A kind of compound knotweed ammonia sensitive tablet and preparation method thereof

Abstract

The present invention relates to a compound polygonum cuspidatum ammonia sensitive tablet and a preparation method thereof, and belongs to the field of medical technology. The raw materials of the compound polygonum cuspidatum ammonia sensitive tablet of the present invention include: polygonum cuspidatum dry cream, bupleurum dry cream, chlorpheniramine maleate, and acetaminophen; the polygonum cuspidatum dry cream contains a product obtained by co-enzyme hydrolysis of polygonum cuspidatum root by hemicellulase and pectinase, then by bromelain enzymolysis, and then by co-fermentation of bacillus licheniformis and bacillus subtilis; the bupleurum dry cream contains a product obtained by co-enzyme hydrolysis of bupleurum root by pepsin, then by co-enzyme hydrolysis of ficin and bromelain. Each component is used in a certain proportion, has good antipyretic, analgesic and anti-inflammatory effects, can reduce the dosage of chlorpheniramine maleate and acetaminophen to a certain extent, is safe and reliable, and is suitable for relieving symptoms such as fever, headache, runny nose, etc. caused by cold.

Description

Technical Field

[0001] The invention belongs to the technical field of medicines, and in particular relates to a compound polygonum cuspidatum ammonia-sensitive tablet and a preparation method thereof. Background Art

[0002] Compound Polygonum cuspidatum Ammonia Tablets is a compound preparation medicine commonly used to relieve cold symptoms. The combination of its ingredients is designed to work synergistically to provide a more comprehensive and effective therapeutic effect.

[0003] The main ingredients of compound Polygonum cuspidatum amino-sensitive tablets include Polygonum cuspidatum, Senecio radix, chlorpheniramine maleate, acetaminophen, etc. Polygonum cuspidatum, as a traditional Chinese medicine, has the effects of clearing away heat and detoxification, promoting dampness and jaundice, dispersing blood stasis and relieving pain. In addition, the anthraquinones, flavonoids and other ingredients contained in Polygonum cuspidatum have anti-inflammatory and antioxidant effects, and have a certain inhibitory effect on the inflammatory response caused by colds. Senecio radix is ​​also a Chinese medicine with the effects of clearing heat and detoxification, improving eyesight, killing insects and relieving itching. The alkaloids, flavonoids and other ingredients it contains have antibacterial and antiviral activities, which help to fight against pathogens in colds. Chlorpheniramine maleate is an antihistamine that can relieve allergic symptoms such as runny nose, sneezing, and nasal congestion caused by colds. Acetaminophen is used for antipyretic and analgesic purposes.

[0004] However, although the compound Polygonum cuspidatum aminosensitive tablets have a certain efficacy in relieving cold symptoms, there are still the following problems in practical application:

[0005] (1) In terms of ingredients, although Polygonum cuspidatum and Senecio grandiflora have certain pharmacological activities, the extraction and purification process of their active ingredients still needs to be further optimized. The current extraction method cannot fully obtain and utilize the active ingredients, which affects the efficacy of the drugs.

[0006] (2) From the perspective of drug safety, chlorpheniramine maleate in Compound Polygonum cuspidatum Aminopeptide Tablets can cause adverse reactions such as drowsiness, fatigue, and dry mouth, which to a certain extent limits the convenience of medication for patients, especially for those who need to engage in work such as driving or operating precision instruments.

[0007] (3) With the continuous mutation of pathogens and the increase of drug resistance, the efficacy of compound Polygonum cuspidatum ammonium-sensitive tablets against some new cold viruses or drug-resistant strains is also challenged.

[0008] This requires continuous drug research and development and improvement to enhance the efficacy and safety of compound knotweed ammonia-sensitive tablets and provide better treatment options for the majority of cold patients. Summary of the invention

[0009] In view of the above-mentioned problems existing in the existing compound polygonum cuspidatum ammonia sensitive tablets, the present invention provides a compound polygonum cuspidatum ammonia sensitive tablets and a preparation method thereof, wherein the polygonum cuspidatum dry paste contains a product obtained by hydrolyzing polygonum cuspidatum roots with hemicellulase and pectinase, then hydrolyzing with bromelain, and then fermenting with Bacillus licheniformis and Bacillus subtilis; the bupleurum dry paste contains a product obtained by hydrolyzing bupleurum roots with pepsin, then hydrolyzing with ficin and bromelain; the polygonum cuspidatum dry paste, bupleurum dry paste, chlorpheniramine maleate, and acetaminophen are used in combination in a certain proportion, which has good antipyretic, analgesic, and anti-inflammatory effects, can reduce the dosage of chlorpheniramine maleate and acetaminophen to a certain extent, is safe and reliable, and is suitable for relieving symptoms such as fever, headache, and runny nose caused by colds. Its specific technical scheme is as follows:

[0010] A compound Polygonum cuspidatum ammonia-sensitive tablet, the raw materials of which include: 10 to 30 parts of Polygonum cuspidatum dry paste, 5 to 15 parts of Bupleurum dry paste, 1 to 5 parts of chlorpheniramine maleate, and 100 to 300 parts of acetaminophen, calculated by mass parts;

[0011] The dried Polygonum cuspidatum paste contains a product obtained by hydrolyzing Polygonum cuspidatum roots with hemicellulase and pectinase, then hydrolyzing with bromelain, and then fermenting with Bacillus licheniformis and Bacillus subtilis; the dried Bupleurum paste contains a product obtained by hydrolyzing Bupleurum roots with pepsin, then hydrolyzing with ficin and bromelain.

