CN117338867B - Traditional Chinese medicine group Fang Pianji for preventing and treating diarrhea of dogs and cats as well as preparation method and application thereof - Google Patents
Traditional Chinese medicine group Fang Pianji for preventing and treating diarrhea of dogs and cats as well as preparation method and application thereof Download PDFInfo
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Abstract
The invention discloses a traditional Chinese medicine group Fang Pianji for preventing and treating diarrhea of dogs and cats, and a preparation method and application thereof, wherein a traditional Chinese medicine composition for preventing and treating diarrhea is prepared from the following components: sugar, rhizoma Atractylodis Macrocephalae, rhizoma Dioscoreae, poria, herba Agrimoniae, and herba Portulacae; the preparation method of the tablet comprises the following steps: (1) Mixing the traditional Chinese medicine composition, a filler, a flavoring agent and a part of disintegrating agent, and sieving; (2) adding a binder and sieving to obtain wet granules; (3) drying, adding the lubricant and the rest of the disintegrating agent. The anti-diarrhea tablet prepared by the invention has the advantages of simpler and more convenient administration mode, easy control of the administration amount, more stable drug content, quick release of the drug in an animal body, simple process, strong operability, easy storage and transportation or carrying, and better palatability of dogs and cats due to the adjustment of the taste of the anti-diarrhea tablet. The traditional Chinese medicine composition is mainly used for treating diarrhea and diarrhea of dogs and cats, and has obvious effects of preventing diarrhea and conditioning intestines and stomach of dogs and cats.
Description
Technical Field
The invention belongs to the field of medicines, and particularly relates to a traditional Chinese medicine group Fang Pianji for preventing and treating diarrhea of dogs and cats, and a preparation method and application thereof.
Background
With the improvement of the living standard of people, more and more people treat pets as a member of families. The pet is in a higher home position, and the consumption of the pet owner on the pet is increased. In terms of food, pet owners not only seek to saturate the pet, but also pay attention to nutrition and health of the pet. Diarrhea is the most frequent occurrence of pets and is also the most concern for pet owners. The existing common products for solving the diarrhea of the pets are probiotic products or are directly treated by using human medicines, and lack of medicines for preventing and treating the diarrhea of the pets special for animals.
The application analyzes the cause of diarrhea diseases of pets, and is mainly caused by malnutrition digestion and malabsorption of feed, intestinal stress and other pathological factors. The pathogenesis is diarrhea caused by intestinal movement disorder caused by intestinal mucosa permeability change due to intestinal lumen osmotic pressure change and fluid secretion increase. According to the case, the invention provides the traditional Chinese medicine composition, which has the effects of treating diarrhea, epigastric distending pain and spleen deficiency diarrhea. After the tablet prepared by feeding the traditional Chinese medicine composition is used, the diarrhea condition of pets is obviously improved, and diarrhea chronic diseases are also better treated. Specifically, the functions of each traditional Chinese medicine in the composition in the prescription are as follows:
(1) The thorn sugar, also called camel thorn, is a traditional folk medicine, is commonly used for treating diarrhea, abdominal distending pain, diabetes and infantile constipation by being matched with other medicines, is also an important feed source of camel, and can be also used as silage for cattle and goats.
(2) Bai Zhu has the actions of tonifying spleen and stomach, drying dampness and regulating middle energizer, and is indicated for diarrhea due to spleen deficiency and jaundice.
(3) The Chinese yam has the effects of strengthening spleen, relieving diarrhea, tonifying lung, tonifying kidney and the like.
(4) Poria has effects of removing dampness, promoting diuresis, invigorating spleen, regulating stomach, tranquilizing mind, and is used for treating dysuria and diarrhea.
(5) Herba et Gemma Agrimoniae has effects of astringing and stopping bleeding, and preventing malaria and dysentery.
(6) Herba Portulacae has effects of clearing heat and detoxicating, dispelling blood and detumescence, and can be used for treating dysentery, purulent blood, stranguria with heat, carbuncle, swelling and malignant sore, diarrhea and dysentery caused by damp heat.
Disclosure of Invention
The invention aims to: the invention aims to solve the technical problem of providing a traditional Chinese medicine composition for preventing and treating diarrhea of dogs and cats aiming at the defects of the prior art.
The invention also solves the technical problem of providing a traditional Chinese medicine preparation for preventing and treating diarrhea of dogs and cats.
The invention also solves the technical problem of providing a preparation method of the traditional Chinese medicine preparation for preventing and treating diarrhea of dogs and cats.
The invention also solves the technical problem of providing the traditional Chinese medicine composition for preventing and treating diarrhea of dogs and cats, and application and products of the traditional Chinese medicine preparation.
In order to solve the technical problems, the invention discloses the following technical scheme:
in a first aspect, the invention discloses a traditional Chinese medicine composition for preventing diarrhea of dogs and cats, which is prepared from the following components: sugar, rhizoma Atractylodis Macrocephalae, rhizoma Dioscoreae, poria, herba Agrimoniae, and herba Portulacae. Wherein, the spiny candy is a monarch drug for strengthening spleen and stomach, astringing intestines and relieving diarrhea; the bighead atractylodes rhizome, rhizoma dioscoreae, poria cocos and poria cocos are used as ministerial drugs for strengthening spleen and eliminating dampness and assisting the glucose to recover gastrointestinal functions; the hairyvein agrimony has the functions of astringing and stopping bleeding, checking malaria and stopping diarrhea, and repairing intestinal injury bleeding as an adjuvant drug; purslane is a guiding drug for clearing heat and detoxicating and clearing damp-heat in intestinal tracts. The combination of the medicines can achieve the effects of strengthening spleen, eliminating dampness, astringing intestines, stopping diarrhea, astringing to stop bleeding, and clearing heat and detoxicating. Through regulating spleen and stomach functions, promoting gastrointestinal digestion and repairing gastrointestinal damage, diarrhea of dogs and cats is improved, and meanwhile appetite is promoted, and solid and healthy excrement is discharged.
