CN113599359B - American ginseng oral disintegrating tablet and preparation method and application thereof - Google Patents
American ginseng oral disintegrating tablet and preparation method and application thereof Download PDFInfo
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- CN113599359B CN113599359B CN202110761168.4A CN202110761168A CN113599359B CN 113599359 B CN113599359 B CN 113599359B CN 202110761168 A CN202110761168 A CN 202110761168A CN 113599359 B CN113599359 B CN 113599359B
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- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
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- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
- A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
- A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
- A23L33/105—Plant extracts, their artificial duplicates or their derivatives
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- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
- A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
- A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
- A23L33/125—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives containing carbohydrate syrups; containing sugars; containing sugar alcohols; containing starch hydrolysates
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- A—HUMAN NECESSITIES
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/25—Araliaceae (Ginseng family), e.g. ivy, aralia, schefflera or tetrapanax
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- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
- A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
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Abstract
The technical scheme of the invention discloses an American ginseng orally disintegrating tablet, a preparation method and an application thereof, wherein the American ginseng orally disintegrating tablet comprises the following components in percentage by mass: 85-95% of fresh American ginseng active freeze-dried powder and 5-15% of cross-linked carboxymethyl flaxseed polysaccharide sodium. The American ginseng orally disintegrating tablet of the technical scheme of the invention can improve the utilization value of American ginseng, is convenient to take or eat to meet the requirements of specific people, and can be used for rehabilitation treatment of patients with throat cancer after operations and chemoradiotherapy.
Description
Technical Field
The invention belongs to the field of deep processing of American ginseng, and particularly relates to an American ginseng orally disintegrating tablet and a preparation method and application thereof.
Background
American ginseng is dry root of American ginseng plant of Araliaceae, panax, and has sweet, slightly bitter and cool properties. The theory of traditional Chinese medicine records that it can play the efficacies of invigorating qi, nourishing yin, clearing heat, promoting the production of body fluid and the like, mainly enters heart, lung and kidney meridians, and is a cold tonifying product. American ginseng has unique medical health care function, and in order to better exert the treatment effect, researchers all over the world make the research work of American ginseng make remarkable progress through multidisciplinary cooperation and multi-field research. At present, the deep-processed products of American ginseng mostly take dried American ginseng as raw materials, and are prepared into foods, medicines or health-care products through the working procedures of high-temperature extraction, concentration, drying and the like. Some volatile components, active enzymes and other heat sensitive components in fresh American ginseng are lost or destroyed in the above-mentioned processing process, which greatly reduces the activity of the deep-processed product of American ginseng.
Oral tablet administration is a concern as the average human life increases and the ability to swallow decreases with age. According to statistics, in the clinical medication process, the incidence rate of difficulty in swallowing tablets and capsules is high, 35% of patients in the elderly have difficulty in swallowing drugs, and the proportion tends to rise with the age, so that the compliance of drug treatment is influenced.
Therefore, the development of an active American ginseng orally disintegrating tablet product can improve the utilization value of American ginseng, meet the requirements of the elderly people and has great practical significance.
Disclosure of Invention
The invention aims to provide an American ginseng orally disintegrating tablet, which is used for improving the utilization value of American ginseng, is convenient to take or eat to meet the requirements of specific people, and can be used for rehabilitation after operations and chemoradiotherapy of patients with throat cancer.
In order to solve the technical problems, in one aspect, the present invention provides an american ginseng orally disintegrating tablet, which comprises, by mass: 85-95% of fresh American ginseng active freeze-dried powder and 5-15% of cross-linked carboxymethyl flaxseed polysaccharide sodium.
Optionally, in the fresh American ginseng active freeze-dried powder, the weight content of ginsenoside Rg1 is more than 3%.
Optionally, the cross-linked sodium carboxymethyl linseed polysaccharide is prepared by the following method: dispersing flaxseed polysaccharide in an organic solvent to form an emulsion, wherein the flaxseed polysaccharide accounts for 30-40% by mass; adding 10-20% by mass of a sodium-containing alkaline substance and 0.01-0.1% by mass of a cross-linking agent into the emulsion, and pretreating at a first temperature; adding carboxymethylation reagent with the mass percent of 10-15% into the pretreated system, and carrying out carboxymethylation reaction at a second temperature; sequentially neutralizing and filtering the reacted system, and washing the obtained filter cake; and drying at a third temperature to obtain the cross-linked carboxymethyl linseed polysaccharide sodium.
Optionally, the organic solvent comprises ethanol, and the washing solution used for washing the filter cake comprises ethanol.
