CN114796353A - Ginseng-wolfberry essence-strengthening particles capable of enhancing immunity and preparation method thereof - Google Patents
Ginseng-wolfberry essence-strengthening particles capable of enhancing immunity and preparation method thereof Download PDFInfo
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- CN114796353A CN114796353A CN202210294918.6A CN202210294918A CN114796353A CN 114796353 A CN114796353 A CN 114796353A CN 202210294918 A CN202210294918 A CN 202210294918A CN 114796353 A CN114796353 A CN 114796353A
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Abstract
The invention provides a ginseng-medlar sperm-strengthening particle for enhancing immunity and a preparation method thereof, belonging to the technical field of health care medicines. The ginseng-wolfberry fruit essence-strengthening particle for enhancing immunity is prepared by taking codonopsis pilosula, wolfberry fruit, astragalus mongholicus, semen cuscutae, schisandra chinensis, angelica sinensis, teasel roots, motherwort, raw oysters, cornu cervi degelatinatum, herba epimedii, medicated leaven, fructus liquidambaris and human placenta as main components and dextrin and steviosin as auxiliary materials, the ginseng-wolfberry essence-strengthening particle develops traditional Chinese medicine decoction into a particle, the defects that decoction is inconvenient to carry, easy to go moldy and deteriorate after being placed for a long time, large taking volume and the like are overcome, once the ginseng-wolfberry essence-strengthening particle is successfully developed, the ginseng-wolfberry essence-strengthening particle is put into mass production, large-scale production drives industrialized development, advantages of rich traditional Chinese medicine resources can be played, employment posts are increased, the capability and technical level of traditional Chinese medicine products can be improved, the competitiveness of the traditional Chinese medicine industry is enhanced, and the economic development of regions is promoted to have important significance.
Description
Technical Field
The invention relates to the field of health-care medicines, in particular to a ginseng-medlar sperm-strengthening particle for enhancing immunity and a preparation method thereof.
Background
With the arrival of the age-related era of population and the opening of comprehensive three-birth policy in China, more and more families prepare to grow two or three births. On the contrary, the fertility of human beings is gradually reduced due to the influence of factors such as environmental pollution, high working pressure, sexual openness, bad living habits and the like, and the contradiction seriously influences the stability of society and the harmony of families and seriously influences the implementation of policies about population. The product, namely the ginseng-wolfberry fruit sperm-strengthening granules, researched and developed by the project has the effects of tonifying kidney and spleen, promoting blood circulation and nourishing blood, clearing heat and promoting diuresis and enhancing immunity, is an effective prescription for treating oligospermia and asthenospermia after being clinically applied for more than ten years, and can better serve the strategy of population and birth policy, so that the implementation of the project has important significance, and is necessary and very reluctant.
The traditional Chinese medicine has unique curative effect on treating the male infertility and accumulates abundant experience. The traditional Chinese medicine considers that the causes of male infertility are complex, including congenital and acquired factors, trauma, emotional strain and the like, and relate to kidney, spleen and liver, wherein the kidney is particularly important. For the etiology and pathogenesis of oligospermia, the traditional Chinese medicine considers that kidney essence is deficient due to congenital weakness, or kidney essence is consumed in dark due to improper atrioventricular organ and excessive tone, or kidney essence is consumed due to five-strain seven-impairment, chronic illness and kidney, or kidney essence is not nourished due to acquired weakness of spleen and stomach and lack of nourishment, and finally kidney essence is lost to form essence deficiency. Kidney stores essence to govern reproduction, and when kidney essence is insufficient, reproductive function is declined, and the essence of the genitals is generated as a source; the damp-heat fumigates the seminal compartment to form turbid, which blocks the essence vessels, or fails to discharge the essence and blocks the blood, or the liver-qi is uncomfortable, the dysfunction of the qi in dispersing, the disorder of qi movement, the blood stasis of the strange meridians, the obstruction of the essence channels, or the chronic disease entering the collaterals, or the phlegm-dampness, or the trauma, or the circuitous route of the spermatic cord and blood vessels, causing turbid stasis and blocking the orifices, thus forming the essence stasis.
The traditional Chinese medicine for enhancing immunity has the defects of decoction, inconvenience in carrying, easiness in going mouldy and going bad after being placed for a long time, large taking volume and the like, and brings bad use experience to users.
Disclosure of Invention
In order to make up for the defects, the invention provides the ginseng-wolfberry fruit essence-strengthening particles for enhancing the immunity and the preparation method thereof, aiming at solving the problems that the traditional Chinese medicine for enhancing the immunity has the defects of decoction, inconvenient carrying, easy mildewing and deterioration after long-term storage, large taking volume and the like, and brings bad use experience to users.
The invention is realized by the following steps:
in a first aspect, the invention provides a ginseng and wolfberry fruit essence strengthening particle for enhancing immunity, which is prepared by taking codonopsis pilosula, wolfberry fruit, astragalus mongholicus, semen cuscutae, schisandra chinensis, angelica sinensis, teasel roots, motherwort, raw oyster shells, cornu cervi degelatinatum, herba epimedii, medicated leaven, fructus liquidambaris and human placenta as main components and taking dextrin and steviosin as auxiliary materials.
In one embodiment of the invention, the weight of the codonopsis pilosula, the wolfberry fruit, the astragalus membranaceus, the dodder, the schisandra chinensis, the angelica sinensis, the teasel root, the motherwort, the raw oyster shell, the cornu cervi degelatinatum, the epimedium herb, the medicated leaven, the sweetgum fruit and the human placenta is 10-20g, 15-25g, 19-28g, 11-19g, 8-14g, 7-12g, 4-17g, 21-38g, 22-39g, 6-14g, 10-19g, 2-15g, 4-16g and 2-6g in sequence.
