalin has poor fat solubility and water solubility, which results in poor absorption in the body, low bioavailability and unstable efficacy, thus limiting the full play of the efficacy. At present, the methods for increasing the solubility of baicalin mainly include drug delivery systems such as liposomes, β-cyclodextrin inclusion compounds and phospholipid complexes. The present invention has found through research that the inclusion step of baicalin and the inclusion agent used have an impact on the stability of Chaihuang oral liquid. When the precipitate obtained by water extraction and acid precipitation method is included with sulfobutyl beta-cyclodextrin sodium, the stability of the obtained Chaihuang oral liquid is higher.
[0015] Although the improvement of the scutellaria baicalensis inclusion complex obtained by inclusion of sodium sulfobutyl beta-cyclodextrin can make the obtained Chaihuang oral liquid have higher stability, the clarity of the Chaihuang oral liquid decreases after being placed for a period of time. For this reason, the present invention conducted further research and found that: 1. The use of hydroxypropyl beta-cyclodextrin can help alleviate the precipitation of Bupleurum volatile oil; 2. The Bupleurum extract is first flocculated with gelatin and activated carbon and then precipitated with alcohol, which can further significantly improve the stability of the Chaihuang oral liquid, so that the obtained Chaihuang oral liquid can be stably placed for 12 months without precipitation.
[0016] In addition, the present invention unexpectedly discovered that the Chaihuang oral liquid prepared by the present invention has better antiviral and liver protection effects.
[0017] The auxiliary materials described in the present invention include sweeteners. The sucrose content in the original Chaihuang oral liquid is relatively high, which is not conducive to the use of diabetic patients and children. Therefore, the present invention intends to use other sweeteners instead of sucrose. In some embodiments, the sweetener in the auxiliary materials is steviol glycoside and / or sucralose. Studies have shown that aspartame in the sweetener will change the properties of Chaihuang oral liquid, and the selection of steviol glycoside or sucralose instead of sucrose will not affect the properties of Chaihuang oral liquid. Among steviol glycoside and sucralose, since steviol glycoside is a natural sweetener, steviol glycoside is selected as the sweetener of Chaihuang oral liquid in the present invention, which can better ensure the safety of Chaihuang oral liquid.
[0018] In some embodiments, the process of water extraction and acid precipitation is: decocting Scutellaria baicalensis with water to obtain a decoction, filtering the decoction to obtain a filtrate, adjusting the pH of the filtrate to 1.5-2.5 with sulfuric acid, and filtering the precipitate after standing. Specifically, the decoction is performed at least twice, each decoction time is 0.9-1.1 hours, and the decoctions are combined.
[0019] In some embodiments, the added amount of sodium sulfobutyl-beta-cyclodextrin is 12-18% of the weight of Scutellaria baicalensis.
[0020] In some embodiments, the added amount of hydroxypropyl-beta-cyclodextrin is 1.6-2.4% of the weight of Bupleurum chinense.
[0021] In some embodiments, the inclusion process is: heating and stirring the solution for inclusion, and specifically, heating stably to 55-65°C.
[0022] In some embodiments, during the extraction process of the bupleurum aqueous solution and the bupleurum residues by decocting with water, the decocting times are at least twice, and the decoctions after decocting are combined, filtered, and concentrated. Specifically, the concentration is to a relative density of 1.05 to 1.10.
[0023] In some embodiments, based on a gelatin solution with a mass concentration of 2%, the amount of gelatin solution added for each kilogram of Bupleurum chinense treated is 35-45 ml.
[0024] In some embodiments, the weight of activated carbon added is 8-12 g per 1 kg of Bupleurum chinense.
[0025] In some embodiments, the flocculation treatment is carried out by heating and ultrasound, specifically, the heating temperature is 55-65° C., and the ultrasound time is 25-30 minutes.
[0026] In some embodiments, 0.8 to 1.2 volumes of ethanol are added during the alcohol precipitation.
[0027] In some embodiments, during the alcohol precipitation process, refrigeration is performed after the addition of ethanol.