Optionally, the sodium-containing basic substance comprises sodium hydroxide, the crosslinking agent comprises epichlorohydrin, and the carboxymethylating agent comprises chloroacetic acid.
Optionally, the first temperature is 30-40 ℃, and the pretreatment time is 15-30min; the second temperature is 50-60 ℃, and the time of the carboxymethylation reaction is 2-3h; the third temperature is 40-55 ℃.
The invention also provides application of the American ginseng orally disintegrating tablet in rehabilitation after throat cancer operation, radiotherapy and chemotherapy.
The invention also provides a preparation method of the American ginseng orally disintegrating tablet, which comprises the following steps: mixing 85-95% of fresh American ginseng active freeze-dried powder by mass and 5-15% of cross-linked carboxymethyl linseed polysaccharide sodium by mass to form a mixture; mixing the mixture with water according to the weight ratio of 1 (1-5) to obtain a suspension of fresh American ginseng active freeze-dried powder; and performing a second freeze drying process on the fresh American ginseng active freeze-dried powder suspension.
Optionally, the second freeze-drying process comprises: cooling the suspension of the fresh American ginseng active freeze-dried powder to-60 to-70 ℃, and keeping the temperature for 0.5 to 5 hours; maintaining the temperature of the suspension of the fresh American ginseng active freeze-dried powder at-20 to-25 ℃ until the frozen ice in the suspension of the fresh American ginseng active freeze-dried powder is sublimated; heating the suspension of the fresh American ginseng active freeze-dried powder after the frozen ice is sublimated to 25-35 ℃, and maintaining until the freeze-drying is finished.
Optionally, the preparation method of the fresh American ginseng active freeze-dried powder comprises the following steps: extracting cleaned and pulverized fresh radix Panacis Quinquefolii with water at 25-35 deg.C as extraction solvent; separating under the centrifugal force of 5000-25000 r/min to obtain separation liquid; concentrating the separated liquid to obtain a concentrated liquid; and (3) carrying out a first freeze-drying process on the concentrated solution to obtain active American ginseng freeze-dried powder, wherein the weight of the active American ginseng freeze-dried powder is 30-40% of the dry weight of the fresh American ginseng, and the weight content of ginsenoside Rg1 in the fresh American ginseng active freeze-dried powder is more than 3%.
Optionally, the first freeze-drying method comprises: cooling the concentrated solution to-55 to-45 ℃ and keeping the temperature for 3 to 5 hours; maintaining the temperature of the concentrated solution at-20 to-25 ℃ until the frozen ice in the concentrated solution is sublimated; and heating the concentrated solution after the frozen ice is sublimated to 20-33 ℃, and maintaining the temperature until the freeze-drying is finished.
Compared with the prior art, the technical scheme of the invention has the following beneficial effects:
the American ginseng orally disintegrating tablet of the technical scheme of the invention does not contain other auxiliary materials except the cross-linked carboxymethyl flaxseed polysaccharide sodium, and the product is safer. The American ginseng orally disintegrating tablet has the sensitization effect, can enhance the curative effect of radiotherapy and chemotherapy, relieve the toxic and side effects of radiotherapy and chemotherapy such as gastrointestinal reaction, remarkably relieve oral cavity and throat mucosa reaction, oral ulcer and pain caused by radiotherapy, remarkably enhance the cellular immunity of an organism, enhance the anti-tumor capability of an organism, and has the effect of promoting wound healing after operation on patients with throat cancer. Therefore, the traditional Chinese medicine composition can be applied to rehabilitation after surgery and radiotherapy and chemotherapy of throat cancer patients, and can promote the development of medicines, foods and health-care foods.
The temperature in the whole process of the preparation method of the American ginseng orally disintegrating tablet in the technical scheme of the invention is not more than 40 ℃, and active enzymes can be kept from being damaged by high temperature.
Drawings
Fig. 1 is a flow chart of a method for preparing cross-linked sodium carboxymethyl linseed polysaccharide according to an embodiment of the present invention;
fig. 2 is a flow chart of a preparation method of the American ginseng orally disintegrating tablet in the embodiment of the invention;
fig. 3 is a flow chart of a preparation method of fresh American ginseng active freeze-dried powder in the embodiment of the invention.
Detailed Description
In order to make those skilled in the art better understand the technical solutions in the present application, the present invention will be further described below with reference to the following embodiments, and it is obvious that the described embodiments are only a part of the embodiments of the present application, and not all embodiments. All other embodiments obtained by a person of ordinary skill in the art based on the embodiments in the present application without making any creative effort shall fall within the protection scope of the present application.