In a second aspect, the present invention further provides a preparation method of the immunity-enhancing ginseng-wolfberry essence-strengthening particles, including the above immunity-enhancing ginseng-wolfberry essence-strengthening particles, and the following steps:
s1: pre-treating, namely, pre-treating raw materials such as codonopsis pilosula, wolfberry fruit, astragalus mongholicus, semen cuscutae, schisandra chinensis, angelica sinensis, teasel roots, motherwort, raw oysters, epimedium and fructus liquidambaris, and sequentially cleaning, cutting and mixing the raw materials by using a cleaning mechanism, a cutting mechanism and a mixing mechanism;
s2: decocting, namely decocting the mixed codonopsis pilosula, the medlar, the astragalus, the dodder, the schisandra chinensis, the angelica, the teasel root, the motherwort, the raw oyster, the epimedium and the sweetgum fruit by using a decocting mechanism;
s3: filtering, filtering to obtain medicinal liquid, and collecting residue of radix Codonopsis, fructus Lycii, radix astragali, semen Cuscutae, fructus Schisandrae chinensis, radix Angelicae sinensis, radix Dipsaci, herba Leonuri, Concha Ostreae, herba Epimedii and fructus Lipuidambaris;
s4: softening, concentrating the medicinal liquid, making into extract, mixing placenta hominis, cornu Cervi Degelatinatum, Massa Medicata Fermentata powder and dextrin, adding into the extract, and making into ointment;
s5: granulating, drying and pulverizing the ointment, adding steviosin, granulating, and drying to obtain granules;
s6: inspecting, namely identifying components in the particles by utilizing thin-layer chromatography identification, microscopic identification, microbial limit inspection, conventional inspection and content measurement;
s7: and pharmacological research, namely, researching whole grains by utilizing clinical research and observation, animal experimental research and toxicological research to obtain pharmacological basis.
In an embodiment of the present invention, the cleaning mechanism in step S1 is composed of a traditional Chinese medicine cleaning machine and a feeding structure, the feeding structure sequentially injects raw materials of codonopsis pilosula, wolfberry fruit, astragalus root, dodder, schisandra fruit, angelica, teasel root, motherwort, raw oyster, epimedium, beautiful sweetgum fruit, etc. into the traditional Chinese medicine cleaning machine, and the traditional Chinese medicine cleaning machine cleans the raw materials.
In an embodiment of the present invention, the dividing and cutting mechanism in step S1 is composed of a dividing and cutting machine and a collecting box, the collecting box is disposed under a feed opening of the dividing and cutting machine, the mixing mechanism is composed of a reaction kettle, a motor, a connecting shaft, a stirring blade and a bin, the motor is fixed on an upper surface of the reaction kettle, an upper end of the connecting shaft is fixed on an output shaft of the motor, the stirring blade is fixed on an outer wall of the connecting shaft, the bin is disposed on the reaction kettle, the dividing and cutting machine divides and cuts the cleaned raw material into sections, the collecting box collects the sections of the raw material, an operator injects the raw material into the reaction kettle through the bin, and the motor operates to drive the stirring blade to mix the raw material.
In an embodiment of the present invention, the decocting unit of step S2 includes a decocting furnace and a filter screen fixed in the decocting furnace, the filter screen is used for injecting the uniformly mixed materials into the decocting furnace, drinking water is injected into the decocting furnace, the decocting furnace is used for decocting the materials, and after the decoction is finished, the filter screen filters out the filter residue to obtain the concentrated liquid medicine.
In an embodiment of the present invention, the thin-layer chromatography identification in step S6 is performed to perform thin-layer chromatography identification research on the medicines of the formula, and the product quality is controlled by selecting an identification method with strong specificity and good reproducibility, for the medicines without identification items and content determination in the legal standard of the medicines, the reference substance is preferably a reference medicine, and then is a reference substance with strong reproducibility and content identification, which works well, for the research on the preparation method of the test product, the selection of the development condition, the selection of the inspection condition, the special inspection and the reproducibility inspection, according to the formula, the medicines are composed, the raw medicine is used as the reference, the pharmacopeia method is referred, the components which can be qualitatively identified are preferably selected according to astragaloside IV in astragalus membranaceus, lycium barbarum polysaccharides and betaine in lycium barbarum, dipsacoside VI in dipsacus aspen, hydrochloric acid threonine in leonurus, ferulic acid in schisandra chinensis, cholol A in schisandra chinensis, and lobetyolin in codonopsis pilosula, determining several qualitative identification items, carrying out microscopic identification on the original medicinal materials which are pulverized and granulated in the prescription, observing and identifying under a microscope, carrying out microbial limit inspection, researching the microbial limit inspection method of the product by using the requirements of the microbial limit inspection method, and carrying out conventional inspection on the ginseng-wolfberry fruit strong essence granules by using conventional inspection, wherein the conventional inspection comprises properties, water content, weight difference, dissolution time limit and the like. The content determination research is carried out according to the medicine formed by a prescription, referring to a pharmacopeia method, in the aspects of determining dipsacus asperoides VI in dipsacus asperoides by adopting a high performance liquid chromatography, determining wolfberry polysaccharides in wolfberry by adopting a visible-ultraviolet spectrophotometry method, determining betaine in wolfberry by adopting a thin layer chromatography, determining hydrochloric acid threonine in leonurus by adopting a TCL method, determining ferulic acid in a angelica by adopting an HPLC method, determining schizandrol A in schisandra by adopting an HPLC method, determining astragaloside in astragalus by adopting an HPLC method or a TCL method and the like, and the experimental research is carried out to find indexes suitable for the quantitative control of the preparation.
In one embodiment of the invention, the clinical study observations in S7 included the case inclusion criteria: the female is not pregnant after taking any contraceptive measures for more than 1 year of regular life; the sperm examination meets the diagnosis standard of oligospermia; anti-sperm antibody negative; the detection method comprises the following steps: performing a complete set of correlation analysis by using a computer-aided semen analysis technology; case grouping and administration methods; case grouping: according to the principles of random, contrast and balance, 120 patients with oligospermia meeting the inclusion standard are numbered according to the sequence of treatment, and are randomly divided into a contrast group taking spermatogenic capsules and a treatment group taking ginseng-wolfberry spermatogenic granules according to a random number table, wherein each group comprises 60 patients; the administration method comprises the following steps: the treatment group takes ginseng, medlar and sperm strengthening granules orally; the control group orally takes the positive control medicine spermatogenic capsule 4 times/time, 3 times/day; observation indexes are as follows: after 1 treatment course, observing the clinical curative effect and the change of sperm parameters; clinical cure: the pregnancy of the female or the sperm density, the motility and the like are recovered to be normal; the method has the following advantages: although the sperm detection is abnormal, the sperm motility rate and the activity of a grade or a + b grade sperms are improved by more than or equal to 30 percent, and the sperm density is improved by more than or equal to 2 multiplied by 109/L after the oligospermia is treated; and (4) invalidation: those which do not meet the above standards.
