CN111110642A - Anoectochilus roxburghii polysaccharide dispersible tablet and preparation method thereof - Google Patents
Anoectochilus roxburghii polysaccharide dispersible tablet and preparation method thereof Download PDFInfo
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Abstract
The invention discloses an anoectochilus formosanus polysaccharide dispersible tablet, which comprises anoectochilus formosanus polysaccharide freeze-dried powder, a filling agent, a disintegrating agent, a swelling auxiliary material, a wetting agent, a flavoring agent and a lubricating agent; also discloses a preparation method of the dispersible tablet, firstly preparing the Anoectochilus roxburghii polysaccharide freeze-dried powder and weighing the components according to the proportion relation; secondly, crushing the weighed components, and then sieving to obtain powder of the components; then uniformly mixing the powdery roxburgh anoectochilus terminal bud freeze-dried powder obtained in the step 2, a filling agent, a part of disintegrating agent, swelling auxiliary materials and a flavoring agent; adding a wetting agent to prepare a soft material; then granulating the soft material; finally, drying and granulating the prepared wet granules to obtain dry granules; finally, uniformly mixing the dry granules obtained in the step 3 with a lubricant and the rest of disintegrant, and tabletting to obtain the anoectochilus formosanus extract dispersible tablets; the prepared dispersible tablet has the advantages of high disintegration and dissolution rate, high absorption speed, high bioavailability, less adverse reaction, good stability, portability and convenient administration.
Description
Technical Field
The invention belongs to the technical field of preparation of traditional Chinese medicine preparations, and particularly relates to an anoectochilus formosanus polysaccharide dispersible tablet and a preparation method thereof.
Background
Anoectochilus roxburghii (Wall.) Lindl belongs to the genus Orchidaceae, is called Anoectochilus roxburghii and Hypericum virens, is a precious traditional Chinese medicinal material in China, is prepared from whole herbs, and has sweet taste and mild nature. The anoectochilus formosanus has pharmacological activities of enhancing immunity, resisting inflammation, resisting oxidation, tonifying heart, lowering blood pressure, lowering blood sugar, resisting osteoporosis, resisting tumor, protecting kidney and the like. Anoectochilus roxburghii is rich in polysaccharide, flavonoid, polyphenol, alkaloid, saponins, amino acid, volatile oil and other components. The polysaccharide is one of the main active ingredients, and has various pharmacological effects of resisting inflammation, resisting oxidation, resisting tumor, resisting fatigue, resisting virus, reducing blood sugar, regulating immunity, etc. The anoectochilus roxburghii polysaccharide has wide application prospect in the fields of food, medicine, health-care products, cosmetics and the like.
The freeze-dried Anoectochilus roxburghii polysaccharide powder has the defects of high viscosity, strong hygroscopicity, easy caking and difficult dissolution when meeting water, slow disintegration speed, poor dispersibility, low dissolution rate, difficult absorption and the like when being prepared into common tablets, capsules and other dosage forms. The dispersible tablet has the characteristics of quick disintegration in water and uniform dispersion, has no special requirements on process production, has approximately the same preparation process as the traditional tablet, and has economic cost; convenient oral administration, quick absorption, high bioavailability, etc. Is especially suitable for old people, children and patients with dysphagia, and belongs to a novel preparation which is developed in recent years. The anoectochilus formosanus polysaccharide is prepared into the dispersible tablet, so that the curative effect of the anoectochilus formosanus is fully exerted, and the development of the field of deep processing of the anoectochilus formosanus is promoted.
Disclosure of Invention
The invention aims to provide the anoectochilus roxburghii polysaccharide dispersible tablet, which solves the problem that the anoectochilus roxburghii polysaccharide freeze-dried powder in the prior art is not easy to dissolve.
The second purpose of the invention is to provide a preparation method of anoectochilus formosanus polysaccharide dispersible tablets.
The first technical scheme adopted by the invention is that the anoectochilus formosanus polysaccharide dispersible tablet comprises anoectochilus formosanus polysaccharide freeze-dried powder and a medicine carrier, wherein the medicine carrier comprises a filling agent, a disintegrating agent, a swelling auxiliary material, a wetting agent, a flavoring agent and a lubricating agent.
The first technical aspect of the present invention is also characterized in that,
the proportion of the roxburgh anoectochilus terminal bud polysaccharide freeze-dried powder, the filling agent, the disintegrating agent, the swelling auxiliary material, the wetting agent, the flavoring agent and the lubricating agent is 30-80 g: 150 g-310 g: 35 g-75 g: 3 g-5 g: 55 mL-280 mL: 0.5 g-3 g: 5g to 15 g.
The filler comprises at least one of microcrystalline cellulose, lactose, mannitol, dextrin, and starch.
The disintegrant comprises at least one of crospolyvinylpyrrolidone, low-substituted hydroxypropyl cellulose, croscarmellose sodium, and sodium carboxymethyl starch.
The swelling adjuvant comprises at least one of sodium alginate, pregelatinized starch, hydroxypropyl cellulose, and compressible starch.
The wetting agent comprises at least one of ethanol solution with the mass fraction of 50-100% and polyvinylpyrrolidone ethanol solution with the mass fraction of 0.5-5%.
The correctant comprises at least one of aspartame, stevioside, and acesulfame potassium.
The lubricant comprises at least one of pulvis Talci, magnesium stearate, silica gel micropowder, polyethylene glycol 6000, and polyethylene glycol 8000.
The second technical scheme adopted by the invention is that the preparation method of the anoectochilus formosanus polysaccharide dispersible tablet is implemented according to the following steps:
step 1, preparing roxburgh anoectochilus terminal bud polysaccharide freeze-dried powder; according to the mixture ratio of 30 g-80 g: 150 g-310 g: 35 g-75 g: 3 g-5 g: 55 mL-280 mL: 0.5 g-3 g: 5g to 15g of roxburgh anoectochilus terminal bud polysaccharide freeze-dried powder, a filling agent, a disintegrating agent, a swelling auxiliary material, a wetting agent, a flavoring agent and a lubricating agent are weighed;
step 2, crushing the components weighed in the step 1, and then sieving to obtain powder of the components;
step 3, uniformly mixing the powdery roxburgh anoectochilus terminal bud freeze-dried powder obtained in the step 2, a filling agent, a part of disintegrating agent, a swelling auxiliary material and a flavoring agent; adding a wetting agent to prepare a soft material; then granulating the soft material; finally, drying and granulating the prepared wet granules to obtain dry granules;
and 4, uniformly mixing the dry granules obtained in the step 3 with a lubricant and the rest of disintegrant, and tabletting to obtain the anoectochilus formosanus extract dispersible tablets.
The second technical solution of the present invention is also characterized in that,
the preparation of the Anoectochilus roxburghii polysaccharide freeze-dried powder in the step 1 is implemented according to the following steps:
step 1.1, taking clematis, and preparing powder after freeze drying;
step 1.2, firstly carrying out enzymolysis on the powder obtained in the step 1.1, then inactivating enzyme of the powder of anoectochilus formosanus after enzymolysis, extracting, filtering and recovering a solvent to obtain an anoectochilus formosanus polysaccharide extracting solution;
step 1.3, adsorbing and decoloring the anoectochilus formosanus polysaccharide extracting solution obtained in the step 1.2 by using an adsorbing material;
step 1.4, resolving and eluting the anoectochilus formosanus polysaccharide extracting solution which is adsorbed and saturated in the step 1.3;
step 1.5, performing ultrafiltration treatment on the anoectochilus roxburghii polysaccharide extracting solution analyzed and eluted in the step 1.4, concentrating the treated solution into clear paste, and freeze-drying to obtain the anoectochilus roxburghii polysaccharide freeze-dried powder.