[0012] The preparation method of the above-mentioned compound polygonum cuspidatum ammonia-sensitive tablets comprises the following steps:

[0013] S1, preparation of Polygonum cuspidatum dry ointment, comprising the following steps:

[0014] The root of Polygonum cuspidatum is crushed, an ethanol aqueous solution of 6 to 8 times the mass of the root of Polygonum cuspidatum is added, and the mixture is extracted at 55 to 60° C. for 2 h to 4 h, and filtered to obtain an extract A and an extract residue B; the extract residue B is dispersed in water of 8 to 10 times the mass of the extract residue B, and the pH is adjusted to 5.0 to 5.5 with an aqueous hydrochloric acid solution, and 1% to 2% of hemicellulase and pectinase by mass of the extract residue B are added respectively, and the mixture is enzymolyzed at 45 to 55° C. for 2 h to 3 h, and the enzyme is inactivated at high temperature, and after cooling to room temperature, the pH is adjusted to 6.5 to 7.5 with an aqueous sodium hydroxide solution, and 0.0% by mass of the extract residue B is added. .5% to 1% bromelain, enzymolysis at 55°C to 60°C for 3h to 4h, high temperature to inactivate the enzyme, after cooling to room temperature, add glucose, ammonium chloride, disodium hydrogen phosphate, and then add 0.3% to 0.8% of the mass of the extract B of Bacillus licheniformis and Bacillus subtilis, respectively, aerobically ferment at 30°C to 37°C for 18h to 25h, high temperature sterilization, after cooling to room temperature, filter with a 5kDa ultrafiltration membrane to obtain a filtrate B1 below 5kDa, combine the filtrate B1 with the extract A, concentrate, and freeze-dry to obtain a Polygonum cuspidatum dry paste with a water content of 4% to 6%;

[0015] S2, the preparation of Bupleurum chinense dry ointment, comprising the following steps:

[0016] The root of bupleurum is crushed, an ethanol aqueous solution of 6 to 8 times the mass of the root of bupleurum is added, and the mixture is extracted at 55 to 60 degrees Celsius for 2 hours to 4 hours, and filtered to obtain an extract C and an extract residue D; the extract residue D is dispersed in water of 8 to 10 times the mass of the extract residue D, and the pH is adjusted to 1.5 to 2.0 by an aqueous hydrochloric acid solution, and pepsin of 1% to 1.5% by mass of the extract residue D is added, and the mixture is enzymatically hydrolyzed at 35 to 38 degrees Celsius for 50 minutes to 60 minutes, and the enzyme is inactivated at high temperature, and after the mixture is cooled to room temperature, the pH is adjusted to 6 to 7 by an aqueous sodium hydroxide solution, and 0.5% to 1% of ficin and bromelain of 0.5% to 1% by mass of the root of bupleurum are added respectively, and the mixture is enzymatically hydrolyzed at 55 to 60 degrees Celsius for 1 hour to 1.5 hours, and the enzyme is inactivated at high temperature, and after the mixture is cooled to room temperature, the mixture is filtered by a 3 kDa ultrafiltration membrane to obtain a filtrate D1 below 3 kDa, and the filtrate D1 is combined with the extract C, concentrated, and freeze-dried to obtain a bupleurum dry paste having a water content of 4% to 6%;

[0017] S3, film making, includes the following steps:

[0018] According to the mass proportions, dried polygonum cuspidatum paste, dried bupleurum paste, chlorpheniramine maleate and acetaminophen are mixed to obtain a mixture, and the mixture is added into pharmaceutically usable auxiliary materials for mixed tablet preparation to obtain compound polygonum cuspidatum ammonia-sensitive tablets.

[0019] In the above preparation method, the volume concentration of the ethanol aqueous solution is 30% to 40%.

[0020] In S1 of the above preparation method, the concentration of the hydrochloric acid aqueous solution is 0.2 mol / L to 0.5 mol / L; the concentration of the sodium hydroxide aqueous solution is 0.2 mol / L to 0.5 mol / L.

[0021] In S1 of the above preparation method, the amount of glucose added is 3% to 6% of the mass of the leaching residue B; the amount of ammonium chloride added is 1% to 2.5% of the mass of the leaching residue B; and the amount of disodium hydrogen phosphate added is 0.1% to 0.5% of the mass of the leaching residue B.

[0022] In S2 of the above preparation method, the concentration of the hydrochloric acid aqueous solution is 0.5 mol / L to 1 mol / L; the concentration of the sodium hydroxide aqueous solution is 0.5 mol / L to 1 mol / L.

[0023] In the above preparation method, the enzymatic activity of the hemicellulase is 100,000 U / g; the enzymatic activity of the pectinase is 100,000 U / g; the enzymatic activity of the bromelain is 200,000 U / g to 400,000 U / g; the enzymatic activity of the pepsin is 10,000 U / g to 12,000 U / g; and the enzymatic activity of the ficin is 100,000 U / g.

[0024] In the above preparation method, the bacterial activity of the Bacillus licheniformis is 20 billion CFU / g to 50 billion CFU / g; the bacterial activity of the Bacillus subtilis is 20 billion CFU / g to 50 billion CFU / g.

[0025] In the above preparation method, the temperature of high temperature enzyme inactivation is 85°C to 90°C and the time is 15min to 25min.

[0026] In the above preparation method, the temperature of the high temperature sterilization is 121° C. and the time is 15 min to 20 min.

[0027] In S3 of the above preparation method, the content of the mixture in the compound Polygonum cuspidatum ammonia-sensitive tablets is 30wt% to 50wt%.

[0028] The compound polygonum cuspidatum ammonia-sensitive tablet and the preparation method thereof provided by the present invention have the following beneficial effects compared with the prior art:

[0029] 1. The dried polygonum cuspidatum paste of the present invention contains a product obtained by hydrolyzing polygonum cuspidatum roots with hemicellulase and pectinase, then hydrolyzing with bromelain, and then fermenting with Bacillus licheniformis and Bacillus subtilis; its ingredients have an inhibitory effect on inflammation and have a good promoting effect of analgesia and antipyretic.

[0030] 2. The dried Bupleurum paste of the present invention contains a product obtained by hydrolyzing Bupleurum root with pepsin and then hydrolyzing it with ficin and bromelain; its ingredients have better cooling and antipyretic effects, and can further improve anti-inflammatory and analgesic effects.

[0031] 3. The dried polygonum cuspidatum paste, dried bupleurum paste, chlorpheniramine maleate and acetaminophen of the present invention are used in a certain proportion, have good antipyretic, analgesic and anti-inflammatory effects, can reduce the dosage of chlorpheniramine maleate and acetaminophen to a certain extent, are safe and reliable, and are suitable for relieving symptoms such as fever, headache and runny nose caused by colds. DETAILED DESCRIPTION

[0032] The present invention is further described below in conjunction with specific implementation cases, but the present invention is not limited to these embodiments. Example

[0033] A compound polygonum cuspidatum ammonia-sensitive tablet. The raw materials of the compound polygonum cuspidatum ammonia-sensitive tablet include: 20 parts of polygonum cuspidatum dry paste, 10 parts of bupleurum dry paste, 3 parts of chlorpheniramine maleate, and 150 parts of acetaminophen, calculated by mass.