In an embodiment of the present invention, the animal experiment in S7 utilizes the effect of the ginseng-wolfberry spermatozoon granules on the sperm quality and the anti-oxidation effect of the weak sperm rats to randomly divide 50 male rats into 5 groups, each group contains 10 rats, each rat is gavaged with ornidazole 400 mg/kg/d to establish a rat weak sperm syndrome model except for the normal group, each rat is gavaged with low, medium and high doses of the ginseng-wolfberry spermatozoon granules, the normal group contains 0.5% sodium carboxymethylcellulose, each group of rats is continuously dosed with 21d to detect the sperm motility, sperm motility rate, sperm count, epididymal malondialdehyde content, superoxide dismutase, glutathione peroxidase and nitric oxide synthase activities of the rats, each group of the testis and epididymal tail of the rat are fixed with 3% glutaraldehyde, and are conventionally pathologically sliced to observe the change of the numbers of the sperm epithelium, epididymal epithelium and intraluminal sperm of the rat, observing cell and subcellular structures of spermatogenic epithelium, epididymal epithelium and sperm by using a transmission electron microscope; influence of the ginseng-wolfberry sperm-strengthening particles on sperm related enzyme activity of the weak sperm rat 50 male SD rats are randomly divided into 5 groups, 10 rats in each group are subjected to gastric lavage with ornidazole to establish a rat weak sperm disease model, the expression of sperm adenylate cyclase and phosphodiesterase gene of the weak sperm rat is detected by adopting real-time fluorescence quantitative PCR, and the influence of sperm acrosome enzyme activity is detected; the influence of the ginseng medlar sperm-strengthening particles on the energy metabolism and the expression of related proteins of weak sperm rats is that 60 SD healthy male rats are randomly divided into a normal group, a model group, a group with high, medium and low doses of the ginseng medlar sperm-strengthening particles and a positive control group, the weak sperm rat model is established by adopting the induction of ornidazole gavage, the concentrations of alpha-glucosidase, fructose, lactate dehydrogenase and malondialdehyde of rat epididymis detected, and the expression of Fas, Fas L, Bcl-2 and Bax proteins of rat testis tissues of each group in rat testis parenchymal tissues is detected by adopting an immunohistochemistry method; the real-time fluorescent quantitative PCR method is adopted to detect the mRNA level of the nuclear factor NF-E2 related factor and succinate dehydrogenase of the epididymis tissue of the rat.
In an embodiment of the present invention, in the toxicology study in S7, 60 healthy kunming mice are selected by an acute toxicity test, and randomly divided into 6 groups, 10 mice in each group are subjected to intragastric administration of 6 different doses of the ginseng and wolfberry fruit sperm-strengthening particles, the intragastric administration is performed once, the observation is performed for 14 days after the administration, the observation indexes include animal weight change, diet, appearance, behavior, secretion, excretion, death and toxic reaction, the visual necropsy should be performed when the toxic reaction of the animal is observed, the microscopic examination should be performed on the tissues when all diseased tissues are recorded, and half lethal dose or maximum tolerance of the ginseng and wolfberry fruit sperm-strengthening particles is determined;
long-term toxicity test, selecting 80 adult healthy SD rats with male and female halves, randomly dividing into 4 groups, each group being 20, dividing into a blank control group, a ginseng and medlar sperm strengthening particle high dose group, a ginseng and medlar sperm strengthening particle medium dose group and a ginseng and medlar sperm strengthening particle low dose group, the blank group being perfused with equal volume drinking water every day, the administration group converting the human equivalent dose according to the body surface area, respectively administering 1/2, 1 and 2 times of ginseng and medlar sperm strengthening particles with the human equivalent dose, perfusing the stomach every day for 1 time, continuously administering for 6 months, weighing 1 time every week, adjusting the administration dose according to the body weight, observing the general conditions of the rats during the experiment, including appearance signs, behavior activity, gland secretion, respiration, defecation, food intake, body weight, death and other conditions, simultaneously determining hematology organ index, hydropathy chemical index, index body weight index and pathological histological detection, and statistical analysis all adopting sps 22.0 statistical software to carry out analysis, the measurement data is expressed in x +/-s, the mean t test of two samples is adopted for comparison among groups, and the variance analysis is adopted for the comparison of the mean of the samples among the groups; the difference is considered to be significant when P is less than 0.05, and in the reproductive toxicity research, 80 adult healthy SD rats are selected, the male-female ratio is 1: 2, cage feeding is started, cage feeding is carried out after administration, the cage feeding is carried out, 20 animals are randomly divided into 4 groups, each group is divided into a blank control group, a ginseng and medlar sperm strengthening particle high dose group, a ginseng and medlar sperm strengthening particle medium dose group and a ginseng and medlar sperm strengthening particle low dose group, the blank group is filled with drinking water with equal volume by stomach every day, the administration group calculates the equivalent dose according to the body surface area, 1/2, 1 and 2 times of equivalent dose of ginseng and medlar sperm strengthening particles are respectively administered to a human body, the stomach filling administration is carried out for 1 time every day, female rats are continuously administered with 21d, administration is continued in the cage mating period after 21d, administration is carried out until the 15 th day of pregnancy of the rats after pregnancy, clinical manifestations and pathological changes are observed, and the male rat fertility rate, the female rat sexual cycle, the pregnancy rate, the pregnant rat mortality rate and the dead fetus rate of each dose group are counted;