The embodiment of the invention provides an American ginseng orally disintegrating tablet, which comprises the following components in percentage by mass: 85% -95% of fresh American ginseng active freeze-dried powder and 5% -15% of cross-linked carboxymethyl flaxseed polysaccharide sodium. The American ginseng has very complex chemical components, the main active components are saponin active enzymes which have obvious antioxidant activity and also contain a plurality of active components such as polysaccharide, volatile oil, trace elements, amino acid and the like. Orally disintegrating tablets, also known as orally disintegrating tablets, are tablets that rapidly disintegrate or dissolve in the oral cavity. The conventional disintegration and dissolution time is several seconds to more than ten seconds, generally not more than 1 minute, the oral cavity does not need water or chewing, and the oral cavity can be quickly disintegrated in saliva to form suspension or solution, and the suspension or solution can enter the stomach by swallowing to take effect. Compared with the common tablet, the tablet can be rapidly disintegrated and then the drug can be absorbed through the mucous membrane to take effect. The preparation is especially suitable for the elderly, children, patients with difficulty in swallowing, or people in water deficiency condition, and has the advantages of rapid onset of drug action and high bioavailability.
The orally disintegrating tablet can improve the taking compliance of part of people, and has the following significance: (1) The dysphagia of some patients is reduced, and the compliance is improved; (2) The medicine for special people and dysphagia patients of old and young people; (3) The medicine can be taken in an emergency or unconditional water environment; some patients who are not used to or convenient to drink water; (4) The actions of some inpatients with inconvenient actions and family patients can be reduced, and the workload of nursing staff is reduced; (5) Some drugs have enhanced bioavailability due to rapid absorption in the mouth or reduced gastrointestinal metabolism.
In the fresh American ginseng active freeze-dried powder, the weight content of the ginsenoside Rg1 is more than 3%.
Referring to fig. 1, the cross-linked sodium carboxymethyl linseed polysaccharide is prepared by the following method:
step S10: dispersing linseed polysaccharide in an organic solvent to form an emulsion, wherein the mass percent of the linseed polysaccharide is 30-40%;
step S20: adding 10-20% by mass of a sodium-containing alkaline substance and 0.01-0.1% by mass of a cross-linking agent into the emulsion, and pretreating at a first temperature;
step S30: adding carboxymethylation reagent with the mass percent of 10% -15% into the pretreated system, and performing carboxymethylation reaction at a second temperature;
step S40: neutralizing and filtering the reacted system in sequence, and washing the obtained filter cake;
step S50: and drying at a third temperature to obtain the cross-linked carboxymethyl linseed polysaccharide sodium.
Wherein the organic solvent comprises ethanol, and a washing liquid adopted when washing the filter cake comprises ethanol. In some embodiments, the organic solvent and the detergent are both 95% ethanol by volume fraction.
The sodium-containing alkaline substance comprises sodium hydroxide, the crosslinking agent comprises epichlorohydrin, and the carboxymethylating agent comprises chloroacetic acid. In some embodiments, the sodium-containing basic material is solid sodium hydroxide, the crosslinking agent is epichlorohydrin, and the carboxymethylating agent is chloroacetic acid.
In some embodiments, the first temperature is 30-40 ℃ and the time of the pretreatment is 15-30min; the second temperature is 50-60 ℃, and the time of the carboxymethylation reaction is 2-3h; the third temperature is 40-55 ℃. The reaction temperature and the reaction time can be used for more completely reacting.
At present, the throat cancer is a common malignant tumor of the head and the neck, and the clinical treatment of the throat cancer mainly comprises operation and radiotherapy, but the throat cancer can cause throat injury, congestion, edema and partial or even complete function loss in different degrees. Postoperative complications and toxic and side effects of radiotherapy and chemotherapy are usually repaired by patients, and effective treatment means for promoting recovery of physique of patients and effective further consolidation treatment are lacked at present. When the American ginseng orally disintegrating tablet provided by the embodiment of the invention is used for rehabilitation treatment after throat cancer operation, radiotherapy and chemotherapy, the American ginseng orally disintegrating tablet can be rapidly disintegrated in the oral cavity of a patient and absorbed through the oral mucosa, and active ingredients and active enzymes in the active American ginseng orally disintegrating tablet act on the focus of throat cancer and an operation wound part through oral blood and lymph circulation, so that the wound is repaired, the tumor growth is inhibited, and the American ginseng orally disintegrating tablet has a remarkable promoting effect on the rehabilitation of throat cancer patients after operation and radiotherapy and chemotherapy.