Wherein the weight portions of each component are 10-20 portions of spinose, 7-10 portions of bighead atractylodes rhizome, 7-10 portions of Chinese yam, 6-8 portions of poria cocos, 6-8 portions of hairyvein agrimony, 6-8 portions of purslane, preferably 10-15 portions of bighead atractylodes rhizome, 6-8 portions of Chinese yam, 5-7 portions of poria cocos, 5-7 portions of hairyvein agrimony, 5-7 portions of purslane, and more preferably 10 portions of spinose, 7 portions of bighead atractylodes rhizome, 7 portions of Chinese yam, 6 portions of poria cocos, 6 portions of hairyvein agrimony and 6 portions of purslane.
In some embodiments, the method of preparing the composition is: mixing the above materials at a certain proportion, pulverizing with pulverizer, sieving with 10 mesh sieve, weighing powder, adding 10 times of deionized water, soaking for 30min, rapidly boiling with strong fire, continuously boiling with slow fire for 30min, filtering to obtain decoction containing medicinal liquid, adding equal amount of deionized water, and repeating decoction. Mixing the two decoctions, standing for precipitation for 60min, vacuum filtering for two times, removing impurities, concentrating all the filtrates at 50deg.C by rotary evaporator, standing at room temperature, spray drying to obtain dry powder, and sieving with 80 mesh sieve to obtain spray-dried powder.
In a second aspect, the invention discloses a traditional Chinese medicine preparation for preventing and treating diarrhea, which comprises (i) the traditional Chinese medicine composition or the extract of the traditional Chinese medicine composition in the first aspect, (ii) pharmaceutically acceptable auxiliary materials or carriers; preferably, the dosage form of the traditional Chinese medicine preparation is a tablet.
Wherein the pharmaceutically acceptable auxiliary materials comprise any one or combination of a filler, a disintegrating agent, a binding agent, a lubricant and a flavoring agent, and preferably comprise the filler, the disintegrating agent, the binding agent, the lubricant and the flavoring agent.
Wherein the filler comprises any one or a combination of pregelatinized starch, dextrin, microcrystalline cellulose and lactose, preferably microcrystalline cellulose.
Wherein the disintegrating agent comprises any one or combination of povidone, sodium carboxymethyl starch and hydroxyethyl cellulose, preferably sodium carboxymethyl starch; preferably, the disintegrating agent is added by an internal and external combination method, namely 50-90% of the total mass of the disintegrating agent, is mixed with the traditional Chinese medicine composition and other auxiliary materials, sieved and granulated, and the rest disintegrating agent is added after drying.
Wherein the binder comprises water or an aqueous ethanol solution, and the volume concentration of the aqueous ethanol solution is 20% -80%, preferably 20% -40% aqueous ethanol solution, and preferably 30% aqueous ethanol solution.
Wherein the lubricant comprises magnesium stearate and/or talc, preferably magnesium stearate.
Wherein the flavoring agent comprises any one or the combination of beef extract powder, fishy smell, milk essence and ethanol water solution of sucralose.
Wherein, the traditional Chinese medicine preparation comprises the following components in parts by weight:
the dosage of the adhesive is 6-12mL/5g of the traditional Chinese medicine composition; preferably, the flavoring agent further comprises sucralose, and the dosage of the sucralose is 0.01-0.2g/100ml of adhesive;
preferably, the method comprises the steps of,
the dosage of the adhesive is 8-10mL/5g of the traditional Chinese medicine composition; preferably, the flavoring agent further comprises sucralose, and the dosage of the sucralose is 0.03-0.1g/100ml of adhesive;
preferably, the method comprises the steps of,
the dosage of the adhesive is 9mL/5g of the traditional Chinese medicine composition; preferably, the flavoring agent further comprises sucralose in an amount of 0.05g/100ml of binder.
The traditional Chinese medicine preparation is prepared by the following method:
(1) Mixing the traditional Chinese medicine composition, a filler, a flavoring agent except sucralose and a part of disintegrating agent, and sieving;
(2) Adding binder or binder containing sucralose, and sieving to obtain wet granule;
(3) Drying, adding lubricant and the rest disintegrating agent, granulating, and tabletting;
in step (1), the partial disintegrating agent accounts for 50% -90%, preferably 60% -80%, preferably 70% of the total mass of the disintegrating agent.
In the step (3), the parameters of the tablet press are that the pressure of the tablet press is 5000KN, and the voltage and power are 220V/0.75kw.
In a third aspect, the invention discloses a preparation method of the traditional Chinese medicine preparation in the second aspect, which comprises the following steps:
(1) Mixing the traditional Chinese medicine composition, a filler, a flavoring agent except sucralose and a part of disintegrating agent, and sieving;
(2) Adding binder or binder containing sucralose, and sieving to obtain wet granule;
(3) Drying, adding lubricant and the rest disintegrating agent, granulating, and tabletting;
in step (1), the partial disintegrating agent accounts for 50% -90%, preferably 60% -80%, preferably 70% of the total mass of the disintegrating agent.
In the step (3), the parameters of the tablet press are that the pressure of the tablet press is 5000KN, and the voltage and power are 220V/0.75kw.
In some embodiments, weighing the medicines, the filling agent, the flavoring agent and part of the disintegrating agent, grinding and uniformly mixing by an equivalent multiplication method, sieving with a sieve of 80-100 meshes, grinding the large particles again, sieving with a sieve of 60-80 meshes, spraying an appropriate amount of adhesive to ensure that all medicines can reach a state of kneading into clusters by hands to be slightly pressed and scattered, quickly sieving with a sieve of 20-30 meshes to prepare wet particles, spreading the wet particles in a tray, putting the wet particles into a 45 ℃ for drying for 90min until the wet particles are completely dried, sieving the dry particles with a sieve of 18-20 meshes to remove the large particles, adding the lubricant and the rest disintegrating agent, uniformly mixing, and finally performing granule finishing and tabletting.