embryo-fetus development toxicity test: randomly grouping, performing intragastric administration on the rats after pregnancy, giving a solvent control and ginseng and wolfberry sperm-strengthening particles, killing the female rats at 20d of pregnancy (GD 20), taking out the fetus, checking the corpus luteum number, the nidation number, the live fetus number, the dead fetus number and the like, performing genotoxicity research, and performing an Ames test: setting five dose groups, a solvent control group, a spontaneous control group and a positive control group of the ginseng medlar sperm-strengthening particles, using a liver S9 of a male rat induced by the combination of beta-naphthoflavone and phenobarbital, preparing an S9 mixed solution according to a standard method to be used as an activation system, testing four strains of TA97, TA98, TA100 and TA102, measuring S9 activity by using an indirect mutagen, performing a flat plate doping method test under the condition of adding and not adding an S9 test after steam sterilization at 0.103 MPa for 20 min, simultaneously using three parallel dishes in each group, and repeating the test, wherein the S9 positive control: TA97 and TA98 were treated with 0.5 μ g/dish of 4-nitroquinoline-N-oxide; TA100 NaN3 at 1.5 mug/dish; TA102 with 1.0 mug/vessel of MMC; the positive control TA102 of + S9 uses 1-8-dihydroxy anthraquinone of 50 mug/vessel, the other three fungus forests use 2-AF of 20 mug/vessel, the volume of the positive control added into each vessel is 0.1 mL, the number of the retromorphous colonies of the test object group is increased by more than one time, namely the number of the retromorphous colonies is equal to or more than 2 times the number of the untreated control, the positive reaction which has the dose reaction relation or has the repeatability and the statistical significance is carried out on at least one test point, namely the positive mutation test of the test object is determined;
bone marrow cell micronucleus assay: half of Kunming mice, 60 mice in each male and female, randomly dividing the initial weight of 25-30 g into 5 groups which are respectively a blank control group, a high-dose group of ginseng and medlar sperm strengthening particles, a medium-dose group of ginseng and medlar sperm strengthening particles, a low-dose group of ginseng and medlar sperm strengthening particles and a cyclophosphamide positive control group, orally carrying out intragastric administration at an interval of 24 h every time, observing for 30 h after the first contamination, adopting a 30 h twice administration method at an interval of 24 h, taking sternum marrow, making a sheet, fixing and Giemsa staining the sternum marrow, counting the number of micronucleus PCB contained in 1000 pleochromophilic erythrocytes of each mouse under an oil lens, calculating the micronucleus cell rate (%), observing the ratio (PCE/NCE) of the pleochromophilic erythrocytes to mature erythrocytes in 200 erythrocytes, and comparing the test group with a control group, wherein the test result is positive when the micronucleus rate has an obvious dose response relation and has statistical significance; positive if the result is reproducible when the difference is statistically significant but dose-response is absent, teratospermia test: the method comprises the following steps of randomly dividing Kunming mice into 5 groups, namely a blank control group, a high-dose group of ginseng and wolfberry fruit sperm-strengthening particles, a medium-dose group of ginseng and wolfberry fruit sperm-strengthening particles, a low-dose group of ginseng and wolfberry fruit sperm-strengthening particles and a cyclophosphamide positive control group (CP, 40 mg/kg. BW), carrying out oral gavage for 5 days according to 20 mL/kg. BW every day, observing for 35 days after first contamination, taking bilateral epididymis of the mice killed after cervical vertebra removal, counting 1000 complete sperms of each male mouse under a high power microscope after fixing 1% of methanol and carrying out eosin staining, distinguishing the number of malformed sperms and the type of the malformed sperms to determine the teratospermia rate, wherein the teratospermia rate of each dose group is at least the same as that of the negative control group or has a statistically significant meaning and a dose response relationship, and then determining the mice to be positive.
The invention has the beneficial effects that: the invention relates to a preparation method of ginseng-wolfberry fruit sperm-strengthening particles for enhancing immunity, which is designed by the above steps, when in use, the raw materials of codonopsis pilosula, wolfberry fruit, astragalus root, dodder seed, schisandra fruit, angelica, teasel root, motherwort, raw oyster shell, epimedium herb and beautiful sweetgum fruit are treated before preparation, the raw materials are washed, cut and mixed by a washing mechanism, a cutting mechanism and a mixing mechanism in sequence, the mixed codonopsis pilosula, wolfberry fruit, astragalus root, dodder seed, schisandra fruit, angelica, teasel root, motherwort, raw oyster shell, epimedium herb and beautiful sweetgum fruit are decocted by a decocting mechanism, the residues of the codonopsis pilosula, wolfberry fruit, astragalus root, the dodder seed, the schisandra fruit, angelica, teasel root, the motherwort, the raw oyster shell, epimedium herb and beautiful sweetgum fruit are filtered to obtain liquid medicine, the liquid medicine is concentrated, the concentrated liquid medicine is extracted, and the human placenta is then extracted, Cornu cervi degelatinatum, medicated leaven powder and dextrin are mixed uniformly and then added into the extract to prepare an ointment, the ointment is dried and pulverized and is granulated by adding stevioside, granulation is dried to form whole granules, the components in the whole granules are identified by utilizing thin-layer chromatography identification, microscopic identification, microbial limit inspection, routine inspection and content measurement, the whole granules are researched by utilizing clinical research and observation, animal experimental research and toxicological research to obtain pharmacological basis, the ginseng and medlar strong essence granule develops the traditional Chinese medicinal decoction into the granules, overcomes the defects of decoction, inconvenient carrying, easy mildew and deterioration after long-term placement, large taking volume and the like, develops the research of the preparation of the traditional Chinese medicinal preparation of proved prescription strong essence for the first time, strives to develop the traditional Chinese medicinal preparation of the ginseng and medlar strong essence granule for treating the oligospermia and asthenospermia, and develops into safe, effective, quality-controllable, economic and convenient preparation, The granule has the advantages of small dosage, convenient clinical medication and convenient carrying and storage, once the ginseng-wolfberry fruit essence-strengthening granules are successfully researched and developed, the mass production is obtained, the large-scale production drives the industrialized development, the advantages of rich traditional Chinese medicine resources can be exerted, employment posts can be increased, the innovation capability and the technical level of traditional Chinese medicine products can be improved, the competitiveness of the traditional Chinese medicine industry is enhanced, and the important significance is realized for promoting the regional economic development.