Step 1.2 is specifically carried out according to the following steps: firstly, adding distilled water into the anoectochilus formosanus powder obtained in the step 1.1 to obtain a mixed solution, wherein the mass ratio of the anoectochilus formosanus powder to the distilled water is 1: 8-22; adding cellulase into the mixed solution and then adjusting the pH value to a target value, wherein the cellulase accounts for 0.3-5% of the mass of the mixed solution; and finally, carrying out ultrasonic-assisted extraction for 1-4 times, each time for 0.5-5 h, respectively filtering the extracting solution, combining the filtrates, and recovering the solvent to obtain the anoectochilus formosanus polysaccharide extracting solution.
The enzymolysis time of the step 1.2 is 1-4 h, the enzymolysis temperature is 35-50 ℃, and the pH target value is 5-8.
The adsorption temperature of the adsorption decoloring process in the step 1.3 is 20-25 ℃, the sample loading speed is 1-2 BV/h, and the sample loading concentration is 4-8 mg/mL.
The adsorbing material in the step 1.3 is macroporous adsorption resin, and the macroporous adsorption resin is any one of D101, NKA-9, D3520, H103, HPD-100, HPD-700, AB-8, HPD722, S-8 and HPD-600.
Analytical elution process parameters of step 1.4: the concentration of the resolution solution is 50 to 70 percent ethanol, the resolution rate is 2 to 4BV/h, and the volume of the resolution solution is 3 to 6 BV.
Step 1.5 is specifically carried out according to the following steps: firstly, ultrafiltration membrane with the interception relative molecular weight of 1000 Da-5000 Da is selected to carry out ultrafiltration treatment on the anoectochilus formosanus polysaccharide extracting solution, then the treated liquid is concentrated into clear paste with the relative density of 1.10-1.30 at 50 ℃, and finally the clear paste is freeze-dried for 60 h-70 h to obtain the anoectochilus formosanus polysaccharide freeze-dried powder.
The specification of the sieve in the step 2 is 80-120 meshes.
The drying temperature in the step 3 is 40-70 ℃, and the granulating device is a swing type granulator for granulation.
The mass ratio of the part of the disintegrant added in the step 3 to the rest part of the disintegrant added in the step 4 is 1: 0.5-1.5.
The first technical scheme of the invention is that the anoectochilus formosanus polysaccharide dispersible tablet has at least the following beneficial effects:
firstly, the disintegrating agent is added in two parts, and one part is added together with the filling agent and the wetting agent; the other part of the granules and tabletting auxiliary materials are wrapped outside the dispersible tablet after granulation, and the external disintegrating agent can rapidly disintegrate the tablet into coarse granules to play a role in primary disintegration; the inner disintegrating agent can disintegrate the coarse particles into fine particles, so that the particles are uniformly dispersed, and the bioavailability is increased;
secondly, the swelling auxiliary material is added, so that swelling and disintegration are accelerated, uniform dispersion of particles is promoted, and bioavailability is further enhanced;
thirdly, the anoectochilus formosanus extract dispersible tablet has high dispersity, high disintegration and dissolution rate, high absorption speed, high bioavailability, less adverse reaction, good stability, convenient carrying and taking, can be swallowed, chewed and sucked, can be placed in water for dispersing and then taken alone or taken together with fruit juice, milk and the like, is particularly suitable for old people and children who are difficult to swallow, has simple preparation process, has no special requirement on production equipment, and is particularly suitable for industrial mass production.
The second technical scheme of the invention is that the preparation method of the anoectochilus formosanus polysaccharide dispersible tablet has at least the following beneficial effects:
firstly, by adopting the freeze drying technology, the anoectochilus formosanus polysaccharide has strong antioxidant function and high health care and treatment values, and is a natural antioxidant health care product. Different drying methods have no significant effect on the protein, amino acid, moisture, pH and viscosity of the anoectochilus roxburghii polysaccharide, but have significant effects on polysaccharide yield, uronic acid, sulfate group content and antioxidant capacity. The yield of the anoectochilus roxburghii polysaccharide prepared by freeze drying and the content of uronic acid and sulfate radical are obviously higher than that of other drying methods, and the obtained anoectochilus roxburghii polysaccharide has better activity on DPPH, ABTS and oxidative stress. The polysaccharide obtained by separation and purification can keep the loose structure through freeze drying, and the redissolution performance is good, so that the subsequent processing of the dispersible tablets is easy;
secondly, an ultrasonic-assisted cellulase method extraction technology is adopted, the polysaccharide in the anoectochilus formosanus is extracted by an ultrasonic-assisted enzyme method, the defects of conventional enzyme extraction and ultrasonic extraction are overcome, the polysaccharide in the extracting solution is taken as an index, so that the polysaccharide in the anoectochilus formosanus is efficiently extracted, the extraction efficiency is improved by 20% compared with that of an enzyme method and is improved by 15% compared with that of an ultrasonic method, and the ultrasonic-assisted cellulase method has a better extraction effect compared with a single extraction method;
thirdly, adopting the combination of macroporous adsorption resin and ultrafiltration membrane treatment technology to decolorize, remove protein, separate and purify the anoectochilus formosanus polysaccharide. The macroporous adsorption resin is adopted to remove protein from the anoectochilus formosanus polysaccharide, so that the method has the advantages of less polysaccharide loss, large adsorption quantity, high adsorption speed, easiness in desorption, simplicity and convenience in regeneration treatment, long service cycle and the like, and is suitable for being used in large quantities in industrial production. The protein removal rate is more than 85%, the decolorization rate is more than 78%, and the polysaccharide retention rate is more than 84%. Ultrafiltration treatment is carried out on the anoectochilus formosanus polysaccharide extracting solution by an ultrafiltration membrane with the intercepted relative molecular weight of 1000-5000 Da, the polysaccharide content of a purified anoectochilus formosanus sample is 78%, which is 3.2 times of the polysaccharide content of 24% in the anoectochilus formosanus sample without ultrafiltration purification, the ultrafiltration purification process of the anoectochilus formosanus polysaccharide can be rapidly optimized, and a basis is provided for industrial production of the anoectochilus formosanus polysaccharide;
fourthly, the roxburgh anoectochilus terminal bud polysaccharide freeze-dried powder prepared by the freeze-drying technology has hygroscopicity, the stability of the dispersible tablets in the storage process is influenced, the phenomena of moisture absorption, sticking and the like easily occur in the preparation process, and the quality and the production efficiency of the dispersible tablets are influenced.
Detailed Description
The present invention will be described in detail with reference to the following embodiments.
The invention discloses a first technical scheme that the anoectochilus formosanus polysaccharide dispersible tablet comprises anoectochilus formosanus polysaccharide freeze-dried powder and a medicine carrier, wherein the medicine carrier comprises a filling agent, a disintegrating agent, a swelling auxiliary material, a wetting agent, a flavoring agent and a lubricating agent; the proportion of the roxburgh anoectochilus terminal bud polysaccharide freeze-dried powder, the filling agent, the disintegrating agent, the swelling auxiliary material, the wetting agent, the flavoring agent and the lubricating agent is 30-80 g: 150 g-310 g: 35 g-75 g: 3 g-5 g: 55 mL-280 mL: 0.5 g-3 g: 5g to 15 g; wherein the filler comprises at least one of microcrystalline cellulose, lactose, mannitol, dextrin and starch; the disintegrating agent comprises at least one of cross-linked polyvinylpyrrolidone, low-substituted hydroxypropyl cellulose, cross-linked sodium carboxymethyl cellulose, and sodium carboxymethyl starch; the swelling auxiliary material comprises at least one of sodium alginate, pregelatinized starch, hydroxypropyl cellulose and compressible starch; the wetting agent comprises at least one of ethanol solution with the mass fraction of 50-100% and polyvinylpyrrolidone ethanol solution with the mass fraction of 0.5-5%; the correctant comprises at least one of aspartame, stevioside, and acesulfame potassium; the lubricant comprises at least one of pulvis Talci, magnesium stearate, silica gel micropowder, polyethylene glycol 6000, and polyethylene glycol 8000.