In some embodiments, the prepared traditional Chinese medicine compound tablet for preventing and treating diarrhea of dogs and cats is 0.4g each tablet, the tablet is in a shallow arc shape, the tablet width is 1-1.2cm, the tablet thickness is 2mm, and the drug content of each tablet is 60%.
In a fourth aspect, the invention discloses the application of the traditional Chinese medicine composition or the traditional Chinese medicine preparation in preparing a product for preventing and treating diarrhea.
In a fifth aspect, the invention discloses a diarrhea preventing and treating product, which comprises the traditional Chinese medicine composition or the traditional Chinese medicine preparation.
In some embodiments, the product is used to control diarrhea in animals, such as cats and dogs.
In some embodiments, the canine and feline dosing regimen is every 1 tablet/2 kg body weight/day.
The beneficial effects are that:
the traditional Chinese medicine composition provided by the invention has the advantage that the spiny candy is a monarch drug for treating diarrhea with spleen strengthening and stomach benefiting and intestine astringents; the bighead atractylodes rhizome, rhizoma dioscoreae, poria cocos and poria cocos are used as ministerial drugs for strengthening spleen and eliminating dampness and assisting the glucose to recover gastrointestinal functions; the hairyvein agrimony has the functions of astringing and stopping bleeding, checking malaria and stopping diarrhea, and repairing intestinal injury bleeding as an adjuvant drug; purslane is a guiding drug for clearing heat and detoxicating and clearing damp-heat in intestinal tracts. The combination of the medicines can achieve the effects of strengthening spleen, eliminating dampness, astringing intestines, stopping diarrhea, astringing to stop bleeding, and clearing heat and detoxicating. Through regulating spleen and stomach functions, promoting gastrointestinal digestion and repairing gastrointestinal damage, diarrhea of dogs and cats is improved, and meanwhile appetite is promoted, and solid and healthy excrement is discharged.
Drawings
The foregoing and/or other advantages of the invention will become more apparent from the following detailed description of the invention when taken in conjunction with the accompanying drawings and detailed description.
FIG. 1 shows a pale yellow shallow arc-shaped circular piece prepared by the method.
FIG. 2 shows the angle of repose measurement method, the fixed hopper method.
Fig. 3 shows a spray-dried powder of the traditional Chinese medicine formula.
Fig. 4 is a graph showing the wetting profile of spray-dried powder of a traditional Chinese medicine formulation.
Fig. 5 is a three-dimensional effect curve diagram of the influence of each factor on the anti-diarrhea sheet of the traditional Chinese medicine, x1=a, x2=b.
Fig. 6 is a three-dimensional effect curve diagram of the influence of each factor on the anti-diarrhea sheet of the traditional Chinese medicine, x1=a, x2=c.
Fig. 7 is a three-dimensional effect curve diagram of the influence of each factor on the anti-diarrhea sheet of the traditional Chinese medicine, x1=a, x2=d.
Fig. 8 is a graph showing the therapeutic effect of the antidiarrheal tablet on partially diarrhea dogs.
Fig. 9 is a graph showing the therapeutic effect of the antidiarrheal tablet on a partially diarrhea cat.
Detailed Description
The invention is described in detail below in connection with the embodiments, but it should be noted that the scope of the invention is not limited by these embodiments and the principle explanation, but is defined by the claims.
According to the traditional Chinese medicine composition, the traditional Chinese medicine composition is pressed into tablets according to the physical property, the physical taste and the relation among substances of the traditional Chinese medicine and the characteristics of diarrhea of pets under the guidance of the traditional Chinese veterinary theory, and the application effect of the traditional Chinese medicine composition is measured.
The experimental methods described in the following examples are all conventional methods unless otherwise specified; the reagents and materials, unless otherwise specified, are commercially available.
In the present invention, any matters or matters not mentioned are directly applicable to those known in the art without modification except for those explicitly stated. Moreover, any embodiment described herein can be freely combined with one or more other embodiments described herein, and the technical solutions or ideas thus formed are all considered as part of the original disclosure or original description of the present invention, and should not be considered as new matters not disclosed or contemplated herein unless such combination would obviously be unreasonable to one skilled in the art.
All of the features disclosed in this invention may be combined in any combination which is understood to be disclosed or described in this invention unless the combination is obviously unreasonable by those skilled in the art.
The numerical points disclosed in the present specification include not only the numerical points specifically disclosed in the embodiments but also the end points of each numerical range in the specification, and any combination of these numerical points should be considered as a disclosed or described range of the present invention.
Technical and scientific terms used in the present invention are defined to have their meanings, and are not defined to have their ordinary meanings in the art.
The drug content in the following examples was represented by mass of main drug ×4/(mass of main drug ×4+mass of auxiliary material) ×100%.
EXAMPLE 1 preparation of spray dried powder of traditional Chinese medicine formulation
Prescription: 10 parts of spiny candy, 7 parts of bighead atractylodes rhizome, 7 parts of Chinese yam, 6 parts of poria cocos, 6 parts of hairyvein agrimony and 6 parts of purslane
Mixing the above materials according to the formula, pulverizing with pulverizer, sieving with 10 mesh sieve, accurately weighing 100g of powder, adding 10 times of deionized water, soaking for 30min, rapidly boiling with strong fire, continuously boiling with slow fire for 30min, filtering to obtain decoction containing water, adding equal amount of deionized water again, and repeating decoction. Mixing the two decoctions, standing for precipitation for 60min, vacuum filtering for two times, removing impurities, concentrating the total filtrate at 50deg.C by rotary evaporator until the concentration is 1ml equal to 4g of the raw materials (i.e. 1g of the main drug is equal to 4g of the drug content), drying, pulverizing the obtained dry powder, and sieving with 80 mesh sieve to obtain spray-dried powder of Chinese medicinal composition.
Example 2 Single-factor screening adjuvant
1. Screening of pre-experiment auxiliary materials
The spray-dried powder prepared in example 1 was subjected to shaping adjuvant selection, and shaping and drug content were used as investigation indicators, whereby a more suitable adjuvant was selected for single-factor screening.