Referring to fig. 2, an embodiment of the present invention further provides a preparation method of an american ginseng orally disintegrating tablet, including:
step S100: mixing 85-95% of fresh American ginseng active freeze-dried powder by mass and 5-15% of cross-linked carboxymethyl linseed polysaccharide sodium by mass to form a mixture;
step S200: mixing the mixture with water according to the weight ratio of 1 (1-5) to obtain a suspension of fresh American ginseng active freeze-dried powder;
step S300: and performing a second freeze drying process on the fresh American ginseng active freeze-dried powder suspension.
Referring to fig. 3, in step S100, the method for preparing the fresh panax quinquefolium active lyophilized powder comprises:
step S110: extracting fresh radix Panacis Quinquefolii cleaned and pulverized at 25-35 deg.C with water as extraction solvent;
step S120: separating under the centrifugal force of 5000-25000 r/min to obtain separation liquid;
step S130: concentrating the separated liquid to obtain a concentrated liquid;
step S140: and (3) carrying out a first freeze-drying process on the concentrated solution to obtain active American ginseng freeze-dried powder, wherein the weight of the active American ginseng freeze-dried powder is 30-40% of the dry weight of the fresh American ginseng, and the ginsenoside Rg1 in the fresh American ginseng active freeze-dried powder accounts for more than 3%.
In the step S110, fresh american ginseng is washed with distilled water and pulverized into particles of 60-100 meshes. Extracting with continuous countercurrent ultrasonic extraction equipment.
In the step S130, a reverse osmosis concentrator (jizhixuan membrane separation technology, ltd) may be used for concentrating to obtain a concentrated solution and reverse osmosis water, wherein the reverse osmosis water may be recycled as an extraction solvent to realize green production.
In the step S140, the first freeze-drying method includes:
step S141: cooling the concentrated solution to-55 to-45 ℃ and keeping the temperature for 3 to 5 hours;
step S142: maintaining the temperature of the concentrated solution at-20 to-25 ℃ until the frozen ice in the concentrated solution is sublimated, wherein the ambient temperature of the concentrated solution is 10 to 15 ℃;
step S143: and heating the concentrated solution after the frozen ice is sublimated to 20-33 ℃, and maintaining the temperature until the freeze-drying is finished.
After the fresh American ginseng active freeze-dried powder is prepared, the content of ginsenoside Rg1 in the fresh American ginseng active freeze-dried powder needs to be measured, and the measurement parameters are as follows:
(1) The instrument Agilent 1260 high performance liquid chromatograph.
(2) The reagent ginsenoside Rg1, the reference substance (China institute for biological products testing), methanol, acetonitrile and phosphoric acid are all chromatographic pure reagents.
(3) Chromatographic conditions the column was C18 (250 mm. Times.4.6 mm,5 μm); the mobile phase is acetonitrile: 1% phosphoric acid solution (20; the flow rate is 1.0mL/min; the detection wavelength is 203nm, and the column temperature is 30 ℃; the amount of sample L was 0. Mu.L. Under the condition of the chromatogram, the theoretical plate number of the chromatographic column is more than 4000 according to the ginsenoside Rg 1.
With continued reference to fig. 1, in step S100, the cross-linked sodium carboxymethyl linseed polysaccharide is prepared by the following method:
step S10: dispersing linseed polysaccharide in an organic solvent to form an emulsion, wherein the mass percent of the linseed polysaccharide is 30-40%;
step S20: adding 10-20% by mass of a sodium-containing alkaline substance and 0.01-0.1% by mass of a cross-linking agent into the emulsion, and carrying out pretreatment at a first temperature;
step S30: adding carboxymethylation reagent with the mass percent of 10-15% into the pretreated system, and carrying out carboxymethylation reaction at a second temperature;
step S40: neutralizing and filtering the reacted system in sequence, and washing the obtained filter cake;
step S50: and drying at a third temperature to obtain the cross-linked carboxymethyl linseed polysaccharide sodium.
In step S10, the organic solvent includes ethanol, for example, the organic solvent is ethanol with a volume fraction of 95%.
In step S20, the sodium-containing alkaline substance includes sodium hydroxide, and the crosslinking agent includes epichlorohydrin. In some embodiments, the sodium-containing basic material is solid sodium hydroxide, the crosslinking agent is epichlorohydrin, and the carboxymethylating agent is chloroacetic acid.
In some embodiments, the first temperature is 30-40 ℃ and the time of the pre-treatment is 15-30min. The pretreatment takes place in a triangular flask equipped with a reflux condenser.