[0034] The preparation method of the above-mentioned compound polygonum cuspidatum ammonia-sensitive tablets comprises the following steps:

[0035] S1, preparation of Polygonum cuspidatum dry ointment, comprising the following steps:

[0036] The root of Polygonum cuspidatum was crushed, and an ethanol aqueous solution with a volume concentration of 35% was added, which was 7 times the mass of the root of Polygonum cuspidatum, and the solution was extracted at 58°C for 3 hours, and filtered to obtain an extract A and an extract residue B; the extract residue B was dispersed in water with a mass of 9 times the mass of the extract residue B, and the pH was adjusted to 5.2 with a 0.3 mol / L hydrochloric acid aqueous solution, and 1.5% of the mass of the extract residue B was added with hemicellulase and pectinase, respectively, and the solution was enzymolyzed at 50°C for 2.5 hours, and the enzyme was inactivated at 88°C for 20 minutes. After cooling to room temperature, the pH was adjusted to 7.0 with a 0.3 mol / L sodium hydroxide aqueous solution, and 0.8% of the mass of the extract residue B was added. Bromelain was enzymolyzed at 58°C for 3.5h, and the enzyme was inactivated at 88°C for 20min. After cooling to room temperature, 4% glucose by weight of the extract B, 2% ammonium chloride by weight of the extract B, and 0.3% disodium hydrogen phosphate by weight of the extract B were added. Then, 0.5% Bacillus licheniformis and Bacillus subtilis by weight of the extract B were added respectively. The mixture was aerobically fermented at 25°C for 20h, and sterilized at 121°C for 18min. After cooling to room temperature, the mixture was filtered using a 5kDa ultrafiltration membrane to obtain a filtrate B1 below 5kDa. The filtrate B1 was combined with the extract A, concentrated, and freeze-dried to obtain a Polygonum cuspidatum dry paste with a water content of 5%;

[0037] S2, the preparation of Bupleurum Root Dry Extract, comprising the following steps:

[0038] The root of bupleurum is crushed, an ethanol aqueous solution with a volume concentration of 35% of 7 times the mass of the root of bupleurum is added, and the mixture is extracted at 58° C. for 3 hours, and filtered to obtain an extract C and an extract residue D; the extract residue D is dispersed in water with a mass of 9 times the mass of the extract residue D, and a hydrochloric acid aqueous solution with a concentration of 0.8 mol / L is used to adjust the pH to 1.8, and pepsin with a mass of 1.2% of the mass of the extract residue D is added, and the mixture is enzymolyzed at 37° C. for 55 minutes, and the enzyme is inactivated at 88° C. for 20 minutes, and after cooling to room temperature, a sodium hydroxide aqueous solution with a concentration of 0.8 mol / L is used to adjust the pH to 6.5, and 0.8% of the mass of the bupleurum root is added with ficin and bromelain, respectively, and the mixture is enzymolyzed at 58° C. for 1 hour, and the enzyme is inactivated at 88° C. for 20 minutes, and after cooling to room temperature, a 3 kDa ultrafiltration membrane is used to filter the mixture to obtain a filtrate D1 with a mass of less than 3 kDa, and the filtrate D1 is combined with the extract C, concentrated, and freeze-dried to obtain a bupleurum dry paste with a water content of 5%;

[0039] S3, film making, includes the following steps:

[0040] According to the mass proportions, dried Polygonum cuspidatum paste, dried Bupleurum paste, chlorpheniramine maleate and acetaminophen are mixed to obtain a mixture, and the mixture is added into pharmaceutically usable excipients for mixed tablet preparation to obtain compound Polygonum cuspidatum ammonia-sensitive tablets; the content of the mixture in the compound Polygonum cuspidatum ammonia-sensitive tablets is 30wt% to 50wt%.

[0041] The enzymatic activity of the hemicellulase used in this embodiment is 100,000 U / g; the enzymatic activity of the pectinase is 100,000 U / g; the enzymatic activity of the bromelain is 300,000 U / g; the enzymatic activity of the pepsin is 10,000 U / g; the enzymatic activity of the ficin is 100,000 U / g. The bacterial activity of Bacillus licheniformis is 30 billion CFU / g; and the bacterial activity of Bacillus subtilis is 30 billion CFU / g.

[0042] Example 1

[0043] A compound polygonum cuspidatum ammonia-sensitive tablet. The raw materials of the compound polygonum cuspidatum ammonia-sensitive tablet include: 10 parts of polygonum cuspidatum dry paste, 5 parts of bupleurum dry paste, 1 part of chlorpheniramine maleate, and 100 parts of acetaminophen, calculated by mass.

[0044] The preparation method of the above-mentioned compound polygonum cuspidatum ammonia-sensitive tablets comprises the following steps:

[0045] S1, preparation of Polygonum cuspidatum dry ointment, comprising the following steps:

[0046] The root of Polygonum cuspidatum was crushed, and an ethanol aqueous solution with a volume concentration of 30% was added, which was 6 times the mass of the root of Polygonum cuspidatum, and the solution was extracted at 55°C for 2h, and filtered to obtain an extract A and an extract residue B; the extract residue B was dispersed in water with a mass of 8 times the mass of the extract residue B, and the pH value was adjusted to 5.0 with a 0.2 mol / L hydrochloric acid aqueous solution, and hemicellulase and pectinase with a mass value of 1% of the extract residue B were added respectively, and the solution was enzymolyzed at 45°C for 2h, and the enzyme was inactivated at 85°C for 15min. After cooling to room temperature, the pH value was adjusted to 6.5 with a 0.2 mol / L sodium hydroxide aqueous solution, and 0.5% spinach with a mass value of the extract residue B was added. The radix protease was enzymolyzed at 55°C for 3h, and the enzyme was inactivated at 85°C for 15min. After cooling to room temperature, 3% glucose by weight of the extract B, 1% ammonium chloride by weight of the extract B, and 0.1% disodium hydrogen phosphate by weight of the extract B were added. Then, 0.3% Bacillus licheniformis and Bacillus subtilis by weight of the extract B were added respectively. The mixture was aerobically fermented at 30°C for 18h, and sterilized at 121°C for 15min. After cooling to room temperature, the mixture was filtered using a 5kDa ultrafiltration membrane to obtain a filtrate B1 below 5kDa. The filtrate B1 was combined with the extract A, concentrated, and freeze-dried to obtain a Polygonum cuspidatum dry paste with a water content of 4%.