Formability investigation results
Weighing the medicines and the filling agent according to the proportion, grinding and uniformly mixing by adopting an equivalent multiplication method, sieving by a 100-mesh sieve, grinding the large particles again, sieving by a 80-mesh sieve, spraying a proper amount of adhesive, kneading the large particles into clusters by hands to be dispersed, rapidly sieving by a 30-mesh sieve to prepare wet particles, putting the wet particles into 45 ℃ and drying for 90min, sieving the dry particles by a 20-mesh sieve to remove the large particles, and finally finishing the particles and tabletting.
According to the results of the formability and the drug content, the auxiliary materials which can be formed are pre-crosslinked starch, potato starch, lactose, microcrystalline cellulose and dextrin, but the pre-crosslinked starch and potato starch have the same properties, and the pre-crosslinked starch can still be formed at a higher drug content, so that the pre-crosslinked starch, lactose, microcrystalline cellulose and dextrin are selected as final fillers for single-factor screening, and the purified water and ethanol are selected as binders for preliminary screening.
2. Screening of fillers
(1) Filler component screening and moldability measurement of filler content
Weighing the above medicines and the required auxiliary materials according to the following table, grinding the weighed main medicines, the filling agent and the flavoring agent by an equivalent multiplication method, uniformly mixing, sieving with a 100-mesh sieve, grinding the large particles again, sieving with a 80-mesh sieve, adding an adhesive, rapidly sieving with a 30-mesh sieve to prepare wet particles, putting the wet particles into a 45 ℃ oven for about 90min to dry completely, sieving the dry particles with a 20-mesh sieve, adding a lubricant into the sieved particles, and carrying out granule straightening and tabletting.
Sheet type: circular piece width: 1.2cm thick sheet: 2mm of
Totaling: 50.00g of the medicine contains 50 percent of medicine
Evaluating and measuring the preparation process and the tablet property, and parallelly measuring repose angles of the three medicaments and auxiliary materials after mixing, so as to select an average value to evaluate the flowability of the medicaments; evaluating the preparation process according to sieving and granulating conditions when the binder is added to prepare wet granules; evaluating the appearance of the formed tablet;
randomly selecting 10 sheets to measure the average hardness; 6 tablets were randomly selected for the determination of drug disintegration time.
From the above results, it can be seen that pregelatinized starch, dextrin and microcrystalline cellulose can be tabletted and formed, and the preparation process of microcrystalline cellulose is optimal, and the disintegration time is also the fastest, so that the filler is selected as microcrystalline cellulose.
(2) Filler selection amount
The proportion of the main medicine and the filling agent is changed, so that the main medicine: adjuvant = 1:3 (drug content=57.1%), main drug: adjuvant = 1:2 (drug content=66.6%), main drug: adjuvant = 2:3 (drug content=72.7%) evaluating and measuring the preparation process and tablet property, parallelly measuring repose angle of three times of drugs mixed with auxiliary materials, so as to select average value to evaluate the fluidity of the drugs; evaluating the preparation process according to sieving and granulating conditions when the binder is added to prepare wet granules; evaluating the appearance of the formed tablet; randomly selecting 10 sheets to measure the average hardness; the disintegration time of the drug was determined by randomly selecting 6 tablets, thereby selecting a suitable drug content range.
The above results indicate that the tablet is not molded when the content is 72.7%, so the maximum content is 66.6%.
3. Screening of adhesives
(1) Screening of adhesive and quantitative determination of adhesive
The binder only plays a role in shaping when making tablets, and water is always used as the binder because the binder is evaporated in the final drying stage, but because the main medicine is concentrated four times and has high viscosity, ethanol (1 g of main medicine is added with 1ml of binder) with a certain proportion is adopted to easily screen and granulate, and therefore purified water and ethanol water solutions with different proportions are selected for screening when making the tablets.
Weighing the above medicines and the required auxiliary materials according to the following table, grinding the weighed main medicines, the filling agent and the flavoring agent by an equivalent multiplication method, uniformly mixing, sieving with a 100-mesh sieve, grinding the large particles again, sieving with a 80-mesh sieve, adding an adhesive, rapidly sieving with a 30-mesh sieve to prepare wet particles, putting the wet particles into a 45 ℃ oven for about 90min to dry completely, sieving the dry particles with a 20-mesh sieve, adding a lubricant into the sieved particles, and carrying out granule straightening and tabletting.
Sheet type: circular piece width: 1.2cm thick sheet: 2mm of
50.00g of the total medicine content is 50.0%
Evaluating and measuring the preparation process and the tablet property, mixing the medicine and auxiliary materials, weighing M1, recording, adding the adhesive, rapidly sieving to prepare wet particles, drying, weighing M2, and calculating the wet particle yield (M2/M1 is 100%); evaluating the appearance of the formed tablet; randomly selecting 10 sheets to measure the average hardness; 6 tablets were randomly selected for the determination of drug disintegration time.
From the above results, it can be seen that the disintegration time of the tablet becomes faster after ethanol is added, but the difference in hardness is not large, and the effect of ethanol contents of different concentrations on the disintegration time is small, so that a 30% ethanol solution is selected as a binder due to cost consideration.
(2) Adhesive selection measurement
The amount of binder was changed, and 6, 12 and 24ml were selected based on the amount of binder in (1) for quantitative determination, and evaluation and determination were made in terms of the manufacturing process and tablet properties: mixing the medicine with auxiliary materials, weighing M1, recording, adding an adhesive, rapidly sieving to prepare wet particles, drying, weighing M2, and calculating wet particle yield (M2/M1 is 100%); evaluating the preparation process according to sieving and granulating conditions when the binder is added to prepare wet granules; evaluating the appearance of the formed tablet; randomly selecting 10 sheets to measure the average hardness; the disintegration time of the drug was determined by randomly selecting 6 tablets, thereby selecting a suitable drug content range.
From the above results, it can be seen that the various indexes of the tablet after adding 12ml of 30% ethanol are obviously better than the dosage of 6ml and 24ml, and compared with the quantitative determination, the dosage of 6ml of 30% ethanol is selected, the granule yield is lower, so that 12ml of 30% ethanol solution is selected as a binder.