In step S30, the carboxymethylating agent comprises chloroacetic acid, for example the carboxymethylating agent is chloroacetic acid. The second temperature is 50-60 ℃, and the time of the carboxymethylation reaction is 2-3h.
In step S40, when the obtained filter cake is washed, the detergent used includes ethanol. In some embodiments, the detergent is ethanol with a volume fraction of 95%.
In step S50, the third temperature is 40-55 ℃.
Before the second freeze-drying process is carried out on the fresh American ginseng active freeze-dried powder suspension, the method further comprises the following steps: and quantitatively adding the fresh American ginseng active freeze-dried powder suspension into a prefabricated double-aluminum bubble cap, and quickly freezing through a liquid nitrogen tunnel.
The second freeze-drying process comprises:
step S310: cooling the suspension of the fresh American ginseng active freeze-dried powder to-60 to-70 ℃, and keeping the temperature for 0.5 to 5 hours;
step S320: maintaining the temperature of the suspension of the fresh American ginseng active freeze-dried powder at-20 to-25 ℃ until the frozen ice in the suspension of the fresh American ginseng active freeze-dried powder is sublimated;
step S330: heating the suspension of the fresh American ginseng active freeze-dried powder after the frozen ice is sublimated to 25-35 ℃, and maintaining until the freeze-drying is finished.
And (3) after the second freeze drying process, packaging to prepare the American ginseng orally disintegrating tablet, wherein the weight of the tablet is 0.1-1 g.
After the American ginseng orally disintegrating tablet is prepared, the disintegration time limit needs to be measured:
referring to the determination method of disintegration time limit in 2020 edition of Chinese pharmacopoeia, 6 American ginseng orally disintegrating tablets are taken, water is taken as a medium, and the temperature is (37.0 +/-1) DEG C. Each time, one tablet is measured, and the time from the moment that the tablet contacts the water surface until the granules completely pass through the screen is the disintegration time. The total number of measurements was 6, and the average disintegration time was calculated. The American ginseng orally disintegrating tablet prepared in the embodiment of the application has the average disintegration time of 1-50 seconds.
Example 1
(1) Preparing fresh American ginseng active freeze-dried powder: taking 10 kg of fresh American ginseng, cleaning the fresh American ginseng with distilled water, crushing the American ginseng into particles of 60-100 meshes, extracting the American ginseng by using continuous countercurrent ultrasonic extraction equipment at the temperature of 25-35 ℃, taking water as an extraction solvent, centrifugally separating an extracting solution, and concentrating the extracting solution by using a reverse osmosis concentrator (Heijizuan membrane separation technology, inc.) to obtain a concentrated solution and reverse osmosis water. The reverse osmosis water is used as an extraction solvent for cyclic utilization, and green production is realized. The concentrated solution is frozen and dried to obtain 1.02 kg of fresh American ginseng active freeze-dried powder. In the fresh American ginseng active freeze-dried powder, the weight content of ginsenoside Rg1 is 3.15%, and the extraction rate of American ginseng saponin is 99.0%.
(2) Preparation of cross-linked carboxymethyl linseed polysaccharide sodium: adding 2500g of flaxseed polysaccharide into 5000mL of ethanol with volume fraction of 95%, fully stirring and uniformly dispersing to form emulsion, adding 1200g of NaOH solid for alkalization, adding 0.05% of epichlorohydrin by mass fraction, placing in a 10L triangular flask, and installing a reflux condenser tube. Pretreating at 35 ℃ for about 20min, then adding 1200g of chloroacetic acid for carboxymethylation, reacting at 55 ℃ for 2.5h, neutralizing, filtering while hot, washing the obtained filter cake with ethanol with the volume fraction of 95%, and then drying in vacuum at 50 ℃ to obtain the cross-linked carboxymethyl linseed polysaccharide sodium.
(3) Preparing American ginseng orally disintegrating tablets: 200g of fresh American ginseng active freeze-dried powder and 10 g of cross-linked carboxymethyl flaxseed polysaccharide sodium are taken, the materials are fully and uniformly mixed in a three-dimensional mixer to obtain a mixture, 250 g of distilled water is added into the mixture, the mixture is mixed to prepare a suspension, the suspension is quantitatively added into a prefabricated double-aluminum bubble cap, and after quick freezing through a liquid nitrogen tunnel, freeze drying is carried out (the prefreezing stage is that a product is put into a box to be cooled to-70 ℃ and kept at-70 ℃ for 1 hour, the prefreezing stage is finished, the sublimating stage is that the temperature of a product layer is controlled at 15 ℃ to be kept at-20 ℃ until the frozen ice in the product is sublimated, the analyzing stage is that the temperature of the product is heated to 30 ℃ and kept until the freeze drying is finished), packaging is carried out, and American ginseng disintegrating tablets are prepared, and the weight of the American ginseng tablets is 0.5 g.