[0047] S2, the preparation of Bupleurum chinense dry ointment, comprising the following steps:

[0048] The root of bupleurum is crushed, and an ethanol aqueous solution with a volume concentration of 30% of 6 times the mass of the root of bupleurum is added, and the mixture is extracted at 55° C. for 2 hours, and filtered to obtain an extract C and an extract residue D; the extract residue D is dispersed in water with a mass of 8 times the mass of the extract residue D, and a hydrochloric acid aqueous solution with a concentration of 0.5 mol / L is used to adjust the pH to 1.5, and pepsin with a mass of 1% of the mass of the extract residue D is added, and the mixture is enzymolyzed at 35° C. for 50 minutes, and the enzyme is inactivated at 85° C. for 15 minutes, and after cooling to room temperature, the pH is adjusted to 6 with a sodium hydroxide aqueous solution with a concentration of 0.5 mol / L, and ficin and bromelain with a mass of 0.5% of the mass of the root of bupleurum are added respectively, and the mixture is enzymolyzed at 55° C. for 1 hour, and the enzyme is inactivated at 85° C. for 15 minutes, and after cooling to room temperature, the mixture is filtered with a 3 kDa ultrafiltration membrane to obtain a filtrate D1 with a mass of less than 3 kDa, and the filtrate D1 is combined with the extract C, concentrated, and freeze-dried to obtain a bupleurum dry paste with a water content of 4%;

[0049] S3, film making, includes the following steps:

[0050] According to the mass proportions, dried Polygonum cuspidatum paste, dried Bupleurum paste, chlorpheniramine maleate and acetaminophen are mixed to obtain a mixture, and the mixture is added into pharmaceutically usable excipients for mixed tablet preparation to obtain compound Polygonum cuspidatum ammonia-sensitive tablets; the content of the mixture in the compound Polygonum cuspidatum ammonia-sensitive tablets is 30wt% to 50wt%.

[0051] The enzymatic activity of the hemicellulase used in this embodiment is 100,000 U / g; the enzymatic activity of the pectinase is 100,000 U / g; the enzymatic activity of the bromelain is 200,000 U / g; the enzymatic activity of the pepsin is 10,000 U / g; the enzymatic activity of the ficin is 100,000 U / g. The bacterial activity of Bacillus licheniformis is 20 billion CFU / g; and the bacterial activity of Bacillus subtilis is 20 billion CFU / g.

[0052] Example 2

[0053] The invention discloses a compound polygonum cuspidatum ammonia-sensitive tablet. The raw materials of the compound polygonum cuspidatum ammonia-sensitive tablet include: 12 parts of polygonum cuspidatum dry paste, 8 parts of bupleurum dry paste, 2 parts of chlorpheniramine maleate and 120 parts of acetaminophen, calculated by weight.

[0054] The preparation method of the above-mentioned compound polygonum cuspidatum ammonia-sensitive tablets comprises the following steps:

[0055] S1, preparation of Polygonum cuspidatum dry ointment, comprising the following steps:

[0056] The root of Polygonum cuspidatum was crushed, and an ethanol aqueous solution with a volume concentration of 32% was added, which was 6.5 times the mass of the root of Polygonum cuspidatum, and the solution was extracted at 56°C for 2.5 hours, and filtered to obtain an extract A and an extract residue B; the extract residue B was dispersed in water with a volume concentration of 8.5 times the mass of the extract residue B, and the pH value was adjusted to 5.1 with a hydrochloric acid aqueous solution with a concentration of 0.25 mol / L, and hemicellulase and pectinase with a mass content of 1.2% of the mass of the extract residue B were added respectively, and the enzyme was hydrolyzed at 48°C for 2 hours, and the enzyme was inactivated at a high temperature of 86°C for 18 minutes. After cooling to room temperature, the pH value was adjusted to 6.8 with a sodium hydroxide aqueous solution with a concentration of 0.3 mol / L, and 0.6% of the mass of the extract residue B was added. The radix protease was enzymolyzed at 56°C for 3.5h, and the enzyme was inactivated at 86°C for 18min. After cooling to room temperature, 3.5% of glucose by weight of the extract B, 1.5% of ammonium chloride by weight of the extract B, and 0.2% of disodium hydrogen phosphate by weight of the extract B were added. Then, 0.4% of the weight of the extract B was added to Bacillus licheniformis and Bacillus subtilis, respectively. The mixture was aerobically fermented at 32°C for 19h, and sterilized at 121°C for 16min. After cooling to room temperature, the mixture was filtered using a 5kDa ultrafiltration membrane to obtain a filtrate B1 below 5kDa. The filtrate B1 was combined with the extract A, concentrated, and freeze-dried to obtain a Polygonum cuspidatum dry paste with a water content of 4.5%.

[0057] S2, the preparation of Bupleurum chinense dry ointment, comprising the following steps:

[0058] The root of bupleurum is crushed, and an ethanol aqueous solution with a volume concentration of 32% of 6.5 times the mass of the root of bupleurum is added, and the mixture is extracted at 56° C. for 2.5 hours, and filtered to obtain an extract C and an extract residue D; the extract residue D is dispersed in water with a volume concentration of 8.5 times the mass of the extract residue D, and a hydrochloric acid aqueous solution with a concentration of 0.6 mol / L is used to adjust the pH to 1.6, and pepsin with a mass of 1.2% of the mass of the extract residue D is added, and the mixture is enzymolyzed at 36° C. for 52 minutes, and the enzyme is inactivated at 56° C. for 18 minutes, and after cooling to room temperature, a sodium hydroxide aqueous solution with a concentration of 0.6 mol / L is used to adjust the pH to 6.2, and 0.6% of the mass of the bupleurum root is added with ficin and bromelain, respectively, and the mixture is enzymolyzed at 56° C. for 1 hour, and the enzyme is inactivated at 86° C. for 18 minutes, and after cooling to room temperature, a 3 kDa ultrafiltration membrane is used to filter the mixture to obtain a filtrate D1 with a mass below 3 kDa, and the filtrate D1 is combined with the extract C, concentrated, and freeze-dried to obtain a bupleurum dry paste with a water content of 4.5%;

[0059] S3, film making, includes the following steps:

[0060] According to the mass proportions, dried Polygonum cuspidatum paste, dried Bupleurum paste, chlorpheniramine maleate and acetaminophen are mixed to obtain a mixture, and the mixture is added into pharmaceutically usable excipients for mixed tablet preparation to obtain compound Polygonum cuspidatum ammonia-sensitive tablets; the content of the mixture in the compound Polygonum cuspidatum ammonia-sensitive tablets is 30wt% to 50wt%.