Drawings
In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings that are required to be used in the embodiments will be briefly described below, it should be understood that the following drawings only illustrate some embodiments of the present invention and therefore should not be considered as limiting the scope, and for those skilled in the art, other related drawings can be obtained according to the drawings without inventive efforts.
Fig. 1 is a production process flow chart of the ginseng-wolfberry fruit essence-strengthening particles for enhancing immunity.
Detailed Description
In order to make the objects, technical solutions and advantages of the embodiments of the present invention more apparent, the technical solutions of the embodiments of the present invention will be described clearly and completely with reference to the accompanying drawings of the embodiments of the present invention, and it is obvious that the described embodiments are some, but not all embodiments of the present invention. All other embodiments, which can be obtained by a person skilled in the art without any inventive step based on the embodiments of the present invention, are within the scope of the present invention.
Examples
Referring to fig. 1, the present invention provides a technical solution: the ginseng-wolfberry fruit sperm-strengthening particles are prepared from 10-20g, 15-25g, 19-28g, 11-19g, 8-14g, 7-12g, 4-17g, 21-38g, 22-39g, 6-14g, 10-19g, 2-15g, 4-16g and 2-6g of radix codonopsitis, wolfberry fruit, astragalus root, dodder, schisandra fruit, Chinese angelica, medicated leaven, sweetgum fruit and human placenta which are used as main components and dextrin and steviosin which are used as auxiliary materials.
Specifically, the invention also provides a preparation method of the ginseng-wolfberry fruit essence-strengthening particles for enhancing immunity, which comprises the following steps:
s1: the pretreatment, the raw materials such as radix codonopsitis, medlar, astragalus, dodder, schisandra, angelica, teasel root, motherwort, raw oyster, epimedium and beautiful sweetgum fruit are treated before preparation, the raw materials are sequentially cleaned, cut and mixed by a cleaning mechanism, a cutting mechanism and a mixing mechanism, the cleaning mechanism in the step S1 consists of a traditional Chinese medicine cleaning machine and a feeding structure, the raw materials such as radix codonopsitis, medlar, astragalus, dodder, schisandra, angelica, teasel root, motherwort, raw oyster, epimedium and beautiful sweetgum fruit are sequentially injected into the traditional Chinese medicine cleaning machine by the feeding structure, the traditional Chinese medicine cleaning machine cleans the raw materials, the medicine property is effectively prevented from being influenced by impurities, the cutting mechanism in the step S1 consists of a cutting machine and a collecting box, the collecting box is arranged under the discharging port of the cutting machine, and the mixing mechanism consists of a reaction kettle, a motor and a motor, The automatic material mixing device comprises a connecting shaft, stirring blades and a material bin, wherein a motor is fixed on the upper surface of a reaction kettle, the upper end of the connecting shaft is fixed on an output shaft of the motor, the stirring blades are fixed on the outer wall of the connecting shaft, the material bin is arranged on the reaction kettle, a splitting machine is used for splitting a cleaned raw material into a section, a collecting box is used for collecting the segmented raw material, an operator injects the raw material into the reaction kettle through the material bin, and the motor works to drive the stirring blades to mix the raw material;
s2: decocting, namely, decocting the mixed codonopsis pilosula, the barbary wolfberry fruit, the astragalus, the south dodder seed, the Chinese magnoliavine fruit, the Chinese angelica, the teasel root, the motherwort, the raw oyster shell, the epimedium herb and the beautiful sweetgum fruit by using a decocting mechanism, wherein the decocting mechanism in the step S2 consists of a decocting furnace and a filter screen plate, the filter screen plate is fixed in the decocting furnace, the uniformly mixed raw materials are injected into the decocting furnace, drinking water is injected into the decocting furnace, the decocting furnace is used for decocting the raw materials, and filter screen plates are used for filtering filter residues after the decoction is finished to obtain concentrated liquid medicine;
s3: filtering, filtering to obtain medicinal liquid, and collecting residue of radix Codonopsis, fructus Lycii, radix astragali, semen Cuscutae, fructus Schisandrae chinensis, radix Angelicae sinensis, radix Dipsaci, herba Leonuri, Concha Ostreae, herba Epimedii and fructus Lipuidambaris;
s4: softening, concentrating the medicinal liquid, making into extract, mixing placenta hominis, cornu Cervi Degelatinatum, Massa Medicata Fermentata powder and dextrin, adding into the extract, and making into ointment;
s5: granulating, drying and pulverizing the ointment, adding steviosin, granulating, and drying to obtain granules;
s6: checking, identifying the components in the granules by thin-layer chromatography identification, microscopic identification, microbial limit inspection, conventional inspection and content measurement, wherein the thin-layer chromatography identification in the step S6 is used for carrying out thin-layer chromatography identification research on the medicines of the formula, the product quality is controlled by selecting an identification method of medicines with strong specificity and good reproducibility, a reference substance is preferably selected for medicines without identification items and content measurement in legal standards of medicinal materials, and secondly, a reference product with strong reproducibility and content identification is used, the work is available, the research on the preparation method of the test product, the selection of development conditions, the selection of inspection conditions, the special inspection and the reproducibility inspection are carried out, the medicines are composed according to the formula, the original medicinal materials are used as the reference, the pharmacopoeia method is referred, aiming at astragaloside in astragalus mongholicus, wolfberry polysaccharide and betaine in wolfberry, dipsacus aspen VI in teasel roots and hydrochloric acid hydrosonine in leonurus, when the ingredients of ferulic acid in Chinese angelica, schizandrol in schisandra and lobetyolin in codonopsis pilosula can be qualitatively identified are preferred, several qualitative identification items are determined, the original medicinal materials which are powdered and granulated in a prescription are microscopically identified, the identification is observed and identified under a microscope, the microbial limit inspection is carried out, the microbial limit