Formula of halite four-flavor granules and extraction and concentration method of halite four-flavor granules

Abstract

The invention relates to the technical field of traditional Chinese medicines, and particularly discloses a halite four-ingredient granule formula and an extraction and concentration method thereof. The halite four-ingredient granule formula comprises halite, fructus piperis longi, fructus chebulae and rhizoma zingiberis; through scientific compatibility of the medicinal materials such as the halite, the fructus piperis longi, the fructus chebulae and the rhizoma zingiberis, the traditional Chinese medicine composition has the remarkable functions of warming the stomach, promoting digestion and detoxifying, can effectively relieve the symptoms such as gastrectasia, stomachache and belching caused by dyspepsia, can regulate the gastrointestinal physiological functions at multiple targets, such as enhancing gastrointestinal motility, promoting gastric secretion and inhibiting the growth of harmful bacteria; therefore, the gastrointestinal tract environment is comprehensively improved, and digestive absorption is promoted.

Description

Technical Field

[0001] The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a formula of Guangming Salt Four-flavor Granule Instant and an extraction and concentration method thereof. Background Art

[0002] In the field of gastrointestinal disease treatment, indigestion is a common symptom that seriously affects the quality of life of patients. Traditionally, the treatment of indigestion mostly uses Western medicine or Chinese medicine alone, but these methods often have problems such as single efficacy, large side effects, or easy to cause drug dependence;

[0003] Traditional medicine such as Mongolian medicine and Tibetan medicine has accumulated rich experience in the treatment of gastrointestinal diseases. Among them, Guangming Salt Four-flavor Granules or similar prescriptions, as one of the traditional prescriptions, are widely used in the treatment of indigestion. However, these traditional prescriptions face many problems in the process of modern development and application, such as quality problems caused by backward preparation technology. Therefore, a formula of Guangming Salt Four-flavor Granules is proposed. Summary of the invention

[0004] The purpose of the present invention is to provide a Guangming Salt Four-flavor Granule Instant Formula and an extraction and concentration method thereof to solve the problems raised in the above-mentioned background technology.

[0005] To achieve the above object, the present invention provides the following technical solutions:

[0006] A formula of Guangming Salt Four-flavor Granule Instant, consisting of the following components:

[0007] Guangming salt, piper longum, terminalia chebula and dried ginger, wherein the weight ratio of the Guangming salt, piper longum, terminalia chebula and dried ginger is 1:1:1:1.

[0008] Preferably, the invention further comprises additives, wherein the additives are 2-5% sucrose, 1-4% dextrin, 0.2-1.1% stabilizer, 0.1-0.2% phytosterol, 1-2% functional polysaccharide and 0.1-0.3% microalgae extract.

[0009] Preferably, the functional polysaccharide includes one or more of tea polysaccharide, wolfberry polysaccharide, tremella polysaccharide, and shiitake polysaccharide.

[0010] A method for extracting and concentrating Guangming Salt Four-flavor Granule Instant, comprising the following steps:

[0011] S1. Pretreatment of medicinal materials: Wash Piper longum, Terminalia chebula, and dried ginger with clean water to remove impurities, then cut them into thin slices. Use supercritical CO2 extraction technology to pretreat the sliced ​​medicinal materials. Set the extraction pressure to 30 MPa, the temperature to 40°C, and the extraction time to 2 hours.

[0012] S2. Microwave-assisted decoction and dynamic extraction: Place the medicinal materials after supercritical CO2 extraction in a microwave decoction pot, add appropriate amount of water so that the water surface slightly passes over the medicinal materials, set the microwave frequency to 2450MHz, the power to 500W, and perform three dynamic extractions, each extraction time is 1 hour, 45 minutes and 30 minutes respectively. During the extraction process, keep the medicinal materials and water in full contact and circulate.

[0013] S3. Concentration and nanofiltration of medicinal liquid: The medicinal liquids obtained from three microwave-assisted decoctions are mixed, and vacuum concentrated to a relative density of 1.0-1.1. The concentrated medicinal liquid is filtered using nanofiltration technology to remove impurities and particles.

[0014] S4. Drug mixing: Add additives and solid lipid nanoparticles to the concentrated drug solution, and use an ultrasonic homogenizer to homogenize the mixed drug solution. Set the ultrasonic frequency to 20 kHz, the power to 200 W, and the homogenization time to 15 minutes.