Determining the disintegration time limit of the American ginseng orally disintegrating tablet: referring to the determination method of disintegration time limit of 2020 edition of Chinese pharmacopoeia, 6 American ginseng orally disintegrating tablets are taken, water is taken as a medium, and the temperature is (37.0 +/-1) DEG C. Each time, measuring the tablet, starting timing from the contact of the tablet and the water surface until the time when all granules pass through the screen is the disintegration time. The total number of measurements was 6, and the average disintegration time was calculated. The average disintegration time of the American ginseng orally-disintegrating tablet is measured to be 10 seconds.
Example 2
Reference example 1 is a method for preparing fresh American ginseng active freeze-dried powder and cross-linked carboxymethyl linseed polysaccharide sodium.
Preparing American ginseng orally disintegrating tablets: taking 500g of fresh American ginseng active freeze-dried powder and 40 g of cross-linked carboxymethyl flaxseed polysaccharide sodium, fully and uniformly mixing the above materials in a three-dimensional mixer to obtain a mixture, adding 550 g of distilled water into the mixture, mixing to prepare a suspension, quantitatively adding the suspension into a prefabricated double-aluminum bubble cap, quickly freezing through a liquid nitrogen tunnel, freeze-drying (a pre-freezing stage, namely feeding the product into a box, cooling the product to-65 ℃, keeping the temperature at-65 ℃ for 1 hour, ending the pre-freezing stage, a sublimation stage, namely controlling the temperature of a plate layer at 10 ℃, keeping the temperature of the product at-20 ℃ until the frozen ice in the product is sublimated, an analysis stage, heating the product to 30 ℃ and keeping the temperature until the freeze-drying is finished), packaging, and preparing the disintegrating American ginseng tablets, wherein the weight of the disintegrating tablets is 0.5 g.
Method for measuring disintegration time of American ginseng orally disintegrating tablet referring to example 1, the average disintegration time of American ginseng orally disintegrating tablet was measured to be 5 seconds.
Example 3
20 g of the fresh American ginseng active freeze-dried powder prepared in the example 1 and 1.6 g of cross-linked carboxymethyl linseed polysaccharide sodium are taken. Mixing the above materials respectively, adding 20 g distilled water to obtain suspension, quantitatively adding the suspension into prefabricated double aluminum bubble cap, quickly freezing via liquid nitrogen tunnel, freeze drying (pre-freezing stage: placing the product into a box to cool the product to-65 deg.C, maintaining at-65 deg.C for 1 hr, ending the pre-freezing stage, sublimating stage: controlling the temperature of the plate layer at 10 deg.C, maintaining the temperature of the product at-20 deg.C until the frozen ice in the product sublimes, resolving stage: heating the product to 30 deg.C, maintaining until the freeze drying is finished), packaging, and making into orally disintegrating tablet of radix Panacis Quinquefolii with weight of 0.5 g.
Comparative example 1
Referring to example 3, only the cross-linked sodium carboxymethyl linseed polysaccharide of example 3 is replaced by microcrystalline cellulose (MCC).
Comparative example 2
Referring to example 3, only croscarmellose sodium linseed polysaccharide in example 3 was replaced with crospovidone (PVPP).
Comparative example 3
Referring to example 3, only the cross-linked sodium carboxymethyl linseed polysaccharide of example 3 was replaced with low-substituted hypromellose (L-HPC).
Comparative example 4
Referring to example 3, only the croscarmellose sodium of example 3 was replaced with croscarmellose sodium (CMC-Na).
With reference to example 1, the disintegration time of the orally disintegrating tablets prepared in example 3 and comparative examples 1 to 4 was measured, and the measurement results are shown in table 1.
TABLE 1 determination of disintegration time
| Examples | Disintegrating agent | Average disintegration time (seconds) |
| Example 3 | Cross-linked sodium carboxymethyl linseed polysaccharide | 6 |
| Comparative example 1 | Microcrystalline cellulose | 60 |
| Comparative example 2 | Cross-linked polyvidone | 35 |
| Comparative example 3 | Low-substituted |
50 |
| Comparative example 4 | Croscarmellose sodium | 45 |
As can be seen from table 1, the cross-linked carboxymethyl linseed polysaccharide sodium according to the embodiment of the present invention has superior disintegration performance, which is far superior to other disintegrants.