[0028] In some embodiments, the supernatant is concentrated to a relative density of 1.14 to 1.16, wherein the relative density is measured at 55 to 65°C.
[0029] In some embodiments, the auxiliary material further comprises a preservative, including but not limited to sodium benzoate.
[0030] Specifically, the preparation process preferably comprises the following steps:
[0031] 1. 500g of Scutellaria baicalensis is decocted twice with water, each time for 1 hour, the decoctions are combined, filtered, sulfuric acid is added to the filtrate to adjust the pH value to 2.0, let stand, filter out the precipitate, wash with an appropriate amount of ethanol and dry, add 250±10ml of water, dissolve to make a suspension, add 70-80g of sodium sulfobutyl beta-cyclodextrin, stir and include in a water bath at 55-65℃ for 1.8-2.2h, and set aside;
[0032] 2. Extract volatile oil from 500 g of Bupleurum by steam distillation, separate the oil-water mixture, add 8-12 g of hydroxypropyl-beta-cyclodextrin, stir and include at 55-65°C for 1.8-2.2 h, and set aside;
[0033] 3. The aqueous solution after distillation of Bupleurum Root and the residue were decocted twice, the first time for 2 hours and the second time for 1 hour, the decoctions were combined, filtered, and the filtrate was concentrated to a relative density of 1.05-1.10 (60°C ± 5°C), 18-22 ml of 2% gelatin solution and 4-6 g of activated carbon were added, and ultrasonication was performed at 60°C for 30 minutes, ethanol was added, refrigerated for 24 hours, centrifuged, and the supernatant was concentrated to a relative density of 1.14-1.16 (60°C ± 5°C);
[0034] 4. Add the above-mentioned Scutellaria baicalensis inclusion compound, adjust the pH value to 5.0-6.5, add water to about 900 ml, refrigerate for 48 hours, add Bupleurum volatile oil inclusion compound, filter, add stevioside 9-11g, sodium benzoate 3g, add water to make up to volume, stir well, and fill.
[0035] On the other hand, a Chaihuang oral liquid is obtained by the above preparation process.
[0036] The beneficial effects of the present invention are:
[0037] The present invention provides a preparation process of Chaihuang oral liquid, and solves the problem of precipitation of Chaihuang oral liquid during storage. The preparation is changed to a sugar-free preparation, the taste of the preparation is improved while reducing the sugar content in the preparation, which causes diabetic patients to be unable to use the preparation and children to have tooth decay due to excessive intake of sugar. Finally, the antiviral and liver protection effects of Chaihuang oral liquid prepared by the new process are better than those of the original process. DETAILED DESCRIPTION
[0038] In order to enable those skilled in the art to more clearly understand the technical solution of the present invention, the technical solution of the present invention will be described in detail below in conjunction with specific experimental examples.
[0039] The current standard for Chaihuang Oral Liquid is Chaihuang Oral Liquid in the 2020 edition of the Chinese Pharmacopoeia, and its preparation method is:
[0040] (1) 500 g of Scutellaria baicalensis is decocted in water twice, each time for 1 hour, the decoctions are combined, filtered, and the filtrate is adjusted to a pH of 2.0 by adding sulfuric acid. The precipitate is filtered, washed with an appropriate amount of ethanol, and dried to obtain a Scutellaria baicalensis extract;
[0041] (2) extracting volatile oil from 500 g of Radix Bupleuri by steam distillation to obtain volatile oil of Radix Bupleuri;
[0042] (3) boiling the distilled aqueous solution and the medicinal residue twice, the first time for 2 hours and the second time for 1 hour, combining the decoctions, filtering, concentrating the filtrate to a relative density of 1.16 to 1.24 (60° C.), adding ethanol to make the alcohol content reach 60%, stirring, refrigerating for 24 hours, filtering, recovering ethanol from the filtrate, and obtaining a concentrated solution with a relative density of 1.14 to 1.16 (60° C.), thereby obtaining the Bupleurum extract;
[0043] (4) Add the above-mentioned Scutellaria baicalensis extract, adjust the pH value to 5.6-5.8, add water to about 900 ml, refrigerate for 48 hours, add Bupleurum volatile oil, filter, add 150 g sucrose and 3 g sodium benzoate, add water to 1000 ml, stir well, and fill.