4. Screening of lubricants
(1) Lubricant composition and quantitative determination
Weighing the above medicines and the required auxiliary materials according to the following table, grinding the weighed main medicines, the filling agent and the flavoring agent by an equivalent multiplication method, uniformly mixing, sieving with a 100-mesh sieve, grinding the large particles again, sieving with a 80-mesh sieve, adding an adhesive, rapidly sieving with a 30-mesh sieve to prepare wet particles, putting the wet particles into 45 ℃ and drying for 90min to completely dry the wet particles into dry particles, sieving the dry particles with a 20-mesh sieve, adding 1% of lubricant into the sieved particles by mass fraction, and carrying out granule sizing and tabletting.
Totaling: 50.0g of the medicine contains 50.0 percent of medicine
Evaluating and measuring the preparation process and the tablet property, and measuring the repose angle of dry particles added with the lubricant three times in parallel, so as to select an average value to evaluate the fluidity of the medicine; randomly selecting 10 sheets to measure the average hardness; 6 tablets were randomly selected for the determination of drug disintegration time.
From the above results, it can be seen that magnesium stearate, talc, magnesium stearate and talc 1 were added: 1 the fluidity of the granules and the hardness of the tablets after mixing do not change much, but after mixing the two, a certain sealing effect is generated on the disintegration of the tablets, and because the lubricating effect of magnesium stearate and talcum powder has less influence on the disintegration time, and because of cost consideration, magnesium stearate is selected as a lubricant.
(2) Lubricant selection amount
Measuring magnesium stearate added with different proportions, evaluating and measuring the manufacturing process and the tablet property, and measuring the repose angle of dry granules added with magnesium stearate with different proportions three times in parallel, so as to select an average value to evaluate the fluidity of the medicine; randomly selecting 10 sheets to measure the average hardness; randomly selecting 6 tablets to measure the disintegration time of the medicine; 20 tablets were randomly selected for determination of the tablet weight difference.
From the above results, it can be seen that the above magnesium stearate amounts are satisfactory, so that the magnesium stearate amount is still 1%.
5. Screening of disintegrants
(1) Disintegrant composition and quantitative determination
Weighing the above medicines and the required auxiliary materials according to the following table, grinding and mixing the weighed main medicines, the filling agent, the flavoring agent and the disintegrating agent (internal adding) by an equivalent multiplication method, sieving with a 100-mesh sieve, grinding large particles again, sieving with a 80-mesh sieve, adding an adhesive, rapidly sieving with a 30-mesh sieve to prepare wet particles, putting the wet particles into 45 ℃ and drying for about 90min to completely dry the wet particles into dry particles, sieving the dry particles with a 20-mesh sieve, adding a lubricant into the sieved particles, and performing granule finishing and tabletting.
Totaling: 50.0g of the medicine contains 50.0 percent of medicine
Evaluating and measuring the appearance and properties of the tablet, and evaluating the appearance and shape of the molded tablet; randomly selecting 10 sheets to measure the average hardness; 6 tablets were randomly selected for the determination of drug disintegration time.
From the above results, it can be seen that the disintegration properties of CMS-Na and PVPK30 are much higher than HEC and the hardness is substantially unchanged, so CMS-Na was selected as disintegrant.
(2) Disintegrant selection amount
Measuring CMS-Na (internal addition) added with different proportions, measuring the properties of the tablets, and randomly selecting 10 tablets to measure the hardness average value; 6 tablets were randomly selected for the determination of drug disintegration time.
From the above results, it can be seen that the addition of 10% of CMS-Na has a significant effect of reducing the disintegration time, so that the amount of disintegrant was determined to be 10% of CMS-Na.
(3) Determination of disintegrant addition method
Measuring CMS-Na (content is 10%) added with different methods, measuring the properties of tablets, and randomly selecting 10 tablets to measure the hardness average value; randomly selecting 6 tablets to measure the disintegration time of the medicine; 20 tablets were randomly selected for determination of the tablet weight difference.
External addition: the disintegrating agent is added externally, the medicine is prepared into dry granules, and the dry granules are added into the disintegrating agent after passing through a 20-mesh screen.
And (3) an inner and outer combination method: the method is that 70% internal addition and 30% external addition are adopted for preparation, and the addition method is the same as the steps.
From the above results, it can be seen that the method of adding the disintegrating agent significantly affects the disintegration time of the tablet, and the selection of 70% internal addition can significantly reduce disintegration while meeting the detection requirements of tablet weight difference, so that the method of combining the inside and the outside is selected.
6. Screening of flavoring agents
The test selects beef essence, fishy smell and milk essence for improving the smell of the tablets, uses sucralose to improve the taste of the drugs, and carries out food intake statistics on fasting healthy dogs and cats, wherein the statistical results are shown in the following table, and the beef extract powder and a 30% ethanol solution of 1% sucralose have better palatability when being used as a flavoring agent.
Example 3 multifactor screening adjuvants
Four auxiliary materials, namely a filling agent, a lubricant, an adhesive and a disintegrating agent (an adding mode: an internal and external combination method) are selected according to factors with the greatest influence on tablet forming and quality in a tabletting process, the dosage range of each type of auxiliary material is determined according to the results of pre-experiment and single factor test measurement, so that the optimal proportion is selected, the optimal proportion is comprehensively selected according to the granulating difficulty, tablet appearance, tablet hardness, disintegration time limit and drug content in the tabletting process according to the grading proportion, the total is 10 minutes, the highest is selected as the optimal proportion, and the following is a measurement range table and a grading standard table of each factor.