[0061] The enzymatic activity of the hemicellulase used in this embodiment is 100,000 U / g; the enzymatic activity of the pectinase is 100,000 U / g; the enzymatic activity of the bromelain is 200,000 U / g; the enzymatic activity of the pepsin is 10,000 U / g; the enzymatic activity of the ficin is 100,000 U / g. The bacterial activity of Bacillus licheniformis is 20 billion CFU / g; and the bacterial activity of Bacillus subtilis is 20 billion CFU / g.

[0062] Example 3

[0063] A compound polygonum cuspidatum ammonia-sensitive tablet. The raw materials of the compound polygonum cuspidatum ammonia-sensitive tablet include: 25 parts of polygonum cuspidatum dry paste, 12 parts of bupleurum dry paste, 4 parts of chlorpheniramine maleate, and 220 parts of acetaminophen, calculated by mass.

[0064] The preparation method of the above-mentioned compound polygonum cuspidatum ammonia-sensitive tablets comprises the following steps:

[0065] S1, preparation of Polygonum cuspidatum dry ointment, comprising the following steps:

[0066] The root of Polygonum cuspidatum was crushed, and an ethanol aqueous solution with a volume concentration of 38% was added, which was 7.5 times the mass of the root of Polygonum cuspidatum, and the solution was extracted at 58°C for 3.5 hours, and filtered to obtain an extract A and an extract residue B; the extract residue B was dispersed in water with a volume concentration of 9.5 times the mass of the extract residue B, and the pH was adjusted to 5.4 with a 0.4 mol / L hydrochloric acid aqueous solution, and 1.8% of the mass of the extract residue B was added with hemicellulase and pectinase, respectively, and the solution was enzymolyzed at 52°C for 2.5 hours, and the enzyme was inactivated at 88°C for 22 minutes. After cooling to room temperature, the pH was adjusted to 7.2 with a 0.4 mol / L sodium hydroxide aqueous solution, and 0.8% of the mass of the extract residue B was added. Bromelain was hydrolyzed at 58°C for 3.5h, and the enzyme was inactivated at 88°C for 22min. After cooling to room temperature, 5% glucose by weight of the extract B, 2.2% ammonium chloride by weight of the extract B, and 0.4% disodium hydrogen phosphate by weight of the extract B were added. Then, 0.6% Bacillus licheniformis and Bacillus subtilis by weight of the extract B were added respectively. The mixture was aerobically fermented at 36°C for 22h, and sterilized at 121°C for 18min. After cooling to room temperature, the mixture was filtered using a 5kDa ultrafiltration membrane to obtain a filtrate B1 below 5kDa. The filtrate B1 was combined with the extract A, concentrated, and freeze-dried to obtain a Polygonum cuspidatum dry paste having a water content of 5.5%;

[0067] S2, the preparation of Bupleurum chinense dry ointment, comprising the following steps:

[0068] The root of bupleurum is crushed, an ethanol aqueous solution with a volume concentration of 38% is added in an amount of 7.5 times the mass of the root of bupleurum, and the mixture is extracted at 58° C. for 3.5 hours, and filtered to obtain an extract C and an extract residue D; the extract residue D is dispersed in water with a volume concentration of 9.5 times the mass of the extract residue D, and a hydrochloric acid aqueous solution with a concentration of 0.8 mol / L is used to adjust the pH to 1.8, and pepsin with a mass of 1.4% of the mass of the extract residue D is added, and the mixture is enzymolyzed at 37° C. for 60 minutes, and the enzyme is inactivated at 90° C. for 15 minutes, and after cooling to room temperature, a sodium hydroxide aqueous solution with a concentration of 0.5 mol / L is used to adjust the pH to 7, and 0.5% of the mass of ficin and bromelain are added in an amount of 0.5% of the mass of the root of bupleurum, respectively, and the mixture is enzymolyzed at 60° C. for 1 hour, and the enzyme is inactivated at 90° C. for 15 minutes, and after cooling to room temperature, a 3 kDa ultrafiltration membrane is used to filter the mixture to obtain a filtrate D1 with a mass below 3 kDa, and the filtrate D1 is combined with the extract C, concentrated, and freeze-dried to obtain a bupleurum dry paste with a water content of 5.5%;

[0069] S3, film making, includes the following steps:

[0070] According to the mass proportions, dried Polygonum cuspidatum paste, dried Bupleurum paste, chlorpheniramine maleate and acetaminophen are mixed to obtain a mixture, and the mixture is added into pharmaceutically usable excipients for mixed tablet preparation to obtain compound Polygonum cuspidatum ammonia-sensitive tablets; the content of the mixture in the compound Polygonum cuspidatum ammonia-sensitive tablets is 30wt% to 50wt%.

[0071] The enzymatic activity of the hemicellulase used in this embodiment is 100,000 U / g; the enzymatic activity of the pectinase is 100,000 U / g; the enzymatic activity of the bromelain is 200,000 U / g; the enzymatic activity of the pepsin is 12,000 U / g; the enzymatic activity of the ficin is 100,000 U / g. The bacterial activity of Bacillus licheniformis is 20 billion CFU / g; and the bacterial activity of Bacillus subtilis is 20 billion CFU / g.

[0072] Example 4

[0073] A compound Polygonum cuspidatum ammonia-sensitive tablet. The raw materials of the compound Polygonum cuspidatum ammonia-sensitive tablet include: 30 parts of Polygonum cuspidatum dry paste, 15 parts of Bupleurum dry paste, 5 parts of chlorpheniramine maleate, and 300 parts of acetaminophen, calculated by mass.