[0044] Experimental Example 1 Study on baicalin inclusion
[0045] The solubility of baicalin in water is extremely low, which is the main factor causing precipitation during long-term storage of Chaihuang oral liquid. Therefore, increasing the stability of baicalin in the preparation is one of the key factors to solve the problem of precipitation during storage.
[0046] Table 1 Results of baicalin inclusion study
[0047]
[0048]
[0049] The experimental results show that the inclusion of baicalin in step (1) is more effective in increasing the dissolution of baicalin than the inclusion in step (4). At the same time, the inclusion effect of sulfobutyl beta-cyclodextrin sodium is better than that of hydroxypropyl beta-cyclodextrin. Therefore, it is tentatively decided to use sulfobutyl beta-cyclodextrin sodium to include baicalin in step (1).
[0050] Experimental Example 2 Study on the inclusion of Bupleurum volatile oil
[0051] The clarity of baicalin decreased after being included with sodium sulfobutyl-beta-cyclodextrin for 6 months, which was suspected to be caused by the volatile oil of Bupleurum. The inclusion study of the volatile oil of Bupleurum was carried out to increase its stability.
[0052] Table 2 Bupleurum volatile oil inclusion study results
[0053]
[0054]
[0055] The experimental results show that the inclusion of Bupleurum volatile oil with sodium sulfobutyl-beta-cyclodextrin has a certain effect on alleviating the precipitation, but the effect is not obvious. The inclusion of Bupleurum volatile oil with hydroxypropyl-beta-cyclodextrin has a better effect, but precipitation still occurs after 9 months. It is suspected that the components in the Bupleurum extract react with baicalin during storage, resulting in the formation of precipitation.
[0056] Experimental Example 3 Study on the Purification of Bupleurum Extract
[0057] The purification process of traditional Chinese medicine extracts is generally alcohol precipitation and flocculation. In the original process of Chaihuang oral liquid, the Bupleurum extract was purified by alcohol precipitation. The purification of Bupleurum extract was studied by different alcohol precipitation concentrations and flocculation.
[0058] Table 3 Results of the study on the purification of Bupleurum extract
[0059]
[0060]
[0061]
[0062]
[0063] Experimental Example 4 Investigation of pH Adjustment Range
[0064] The original process step (4) adjusted the pH to 5.6-5.8, which had a too narrow range. In actual operation, the adjustment often exceeded the range. After the above process improvements were made, the pH adjustment range was investigated.
[0065]
[0066]
[0067]
[0068] Experimental Example 5 Sweetener Screening
[0069] The original process preparation adds 150g of sucrose for every 1000ml. The sucrose content is relatively high and is not suitable for use by diabetic patients and children. Other sweeteners are used to replace sucrose to make it more suitable for use by diabetic and child patients and improve their clinical compliance.
[0070] Table 4 Sweetener screening study results
[0071]
[0072]
[0073]
[0074] The experimental results show that changing the sweetener to aspartame will affect the properties of the preparation, while stevioside and sucralose will not affect the properties of the preparation, and both can meet the public's taste needs. However, stevioside is a natural sweetener. In order to ensure the safety of the preparation, stevioside was finally selected to replace sucrose as a sweetener.
[0075] Experimental Example 6 Stability Study
[0076] Three batches of Chaihuang oral liquid samples were prepared according to the above process for accelerated and long-term stability studies.