TABLE 3-1 response surface test recipe
TABLE 3-2 Table of the ranges of measurement of the factors mainly affecting the molding and quality of tablets
TABLE 3-3 physical parameter scoring criteria
Tables 3-4 preparation Process scoring criteria
TABLE 3-5 response surface Experimental design
Note that: the mass of the filler was determined based on the disintegrant and the lubricant, and in experiment 1, the mass of the disintegrant was 25g×10% =2.5 g, the mass of the lubricant was 25g×0.55% =0.1375 g, the mass of the taste modifier was 1g, and the mass of the filler was 20-2.5-0.1375-1= 16.3625g. Determining the prescription according to the response surface result as shown in tables 3-5;
tables 3 to 5
The crude drug content of the prescription is 63.5%, wherein the filler is 53%, the disintegrant is 10% (with an internal adding ratio of 70%), the lubricant is 0.55%, 9ml of 30% ethanol solution adhesive is added per 5g of main drug, and the flavoring agent is 6% and sucralose-30% ethanol solution.
The results of the detection are shown in tables 3 to 6.
Tables 3 to 6
Example 4 quality inspection of tablets
According to the prescription optimization result, the dosage of the medicines and the auxiliary materials in the prescription in the embodiment 3 is increased by 10 times, the medicines and the required auxiliary materials are weighed, 70% of the total mass of the weighed main medicines, the filling agent, the flavoring agent and the disintegrating agent is ground and mixed uniformly by an equivalent multiplication method, then the main medicines, the filling agent, the flavoring agent and the disintegrating agent are sieved by a 100-mesh sieve, large particles are ground again and sieved by an 80-mesh sieve, an adhesive is added, wet particles are quickly sieved by a 30-mesh sieve, the wet particles are put into 45 ℃ and dried for 90 minutes to be completely dried into dry particles, the dry particles are sieved by a 20-mesh sieve, and the sieved particles are added with a lubricant and additional surplus disintegrating agent to carry out granule straightening tabletting.
Three batches of tablets were prepared by the same method, and the weight difference, hardness, friability, disintegration time, palatability, appearance and other properties of the tablets were examined.
1. Sheet weight difference detection result
The tablets are checked according to the method specified in the second annex tablet weight difference item of the animal pharmacopoeia of the people's republic of China in 2020 edition. Randomly taking 20 pieces of the test sample, precisely weighing the total weight, and precisely weighing each piece after the average piece weight is obtained. The measured sheet weights were compared with the average sheet weights and the sheet weight differences were calculated as follows:
note that: the average tablet weight is more than 0.4g, and the weight difference limit is +/-5%.
The results show that the weight difference of the test products is within the limit range, and accords with the pharmacopoeia weight difference regulation.
2. Hardness detection
For the hardness requirement of the tablet, the examination item is not specified in the pharmacopoeia clearly and uniformly, and the hardness of the tablet is specified to be not less than 50N in combination with the actual condition of the hardness requirement when the tablet is prepared. 10 tablets of the product are arbitrarily taken, and the hardness grade of a sample is measured according to a four-purpose tablet tester, so that the following results are obtained:
the results show that the hardness of the samples meets the regulations.
3. Friability inspection
Three batches of medicines, 20 tablets each, were randomly taken, and the fallen powder was blown off by a blower and precisely weighed, referring to the examination method for friability of tablets in the edition 2020 of Chinese pharmacopoeia. Friability was measured using a friability scale in a four-purpose tablet meter, shaken for 5min, taken out, removed from the powder by the same method, and precisely weighed. The weight loss was calculated and checked for the presence of splits and fragments, with the following results:
note that: 1. tablets requiring a weight loss of not more than 1% and no breakage, cracks and pulverization to be detected; "-" indicates undetected.
The test results show that the weight loss of all three batches of samples is less than 1%, and the friability of the preparation is proved to be in accordance with the pharmacopoeia regulations.
4. Disintegration time limit detection
Taking 6 tablets of three batches of test sample tablets respectively, respectively placing the tablets into glass tubes of a hanging basket of a disintegrating instrument according to the rule of 89 disintegration time limit inspection method of two appendices of the beast pharmacopoeia of the people's republic of China, adding a baffle plate into an aqueous solution at 37+/-1 ℃, starting the disintegrating instrument to inspect, and recording the disintegration time after all the tablets disintegrate and pass through a screen, wherein the result is as follows:
note that: the standard specifies that the tablet should disintegrate completely within 30 min.
The results show that the disintegration time of the prepared three batches of Chinese medicinal tablets in water at 37+/-1 ℃ is lower than 30 minutes, and the preparation meets the requirements of Chinese animal pharmacopoeia.
5. Appearance and palatability observations
As shown in figure 1, the finished product of the medicine is light yellow with uniform color, conical shape, smooth and uniform surface, no splinter and fragments, complete luster, consistent color, slightly sweet taste and light beef flavor.
Palatability observations were made on empty and healthy dogs and cats as follows:
example 5 diarrhea canine case screening
Diarrhea dogs were selected based on stool scores. Diarrhea dogs with stool scores of 1 were selected for testing, and specific stool scores were as follows: 1, the method comprises the following steps: complete liquid manure; 2, the method comprises the following steps: the excrement has high humidity, is not completely in a liquid state, is not easy to pick up, and can be adhered at the perianal part in some cases; 3, the method comprises the following steps: the excrement is moist and cylindrical, and residues are left when the excrement is picked up from the ground; 4, the following steps: the surface of the excrement has clear visible lines and chaps, is easy to pick up, and basically has no residue on the ground; 5, the method comprises the following steps: the water content is extremely low, and the product is dry, fragile and blocky. Wherein stool score 3 was divided into normal stools. A total of 15 clinical diarrhea canine cases with a clinical diarrhea stool score of 1 were obtained for testing.
1. Test design
After 15 clinical diarrhea canine cases are tested and diarrhea caused by infectious disease factors is eliminated, the common diarrhea is diagnosed and treated by adopting the traditional Chinese medicine antidiarrheal tablets, each canine is fed with the traditional Chinese medicine antidiarrheal tablets prepared in example 4 2 hours after meals every day, each canine is fed with 1 tablet every 2kg body weight every day, the maximum treatment day is 5 days, the daily fecal score is recorded, and the treatment effect is evaluated.