The second technical scheme disclosed by the invention is that the preparation method of the anoectochilus formosanus polysaccharide dispersible tablet is implemented according to the following steps:
step 1, preparing roxburgh anoectochilus terminal bud polysaccharide freeze-dried powder; 30 g-80 g according to the mixture ratio: 150 g-310 g: 35 g-75 g: 3 g-5 g: 55 mL-280 mL: 0.5 g-3 g: 5g to 15g of roxburgh anoectochilus terminal bud polysaccharide freeze-dried powder, a filling agent, a disintegrating agent, a swelling auxiliary material, a wetting agent, a flavoring agent and a lubricating agent are weighed;
the preparation of the Anoectochilus roxburghii polysaccharide freeze-dried powder in the step 1 comprises the following specific steps:
step 1.1, taking clematis, and preparing powder after freeze drying;
step 1.2, firstly carrying out enzymolysis on the powder obtained in the step 1.1, then carrying out ultrasonic-assisted extraction on the enzymolyzed anoectochilus roxburghii powder for 1-4 times after enzyme deactivation, wherein each time is 0.5-5 h, respectively filtering the extracting solution, combining the filtrates, and recovering the solvent to obtain an anoectochilus roxburghii polysaccharide extracting solution; wherein, the enzymolysis specifically comprises the following steps: adding distilled water into the anoectochilus roxburghii powder to obtain a mixed solution, wherein the mass ratio of the anoectochilus roxburghii powder to the distilled water is 1: 8-22; adding cellulase into the mixed solution, and adjusting the pH value to a target value, wherein the cellulase accounts for 0.3-5% of the mass of the mixed solution, the enzymolysis time is 1-4 h, the enzymolysis temperature is 35-50 ℃, and the pH target value is 5-8; the enzyme deactivation temperature is 80 ℃, and the enzyme deactivation time is 10-15 min;
step 1.3, adsorbing and decoloring the anoectochilus formosanus polysaccharide extracting solution obtained in the step 1.2 by using an adsorbing material; wherein the adsorption temperature of the adsorption decoloring process is 20-25 ℃, the sample loading speed is 1-2 BV/h, and the sample loading concentration is 4-8 mg/mL; the adsorption material is macroporous adsorption resin, and the macroporous adsorption resin is any one of D101, NKA-9, D3520, H103, HPD-100, HPD-700, AB-8, HPD722, S-8 and HPD-600;
step 1.4, resolving and eluting the anoectochilus formosanus polysaccharide extracting solution which is adsorbed and saturated in the step 1.3; analyzing elution process parameters: the concentration of the resolution solution is 50 to 70 percent ethanol, the resolution rate is 2 to 4BV/h, and the volume of the resolution solution is 3 to 6 BV;
step 1.5, selecting an ultrafiltration membrane with the relative molecular weight cutoff of 1000 Da-5000 Da to carry out ultrafiltration treatment on the anoectochilus roxburghii polysaccharide extracting solution obtained in the step 1.4, concentrating the treated liquid into clear paste with the relative density of 1.10-1.30 at 50 ℃, and finally freeze-drying the clear paste for 60 h-70 h to obtain the anoectochilus roxburghii polysaccharide freeze-dried powder;
step 2, crushing the components weighed in the step 1, and then sieving to obtain powder of the components; wherein the specification of the sieve is 80-120 meshes;
step 3, uniformly mixing the powdery roxburgh anoectochilus terminal bud freeze-dried powder obtained in the step 2, a filling agent, a part of disintegrating agent, a swelling auxiliary material and a flavoring agent; adding a wetting agent to prepare a soft material; then granulating the soft material; finally, drying and granulating the prepared wet granules to obtain dry granules; wherein the drying temperature is 40-70 ℃, and the granulating device is a swing granulator for granulation;
step 4, uniformly mixing the dry granules obtained in the step 3 with a lubricant and the rest of disintegrant, and tabletting to obtain anoectochilus formosanus extract dispersible tablets; wherein the mass ratio of part of the disintegrant added in the step 3 to the rest part of the disintegrant added in the step 4 is 1: 0.5-1.5.
Example 1
The preparation method of every 1000 anoectochilus roxburghii polysaccharide dispersible tablets comprises the following steps:
step 1, firstly preparing roxburgh anoectochilus terminal bud polysaccharide freeze-dried powder, and specifically comprising the following steps:
step 1.1, taking clematis, and preparing powder after freeze drying;
step 1.2, firstly carrying out enzymolysis on the powder obtained in the step 1.1, then carrying out ultrasonic-assisted extraction on the enzymolyzed anoectochilus formosanus powder for 3 times (1 hour each time), respectively filtering the extracting solution, combining the filtrates, and recovering the solvent to obtain an anoectochilus formosanus polysaccharide extracting solution; wherein, the enzymolysis specifically comprises the following steps: adding distilled water into the anoectochilus formosanus powder to obtain a mixed solution, wherein the mass ratio of the anoectochilus formosanus powder to the distilled water is 1: 10; adding cellulase into the mixed solution, and adjusting the pH value to a target value, wherein the cellulase accounts for 0.5 percent of the mass of the mixed solution, the enzymolysis time is 1h, the enzymolysis temperature is 40 ℃, and the target pH value is 5; the enzyme deactivation temperature is 80 ℃, and the enzyme deactivation time is 10 min;
step 1.3, adsorbing and decoloring the anoectochilus formosanus polysaccharide extracting solution obtained in the step 1.2 by using macroporous adsorption resin AB-8; wherein the adsorption temperature of the adsorption decoloring process is 25 ℃, the sample loading speed is 2BV/h, and the sample loading concentration is 8 mg/mL;
step 1.4, resolving and eluting the anoectochilus formosanus polysaccharide extracting solution which is adsorbed and saturated in the step 1.3; analyzing elution process parameters: the concentration of the analysis solution is 70% ethanol, the analysis rate is 4BV/h, and the volume of the analysis solution is 6 BV;
step 1.5, selecting an ultrafiltration membrane with the relative molecular weight cutoff of 1000 Da-5000 Da to carry out ultrafiltration treatment on the anoectochilus roxburghii polysaccharide extracting solution obtained in the step 1.4, concentrating the treated liquid into clear paste with the relative density of 1.10-1.30 at 50 ℃, and finally freeze-drying the clear paste for 60 hours to obtain the anoectochilus roxburghii polysaccharide freeze-dried powder;
step 1.6, weighing 80g of roxburgh anoectochilus terminal bud polysaccharide freeze-dried powder and a medicine carrier, wherein the medicine carrier comprises: 80g of microcrystalline cellulose as a filler, 100g of lactose, 40g of cross-linked polyvinylpyrrolidone as a disintegrating agent, 5g of alginic acid as a swelling auxiliary material, 55mL of ethanol solution of 5% polyvinylpyrrolidone as a wetting agent, 1g of stevioside as a flavoring agent and 600010g of polyethylene glycol as a lubricant;
step 2, crushing the components weighed in the step 1.6, and then sieving to obtain powder of the components; wherein the specification of the sieve is 80 meshes;
step 3, uniformly mixing the powdery roxburgh anoectochilus terminal bud freeze-dried powder obtained in the step 2, a filling agent, 20g of a disintegrating agent, a swelling auxiliary material and a flavoring agent; adding a wetting agent to prepare a soft material; then granulating the soft material; finally, drying and granulating the prepared wet granules to obtain dry granules; wherein the drying temperature is 60 ℃, and the granulating device is a swing granulator for granulation;
and 4, uniformly mixing the dry granules obtained in the step 3 with a lubricant and the rest 20g of disintegrant, and tabletting to obtain the anoectochilus formosanus extract dispersible tablets.