Example 4
Clinical efficacy experiments were conducted on the American ginseng orally disintegrating tablets prepared in example 3.
(1) Study cases:
clinical observation study was conducted on 122 patients with throat cancer, wherein 66 patients were treated with American ginseng orally disintegrating tablets; in 56 control groups, xiaoaiping tablets were used.
(2) The research method comprises the following steps:
treatment groups: after the operation and the radiotherapy and chemotherapy are finished, the daily dose is 6 tablets, and each tablet is 0.5 g.
Control group: the Xiaoaiping tablets are taken 24 tablets per day.
The two groups are administered continuously for 5 days, and rest for 2 days, 4 weeks is a treatment course.
(3) Clinical efficacy observation items:
a. whether gastrointestinal response is reduced after chemotherapy: the main gastrointestinal reactions after chemotherapy are nausea and vomiting, anorexia, constipation and diarrhea, the nausea is relieved after 3 times of administration, the vomiting times are reduced by more than 2 times compared with the times before administration, the appetite is increased, the constipation is relieved, the diarrhea times are reduced by more than 2 times, and the count is 1; no change before and after dosing was found to be ineffective and the count was 0.
b. Whether blood leukocytes are increased: myelosuppression is a common side effect of chemoradiotherapy, mainly manifested as a decrease in leukocytes in blood, and after administration, the increase in leukocytes in blood is 1 × 109/L to 1,2 × 109/L counts to 2,3 × 109/L and above counts to 3, both of which are effective; after taking the medicine, the increase of the blood leucocyte is less than 1 × 109/L counting and is 0 compared with the increase before taking the medicine, and the effect is not achieved.
c. Whether oral ulcer is reduced after radiotherapy: the incidence rate of oral ulcer after head and neck radiotherapy is high, almost 100%, oral ulcer can also appear in a part of chemotherapy patients, the area and depth of the oral ulcer are recorded before and after the medicine is taken, the count of the area reduction by 25% is 0, and the oral ulcer is ineffective; the area reduction is 1 percent by 25 to 50 percent, 2 percent by 50 to 75 percent and 3 percent by more than 75 percent, which are all effective; the superficial ulcer disappears or deep ulcer changes into superficial ulcer of 1, deep ulcer disappears of 2, and there is no obvious change of 0 before and after administration.
d. Whether the pain in the mouth and throat is relieved: after the medicine is taken, the change is not obvious or no change is counted as 0 compared with the medicine taken, and the effect is not achieved; the pain was slightly relieved to 1 and significantly relieved to 2, both being effective.
The above clinical applicationThe results of efficacy observations are shown in table 2, where, \1093 2 The chi-square value of chi-square test in SPASS statistical analysis, P is probability.
TABLE 2 comparison of the therapeutic effects of the treatment groups with those of the control group
(4) And (4) analyzing results:
clinical research shows that the American ginseng orally disintegrating tablet taken after throat cancer operation or radiotherapy and chemotherapy has sensitizing effect, can strengthen the curative effect of radiotherapy and chemotherapy, reduce the toxic side effect of radiotherapy and chemotherapy, such as gastrointestinal tract reaction, obviously reduce the oral cavity and throat mucosa reaction, oral ulcer and pain caused by radiotherapy, obviously strengthen the cell immunity of organism and strengthen the anti-tumor capacity of organism. Meanwhile, the American ginseng orally disintegrating tablet has the function of promoting wound healing after throat cancer surgery.
Although the present invention has been described with reference to the preferred embodiments, it is not intended to limit the present invention, and those skilled in the art can make modifications and variations of the present invention without departing from the spirit and scope of the present invention.
Claims (10)
1. The American ginseng orally disintegrating tablet is characterized by comprising the following components in percentage by mass: 85% -95% of fresh American ginseng active freeze-dried powder and 5% -15% of cross-linked carboxymethyl flaxseed polysaccharide sodium.
2. The American ginseng orally-disintegrating tablet as claimed in claim 1, wherein the weight content of ginsenoside Rg1 in the fresh American ginseng active freeze-dried powder is more than 3%.