[0077] The first batch of processes (220401):
[0078] 1. 500g of Scutellaria baicalensis is decocted twice, 5000ml of water is added for the first time, and 4000ml of water is added for the second time, each time for 1 hour, the decoction is combined, filtered, sulfuric acid is added to the filtrate to adjust the pH value to 2.0, let it stand, filter out the precipitate, wash it with an appropriate amount of ethanol and dry it, add 250ml of water, dissolve it into a suspension, add 75g of sodium sulfobutyl beta-cyclodextrin, stir and include it in a water bath at 60℃ for 2h, and set aside;
[0079] 2. Extract volatile oil from 500g of Bupleurum by steam distillation, add 5000ml of water, take 750ml (1.5 times the amount) of the oil-water mixture, add 10g of hydroxypropyl-beta-cyclodextrin, stir and include at 60℃ for 2 hours, and set aside;
[0080] 3. The aqueous solution after distillation of Bupleurum Root and the residues were decocted twice with water. 4000 ml of water was added for the first time and decocted for 2 hours. 3000 ml of water was added for the second time and decocted for 1 hour. The decoctions were combined and filtered. The filtrate was concentrated to a relative density of 1.05 (60°C). 20 ml of 2% gelatin solution and 5 g of activated carbon were added. The mixture was ultrasonicated at 60°C for 30 minutes. An equal amount of ethanol was added. The mixture was refrigerated for 24 hours and centrifuged. The supernatant was concentrated to a relative density of 1.15 (65°C).
[0081] 4. Add the above-mentioned Scutellaria baicalensis inclusion compound, adjust the pH value to 5.8, add water to about 900 ml, refrigerate for 48 hours, add Bupleurum volatile oil inclusion compound, filter, add stevioside 11g, sodium benzoate 3g, add water to 1000 ml, stir well, and fill.
[0082] The second batch of processes (220402):
[0083] 1. 500g of Scutellaria baicalensis was decocted twice with water, 4000ml of water was added for the first time, and 3000ml of water was added for the second time, each time for 1 hour, the decoction was combined, filtered, sulfuric acid was added to the filtrate to adjust the pH value to 2.0, and the precipitate was filtered out, washed with an appropriate amount of ethanol and dried, 240ml of water was added, and dissolved into a suspension, 70g of sodium sulfobutyl beta-cyclodextrin was added, and the mixture was stirred and included in a water bath at 60°C for 2.2h, and then used for standby;
[0084] 2. Extract volatile oil from 500g of Bupleurum by steam distillation, add 5000ml of water, take 750ml (1.5 times the amount) of the oil-water mixture, add 12g of hydroxypropyl-beta-cyclodextrin, stir and include at 60℃ for 2 hours, and set aside;
[0085] 3. The aqueous solution after distillation of Bupleurum Root and the residues were decocted twice with water. 2000 ml of water was added for the first time and decocted for 2 hours. 3000 ml of water was added for the second time and decocted for 1 hour. The decoctions were combined and filtered. The filtrate was concentrated to a relative density of 1.10 (63°C). 16 ml of 2% gelatin solution and 6 g of activated carbon were added. The mixture was ultrasonicated at 60°C for 30 minutes. 0.8 times the amount of ethanol was added. The mixture was refrigerated for 24 hours and centrifuged. The supernatant was concentrated to a relative density of 1.14 (60°C).
[0086] 4. Add the above-mentioned Scutellaria baicalensis inclusion compound, adjust the pH value to 5.2, add water to about 900 ml, refrigerate for 48 hours, add Bupleurum volatile oil inclusion compound, filter, add 9g of stevioside and 3g of sodium benzoate, add water to 1000ml, stir well, and fill.
[0087] The third batch of processes (220403):
[0088] 1. 500g of Scutellaria baicalensis is decocted twice, 5000ml of water is added for the first time, and 5000ml of water is added for the second time, each time for 1 hour, the decoction is combined, filtered, sulfuric acid is added to the filtrate to adjust the pH value to 2.0, let stand, filter out the precipitate, wash with an appropriate amount of ethanol and dry, add 260ml of water, dissolve to make a suspension, add 80g of sodium sulfobutyl beta-cyclodextrin, stir and include in a water bath at 60℃ for 1.8h, and set aside;
[0089] 2. Extract volatile oil from 500g of Bupleurum by steam distillation, add 3000ml of water, take out 750ml of oil-water mixture, add 8g of hydroxypropyl-beta-cyclodextrin, stir and include at 60℃ for 2 hours, and set aside;
[0090] 3. The aqueous solution after distillation of Bupleurum and the residues were decocted twice with water, 2500ml of water was added for the first time and decocted for 2 hours, and 2500ml of water was added for the second time and decocted for 1 hour, the decoctions were combined, filtered, and the filtrate was concentrated to a relative density of 1.08 (56°C), 24ml of 2% gelatin solution and 4g of activated carbon were added, ultrasonicated at 60°C for 30 minutes, 1.2 times the amount of ethanol was added, refrigerated for 24 hours, centrifuged, and the supernatant was concentrated to a relative density of 1.16 (65°C);
[0091] 4. Add the above-mentioned Scutellaria baicalensis inclusion compound, adjust the pH value to 6.1, add water to about 900 ml, refrigerate for 48 hours, add Bupleurum volatile oil inclusion compound, filter, add 10g stevioside, 3g sodium benzoate, add water to 1000ml, stir well, and fill.