[0015] S5. Spray granulation and fluidized bed drying: The homogenized liquid medicine is granulated by a spray granulator, the spray pressure is set to 0.5 MPa, the air inlet temperature is 120-140°C, the air outlet temperature is 80-100°C, and the fluidized bed drying technology is used to dry the prepared wet granules, the drying temperature is set to 60-80°C, and the drying time is 1-2 hours.

[0016] S6. Granulation and packaging: The dried granules are sieved for granulation and removal of fine powder, and the prepared granules are sealed and packaged to produce Guangming Salt Four-flavor Granules.

[0017] Compared with the prior art, the present invention has the following beneficial effects:

[0018] (1) Through the scientific combination of medicinal materials such as Guangming Salt, Piper longum, Terminalia chebula, and dried ginger, it has significant functions of warming the stomach, digesting food, and detoxifying. It can effectively relieve symptoms such as bloating, stomach pain, and belching caused by indigestion. It can regulate gastrointestinal physiological functions at multiple targets, such as enhancing gastrointestinal motility, promoting gastric juice secretion, and inhibiting the growth of harmful bacteria, thereby comprehensively improving the gastrointestinal environment and promoting digestion and absorption.

[0019] (2) Extraction and purification technology is used to ensure that the content of each active ingredient in the formula is stable and meets the standard, which is conducive to the disintegration and dissolution of the drug in the body and improves bioavailability. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] Figure 1 It is a process flow chart of the present invention. DETAILED DESCRIPTION

[0021] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0022] Embodiment 1:

[0023] See also Figure 1 As shown, a formula of Guangming Salt Four-Flavor Granule Infusion is composed of the following components: Guangming Salt, Piper Longum, Terminalia Chebula, and Dried Ginger, and the weight ratio of Guangming Salt, Piper Longum, Terminalia Chebula, and Dried Ginger is 1:1:1:1.

[0024] In one embodiment of the present invention, additives are further included, and the additives are 5% sucrose, 2% dextrin, 0.5% stabilizer, 0.1% phytosterol, 1% functional polysaccharide and 0.3% microalgae extract.

[0025] In one embodiment of the present invention, the functional polysaccharide includes one or more of tea polysaccharide, wolfberry polysaccharide, tremella polysaccharide, and shiitake polysaccharide.

[0026] A method for extracting and concentrating Guangming Salt Four-flavor Granule Instant, comprising the following steps:

[0027] S1. Pretreatment of medicinal materials: Wash Piper longum, Terminalia chebula, and dried ginger with clean water to remove impurities, then cut them into thin slices. Use supercritical CO2 extraction technology to pretreat the sliced ​​medicinal materials. Set the extraction pressure to 30 MPa, the temperature to 40°C, and the extraction time to 2 hours.

[0028] S2. Microwave-assisted decoction and dynamic extraction: Place the medicinal materials after supercritical CO2 extraction in a microwave decoction pot, add appropriate amount of water so that the water surface slightly passes over the medicinal materials, set the microwave frequency to 2450MHz, the power to 500W, and perform three dynamic extractions, each extraction time is 1 hour, 45 minutes and 30 minutes respectively. During the extraction process, keep the medicinal materials and water in full contact and circulate.

[0029] S3. Concentration and nanofiltration of medicinal liquid: The medicinal liquids obtained from three microwave-assisted decoctions are mixed, and vacuum concentrated to a relative density of 1.0. The concentrated medicinal liquid is filtered using nanofiltration technology to remove impurities and particles.

[0030] S4. Drug mixing: Add additives and solid lipid nanoparticles to the concentrated drug solution, and use an ultrasonic homogenizer to homogenize the mixed drug solution. Set the ultrasonic frequency to 20 kHz, the power to 200 W, and the homogenization time to 15 minutes.

[0031] S5. Spray granulation and fluidized bed drying: The homogenized liquid medicine is granulated by a spray granulator. The spray pressure is set to 0.5 MPa, the air inlet temperature is set to 120°C, and the air outlet temperature is set to 80°C. The fluidized bed drying technology is used to dry the prepared wet granules. The drying temperature is set to 60°C and the drying time is set to 1-2 hours.

[0032] S6. Granulation and packaging: The dried granules are sieved for granulation and removal of fine powder, and the prepared granules are sealed and packaged to produce Guangming Salt Four-flavor Granules.

[0033] Embodiment 2:

[0034] See also Figure 1 As shown, a formula of Guangming Salt Four-Flavor Granule Infusion is composed of the following components: Guangming Salt, Piper Longum, Terminalia Chebula, and Dried Ginger, and the weight ratio of Guangming Salt, Piper Longum, Terminalia Chebula, and Dried Ginger is 1:1:1:1.