Through detection, the anoectochilus formosanus polysaccharide dispersible tablet of the embodiment can be completely disintegrated within 3min and reach a uniform dispersion state, and the dissolution rate within 30min is 95%.
Example 2
The preparation method of every 1000 anoectochilus roxburghii polysaccharide dispersible tablets comprises the following steps:
step 1, preparing roxburgh anoectochilus terminal bud polysaccharide freeze-dried powder; the method comprises the following specific steps:
step 1.1, taking clematis, and preparing powder after freeze drying;
step 1.2, firstly carrying out enzymolysis on the powder obtained in the step 1.1, then carrying out ultrasonic-assisted extraction on the enzymolyzed anoectochilus formosanus powder for 4 times (0.5 h each time), respectively filtering the extracting solutions, combining the filtrates, and recovering the solvent to obtain an anoectochilus formosanus polysaccharide extracting solution; wherein, the enzymolysis specifically comprises the following steps: adding distilled water into the anoectochilus formosanus powder to obtain a mixed solution, wherein the mass ratio of the anoectochilus formosanus powder to the distilled water is 1: 8; adding cellulase into the mixed solution, and adjusting the pH value to a target value, wherein the cellulase accounts for 0.3 percent of the mass of the mixed solution, the enzymolysis time is 4 hours, the enzymolysis temperature is 50 ℃, and the target value of the pH value is 8; the enzyme deactivation temperature is 80 ℃, and the enzyme deactivation time is 15 min;
step 1.3, adsorbing and decoloring the anoectochilus formosanus polysaccharide extracting solution obtained in the step 1.2 by using an adsorbing material H103; wherein the adsorption temperature of the adsorption decoloring process is 20 ℃, the sample loading speed is 1BV/h, and the sample loading concentration is 4 mg/mL;
step 1.4, resolving and eluting the anoectochilus formosanus polysaccharide extracting solution which is adsorbed and saturated in the step 1.3; analyzing elution process parameters: the concentration of the analysis solution is 50% ethanol, the analysis rate is 2BV/h, and the volume of the analysis solution is 3 BV;
step 1.5, selecting an ultrafiltration membrane with the relative molecular weight cutoff of 1000 Da-5000 Da to carry out ultrafiltration treatment on the anoectochilus roxburghii polysaccharide extracting solution obtained in the step 1.4, concentrating the treated liquid into clear paste with the relative density of 1.10-1.30 at 50 ℃, and finally freeze-drying the clear paste for 70 hours to obtain the anoectochilus roxburghii polysaccharide freeze-dried powder;
step 1.6, weighing 30g of roxburgh anoectochilus terminal bud polysaccharide freeze-dried powder and a medicine carrier, wherein the medicine carrier comprises: 80g of filler dextrin, 160g of lactose, 35g of disintegrant crosslinked polyvinylpyrrolidone, 5g of swelling auxiliary material sodium alginate, 120mL of ethanol solution of 0.5% of wetting agent polyvinylpyrrolidone, 0.5g of flavoring agent stevioside and 600010g of lubricant polyethylene glycol;
step 2, crushing the components weighed in the step 1, and then sieving to obtain powder of the components; wherein the specification of the sieve is 120 meshes;
step 3, uniformly mixing the powdery roxburgh anoectochilus terminal bud freeze-dried powder obtained in the step 2, a filling agent, 20g of a disintegrating agent, a swelling auxiliary material and a flavoring agent; adding a wetting agent to prepare a soft material; then granulating the soft material; finally, drying and granulating the prepared wet granules to obtain dry granules; wherein the drying temperature is 70 ℃, and the granulating device is a swing granulator for granulation;
step 4, uniformly mixing the dry granules obtained in the step 3 with a lubricant and the rest 15g of disintegrant, and tabletting to obtain anoectochilus formosanus extract dispersible tablets;
through detection, the anoectochilus formosanus polysaccharide dispersible tablet of the embodiment can be completely disintegrated within 3min and reach a uniform dispersion state, and the dissolution rate within 30min is 96.8%.
Example 3
The preparation method of every 1000 anoectochilus roxburghii polysaccharide dispersible tablets comprises the following steps:
step 1, preparing roxburgh anoectochilus terminal bud polysaccharide freeze-dried powder; the method comprises the following specific steps:
step 1.1, taking clematis, and preparing powder after freeze drying;
step 1.2, firstly carrying out enzymolysis on the powder obtained in the step 1.1, then carrying out ultrasonic-assisted extraction on the enzymolyzed anoectochilus formosanus powder for 1 time, each time for 5 hours, respectively filtering the extracting solution, combining the filtrates, and recovering the solvent to obtain an anoectochilus formosanus polysaccharide extracting solution; wherein, the enzymolysis specifically comprises the following steps: adding distilled water into the anoectochilus formosanus powder to obtain a mixed solution, wherein the mass ratio of the anoectochilus formosanus powder to the distilled water is 1: 22; adding cellulase into the mixed solution, and adjusting the pH value to a target value, wherein the cellulase accounts for 2% of the mass of the mixed solution, the enzymolysis time is 1h, the enzymolysis temperature is 40 ℃, and the target pH value is 5; the enzyme deactivation temperature is 80 ℃, and the enzyme deactivation time is 10 min;
step 1.3, adsorbing and decoloring the anoectochilus roxburghii polysaccharide extracting solution obtained in the step 1.2 by using an adsorbing material D101; wherein the adsorption temperature of the adsorption decoloring process is 25 ℃, the sample loading speed is 2BV/h, and the sample loading concentration is 8 mg/mL;
step 1.4, resolving and eluting the anoectochilus formosanus polysaccharide extracting solution which is adsorbed and saturated in the step 1.3; analyzing elution process parameters: the concentration of the analysis solution is 70% ethanol, the analysis rate is 4BV/h, and the volume of the analysis solution is 6 BV;
step 1.5, selecting an ultrafiltration membrane with the relative molecular weight cutoff of 1000 Da-5000 Da to carry out ultrafiltration treatment on the anoectochilus roxburghii polysaccharide extracting solution obtained in the step 1.4, concentrating the treated liquid into clear paste with the relative density of 1.10-1.30 at 50 ℃, and finally freeze-drying the clear paste for 60 hours to obtain the anoectochilus roxburghii polysaccharide freeze-dried powder;
step 1.6, weighing 80g of roxburgh anoectochilus terminal bud polysaccharide freeze-dried powder and a medicine carrier, wherein the medicine carrier comprises: 80g of filler starch, 100g of lactose, 35g of disintegrant low-substituted hydroxypropyl cellulose, 3g of swelling auxiliary material pregelatinized starch, 70mL of ethanol solution of 50% of wetting agent polyvinylpyrrolidone, 1g of corrective stevioside, 60005g of lubricant polyethylene glycol and 5g of superfine silica gel powder;
step 2, crushing the components weighed in the step 1, and then sieving to obtain powder of the components; wherein the specification of the sieve is 100 meshes;
step 3, uniformly mixing the powdery roxburgh anoectochilus terminal bud freeze-dried powder obtained in the step 2, a filling agent, 18g of a disintegrating agent, a swelling auxiliary material and a flavoring agent; adding a wetting agent to prepare a soft material; then granulating the soft material; finally, drying and granulating the prepared wet granules to obtain dry granules; wherein the drying temperature is 40-70 ℃, and the granulating device is a swing granulator for granulation;
step 4, uniformly mixing the dry granules obtained in the step 3 with a lubricant and the rest 17g of disintegrant, and tabletting to obtain anoectochilus formosanus extract dispersible tablets;
through detection, the anoectochilus formosanus polysaccharide dispersible tablet of the embodiment can be completely disintegrated and reach a uniform dispersion state within 3min, and the dissolution rate within 30min is 90.3%.