[0092] Table 5 Summary of accelerated stability test results of Chaihuang oral liquid (batch number: 220401)
[0093]
[0094]
[0095] Table 6 Summary of accelerated stability test results of Chaihuang oral liquid (batch number: 220402)
[0096]
[0097]
[0098] Table 7 Summary of accelerated stability test results of Chaihuang oral liquid (batch number: 220403)
[0099]
[0100] Table 8 Summary of long-term stability test results of Chaihuang oral liquid (batch number: 220401)
[0101]
[0102]
[0103] Table 9 Summary of long-term stability test results of Chaihuang oral liquid (batch number: 220402)
[0104]
[0105]
[0106] Table 10 Summary of long-term stability test results of Chaihuang oral liquid (batch number: 220403)
[0107]
[0108]
[0109] The experimental results show that the new process has good stability and can ensure the safety, effectiveness and quality controllability of the preparation within its shelf life.
[0110] Experimental Example 7 In vivo antiviral experiment
[0111] 80 ICR mice (SPF / VAF grade), with a body weight of (16.0±1)g, half male and half female, were randomly divided into 4 groups, including normal control group, model group, Chaihuang oral liquid original process group, and Chaihuang oral liquid new process group (220401 batch), with 20 mice in each group. After the mice were lightly anesthetized with ether, except for the normal control group, the mice in other groups were lightly anesthetized with ether and infected with 50μL of PR8 influenza virus liquid through nasal drops; the normal control group was inoculated with 50μL of normal saline. After 2h of infection, the Chaihuang oral liquid original process group and the new process group were given the corresponding drugs to the mice in the drug group by gavage, and the other two control groups and the model group were given normal saline, 200μL per mouse, once a day, for 15 consecutive days.
[0112] On the 2nd, 4th, 6th and 8th day after infection, 4 mice were randomly selected from each group and killed after anesthesia. The lung lesions were observed by dissection and blood samples were collected.
[0113] Experimental results:
[0114] Table 11 Antiviral study results of Chaihuang oral liquid
[0115]
[0116] The survival rate of animals in the normal control group, original process group and new process group was 100%, and the survival rate of animals in the model group was 75%. Death began to occur on the 6th to 8th day. There was no significant difference in the final body weight of animals in the normal control group and the new process group, and the original process group had a slight decrease.
[0117] Compared with the normal control group, the lung lesions of animals in the model group were the most serious 4 to 6 days after infection, the reticular structure of the lungs basically disappeared, the alveolar wall thickened, the alveolar epithelium was damaged and shed, the alveolar capillaries were severely congested, and a large number of inflammatory cells infiltrated in the lung septa. The new process group was able to alleviate lung lesions after the start of treatment. Although there were more obvious lung lesions on the second day of treatment, it was significantly improved compared with the model group. The efficacy was significant on the 4th to 6th day of treatment, and it was close to normal lungs on the 6th day of treatment, with a clearer reticular structure. The original process group had more obvious lung lesions on the second day of treatment, and it was close to normal lungs on the 8th day of treatment, indicating that the new process group was better than the original process group.
[0118] Compared with the normal control group, the neutrophil count in the model group was increased and the lymphocyte count was decreased. The neutrophil count in the Chaihuang oral liquid group showed an increase in the neutrophil count and a decrease in the lymphocyte count on the second day of treatment, but returned to normal on the 4th to 6th day of treatment.