[0035] In one embodiment of the present invention, additives are further included, and the additives are 2% sucrose, 2% dextrin, 0.9% stabilizer, 0.2% phytosterol, 1% functional polysaccharide and 0.2% microalgae extract.

[0036] In one embodiment of the present invention, the functional polysaccharide includes one or more of tea polysaccharide, wolfberry polysaccharide, tremella polysaccharide, and shiitake polysaccharide.

[0037] A method for extracting and concentrating Guangming Salt Four-flavor Granule Instant, comprising the following steps:

[0038] S1. Pretreatment of medicinal materials: Wash Piper longum, Terminalia chebula, and dried ginger with clean water to remove impurities, then cut them into thin slices. Use supercritical CO2 extraction technology to pretreat the sliced ​​medicinal materials. Set the extraction pressure to 30 MPa, the temperature to 40°C, and the extraction time to 2 hours.

[0039] S2. Microwave-assisted decoction and dynamic extraction: Place the medicinal materials after supercritical CO2 extraction in a microwave decoction pot, add appropriate amount of water so that the water surface slightly passes over the medicinal materials, set the microwave frequency to 2450MHz, the power to 500W, and perform three dynamic extractions, each extraction time is 1 hour, 45 minutes and 30 minutes respectively. During the extraction process, keep the medicinal materials and water in full contact and circulate.

[0040] S3. Concentration and nanofiltration of medicinal liquid: The medicinal liquids obtained from three microwave-assisted decoctions are mixed, and vacuum concentrated to a relative density of 1.1. The concentrated medicinal liquid is filtered using nanofiltration technology to remove impurities and particles.

[0041] S4. Drug mixing: Add additives and solid lipid nanoparticles to the concentrated drug solution, and use an ultrasonic homogenizer to homogenize the mixed drug solution. Set the ultrasonic frequency to 20 kHz, the power to 200 W, and the homogenization time to 15 minutes.

[0042] S5. Spray granulation and fluidized bed drying: The homogenized liquid medicine was granulated by a spray granulator. The spray pressure was set to 0.5 MPa, the air inlet temperature was set to 140°C, and the air outlet temperature was set to 100°C. The fluidized bed drying technology was used to dry the prepared wet granules. The drying temperature was set to 80°C and the drying time was set to 2 hours.

[0043] S6. Granulation and packaging: The dried granules are sieved for granulation and removal of fine powder, and the prepared granules are sealed and packaged to produce Guangming Salt Four-flavor Granules.

[0044] Experimental example:

[0045] The ingredients of the above-mentioned Guangming Salt Four-flavor Granules were tested, among which:

[0046] The content of active ingredients in the granules was determined by HPLC, as shown in the following table:

[0047] Sodium chloride content 26.0％±0.4％ Piperine content 0.85％±0.03％ Tannin content 3.5％±0.1％ Gingerol content 1.7％±0.04％

[0048] Additive uniformity check using UV-Vis spectrophotometer:

[0049] The content of each additive is within ±5% of the nominal value and is evenly distributed;

[0050] The physical properties of the particles were measured using a particle size analyzer and a moisture analyzer, as shown in the following table:

[0051]

[0052]

[0053] Microbiological Limit Test:

[0054] Conduct microbiological testing on finished products in accordance with relevant standards, including total bacteria count, mold and yeast count, which all meet the microbial limit standards for pharmaceuticals;

[0055] From the above, it can be seen that the Guangming Salt Four-flavor Granules prepared in the above embodiments have a high and stable content of active ingredients, uniform distribution of additives, the physical properties of the particles meet the requirements, and the microbial limits meet the standards. The granules show good safety and effectiveness.

[0056] At the same time, 120 patients diagnosed with dyspepsia were selected and randomly divided into two groups, 60 people in each group. The experimental group took Guangming Salt Four-flavor Granules, 3 times a day, 1 pack each time; the control group took a placebo with similar appearance and taste, and the method of taking was the same as the experimental group. The observation period was 4 weeks.

[0057] The age distribution of the two groups of patients was similar, with an average age of 40±10 years. There were 32 males and 28 females in the experimental group, and 30 males and 30 females in the control group. The average disease course was 6±3 months.

[0058] Dyspepsia symptom score (using a standardized scale with a total score of 10 points, with higher scores indicating more severe symptoms): the baseline score in the experimental group was 7.5±1.5 points, and the baseline score in the control group was 7.4±1.4 points;

[0059] The experimental data are as follows:

[0060]

[0061] The results of this experiment show that Guangming Salt Four-flavor Granules have significant therapeutic effects in relieving dyspepsia symptoms and are highly safe. Compared with the control group, the dyspepsia symptom scores of patients in the experimental group were significantly reduced and the symptom relief rate was significantly improved.