Example 4
The preparation method of every 1000 anoectochilus roxburghii polysaccharide dispersible tablets comprises the following steps:
step 1, preparing roxburgh anoectochilus terminal bud polysaccharide freeze-dried powder; the method comprises the following specific steps:
step 1.1, taking clematis, and preparing powder after freeze drying;
step 1.2, firstly carrying out enzymolysis on the powder obtained in the step 1.1, then carrying out ultrasonic-assisted extraction on the enzymolyzed anoectochilus formosanus powder for 3 times (1 hour each time), respectively filtering the extracting solution, combining the filtrates, and recovering the solvent to obtain an anoectochilus formosanus polysaccharide extracting solution; wherein, the enzymolysis specifically comprises the following steps: adding distilled water into the anoectochilus formosanus powder to obtain a mixed solution, wherein the mass ratio of the anoectochilus formosanus powder to the distilled water is 1: 20; adding cellulase into the mixed solution, and adjusting the pH value to a target value, wherein the cellulase accounts for 5% of the mass of the mixed solution, the enzymolysis time is 2h, the enzymolysis temperature is 40 ℃, and the target pH value is 8; the enzyme deactivation temperature is 80 ℃, and the enzyme deactivation time is 10 min;
step 1.3, adsorbing and decoloring the anoectochilus roxburghii polysaccharide extracting solution obtained in the step 1.2 by using an adsorbing material HPD 722; wherein the adsorption temperature of the adsorption decoloring process is 25 ℃, the sample loading speed is 2BV/h, and the sample loading concentration is 8 mg/mL;
step 1.4, resolving and eluting the anoectochilus formosanus polysaccharide extracting solution which is adsorbed and saturated in the step 1.3; analyzing elution process parameters: the concentration of the analysis solution is 70% ethanol, the analysis rate is 4BV/h, and the volume of the analysis solution is 6 BV;
step 1.5, selecting an ultrafiltration membrane with the relative molecular weight cutoff of 1000 Da-5000 Da to carry out ultrafiltration treatment on the anoectochilus roxburghii polysaccharide extracting solution obtained in the step 1.4, concentrating the treated liquid into clear paste with the relative density of 1.10-1.30 at 50 ℃, and finally freeze-drying the clear paste for 60 hours to obtain the anoectochilus roxburghii polysaccharide freeze-dried powder;
step 1.6, weighing 80g of roxburgh anoectochilus terminal bud polysaccharide freeze-dried powder and a medicine carrier, wherein the medicine carrier comprises: 130g of microcrystalline cellulose as a filler, 180g of lactose, 40g of croscarmellose sodium as a disintegrating agent, 5g of sodium alginate as a swelling auxiliary material, 280mL of 100% ethanol solution as a wetting agent, 3g of stevioside as a flavoring agent and 800010g of polyethylene glycol as a lubricant;
step 2, crushing the components weighed in the step 1, and then sieving to obtain powder of the components; wherein the specification of the sieve is 120 meshes;
step 3, uniformly mixing the powdery roxburgh anoectochilus terminal bud freeze-dried powder obtained in the step 2, a filling agent, 16g of a disintegrating agent, a swelling auxiliary material and a flavoring agent; adding a wetting agent to prepare a soft material; then granulating the soft material; finally, drying the prepared wet granules, and finishing the granules by a 20-mesh sieve to obtain dry granules; wherein the drying temperature is 60 ℃, and the granulating device is a swing granulator for granulation;
and 4, uniformly mixing the dry granules obtained in the step 3 with a lubricant and the rest 24g of disintegrant, and tabletting to obtain the anoectochilus formosanus extract dispersible tablets.
Through detection, the anoectochilus formosanus polysaccharide dispersible tablet of the embodiment can be completely disintegrated and reach a uniform dispersion state within 3min, and the dissolution rate within 30min is 94.5%.
Example 5
The preparation method of every 1000 anoectochilus roxburghii polysaccharide dispersible tablets comprises the following steps:
step 1, preparing roxburgh anoectochilus terminal bud polysaccharide freeze-dried powder; the method comprises the following specific steps:
step 1.2, firstly carrying out enzymolysis on the powder obtained in the step 1.1, then carrying out ultrasonic-assisted extraction on the enzymolyzed anoectochilus formosanus powder for 3 times (1 hour each time), respectively filtering the extracting solution, combining the filtrates, and recovering the solvent to obtain an anoectochilus formosanus polysaccharide extracting solution; wherein, the enzymolysis specifically comprises the following steps: adding distilled water into the anoectochilus formosanus powder to obtain a mixed solution, wherein the mass ratio of the anoectochilus formosanus powder to the distilled water is 1: 22; adding cellulase into the mixed solution, and adjusting the pH value to a target value, wherein the cellulase accounts for 0.3 percent of the mass of the mixed solution, the enzymolysis time is 1h, the enzymolysis temperature is 40 ℃, and the target pH value is 5; the enzyme deactivation temperature is 80 ℃, and the enzyme deactivation time is 10 min;
step 1.3, adsorbing and decoloring the anoectochilus roxburghii polysaccharide extracting solution obtained in the step 1.2 by using an adsorbing material S-8; wherein the adsorption temperature of the adsorption decoloring process is 25 ℃, the sample loading speed is 2BV/h, and the sample loading concentration is 8 mg/mL;
step 1.4, resolving and eluting the anoectochilus formosanus polysaccharide extracting solution which is adsorbed and saturated in the step 1.3; analyzing elution process parameters: the concentration of the analysis solution is 70% ethanol, the analysis rate is 4BV/h, and the volume of the analysis solution is 6 BV;
step 1.5, selecting an ultrafiltration membrane with the relative molecular weight cutoff of 1000 Da-5000 Da to carry out ultrafiltration treatment on the anoectochilus roxburghii polysaccharide extracting solution obtained in the step 1.4, concentrating the treated liquid into clear paste with the relative density of 1.10-1.30 at 50 ℃, and finally freeze-drying the clear paste for 60 hours to obtain the anoectochilus roxburghii polysaccharide freeze-dried powder;
step 1.6, weighing 80g of roxburgh anoectochilus terminal bud polysaccharide freeze-dried powder and a medicine carrier, wherein the medicine carrier comprises: 80g of microcrystalline cellulose as a filler, 200g of lactose, 40g of cross-linked polyvinylpyrrolidone as a disintegrant, 5g of hydroxypropyl cellulose as a swelling auxiliary material, 200mL of wetting agent water, 0.5g of acesulfame as a flavoring agent and 800015g of polyethylene glycol as a lubricant;
step 2, crushing the components weighed in the step 1, and then sieving to obtain powder of the components; wherein the specification of the sieve is 80 meshes;
step 3, uniformly mixing the powdery roxburgh anoectochilus terminal bud freeze-dried powder obtained in the step 2, a filling agent, 26g of a disintegrating agent, a swelling auxiliary material and a flavoring agent; adding a wetting agent to prepare a soft material; then granulating the soft material; finally, drying the prepared wet granules, and finishing the granules by a 20-mesh sieve to obtain dry granules; wherein the drying temperature is 60 ℃, and the granulating device is a swing granulator for granulation;
and 4, uniformly mixing the dry granules obtained in the step 3 with a lubricant and the rest 14g of disintegrant, and tabletting to obtain the anoectochilus formosanus extract dispersible tablets.