3. The American ginseng orally disintegrating tablet of claim 1, wherein the cross-linked sodium carboxymethyl linseed polysaccharide is obtained by the method comprising:
dispersing linseed polysaccharide in an organic solvent to form an emulsion, wherein the mass percent of the linseed polysaccharide is 30-40%;
adding 10-20% by mass of a sodium-containing alkaline substance and 0.01-0.1% by mass of a cross-linking agent into the emulsion, and carrying out pretreatment at a first temperature;
adding carboxymethylation reagent with the mass percent of 10-15% into the pretreated system, and carrying out carboxymethylation reaction at a second temperature;
neutralizing and filtering the reacted system in sequence, and washing the obtained filter cake;
and drying at a third temperature to obtain the cross-linked carboxymethyl linseed polysaccharide sodium.
4. The American ginseng orally disintegrating tablet of claim 3, wherein the organic solvent comprises ethanol and the washing solution used to wash the filter cake comprises ethanol.
5. The American ginseng orally disintegrating tablet of claim 3, wherein the sodium containing basic substance comprises sodium hydroxide, the crosslinking agent comprises epichlorohydrin, and the carboxymethylation agent comprises chloroacetic acid.
6. The American ginseng orally disintegrating tablet of claim 3, wherein the first temperature is 30-40 ℃, and the time of the pretreatment is 15-30min; the second temperature is 50-60 ℃, and the time of the carboxymethylation reaction is 2-3h; the third temperature is 40-55 ℃.
7. A preparation method of American ginseng orally disintegrating tablets is characterized by comprising the following steps:
mixing 85-95% of fresh American ginseng active freeze-dried powder by mass and 5-15% of cross-linked carboxymethyl linseed polysaccharide sodium by mass to form a mixture;
mixing the mixture with water according to the weight ratio of 1 (1-5) to obtain a suspension of fresh American ginseng active freeze-dried powder;
and performing a second freeze-drying process on the fresh American ginseng active freeze-dried powder suspension.
8. The method for preparing American ginseng orally disintegrating tablets according to claim 7, wherein the second freeze-drying process comprises:
cooling the suspension of the fresh American ginseng active freeze-dried powder to-60 to-70 ℃, and keeping the temperature for 0.5 to 5 hours;
maintaining the temperature of the suspension of the fresh American ginseng active freeze-dried powder at-20 to-25 ℃ until the frozen ice in the suspension of the fresh American ginseng active freeze-dried powder is sublimated;
heating the suspension of the fresh American ginseng active freeze-dried powder after the frozen ice is sublimated to 25-35 ℃, and maintaining until the freeze-drying is finished.
9. The method for preparing American ginseng orally disintegrating tablets according to claim 7, wherein the method for preparing the fresh American ginseng active freeze-dried powder comprises the following steps:
extracting cleaned and pulverized fresh radix Panacis Quinquefolii with water at 25-35 deg.C as extraction solvent;
separating under the centrifugal force of 5000-25000 r/min to obtain separation liquid;
concentrating the separated liquid to obtain a concentrated liquid;
and (3) carrying out a first freeze-drying process on the concentrated solution to obtain active American ginseng freeze-dried powder, wherein the weight of the active American ginseng freeze-dried powder is 30-40% of the dry weight of the fresh American ginseng, and the weight content of ginsenoside Rg1 in the fresh American ginseng active freeze-dried powder is more than 3%.
10. The method for preparing American ginseng orally disintegrating tablets of claim 9, wherein the first freeze-drying method comprises:
cooling the concentrated solution to-55 to-45 ℃ and keeping the temperature for 3 to 5 hours;
maintaining the temperature of the concentrated solution at-20 to-25 ℃ until the frozen ice in the concentrated solution is sublimated;
and heating the concentrated solution after the frozen ice is sublimated to 20-33 ℃, and maintaining the temperature until the freeze-drying is finished.
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| US20040258740A1 (en) * | 2003-04-10 | 2004-12-23 | Nene Labs | Transdermal delivery composition |
| WO2014170947A1 (en) * | 2013-04-15 | 2014-10-23 | 三生医薬株式会社 | Collapsible capsule, manufacturing method therefor and smoking implement |
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| AU2015202521A1 (en) * | 2005-07-26 | 2015-05-28 | Knauf Insulation Gmbh | Binders and materials made therewith |
| CN104523791A (en) * | 2015-01-23 | 2015-04-22 | 通化鑫业生物科技研发有限公司 | Orally disintegrating tablet containing fresh ginseng active extract and preparation method thereof |
| CN108553494A (en) * | 2018-06-11 | 2018-09-21 | 通化鑫业生物科技研发有限公司 | Fresh ginseng activity extract and its application in preparing mitigation surgical patient pain medication |
| CN110200926A (en) * | 2019-07-15 | 2019-09-06 | 通化鑫业生物科技研发有限公司 | Composite reactive freeze-dried powder and its preparation method and application |
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