[0074] The preparation method of the above-mentioned compound polygonum cuspidatum ammonia-sensitive tablets comprises the following steps:

[0075] S1, preparation of Polygonum cuspidatum dry ointment, comprising the following steps:

[0076] The root of Polygonum cuspidatum was crushed, and an ethanol aqueous solution with a volume concentration of 40% was added, which was 8 times the mass of the root of Polygonum cuspidatum, and the solution was extracted at 60°C for 4 hours, and filtered to obtain an extract A and an extract residue B; the extract residue B was dispersed in water with a mass of 10 times the mass of the extract residue B, and the pH was adjusted to 5.5 with a 0.5 mol / L hydrochloric acid aqueous solution, and hemicellulase and pectinase with a mass of 2% of the mass of the extract residue B were added respectively, and the enzyme was hydrolyzed at 55°C for 3 hours, and the enzyme was inactivated at 90°C for 25 minutes. After cooling to room temperature, the pH was adjusted to 7.5 with a 0.5 mol / L sodium hydroxide aqueous solution, and pineapple egg yolk with a mass of 1% of the mass of the extract residue B was added. white enzyme, enzymolysis at 60°C for 4h, high temperature inactivation at 90°C for 25min, after cooling to room temperature, adding 6% glucose by weight of leaching residue B, 2.5% ammonium chloride by weight of leaching residue B, 0.5% disodium hydrogen phosphate by weight of leaching residue B, and then adding 0.8% Bacillus licheniformis and Bacillus subtilis by weight of leaching residue B respectively, aerobically fermenting at 37°C for 25h, high temperature sterilization at 121°C for 20min, after cooling to room temperature, filtering with a 5kDa ultrafiltration membrane to obtain a filtrate B1 below 5kDa, combining the filtrate B1 with the leaching solution A, concentrating, and freeze-drying to obtain a Polygonum cuspidatum dry paste with a water content of 6%;

[0077] S2, the preparation of Bupleurum Root Dry Extract, comprising the following steps:

[0078] The root of bupleurum is crushed, an ethanol aqueous solution with a volume concentration of 40% of which is 8 times the mass of the root of bupleurum is added, and the mixture is extracted at 60° C. for 4 hours, and filtered to obtain an extract C and an extract residue D; the extract residue D is dispersed in water with a volume concentration of 10 times the mass of the extract residue D, and a hydrochloric acid aqueous solution with a concentration of 1 mol / L is used to adjust the pH to 2.0, and pepsin with a mass of 1.5% of the mass of the extract residue D is added, and the mixture is enzymolyzed at 38° C. for 60 minutes, and the enzyme is inactivated at 90° C. for 25 minutes, and after the mixture is cooled to room temperature, the pH is adjusted to 7 with a sodium hydroxide aqueous solution with a concentration of 1 mol / L, and ficin and bromelain with a mass of 1% of the mass of the root of bupleurum are added respectively, and the mixture is enzymolyzed at 60° C. for 1.5 hours, and the enzyme is inactivated at 90° C. for 25 minutes, and after the mixture is cooled to room temperature, a 3 kDa ultrafiltration membrane is used for filtering to obtain a filtrate D1 with a mass below 3 kDa, and the filtrate D1 is combined with the extract C, concentrated, and freeze-dried to obtain a bupleurum dry paste with a water content of 6%;

[0079] S3, film making, includes the following steps:

[0080] According to the mass proportions, dried Polygonum cuspidatum paste, dried Bupleurum paste, chlorpheniramine maleate and acetaminophen are mixed to obtain a mixture, and the mixture is added into pharmaceutically usable excipients for mixed tablet preparation to obtain compound Polygonum cuspidatum ammonia-sensitive tablets; the content of the mixture in the compound Polygonum cuspidatum ammonia-sensitive tablets is 30wt% to 50wt%.

[0081] The enzymatic activity of the hemicellulase used in this embodiment is 100,000 U / g; the enzymatic activity of the pectinase is 100,000 U / g; the enzymatic activity of the bromelain is 400,000 U / g; the enzymatic activity of the pepsin is 12,000 U / g; the enzymatic activity of the ficin is 100,000 U / g. The bacterial activity of Bacillus licheniformis is 50 billion CFU / g; and the bacterial activity of Bacillus subtilis is 50 billion CFU / g.

[0082] Comparative Example 1

[0083] In the preparation of the dried polygonum cuspidatum paste, the extract A is directly concentrated and freeze-dried to obtain a dried polygonum cuspidatum paste with a water content of 5%; other parameters and methods are the same as in Example 1.

[0084] Comparative Example 2

[0085] In the preparation of Bupleurum Root Extract, the extract C is directly concentrated and freeze-dried to obtain Bupleurum Root Extract with a water content of 5%; other parameters and methods are the same as in Example 1.

[0086] Comparative Example 3

[0087] In the preparation of the Polygonum cuspidatum dry paste, the extract A is directly concentrated and freeze-dried to obtain a Polygonum cuspidatum dry paste with a water content of 5%; in the preparation of the Bupleurum dry paste, the extract C is directly concentrated and freeze-dried to obtain a Bupleurum dry paste with a water content of 5%; other parameters and methods are the same as in Example 1.

[0088] Comparative Example 4

[0089] In the preparation of the dried polygonum cuspidatum paste, no fermentation with Bacillus licheniformis and Bacillus subtilis is performed, and the enzymatic hydrolysis product of bromelain is directly combined with the extract A, concentrated, and freeze-dried to obtain a dried polygonum cuspidatum paste with a water content of 5%; other parameters and methods are the same as in Example 1.

[0090] Comparative Example 5

[0091] In the preparation of the dried bupleurum extract, the enzymolysis of ficin and bromelain is not performed, and the enzymolysis product of pepsin is directly combined with the extract C, concentrated, and freeze-dried to obtain the dried bupleurum extract with a water content of 5%; other parameters and methods are the same as in Example 1.

[0092] Comparative Example 6

[0093] In the preparation of the Polygonum cuspidatum dry paste, Bacillus licheniformis and Bacillus subtilis fermentation are not performed, and the enzymatic hydrolysis product of bromelain is directly combined with the extract A, concentrated, and freeze-dried to obtain a Polygonum cuspidatum dry paste with a water content of 5%; in the preparation of the Bupleurum dry paste, ficin and bromelain enzymatic hydrolysis are not performed, and the enzymatic hydrolysis product of pepsin is directly combined with the extract C, concentrated, and freeze-dried to obtain a Bupleurum dry paste with a water content of 5%; other parameters and methods are the same as in Example 1.

[0094] The mixtures prepared in the above embodiments and the mixtures prepared in the comparative examples were subjected to the following tests:

[0095] 1. Antipyretic Experiment

[0096] A number of healthy rats (half male and half female) were selected and fed adaptively for 3 days, and the rectal temperature test was performed to monitor the body temperature once a day. 112 rats (half male and half female) were screened out as qualified (rats with a single body temperature exceeding 37.5°C or a temperature difference of more than 0.5°C between two times were excluded) and randomly divided into 14 groups, 8 rats in each group (half male and half female), namely blank control group, model control group, positive control group (acetaminophen granules 20 mg / kg), example group (20 mg / kg corresponding to the mixture of the example), and comparative example group (20 mg / kg corresponding to the mixture of the comparative example).