[0062] In the above combination of ingredients:

[0063] Bright salt, as one of the main ingredients of this formula, has the function of seasoning and replenishing the minerals needed by the human body;

[0064] Piper longum is a spice and Chinese medicinal material. Its fruit is rich in spicy ingredients and has the effects of warming the middle and dispelling cold, promoting qi and relieving pain. In granules, it can enhance the warming nature of the formula and help relieve symptoms such as spleen and stomach deficiency and cold.

[0065] Terminalia chebula is a commonly used Chinese herbal medicine that has the effects of astringing the intestines and stopping diarrhea, astringing the lungs and stopping coughs. In granules, it is used to assist in the treatment of respiratory and digestive tract symptoms such as diarrhea and coughs, and to enhance the astringent and antitussive effects of the formula.

[0066] Dried ginger is a dried product of ginger, which has a spicy taste and warming properties. It is widely used in traditional Chinese medicine to treat symptoms such as spleen and stomach deficiency, vomiting and diarrhea. In granules, it is used to enhance the warming and cold-dispelling effect of the formula, promote digestion and relieve gastrointestinal discomfort.

[0067] Although embodiments of the present invention have been shown and described, it will be appreciated by those skilled in the art that various changes, modifications, substitutions and variations may be made to the embodiments without departing from the principles and spirit of the present invention, and that the scope of the present invention is defined by the appended claims and their equivalents.

Claims

1. A formula of Guangming Salt Four-flavor Granule Instant, characterized in that: The invention is composed of the following components: guangming salt, piper longum, terminalia chebula and dried ginger, wherein the weight ratio of the guangming salt, piper longum, terminalia chebula and dried ginger is 1:1:1:

1.

2. The formula of Guangming Salt Four-flavor Granules according to claim 1, characterized in that: The invention also comprises additives, which include 2-5% sucrose, 1-4% dextrin, 0.2-1.1% stabilizer, 0.1-0.2% phytosterol, 1-2% functional polysaccharide and 0.1-0.3% microalgae extract.

3. The formula of Guangming Salt Four-flavor Granules according to claim 1, characterized in that: The functional polysaccharide includes one or more of tea polysaccharide, wolfberry polysaccharide, tremella polysaccharide and shiitake polysaccharide.

4. A method for extracting and concentrating Guangming Salt Four-flavor Granules, characterized in that: The following steps are involved: S1. Pretreatment of medicinal materials: Wash Piper longum, Terminalia chebula, and dried ginger with clean water to remove impurities, then cut them into thin slices. Use supercritical CO2 extraction technology to pretreat the sliced ​​medicinal materials. Set the extraction pressure to 30 MPa, the temperature to 40°C, and the extraction time to 2 hours. S2. Microwave-assisted decoction and dynamic extraction: Place the medicinal materials after supercritical CO2 extraction in a microwave decoction pot, add appropriate amount of water so that the water surface slightly passes over the medicinal materials, set the microwave frequency to 2450MHz, the power to 500W, and perform three dynamic extractions, each extraction time is 1 hour, 45 minutes and 30 minutes respectively. During the extraction process, keep the medicinal materials and water in full contact and circulate. S3. Concentration and nanofiltration of medicinal liquid: The medicinal liquids obtained from three microwave-assisted decoctions are mixed, and vacuum concentrated to a relative density of 1.0-1.

1. The concentrated medicinal liquid is filtered using nanofiltration technology to remove impurities and particles. S4. Drug mixing: Add additives and solid lipid nanoparticles to the concentrated drug solution, and use an ultrasonic homogenizer to homogenize the mixed drug solution. Set the ultrasonic frequency to 20 kHz, the power to 200 W, and the homogenization time to 15 minutes. S5. Spray granulation and fluidized bed drying: The homogenized liquid medicine is granulated by a spray granulator, the spray pressure is set to 0.5 MPa, the air inlet temperature is 120-140°C, the air outlet temperature is 80-100°C, and the fluidized bed drying technology is used to dry the prepared wet granules, the drying temperature is set to 60-80°C, and the drying time is 1-2 hours. S6. Granulation and packaging: The dried granules are sieved for granulation and removal of fine powder, and the prepared granules are sealed and packaged to produce Guangming Salt Four-flavor Granules.

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