Through detection, the anoectochilus formosanus polysaccharide dispersible tablet of the embodiment can be completely disintegrated and reach a uniform dispersion state within 3min, and the dissolution rate within 30min is 89.7%.
Example 6
The preparation method of every 1000 anoectochilus roxburghii polysaccharide dispersible tablets comprises the following steps:
step 1, preparing roxburgh anoectochilus terminal bud polysaccharide freeze-dried powder; the method comprises the following specific steps:
step 1.1, taking clematis, and preparing powder after freeze drying;
step 1.2, firstly carrying out enzymolysis on the powder obtained in the step 1.1, then carrying out ultrasonic-assisted extraction on the enzymolyzed anoectochilus formosanus powder for 3 times, each time for 5 hours, respectively filtering the extracting solution, combining the filtrates, and recovering the solvent to obtain an anoectochilus formosanus polysaccharide extracting solution; wherein, the enzymolysis specifically comprises the following steps: adding distilled water into the anoectochilus formosanus powder to obtain a mixed solution, wherein the mass ratio of the anoectochilus formosanus powder to the distilled water is 1: 18; adding cellulase into the mixed solution, and adjusting the pH value to a target value, wherein the cellulase accounts for 0.3 percent of the mass of the mixed solution, the enzymolysis time is 1h, the enzymolysis temperature is 40 ℃, and the target pH value is 5; the enzyme deactivation temperature is 80 ℃, and the enzyme deactivation time is 10 min;
step 1.3, adsorbing and decoloring the anoectochilus formosanus polysaccharide extracting solution obtained in the step 1.2 by using an adsorbing material D3520; wherein the adsorption temperature of the adsorption decoloring process is 25 ℃, the sample loading speed is 2BV/h, and the sample loading concentration is 8 mg/mL;
step 1.4, resolving and eluting the anoectochilus formosanus polysaccharide extracting solution which is adsorbed and saturated in the step 1.3; analyzing elution process parameters: the concentration of the analysis solution is 70% ethanol, the analysis rate is 4BV/h, and the volume of the analysis solution is 6 BV;
step 1.5, selecting an ultrafiltration membrane with the relative molecular weight cutoff of 1000 Da-5000 Da to carry out ultrafiltration treatment on the anoectochilus roxburghii polysaccharide extracting solution obtained in the step 1.4, concentrating the treated liquid into clear paste with the relative density of 1.10-1.30 at 50 ℃, and finally freeze-drying the clear paste for 60 hours to obtain the anoectochilus roxburghii polysaccharide freeze-dried powder;
step 1.6, weighing 80g of roxburgh anoectochilus terminal bud polysaccharide freeze-dried powder and a medicine carrier, wherein the medicine carrier comprises: 50g of microcrystalline cellulose and 100g of lactose as fillers, 35g of cross-linked polyvinylpyrrolidone as a disintegrating agent, 5g of sodium alginate as a swelling auxiliary material, 120mL of ethanol solution of 0.5 percent polyvinylpyrrolidone and 120mL of 50 percent ethanol as a wetting agent, 2g of stevioside as a flavoring agent and 10g of magnesium stearate as a lubricant
Step 2, crushing the components weighed in the step 1, and then sieving to obtain powder of the components; wherein the specification of the sieve is 100 meshes;
step 3, uniformly mixing the powdery roxburgh anoectochilus terminal bud freeze-dried powder obtained in the step 2, a filling agent, 20g of a disintegrating agent, a swelling auxiliary material and a flavoring agent; adding a wetting agent to prepare a soft material; then granulating the soft material; finally, drying and granulating the prepared wet granules to obtain dry granules; wherein the drying temperature is 60 ℃, and the granulating device is a swing granulator for granulation;
and 4, uniformly mixing the dry granules obtained in the step 3 with a lubricant and the rest 15g of disintegrant, and tabletting to obtain the anoectochilus formosanus extract dispersible tablets.
Through detection, the anoectochilus formosanus polysaccharide dispersible tablet of the embodiment can be completely disintegrated within 3min and reach a uniform dispersion state, and the dissolution rate within 30min is 87.4%.
Example 7
The preparation method of every 1000 anoectochilus roxburghii polysaccharide dispersible tablets comprises the following steps: step 1, preparing roxburgh anoectochilus terminal bud polysaccharide freeze-dried powder; the method comprises the following specific steps:
step 1.2, firstly carrying out enzymolysis on the powder obtained in the step 1.1, then carrying out ultrasonic-assisted extraction on the enzymolyzed anoectochilus formosanus powder for 3 times (2 hours each time), respectively filtering the extracting solution, combining the filtrates, and recovering the solvent to obtain an anoectochilus formosanus polysaccharide extracting solution; wherein, the enzymolysis specifically comprises the following steps: adding distilled water into the anoectochilus formosanus powder to obtain a mixed solution, wherein the mass ratio of the anoectochilus formosanus powder to the distilled water is 1: 10; adding cellulase into the mixed solution, and adjusting the pH value to a target value, wherein the cellulase accounts for 5% of the mass of the mixed solution, the enzymolysis time is 2h, the enzymolysis temperature is 45 ℃, and the target value of the pH value is 7.5; the enzyme deactivation temperature is 80 ℃, and the enzyme deactivation time is 15 min;
step 1.3, adsorbing and decoloring the anoectochilus roxburghii polysaccharide extracting solution obtained in the step 1.2 by using an adsorbing material HPD-700; wherein the adsorption temperature of the adsorption decoloring process is 25 ℃, the sample loading speed is 2BV/h, and the sample loading concentration is 8 mg/mL;
step 1.4, resolving and eluting the anoectochilus formosanus polysaccharide extracting solution which is adsorbed and saturated in the step 1.3; analyzing elution process parameters: the concentration of the analysis solution is 70% ethanol, the analysis rate is 4BV/h, and the volume of the analysis solution is 6 BV;
step 1.5, selecting an ultrafiltration membrane with the relative molecular weight cutoff of 1000 Da-5000 Da to carry out ultrafiltration treatment on the anoectochilus roxburghii polysaccharide extracting solution obtained in the step 1.4, concentrating the treated liquid into clear paste with the relative density of 1.10-1.30 at 50 ℃, and finally freeze-drying the clear paste for 60 hours to obtain the anoectochilus roxburghii polysaccharide freeze-dried powder;
step 1.6, weighing 80g of roxburgh anoectochilus terminal bud polysaccharide freeze-dried powder and a medicine carrier, wherein the medicine carrier comprises: 80g of microcrystalline cellulose as a filling agent, 100g of lactose, 40g of cross-linked polyvinylpyrrolidone as a disintegrating agent, 3g of starch and 2g of sodium alginate as swelling auxiliary materials, 90mL of ethanol solution of 5% polyvinylpyrrolidone as a wetting agent, 1g of aspartame as a flavoring agent and 10g of talcum powder as a lubricant;
step 2, crushing the components weighed in the step 1, and then sieving to obtain powder of the components; wherein the specification of the sieve is 120 meshes;
step 3, uniformly mixing the powdery roxburgh anoectochilus terminal bud freeze-dried powder obtained in the step 2, a filling agent, 20g of a disintegrating agent, a swelling auxiliary material and a flavoring agent; adding a wetting agent to prepare a soft material; then granulating the soft material; finally, drying the prepared wet granules, and finishing the granules by a 20-mesh sieve to obtain dry granules; wherein the drying temperature is 60 ℃, and the granulating device is a swing granulator for granulation;
step 4, uniformly mixing the dry granules obtained in the step 3 with a lubricant and the rest 20g of disintegrant, and tabletting to obtain anoectochilus formosanus extract dispersible tablets; wherein the mass ratio of part of the disintegrant added in the step 3 to the rest part of the disintegrant added in the step 4 is 1: 0.5-1.5.