inspection method of the product is researched by utilizing the requirement of the microbial limit inspection method, and the conventional inspection is carried out on the ginseng-wolfberry fruit strong essence granules, wherein the conventional inspection comprises the conventional inspection of properties, moisture, weight difference, dissolution time limit and the like. The content determination research is carried out according to the medicine formed by a prescription, referring to a pharmacopeia method, in the aspects of determining dipsacus asperoides VI in dipsacus asperoides by adopting a high performance liquid chromatography, determining wolfberry polysaccharides in wolfberry by adopting a visible-ultraviolet spectrophotometry method, determining betaine in wolfberry by adopting a thin-layer chromatography, determining hydrochloric acid threonine in leonurus by adopting a TCL method, determining ferulic acid in a angelica by adopting an HPLC method, determining schizandrol A in schisandra by adopting an HPLC method, determining astragaloside in astragalus by adopting an HPLC method or a TCL method and the like, and the experimental research is carried out to find out indexes suitable for the quantitative control of the preparation;
s7: pharmacological studies, wherein clinical research observation, animal experimental studies and toxicology studies are used for studying whole granules to obtain pharmacological bases, and the clinical research observation in S7 brings cases into the standard: the female is not pregnant after taking any contraceptive measures for more than 1 year of regular life; the sperm examination meets the diagnosis standard of oligospermia; anti-sperm antibody negative; the detection method comprises the following steps: performing a complete set of correlation analysis by using a computer-aided semen analysis technology; case grouping and administration methods; case grouping: according to the principles of random, contrast and balance, 120 patients with oligospermia meeting the inclusion standard are numbered according to the sequence of treatment, and are randomly divided into a contrast group taking spermatogenic capsules and a treatment group taking ginseng-wolfberry spermatogenic granules according to a random number table, wherein each group comprises 60 patients; the administration method comprises the following steps: the treatment group takes ginseng, medlar and sperm strengthening granules orally; the control group orally takes the positive control medicine spermatogenic capsule 4 times/time, 3 times/day; observation indexes are as follows: after 1 treatment course, observing the clinical curative effect and the change of sperm parameters; clinical cure: the pregnancy of the female or the sperm density, the motility and the like are recovered to be normal; the method has the following advantages: although the sperm detection is abnormal, the sperm motility rate and the activity of a grade or a + b grade sperms are improved by more than or equal to 30 percent, and the sperm density is improved by more than or equal to 2 multiplied by 109/L after the oligospermia is treated; and (4) invalidation: the animal experiment research in S7 utilizes the influence of the ginseng and wolfberry sperm-strengthening particles on sperm quality and the research of antioxidant effect of weak sperm rats to randomly divide 50 male rats into 5 groups, each group contains 10 rats, each rat is administered with ornidazole 400 mg/kg/d to establish a rat weak sperm disease model except for the normal group, each rat is administered with low, medium and high doses of the ginseng and wolfberry sperm-strengthening particles, the normal group is administered with 0.5% sodium carboxymethylcellulose, each group of rats is administered with 21d continuously to detect the sperm motility, sperm motility rate, sperm count, epididymal malondialdehyde content and superoxide dismutase, glutathione peroxidase and nitric oxide synthase activity of the rat, each group of rat testis and epididymal tail are fixed with 3% glutaraldehyde, the rat epididymal epithelium, epididymal epithelium and intraluminal sperm number change are observed by conventional pathological sectioning, observing cell and subcellular structures of spermatogenic epithelium, epididymal epithelium and sperm by using a transmission electron microscope; influence of the ginseng-wolfberry sperm-strengthening particles on sperm related enzyme activity of the weak sperm rat 50 male SD rats are randomly divided into 5 groups, 10 rats in each group are subjected to gastric lavage with ornidazole to establish a rat weak sperm disease model, the expression of sperm adenylate cyclase and phosphodiesterase gene of the weak sperm rat is detected by adopting real-time fluorescence quantitative PCR, and the influence of sperm acrosome enzyme activity is detected; the influence of the ginseng and medlar sperm-strengthening particles on the energy metabolism and the expression of related proteins of the rat with weak sperm is that 60 SD healthy male rats are randomly divided into a normal group, a model group, a group with high, medium and low doses of the ginseng and medlar sperm-strengthening particles and a positive control group, the rat model with weak sperm is established by adopting the induction of ornidazole gavage, the concentrations of alpha-glucosidase, fructose, lactate dehydrogenase and malondialdehyde of epididymis tissues of the rat are detected, and the expression of Fas, Fas L, Bcl-2 and Bax proteins in testicular parenchyma tissues of the rat of each group is detected by adopting an immunohistochemical method; detecting the mRNA level of NF-E2 related factors and succinate dehydrogenase of rat epididymis tissue nuclear factors by a real-time fluorescent quantitative PCR method, wherein 60 healthy Kunming mice are selected by an acute toxicity test in toxicology research in S7 and randomly divided into 6 groups, 10 mice in each group are respectively subjected to intragastric administration of 6 different doses of ginseng and wolfberry spermatozoa particles, the intragastric administration is carried out once, 14 days are observed after the administration, the observation indexes comprise animal weight change, diet, appearance, behavior, secretion, excrement, death condition, toxic reaction and the like, visual necropsy should be carried out when the toxic reaction of animals is observed, microscopic examination should be carried out on tissues when all pathological tissues are recorded, and half lethal dose or maximum tolerance of the ginseng and wolfberry spermatozoa particles is measured;