[0119] Compared with the normal control group, the serum ALT and AST levels in the model group were significantly higher than those in the control group. The original process group showed an increasing trend on the second day of treatment, and the serum ALT and AST levels tended to normal values on the 4th to 6th days of treatment. There was no increase in serum ALT and AST levels in the new process group, indicating that the new process group has a better protective effect on the liver than the original process group.
[0120] The above experimental results show that the new process is superior to the original process in antiviral and liver protection after influenza virus infection.
[0121] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. For those skilled in the art, the present invention may have various modifications and variations. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present invention shall be included in the protection scope of the present invention.
Claims
1. A preparation process of Chaihuang oral liquid, characterized in that: The steps include: The baicalin was extracted from Scutellaria baicalensis by water extraction and acid precipitation, and the precipitate after extraction was mixed with sodium sulfobutyl beta-cyclodextrin to obtain the Scutellaria baicalensis inclusion complex. Bupleurum volatile oil, Bupleurum aqueous solution and Bupleurum residue were obtained by steam distillation. Mixing and including the bupleurum volatile oil with hydroxypropyl beta-cyclodextrin to obtain a bupleurum volatile oil inclusion compound; The bupleurum aqueous solution and the bupleurum residue are boiled and extracted, gelatin and activated carbon are added for flocculation, and then alcohol precipitation is performed, and the supernatant after alcohol precipitation is concentrated to obtain a bupleurum concentrate; The scutellaria baicalensis inclusion compound is added to the bupleurum concentrated solution to adjust the pH value to 5.0-6.5, water is added for refrigeration, and then the bupleurum volatile oil inclusion compound is added, auxiliary materials are added after filtering, and water is added to obtain the product.
2. The preparation process of Chaihuang oral liquid as claimed in claim 1, characterized in that: The sweetener in the auxiliary material is steviol glycoside and / or sucralose, preferably steviol glycoside.
3. The preparation process of Chaihuang oral liquid as claimed in claim 1, characterized in that: The process of water extraction and acid precipitation extraction is as follows: add water to Scutellaria baicalensis and boil it to obtain a decoction, filter the decoction to obtain a filtrate, adjust the pH of the filtrate to 1.5-2.5 with sulfuric acid, and filter out the precipitate after standing.
4. The preparation process of Chaihuang oral liquid as claimed in claim 1, characterized in that: The added amount of sulfobutyl beta-cyclodextrin sodium is 12-18% of the weight of Scutellaria baicalensis; Alternatively, the added amount of hydroxypropyl-beta-cyclodextrin is 1.6-2.4% of the weight of Bupleurum chinense.
5. The preparation process of Chaihuang oral liquid as claimed in claim 1, characterized in that: The process of inclusion is: heating and stirring inclusion in the solution; Or, in the process of decocting and extracting the Bupleurum aqueous solution and the Bupleurum residue with water, the decocting times are at least twice, and the decoctions after decocting are combined, filtered and concentrated.
6. The preparation process of Chaihuang oral liquid as claimed in claim 1, characterized in that: Based on a gelatin solution with a mass concentration of 2%, the amount of gelatin solution added to treat 1 kg of Bupleurum is 35-45 ml; Alternatively, the weight of activated carbon added for each kilogram of Bupleurum chinense treated is 8 to 12 g.
7. The preparation process of Chaihuang oral liquid as claimed in claim 1, characterized in that: The flocculation treatment method is heating and ultrasound.
8. The preparation process of Chaihuang oral liquid as claimed in claim 1, characterized in that: Add 0.8 to 1.2 times the volume of ethanol to the alcohol precipitation; Alternatively, during the alcohol precipitation process, ethanol is added and then refrigerated.
9. The preparation process of Chaihuang oral liquid as claimed in claim 1, characterized in that: The supernatant was concentrated to a relative density of 1.14 to 1.16; Alternatively, the auxiliary material further comprises a preservative; preferably, the preservative is sodium benzoate.
10. A Chaihuang oral liquid, characterized in that: The method is obtained by the preparation process shown in any one of claims 1 to 9.