Through detection, the anoectochilus formosanus polysaccharide dispersible tablet of the embodiment can be completely disintegrated within 3min and reach a uniform dispersion state, and the dissolution rate within 30min is 96.7%.
Example 8
The preparation method of every 1000 anoectochilus roxburghii polysaccharide dispersible tablets comprises the following steps:
step 1, preparing roxburgh anoectochilus terminal bud polysaccharide freeze-dried powder, comprising the following specific steps:
step 1.1, taking clematis, and preparing powder after freeze drying;
step 1.2, firstly carrying out enzymolysis on the powder obtained in the step 1.1, then carrying out ultrasonic-assisted extraction on the enzymolyzed anoectochilus formosanus powder for 3 times (1 hour each time), respectively filtering the extracting solution, combining the filtrates, and recovering the solvent to obtain an anoectochilus formosanus polysaccharide extracting solution; wherein, the enzymolysis specifically comprises the following steps: adding distilled water into the anoectochilus formosanus powder to obtain a mixed solution, wherein the mass ratio of the anoectochilus formosanus powder to the distilled water is 1: 10; adding cellulase into the mixed solution, and adjusting the pH value to a target value, wherein the cellulase accounts for 2% of the mass of the mixed solution, the enzymolysis time is 4h, the enzymolysis temperature is 35 ℃, and the target pH value is 5; the enzyme deactivation temperature is 80 ℃, and the enzyme deactivation time is 10-15 min;
step 1.3, adsorbing and decoloring the anoectochilus roxburghii polysaccharide extracting solution obtained in the step 1.2 by using an adsorbing material HPD-100; wherein the adsorption temperature of the adsorption decoloring process is 25 ℃, the sample loading speed is 2BV/h, and the sample loading concentration is 8 mg/mL; step 1.4, resolving and eluting the anoectochilus formosanus polysaccharide extracting solution which is adsorbed and saturated in the step 1.3; analyzing elution process parameters: the concentration of the analysis solution is 70% ethanol, the analysis rate is 4BV/h, and the volume of the analysis solution is 6 BV;
step 1.5, selecting an ultrafiltration membrane with the relative molecular weight cutoff of 1000 Da-5000 Da to carry out ultrafiltration treatment on the anoectochilus roxburghii polysaccharide extracting solution obtained in the step 1.4, concentrating the treated liquid into clear paste with the relative density of 1.10-1.30 at 50 ℃, and finally freeze-drying the clear paste for 60 hours to obtain the anoectochilus roxburghii polysaccharide freeze-dried powder;
step 1.6, weighing 40g of roxburgh anoectochilus terminal bud polysaccharide freeze-dried powder and a medicine carrier, wherein the medicine carrier comprises: 50g of microcrystalline cellulose as a filling agent, 100g of lactose, 60g of cross-linked polyvinylpyrrolidone as a disintegrating agent, 5g of sodium alginate as a swelling auxiliary material, 110mL of ethanol solution of 5% polyvinylpyrrolidone as a wetting agent, 1g of stevioside as a flavoring agent and 80005g of polyethylene glycol as a lubricant;
step 2, crushing the components weighed in the step 1, and then sieving to obtain powder of the components; wherein the specification of the sieve is 100 meshes;
step 3, uniformly mixing the powdery roxburgh anoectochilus terminal bud freeze-dried powder obtained in the step 2, a filling agent, 20g of a disintegrating agent, a swelling auxiliary material and a flavoring agent; adding a wetting agent to prepare a soft material; then granulating the soft material; finally, drying the prepared wet granules, and finishing the granules by a 20-mesh sieve to obtain dry granules; wherein the drying temperature is 60 ℃, and the granulating device is a swing granulator for granulation;
and 4, uniformly mixing the dry granules obtained in the step 3 with a lubricant and the rest 20g of disintegrant, and tabletting to obtain the anoectochilus formosanus extract dispersible tablets.
Through detection, the anoectochilus formosanus polysaccharide dispersible tablet of the embodiment can be completely disintegrated within 3min and reach a uniform dispersion state, and the dissolution rate within 30min is 96.7%.
Example 9
The preparation method of every 1000 anoectochilus roxburghii polysaccharide dispersible tablets comprises the following steps:
step 1, preparing roxburgh anoectochilus terminal bud polysaccharide freeze-dried powder; the method comprises the following specific steps:
step 1.2, firstly carrying out enzymolysis on the powder obtained in the step 1.1, then carrying out ultrasonic-assisted extraction on the enzymolyzed anoectochilus formosanus powder for 3 times (1 hour each time), respectively filtering the extracting solution, combining the filtrates, and recovering the solvent to obtain an anoectochilus formosanus polysaccharide extracting solution; wherein, the enzymolysis specifically comprises the following steps: adding distilled water into the anoectochilus roxburghii powder to obtain a mixed solution, wherein the mass ratio of the anoectochilus roxburghii powder to the distilled water is 1: 8-22; adding cellulase into the mixed solution, and adjusting the pH value to a target value, wherein the cellulase accounts for 0.3 percent of the mass of the mixed solution, the enzymolysis time is 2 hours, the enzymolysis temperature is 50 ℃, and the target value of the pH value is 5; the enzyme deactivation temperature is 80 ℃, and the enzyme deactivation time is 10 min;
step 1.3, adsorbing and decoloring the anoectochilus formosanus polysaccharide extracting solution obtained in the step 1.2 by using an adsorbing material NKA-9; wherein the adsorption temperature of the adsorption decoloring process is 25 ℃, the sample loading speed is 2BV/h, and the sample loading concentration is 8 mg/mL;
step 1.4, resolving and eluting the anoectochilus formosanus polysaccharide extracting solution which is adsorbed and saturated in the step 1.3; analyzing elution process parameters: the concentration of the analysis solution is 70% ethanol, the analysis rate is 4BV/h, and the volume of the analysis solution is 6 BV;
step 1.5, selecting an ultrafiltration membrane with the relative molecular weight cutoff of 1000 Da-5000 Da to carry out ultrafiltration treatment on the anoectochilus roxburghii polysaccharide extracting solution obtained in the step 1.4, concentrating the treated liquid into clear paste with the relative density of 1.10-1.30 at 50 ℃, and finally freeze-drying the clear paste for 60 hours to obtain the anoectochilus roxburghii polysaccharide freeze-dried powder;
step 1.6, weighing 80g of roxburgh anoectochilus terminal bud polysaccharide freeze-dried powder and a medicine carrier, wherein the medicine carrier comprises: 300g of filler lactose, 75g of disintegrant carboxymethyl starch sodium, 5g of swelling auxiliary material sodium alginate, 100mL of ethanol solution of wetting agent 5% polyvinylpyrrolidone, 1g of flavoring agent stevioside and 10g of lubricant micropowder silica gel;
step 2, crushing the components weighed in the step 1, and then sieving to obtain powder of the components; wherein the specification of the sieve is 100 meshes;
step 3, uniformly mixing the powdery roxburgh anoectochilus terminal bud freeze-dried powder obtained in the step 2, a filling agent, 50g of a disintegrating agent, a swelling auxiliary material and a flavoring agent; adding a wetting agent to prepare a soft material; then granulating the soft material; finally, drying and granulating the prepared wet granules to obtain dry granules; wherein the drying temperature is 60 ℃, and the granulating device is a swing granulator for granulation;
and 4, uniformly mixing the dry granules obtained in the step 3 with a lubricant and the rest 25g of disintegrant, and tabletting to obtain the anoectochilus formosanus extract dispersible tablets.