[0097] Construction of a rat fever model: fasting but not drinking water overnight the day before the model was prepared, and the rats were allowed to empty their stools. The body temperature of each rat was measured once before modeling as the basal body temperature. The model control group, positive control group, embodiment group, and comparative group were all injected with 20% dry yeast suspension (10 mL / kg) to replicate the rat fever model. The model was successful when the rectal temperature exceeded 37.5°C; the blank control group was injected with an equal amount of normal saline.

[0098] Treatment: The positive control group was given 40 mg / kg of acetaminophen granules by oral gavage every day. The example group was given 20 mg / kg of the mixture of the corresponding example by oral gavage every day. The comparative example group was given 20 mg / kg of the mixture of the corresponding proportion by oral gavage every day. The blank control group and the model control group were given an equal amount of normal saline.

[0099] The rectal temperature of the rats in each group was measured 1, 2, 3, and 4 hours after administration. The results are shown in Table 1 below.

[0100] Table 1 Antipyretic test results (average value)

[0101] Group 1h rectal temperature ℃ 2h rectal temperature℃ 3h rectal temperature℃ 4h rectal temperature ℃ Blank control group 36.64 36.72 36.85 36.70 Model control group 37.95 38.36 38.56 38.96 Positive control group 37.53 37.13 36.92 37.07 Example 1 37.48 36.84 36.55 36.44 Example 2 37.62 37.09 36.87 36.61 Example 3 37.55 36.92 36.73 36.52 Example 4 37.44 36.95 36.78 36.57 Example 5 37.67 37.01 36.86 36.65 Comparative Example 1 37.75 37.23 37.17 37.22 Comparative Example 2 37.68 37.07 36.94 37.17 Comparative Example 3 37.85 37.55 37.36 37.48 Comparative Example 4 37.72 37.21 37.13 37.20 Comparative Example 5 37.64 37.02 36.91 37.13 Comparative Example 6 37.82 37.51 37.33 37.42

[0102] From the above results, it can be seen that the mixtures of Comparative Examples 1 to 5 have a good cooling effect, and compared with acetaminophen, the long-term cooling effect of the composition is better and more stable. From the results of Comparative Examples 1 to 6, it can be seen that the conventional water extraction method (without adding enzymolysis or fermentation) and the products after omitting the enzymolysis or fermentation steps have greatly reduced cooling effect and long-term cooling stability.

[0103] 2. Analgesia Experiment

[0104] Several ICR mice were selected, and the pain threshold in an environment of 55±0.5℃ was determined by the hot plate method. Each mouse was measured twice, with an interval of 30min each time; the average value obtained from the two measurements was used as the basic pain threshold of the mouse, and 104 mice with a pain threshold of 10s to 30s were selected and randomly divided into 13 groups, with 8 mice in each group (half male and half female). They were blank control group, positive control group, embodiment group, and comparative group. The positive control group was gavaged with 20 mg / kg of acetaminophen granules; the embodiment group was gavaged with 20 mg / kg of the corresponding embodiment composition; the comparative group was gavaged with 20 mg / kg of the corresponding comparative composition; the blank control group was gavaged with an equal amount of distilled water. The drug was administered twice a day, with an interval of 12 hours each time, for 7 consecutive days. One hour after the last administration, the pain threshold in an environment of 55±0.5℃ was determined by the hot plate method. The test results are shown in Table 2 below.

[0105] Table 2 Analgesia test results (average value)

[0106] Group Pain threshold Group Pain threshold Blank control group 17.2 Comparative Example 1 25.7 Positive control group 25.4 Comparative Example 2 26.1 Example 1 30.2 Comparative Example 3 23.2 Example 2 27.3 Comparative Example 4 25.9 Example 3 28.4 Comparative Example 5 26.4 Example 4 28.9 Comparative Example 6 23.5 Example 5 27.5

[0107] From the above results, it can be seen that the mixtures of Comparative Examples 1 to 5 have a good analgesic effect, and the analgesic effect of the composition is better than that of acetaminophen. From the results of Comparative Examples 1 to 6, it can be seen that the conventional water extraction method (without adding enzymolysis or fermentation) and the products after omitting the enzymolysis or fermentation steps have greatly reduced analgesia.

[0108] 3. Anti-inflammatory Experiment

[0109] 112 healthy Kunming mice, half male and half female, were selected and divided into 14 groups, 8 mice in each group (half male and half female), namely blank control group, model control group, positive control group (aspirin 400 mg / kg), embodiment group (corresponding to the composition of each embodiment 400 mg / kg), comparative group (corresponding to the composition of each comparative example 400 mg / kg). The positive control group was gavaged with aspirin 400 mg / kg; the embodiment group and the comparative group were given a composition of 400 mg / kg by stomach administration, and the blank control group and the model control group were gavaged with an equal amount of distilled water; the drug was administered once a day for 7 consecutive days. One hour after the last administration, the model control group, the positive control group, the embodiment group, and the comparative group were all smeared with 50 μL of xylene on the front and back sides of the right ear of the mouse, and the other ear was used as a blank control. The blank control group was smeared with an equal amount of distilled water. The mice were killed 30 minutes after inflammation, and the two ears were cut along the baseline of the auricle. The hole puncher punched a round hole ear piece at the same position of the left and right ears, and weighed with an electronic balance. The weight difference of the left and right ear pieces was calculated as the swelling index: swelling degree (mg) = right ear piece weight - left ear piece weight; swelling inhibition rate (%) = [(swelling degree of the model group - swelling degree of the drug administration group) / swelling degree of the model group] × 100%. The test results are shown in Table 3 below.

[0110] Table 3 Anti-inflammatory test results (average value)

[0111] Group Swelling inhibition rate (%) Group Swelling inhibition rate (%) Blank control group — Comparative Example 1 20.1 Model control group — Comparative Example 2 22.4 Positive control group 31.2 Comparative Example 3 15.3 Example 1 29.8 Comparative Example 4 21.5 Example 2 27.6 Comparative Example 5 23.8 Example 3 28.3 Comparative Example 6 16.2 Example 4 28.5 Example 5 27.9

[0112] It can be seen from the above results that the mixtures of Comparative Examples 1 to 5 have good anti-inflammatory effects. From the results of Comparative Examples 1 to 6, it can be seen that the products of the conventional water extraction method (without adding enzymatic hydrolysis or fermentation products) and after omitting the enzymatic hydrolysis or fermentation steps have greatly reduced anti-inflammatory effects.