2. Results
The therapeutic effects of the traditional Chinese medicine antidiarrheal tablet on diarrhea dogs are shown in the following table 5. The traditional Chinese medicine antidiarrheal tablet is cured completely after 5 days of treatment, and the cure rate reaches 100%. Wherein 1 is cured by 1 day, 3 is cured by 2 days, 8 is cured by 3 days, 2 is cured by 4 days, 1 is cured by 5 days, and the number of cures is the largest by 3 days.
Table 5 analysis of the therapeutic effect of the chinese medicinal antidiarrheal tablet on diarrhea dogs
3. Conclusion(s)
The traditional Chinese medicine antidiarrheal tablet has the highest cure quantity in 3 days of treatment of diarrhea dogs, the total cure rate is 100% after 5 days of administration, and as shown in the treatment result of fig. 8, the loose stool of which the stool is not formed before the medicine feeding can be seen, and the traditional Chinese medicine antidiarrheal tablet is converted into healthy strip-shaped stool and tangible solid stool after 1 day of treatment, which shows that the traditional Chinese medicine antidiarrheal tablet has better effect on common diarrhea of dogs.
Example 6 diarrhea cat case screening:
diarrhea cats were selected based on stool scores. Diarrhea cats with stool scores of 1 were selected for the test, and specific stool scoring criteria are shown in example 5. The total screening is carried out to obtain 20 clinical diarrhea cat cases with the weight of about 2kg and the fecal score of 1 minute.
1. Test design
The test shows that 20 cases of clinical diarrhea and cat are common diarrhea after diarrhea caused by infectious disease factors is eliminated, and 20 cases of diarrhea are treated by the traditional Chinese medicine antidiarrheal tablet. Traditional Chinese medicine antidiarrheal tablet the traditional Chinese medicine antidiarrheal tablet prepared in example 4 is fed 2h after meals, 1 tablet is given to each cat every 2kg body weight every day, the maximum treatment days are 5 days, and the daily fecal scores are recorded to evaluate the treatment effect.
2. Results
The therapeutic effects of the antidiarrheal tablet on diarrhea cats are shown in table 6 below. The diarrhea cats with the antidiarrheal tablets prepared from the traditional Chinese medicine are all cured after being treated for 5 days, and the cure rate reaches 100%. Wherein, the medicine is cured by 1 day, the medicine is cured by 2 days, the medicine is cured by 4 days, the medicine is cured by 3 days, the medicine is cured by 1 day, and the medicine is cured by 3 days, so that the cure quantity is the largest.
Table 6 analysis of therapeutic Effect of Chinese medicinal antidiarrheal tablet on diarrhea cats
3. Conclusion(s)
The traditional Chinese medicine antidiarrheal tablet has the highest cure quantity in 3 days on the treatment days of diarrhea cats, the total cure rate is 100% after 5 days of administration, and as the treatment result of fig. 9, the excrement is in a water shape and is not formed, the excrement is converted into healthy strip-shaped excrement and columnar excrement after 1-4 days of treatment, the diarrhea of the diarrhea cats with serious diseases is obviously improved after 2 days of administration, the excrement is converted into thin excrement from the non-formed water-shaped excrement, and the shape of the healthy excrement can be recovered after 4 days, so that the traditional Chinese medicine antidiarrheal tablet has a good treatment effect on diarrhea of cats.
The foregoing examples illustrate only a few embodiments of the invention and are described in detail herein without thereby limiting the scope of the invention. It should be noted that it will be apparent to those skilled in the art that several variations and modifications can be made without departing from the spirit of the invention, which are all within the scope of the invention. Accordingly, the scope of protection of the present invention is to be determined by the appended claims.
Claims (28)
1. The traditional Chinese medicine composition for pets for preventing and treating diarrhea is characterized by being prepared from the following components in parts by weight: sugar, rhizoma Atractylodis Macrocephalae, rhizoma Dioscoreae, poria, herba Agrimoniae, and herba Portulacae; the components comprise 10-20 parts of spinose, 7-10 parts of bighead atractylodes rhizome, 7-10 parts of Chinese yam, 6-8 parts of poria cocos, 6-8 parts of hairyvein agrimony and 6-8 parts of purslane.
2. The traditional Chinese medicine composition for pets for preventing and treating diarrhea is characterized by being prepared from the following components in parts by weight: 10-15 parts of spiny candy, 6-8 parts of bighead atractylodes rhizome, 6-8 parts of Chinese yam, 5-7 parts of poria cocos, 5-7 parts of hairyvein agrimony and 5-7 parts of purslane.
3. The traditional Chinese medicine composition according to claim 1, wherein the weight parts of each component are 10 parts of thorn, 7 parts of bighead atractylodes rhizome, 7 parts of Chinese yam, 6 parts of poria cocos, 6 parts of hairyvein agrimony and 6 parts of purslane.
4. A traditional Chinese medicine preparation for pets for preventing and treating diarrhea, which is characterized by comprising (i) the traditional Chinese medicine composition of claim 1 or 2 and (ii) pharmaceutically acceptable auxiliary materials or carriers.
5. The traditional Chinese medicine preparation according to claim 4, wherein the dosage form of the traditional Chinese medicine preparation is a tablet.
6. The traditional Chinese medicine preparation according to claim 4, wherein the pharmaceutically acceptable auxiliary materials comprise any one or a combination of a filler, a disintegrating agent, an adhesive, a lubricant and a flavoring agent.
7. The traditional Chinese medicine preparation according to claim 4, wherein the pharmaceutically acceptable auxiliary materials comprise a filler, a disintegrating agent, an adhesive, a lubricant and a flavoring agent.
8. The traditional Chinese medicine preparation according to claim 4, wherein the traditional Chinese medicine preparation comprises the following components in parts by weight:
3-7 parts of the traditional Chinese medicine composition
7.25-10.25 parts of filler
0.55-2.65 parts of disintegrating agent
0.06-1 part of lubricant
0.5-1.5 parts of flavoring agent
The dosage of the adhesive is 6-12mL/5g of the traditional Chinese medicine composition.