Through detection, the anoectochilus formosanus polysaccharide dispersible tablet of the embodiment can be completely disintegrated and reach a uniform dispersion state within 3min, and the dissolution rate within 30min is 89.7%.
Example 10
The preparation method of every 1000 anoectochilus roxburghii polysaccharide dispersible tablets comprises the following steps:
the procedure of example 9 was followed except that the adsorbent material in step 1.3 was HPD-600, and the dispersible tablet of Anoectochilus roxburghii polysaccharide was found to disintegrate completely and reach a uniform dispersion state within 3min, with a dissolution rate of 89.7% within 30 min.
Claims (15)
1. The anoectochilus formosanus polysaccharide dispersible tablet is characterized by comprising anoectochilus formosanus polysaccharide freeze-dried powder and a medicine carrier, wherein the medicine carrier comprises a filling agent, a disintegrating agent, a swelling auxiliary material, a wetting agent, a flavoring agent and a lubricating agent.
2. The anoectochilus formosanus polysaccharide dispersible tablet of claim 1, wherein the proportion of the anoectochilus formosanus polysaccharide freeze-dried powder, the filler, the disintegrant, the swelling auxiliary material, the wetting agent, the flavoring agent and the lubricant is 30-80 g: 150 g-310 g: 35 g-75 g: 3 g-5 g: 55 mL-280 mL: 0.5 g-3 g: 5g to 15 g.
3. The dispersible tablet of Anoectochilus roxburghii polysaccharide of claim 1, wherein the filler comprises at least one of microcrystalline cellulose, lactose, mannitol, dextrin and starch.
4. The dispersible tablet of Anoectochilus roxburghii polysaccharide of claim 1, wherein the disintegrating agent comprises at least one of crospolyvinylpyrrolidone, low-substituted hydroxypropyl cellulose, croscarmellose sodium and sodium carboxymethyl starch.
5. The anoectochilus formosanus polysaccharide dispersible tablet of claim 1, wherein the swelling auxiliary material comprises at least one of sodium alginate, pregelatinized starch, hydroxypropyl cellulose and compressible starch.
6. The anoectochilus formosanus polysaccharide dispersible tablet according to claim 1, wherein the wetting agent comprises at least one of 50-100% by weight of ethanol solution and 0.5-5% by weight of polyvinylpyrrolidone ethanol solution.
7. The anoectochilus formosanus polysaccharide dispersible tablet of claim 1, wherein the flavoring agent comprises at least one of aspartame, stevioside and acesulfame potassium.
8. The anoectochilus formosanus polysaccharide dispersible tablet according to claim 1, wherein the lubricant comprises at least one of talc, magnesium stearate, aerosil, polyethylene glycol 6000 and polyethylene glycol 8000.
9. A preparation method of anoectochilus formosanus polysaccharide dispersible tablets is characterized by comprising the following steps:
step 1, preparing roxburgh anoectochilus terminal bud polysaccharide freeze-dried powder; weighing the Anoectochilus roxburghii polysaccharide freeze-dried powder, the filling agent, the disintegrating agent, the swelling auxiliary material, the wetting agent, the flavoring agent and the lubricant according to the proportioning relation of claim 2;
step 2, crushing the components weighed in the step 1, and then sieving to obtain powder of the components;
step 3, uniformly mixing the powdery roxburgh anoectochilus terminal bud freeze-dried powder obtained in the step 2, a filling agent, a part of disintegrating agent, a swelling auxiliary material and a flavoring agent; adding a wetting agent to prepare a soft material; then granulating the soft material; finally, drying and granulating the prepared wet granules to obtain dry granules, wherein the drying temperature is 40-70 ℃, and the granulating device is a swing granulator for granulating;
and 4, uniformly mixing the dry granules obtained in the step 3 with a lubricant and the rest of disintegrant, and tabletting to obtain the anoectochilus formosanus extract dispersible tablets.
10. The method for preparing anoectochilus formosanus polysaccharide dispersible tablets according to claim 9, wherein the preparation of the anoectochilus formosanus polysaccharide lyophilized powder in the step 1 is specifically implemented according to the following steps:
step 1.1, taking clematis, and preparing powder after freeze drying;
step 1.2, firstly carrying out enzymolysis on the powder obtained in the step 1.1, then inactivating enzyme of the powder of anoectochilus formosanus after enzymolysis, extracting, filtering and recovering a solvent to obtain an anoectochilus formosanus polysaccharide extracting solution;
step 1.3, adsorbing and decoloring the anoectochilus formosanus polysaccharide extracting solution obtained in the step 1.2 by using an adsorbing material;
step 1.4, resolving and eluting the anoectochilus formosanus polysaccharide extracting solution which is adsorbed and saturated in the step 1.3; the adsorption temperature of the adsorption decoloring process is 20-25 ℃, the sample loading speed is 1-2 BV/h, and the sample loading concentration is 4-8 mg/mL;
step 1.5, performing ultrafiltration treatment on the anoectochilus roxburghii polysaccharide extracting solution analyzed and eluted in the step 1.4, concentrating the treated solution into clear paste, and freeze-drying to obtain the anoectochilus roxburghii polysaccharide freeze-dried powder.
11. The method for preparing anoectochilus formosanus polysaccharide dispersible tablets according to claim 10, wherein the step 1.2 is specifically implemented according to the following steps: firstly, adding distilled water into the anoectochilus formosanus powder obtained in the step 1.1 to obtain a mixed solution, wherein the mass ratio of the anoectochilus formosanus powder to the distilled water is 1: 8-22; adding cellulase into the mixed solution, and adjusting the pH value to a target value, wherein the enzymolysis time is 1-4 h, the enzymolysis temperature is 35-50 ℃, the target pH value is 5-8, and the cellulase accounts for 0.3-5% of the mass of the mixed solution; and finally, carrying out ultrasonic-assisted extraction for 1-4 times, each time for 0.5-5 h, respectively filtering the extracting solution, combining the filtrates, and recovering the solvent to obtain the anoectochilus formosanus polysaccharide extracting solution.
12. The method for preparing anoectochilus formosanus polysaccharide dispersible tablet according to claim 10, wherein the adsorbing material in step 1.3 is macroporous adsorbent resin, and the macroporous adsorbent resin is any one of D101, NKA-9, D3520, H103, HPD-100, HPD-700, AB-8, HPD722, S-8 and HPD-600.
13. The method for preparing anoectochilus formosanus polysaccharide dispersible tablets according to claim 10, wherein the analytical elution process parameters in step 1.4 are as follows: the concentration of the analysis solution is 50-70% ethanol, the analysis rate is 2-4 BV/h, and the volume of the analysis solution is 3-6 BV.
14. The method for preparing anoectochilus formosanus polysaccharide dispersible tablets according to claim 10, wherein the step 1.5 is specifically implemented according to the following steps: firstly, ultrafiltration membrane with the interception relative molecular weight of 1000 Da-5000 Da is selected to carry out ultrafiltration treatment on the anoectochilus formosanus polysaccharide extracting solution, then the treated liquid is concentrated into clear paste with the relative density of 1.10-1.30 at 50 ℃, and finally the clear paste is freeze-dried for 60 h-70 h to obtain the anoectochilus formosanus polysaccharide freeze-dried powder.
15. The method for preparing anoectochilus formosanus polysaccharide dispersible tablets according to claim 9, wherein the mass ratio of the part of disintegrant added in step 3 to the rest of disintegrant added in step 4 is 1: 0.5-1.5.
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