long-term toxicity test, selecting 80 adult healthy SD rats with male and female halves, randomly dividing into 4 groups, each group being 20, dividing into a blank control group, a ginseng and medlar sperm strengthening particle high dose group, a ginseng and medlar sperm strengthening particle medium dose group and a ginseng and medlar sperm strengthening particle low dose group, the blank group being perfused with equal volume drinking water every day, the administration group converting the human equivalent dose according to the body surface area, respectively administering 1/2, 1 and 2 times of ginseng and medlar sperm strengthening particles with the human equivalent dose, perfusing the stomach every day for 1 time, continuously administering for 6 months, weighing 1 time every week, adjusting the administration dose according to the body weight, observing the general conditions of the rats during the experiment, including appearance signs, behavior activity, gland secretion, respiration, defecation, food intake, body weight, death and other conditions, simultaneously determining hematology organ index, hydropathy chemical index, index body weight index and pathological histological detection, and statistical analysis all adopting sps 22.0 statistical software to carry out analysis, the measurement data is expressed in x +/-s, the mean t test of two samples is adopted for comparison among groups, and the variance analysis is adopted for the comparison of the mean of the samples among the groups; the difference is considered to be significant when P is less than 0.05, and in the reproductive toxicity research, 80 adult healthy SD rats are selected, the male-female ratio is 1: 2, cage feeding is started, cage feeding is carried out after administration, the cage feeding is carried out, 20 animals are randomly divided into 4 groups, each group is divided into a blank control group, a ginseng and medlar sperm strengthening particle high dose group, a ginseng and medlar sperm strengthening particle medium dose group and a ginseng and medlar sperm strengthening particle low dose group, the blank group is filled with drinking water with equal volume by stomach every day, the administration group calculates the equivalent dose according to the body surface area, 1/2, 1 and 2 times of equivalent dose of ginseng and medlar sperm strengthening particles are respectively administered to a human body, the stomach filling administration is carried out for 1 time every day, female rats are continuously administered with 21d, administration is continued in the cage mating period after 21d, administration is carried out until the 15 th day of pregnancy of the rats after pregnancy, clinical manifestations and pathological changes are observed, and the male rat fertility rate, the female rat sexual cycle, the pregnancy rate, the pregnant rat mortality rate and the dead fetus rate of each dose group are counted;
embryo-fetus development toxicity test: randomly grouping, performing intragastric administration on the rats after pregnancy, giving a solvent control and ginseng and wolfberry sperm-strengthening particles, killing the female rats at 20d of pregnancy (GD 20), taking out the fetus, checking the corpus luteum number, the nidation number, the live fetus number, the dead fetus number and the like, performing genotoxicity research, and performing an Ames test: setting five dose groups, a solvent control group, a spontaneous control group and a positive control group of the ginseng medlar sperm-strengthening particles, using a liver S9 of a male rat induced by the combination of beta-naphthoflavone and phenobarbital, preparing an S9 mixed solution according to a standard method to be used as an activation system, testing four strains of TA97, TA98, TA100 and TA102, measuring S9 activity by using an indirect mutagen, performing a flat plate doping method test under the condition of adding and not adding an S9 test after steam sterilization at 0.103 MPa for 20 min, simultaneously using three parallel dishes in each group, and repeating the test, wherein the S9 positive control: TA97 and TA98 were treated with 0.5 μ g/dish of 4-nitroquinoline-N-oxide; TA100 NaN3 at 1.5 mug/dish; TA102 with 1.0 mug/vessel of MMC; the positive control TA102 of + S9 uses 1-8-dihydroxy anthraquinone of 50 mug/vessel, the other three fungus forests use 2-AF of 20 mug/vessel, the volume of the positive control added into each vessel is 0.1 mL, the number of the retromorphous colonies of the test object group is increased by more than one time, namely the number of the retromorphous colonies is equal to or more than 2 times the number of the untreated control, the positive reaction which has the dose reaction relation or has the repeatability and the statistical significance is carried out on at least one test point, namely the positive mutation test of the test object is determined;
bone marrow cell micronucleus assay: half of Kunming mice, 60 mice in each male and female, randomly dividing the initial weight of 25-30 g into 5 groups which are respectively a blank control group, a high-dose group of ginseng and medlar sperm strengthening particles, a medium-dose group of ginseng and medlar sperm strengthening particles, a low-dose group of ginseng and medlar sperm strengthening particles and a cyclophosphamide positive control group, orally carrying out intragastric administration at an interval of 24 h every time, observing for 30 h after the first contamination, adopting a 30 h twice administration method at an interval of 24 h, taking sternum pith, making a sheet, fixing and Giemsa staining on each mouse under an oil microscope, counting the number of micronucleus PCB in 1000 pleochromatic erythrocytes under the oil microscope, calculating micronucleus cell rate (%), observing the ratio (PCE/NCE) of the pleochromatic erythrocytes to mature erythrocytes in 200 erythrocytes, and comparing the test group with a control group, wherein the test result micronucleus rate has obvious dose response relation and is a positive result when the test group has statistical significance; positive if the result is reproducible when the difference is statistically significant but dose-response is absent, teratospermia test: the method comprises the following steps of randomly dividing Kunming mice into 5 groups, namely a blank control group, a high-dose group of ginseng and wolfberry fruit sperm-strengthening particles, a medium-dose group of ginseng and wolfberry fruit sperm-strengthening particles, a low-dose group of ginseng and wolfberry fruit sperm-strengthening particles and a cyclophosphamide positive control group (CP, 40 mg/kg. BW), carrying out oral gavage for 5 days according to 20 mL/kg. BW every day, observing for 35 days after first contamination, taking bilateral epididymis of the mice killed after cervical vertebra removal, counting 1000 complete sperms of each male mouse under a high power microscope after fixing 1% of methanol and carrying out eosin staining, distinguishing the number of malformed sperms and the type of the malformed sperms to determine the teratospermia rate, wherein the teratospermia rate of each dose group is at least the same as that of the negative control group or has a statistically significant meaning and a dose response relationship, and then determining the mice to be positive.