9. The traditional Chinese medicine preparation according to claim 4, wherein the traditional Chinese medicine preparation comprises the following components in parts by weight:
4-6 parts of the traditional Chinese medicine composition
8.25 to 9.25 portions of filling agent
1.05 to 2.15 portions of disintegrating agent
0.08-0.5 part of lubricant
0.8-1.2 parts of flavoring agent
The dosage of the adhesive is 8-10mL/5g of the traditional Chinese medicine composition.
10. The traditional Chinese medicine preparation according to claim 4, wherein the traditional Chinese medicine preparation comprises the following components in parts by weight:
5 parts of the traditional Chinese medicine composition
8.75 parts of filler
1.65 parts of disintegrating agent
0.1 part of lubricant
1 part of corrigent
The dosage of the adhesive is 9mL/5g of the traditional Chinese medicine composition.
11. The traditional Chinese medicine preparation according to any one of claims 5-10, wherein the filler comprises any one or a combination of pregelatinized starch, dextrin, microcrystalline cellulose and lactose.
12. The traditional Chinese medicine preparation according to any one of claims 5-10, wherein the filler is microcrystalline cellulose.
13. The traditional Chinese medicine preparation according to any one of claims 5-10, wherein the disintegrant comprises any one or a combination of povidone, sodium carboxymethyl starch and hydroxyethyl cellulose.
14. The traditional Chinese medicine preparation according to any one of claims 5-10, wherein the disintegrant is sodium carboxymethyl starch.
15. The traditional Chinese medicine preparation according to any one of claims 5 to 10, wherein the binder comprises water or an aqueous ethanol solution, and the volume concentration of the aqueous ethanol solution is 20% -80%.
16. The traditional Chinese medicine preparation according to any one of claims 5-10, wherein the binder is 20% -40% ethanol aqueous solution.
17. The traditional Chinese medicine preparation according to any one of claims 5 to 10, wherein the binder is 30% ethanol aqueous solution.
18. The traditional Chinese medicine preparation according to any one of claims 5-10, characterized in that the lubricant comprises magnesium stearate and/or talc.
19. The traditional Chinese medicine preparation according to any one of claims 5-10, wherein the lubricant is magnesium stearate.
20. The traditional Chinese medicine preparation according to any one of claims 5-10, wherein the flavoring agent comprises any one or a combination of beef extract powder, fishy smell, milk essence and an ethanol aqueous solution of sucralose.
21. The traditional Chinese medicine preparation according to claim 6 or 7, which is prepared by the following method:
(1) Mixing the traditional Chinese medicine composition, a filler, a flavoring agent and a part of disintegrating agent, and sieving;
(2) Adding binder, and sieving to obtain wet granule;
(3) Drying, adding lubricant and the rest disintegrating agent;
in the step (1), the partial disintegrating agent accounts for 50-90% of the total mass of the disintegrating agent.
22. The traditional Chinese medicine preparation according to claim 21, wherein the partial disintegrating agent is 60% -80% of the total mass of the disintegrating agent.
23. The traditional Chinese medicine preparation according to claim 21, wherein the partial disintegrant is 70% of the total mass of the disintegrant.
24. The method for preparing the Chinese medicinal preparation according to claim 6 or 7, comprising the following steps:
(1) Mixing the traditional Chinese medicine composition, a filler, a flavoring agent and a part of disintegrating agent, and sieving;
(2) Adding binder, and sieving to obtain wet granule;
(3) Drying, adding lubricant and the rest disintegrating agent;
in the step (1), the partial disintegrating agent accounts for 50-90% of the total mass of the disintegrating agent.
25. The method for preparing a pharmaceutical formulation according to claim 24, wherein the partial disintegrant is 60% -80% of the total mass of the disintegrant.
26. The method for preparing a pharmaceutical formulation according to claim 24, wherein the partial disintegrant is 70% of the total mass of the disintegrant.
27. Use of a traditional Chinese medicine composition according to any one of claims 1-3, or a traditional Chinese medicine preparation according to any one of claims 4-23, for the preparation of a pet product for the prevention and treatment of diarrhea.
28. A pet product for preventing and treating diarrhea, comprising the traditional Chinese medicine composition according to any one of claims 1 to 3, or the traditional Chinese medicine preparation according to any one of claims 4 to 23.
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Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102908491A (en) * | 2012-11-15 | 2013-02-06 | 郑军辉 | Chinese medicinal powder for treating chronic diarrhea and preparation method thereof |
| CN103751201A (en) * | 2014-01-03 | 2014-04-30 | 聊城大学 | Anti-parasitic orally disintegrating tablet for dogs and cats and preparation method thereof |
| CN115770251A (en) * | 2022-11-30 | 2023-03-10 | 石河子大学 | Application of polysaccharide in preparing medicine for preventing and/or treating ulcerative colitis |
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Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102908491A (en) * | 2012-11-15 | 2013-02-06 | 郑军辉 | Chinese medicinal powder for treating chronic diarrhea and preparation method thereof |
| CN103751201A (en) * | 2014-01-03 | 2014-04-30 | 聊城大学 | Anti-parasitic orally disintegrating tablet for dogs and cats and preparation method thereof |
| CN115770251A (en) * | 2022-11-30 | 2023-03-10 | 石河子大学 | Application of polysaccharide in preparing medicine for preventing and/or treating ulcerative colitis |
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| 中药多糖对PRRS 疫苗的免疫增强 作用研究进展;陈晓兰 等;黑龙江畜牧兽医;20130515(第5期);29-31 * |
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| 天然抗腹泻维吾尔药的研究进展;阿衣努尔・阿布都克热木;卡力比努尔・依地力斯;吐尔逊阿依・热合木提拉;;中国民族医药杂志;20170828(第08期);46-47 * |
| 犬猫腹泻辨证施治;许剑琴;王自力;麻武仁;尹朋;;中兽医学杂志;20130415(第02期);35-38 * |
| 阿衣努尔・阿布都克热木 * |
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