Claims

1. A compound Polygonum cuspidatum ammonia-sensitive tablet, characterized in that: The raw materials of the compound Polygonum cuspidatum amino-sensitive tablets include: 10 to 30 parts of Polygonum cuspidatum dry paste, 5 to 15 parts of Bupleurum dry paste, 1 to 5 parts of chlorpheniramine maleate and 100 to 300 parts of acetaminophen, calculated by weight; The preparation method of the dried polygonum cuspidatum paste comprises the following steps: taking the polygonum cuspidatum root and crushing it, adding ethanol aqueous solution with the weight of 6 to 8 times of the polygonum cuspidatum root, extracting at 55 to 60 degrees Celsius for 2 hours to 4 hours, filtering, and obtaining an extract A and an extract residue B; dispersing the extract residue B in water with the weight of 8 to 10 times of the extract residue B, adjusting the pH value to 5.0 to 5.5 with hydrochloric acid aqueous solution, adding hemicellulase and pectinase with the weight of 1% to 2% of the extract residue B respectively, performing enzymolysis at 45 to 55 degrees Celsius for 2 hours to 3 hours, killing the enzymes at high temperature, cooling to room temperature, adjusting the pH value to 6.5 to 7.5 with sodium hydroxide aqueous solution, and adding bromelain with the weight of 0.5% to 1% of the extract residue B. , enzymolysis at 55°C to 60°C for 3h to 4h, high temperature to inactivate the enzyme, after cooling to room temperature, add 3% to 6% of glucose by weight of the leaching residue B, 1% to 2.5% of ammonium chloride by weight of the leaching residue B, 0.1% to 0.5% of disodium hydrogen phosphate by weight of the leaching residue B, and then add 0.3% to 0.8% of Bacillus licheniformis and Bacillus subtilis by weight of the leaching residue B, respectively, aerobically ferment at 30°C to 37°C for 18h to 25h, sterilize at high temperature, after cooling to room temperature, filter with a 5kDa ultrafiltration membrane to obtain a filtrate B1 below 5kDa, combine the filtrate B1 with the leaching solution A, concentrate, and freeze-dry to obtain a Polygonum cuspidatum dry paste with a water content of 4% to 6%; The preparation method of the dried bupleurum paste comprises the following steps: taking bupleurum root and crushing it, adding ethanol aqueous solution with the mass of 6 to 8 times of the mass of bupleurum root, extracting at 55 to 60° C. for 2 to 4 hours, filtering to obtain an extract C and an extract residue D; dispersing the extract residue D in water with the mass of 8 to 10 times of the mass of the extract residue D, adjusting the pH to 1.5 to 2.0 with hydrochloric acid aqueous solution, adding pepsin with the mass of 1% to 1.5% of the mass of the extract residue D, and enzymolyzing at 35 to 38° C. for 50 minutes. The mixture was heated to 40 °C for 1 h to 60 min, the enzyme was inactivated at high temperature, and after cooling to room temperature, the pH was adjusted to 6 to 7 with an aqueous sodium hydroxide solution, and 0.5% to 1% of the mass of bupleurum root ficiproside and bromelain were added respectively. The mixture was enzymolyzed at 55 °C to 60 °C for 1 h to 1.5 h, the enzyme was inactivated at high temperature, and after cooling to room temperature, the mixture was filtered with a 3 kDa ultrafiltration membrane to obtain a filtrate D1 below 3 kDa. The filtrate D1 was combined with the extract C, concentrated, and freeze-dried to obtain a bupleurum root paste with a water content of 4% to 6%.

2. A compound Polygonum cuspidatum ammonia sensitive tablet according to claim 1, characterized in that: The volume concentration of the ethanol aqueous solution is 30% to 40%.

3. A compound Polygonum cuspidatum ammonia sensitive tablet according to claim 1, characterized in that: In the preparation method of the dried polygonum cuspidatum paste, the concentration of the hydrochloric acid aqueous solution is 0.2 mol / L to 0.5 mol / L; the concentration of the sodium hydroxide aqueous solution is 0.2 mol / L to 0.5 mol / L.

4. A compound Polygonum cuspidatum ammonia sensitive tablet according to claim 1, characterized in that: In the preparation method of the dried bupleurum extract, the concentration of the hydrochloric acid aqueous solution is 0.5 mol / L to 1 mol / L; the concentration of the sodium hydroxide aqueous solution is 0.5 mol / L to 1 mol / L.

5. A compound Polygonum cuspidatum ammonia sensitive tablet according to claim 1, characterized in that: The enzymatic activity of the hemicellulase is 100,000 U / g; the enzymatic activity of the pectinase is 100,000 U / g; the enzymatic activity of the bromelain is 200,000 U / g to 400,000 U / g; the enzymatic activity of the pepsin is 10,000 U / g to 12,000 U / g; and the enzymatic activity of the ficin is 100,000 U / g.

6. A compound Polygonum cuspidatum ammonia sensitive tablet according to claim 1, characterized in that: The bacterial activity of the Bacillus licheniformis is 20 billion CFU / g to 50 billion CFU / g; the bacterial activity of the Bacillus subtilis is 20 billion CFU / g to 50 billion CFU / g.

7. A compound Polygonum cuspidatum ammonia-sensitive tablet according to claim 1, characterized in that: The temperature of the high temperature enzyme inactivation is 85°C to 90°C, and the time is 15min to 25min.

8. A compound Polygonum cuspidatum ammonia sensitive tablet according to claim 1, characterized in that: The temperature of the high temperature sterilization is 121° C., and the time is 15 min to 20 min.

9. A method for preparing a compound polygonum cuspidatum ammonia-sensitive tablet, used for preparing a compound polygonum cuspidatum ammonia-sensitive tablet according to claim 1, characterized in that: The preparation method comprises the following steps: According to the mass proportions, dried polygonum cuspidatum paste, dried bupleurum paste, chlorpheniramine maleate and acetaminophen are mixed to obtain a mixture, and the mixture is added into pharmaceutically usable auxiliary materials for mixed tablet preparation to obtain compound polygonum cuspidatum ammonia-sensitive tablets.

10. The method for preparing a compound Polygonum cuspidatum ammonia-sensitive tablet according to claim 9, characterized in that: The content of the mixture in the compound Polygonum cuspidatum ammonia-sensitive tablet is 30wt% to 50wt%.