Specifically, the preparation method of the immunity-enhancing ginseng-wolfberry essence-strengthening particle has the working principle that: when in use, the raw materials of radix codonopsitis, medlar, astragalus root, dodder, schisandra fruit, angelica, dipsacus root, motherwort, raw oyster, epimedium and sweetgum fruit are processed before preparation, the raw materials are washed, cut and mixed by a washing mechanism, a cutting mechanism and a mixing mechanism in sequence, the mixed raw materials of radix codonopsitis, medlar, astragalus root, dodder seed, schisandra fruit, angelica, teasel root, motherwort, raw oyster, epimedium and sweetgum fruit are decocted by a decocting mechanism, the residues existing in the radix codonopsitis, medlar, astragalus root, dodder seed, schisandra fruit, angelica, teasel root, motherwort, raw oyster, epimedium and sweetgum fruit are filtered to obtain liquid medicine, the liquid medicine is concentrated, the concentrated liquid medicine is extracted to obtain extract, and the extract is added into the extract after the placenta hominis, cornu cervi degelatinatum, medicated leaven powder and dextrin are uniformly mixed to prepare ointment, the ointment is dried and pulverized and is added with steviosin to prepare granules, drying the granules to form whole granules, utilizing thin-layer chromatography identification, microscopic identification, microbial limit inspection and routine inspection and content measurement to identify components in the whole granules, utilizing clinical research observation, animal experiment research and toxicology research to research the whole granules to obtain pharmacological basis, developing the traditional Chinese medicine decoction into granules by the Shenqi Qiangjing granules, overcoming the defects of decoction, inconvenient carrying, easy mildew and deterioration after long-term placement, large taking volume and the like, developing preparation research on proved recipe Qiangjing decoction of traditional Chinese medicine for the first time, striving to develop traditional Chinese medicine preparation Shenqi Qiangjing granules for treating a few and weak sperm diseases, developing and preparing the Shenqi Qiangjing granules which are safe, effective, controllable in quality, economical and convenient in taking, convenient in clinical medication and convenient to carry and store, once the Shenqi Qiangjing granules are successful, mass production is obtained, and industrial development is driven by the production, the advantages of rich traditional Chinese medicine resources can be brought into play, employment posts can be increased, the innovation capability and technical level of traditional Chinese medicine products can be improved, the competitiveness of the traditional Chinese medicine industry is enhanced, and the important significance is achieved for promoting regional economic development.
The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention, and various modifications and changes may be made by those skilled in the art. Any modification, equivalent replacement, or improvement made within the spirit and principle of the present invention should be included in the protection scope of the present invention.
Claims (10)
1. The ginseng-wolfberry fruit essence-strengthening particle is characterized by being prepared from codonopsis pilosula, wolfberry fruit, astragalus membranaceus, semen cuscutae, schisandra chinensis, angelica sinensis, teasel roots, motherwort, raw oysters, cornu cervi degelatinatum, herba epimedii, medicated leaven, liquidambar formosana and human placenta as main components and dextrin and steviosin as auxiliary materials.
2. The granule of ginseng and wolfberry fruit for enhancing immunity according to claim 1, wherein the weight of the radix codonopsis pilosulae, the fruit of Chinese wolfberry, the root of membranous milk vetch, the seed of Chinese dodder, the fruit of Chinese magnoliavine, the root of Chinese angelica, the teasel root, the motherwort, the raw oyster shell, the cornu cervi degelatinatum, the epimedium, the medicated leaven, the beautiful sweetgum fruit and the human placenta are 10-20g, 15-25g, 19-28g, 11-19g, 8-14g, 7-12g, 4-17g, 21-38g, 22-39g, 6-14g, 10-19g, 2-15g, 4-16g and 2-6g in sequence.
3. The preparation method of the ginseng-wolfberry fruit sperm-strengthening particle for enhancing the immunity according to any one of claims 1 to 2, which is characterized by comprising the following steps:
s1: pre-treating, namely, pre-treating raw materials such as codonopsis pilosula, wolfberry fruit, astragalus mongholicus, semen cuscutae, schisandra chinensis, angelica sinensis, teasel roots, motherwort, raw oysters, epimedium and fructus liquidambaris, and sequentially cleaning, cutting and mixing the raw materials by using a cleaning mechanism, a cutting mechanism and a mixing mechanism;
s2: decocting, namely decocting the mixed codonopsis pilosula, the medlar, the astragalus, the dodder, the schisandra chinensis, the angelica, the teasel root, the motherwort, the raw oyster, the epimedium and the sweetgum fruit by using a decocting mechanism;
s3: filtering, filtering to obtain medicinal liquid, and collecting residue of radix Codonopsis, fructus Lycii, radix astragali, semen Cuscutae, fructus Schisandrae chinensis, radix Angelicae sinensis, radix Dipsaci, herba Leonuri, Concha Ostreae, herba Epimedii and fructus Lipuidambaris;
s4: softening, concentrating the medicinal liquid, making into extract, mixing placenta hominis, cornu Cervi Degelatinatum, Massa Medicata Fermentata powder and dextrin, adding into the extract, and making into ointment;
s5: granulating, drying and pulverizing the ointment, adding steviosin, granulating, and drying to obtain granules;
s6: inspecting, namely identifying components in the particles by utilizing thin-layer chromatography identification, microscopic identification, microbial limit inspection, conventional inspection and content measurement;
s7: and pharmacological research, namely, researching whole grains by utilizing clinical research and observation, animal experimental research and toxicological research to obtain pharmacological basis.
4. The method of claim 3, wherein the cleaning mechanism of step S1 comprises a traditional Chinese medicine cleaning machine and a feeding structure, wherein the feeding structure sequentially injects raw materials of radix Codonopsis, fructus Lycii, radix astragali, semen Cuscutae, fructus Schisandrae chinensis, radix Angelicae sinensis, radix Dipsaci, herba Leonuri, Concha Ostreae, herba Epimedii, and fructus Lipuidambaris into the traditional Chinese medicine cleaning machine, and the traditional Chinese medicine cleaning machine cleans the raw materials.
5. The preparation method of the immunity-enhancing ginseng-wolfberry fruit kernel granules according to claim 3, wherein in the step S1, the cutting mechanism is composed of a cutting machine and a collecting box, the collecting box is arranged under a feed opening of the cutting machine, the mixing mechanism is composed of a reaction kettle, a motor, a connecting shaft, stirring blades and a bin, the motor is fixed on the upper surface of the reaction kettle, the upper end of the connecting shaft is fixed on an output shaft of the motor, the stirring blades are fixed on the outer wall of the connecting shaft, the bin is arranged on the reaction kettle, the cutting machine cuts the cleaned raw materials into sections, the collecting box collects the sections of the raw materials, an operator injects the raw materials into the reaction kettle through the bin, and the motor operates to drive the stirring blades to mix the raw materials.
6. The method of claim 3, wherein the decoction unit of step S2 comprises a decoction vessel and a filter screen, the filter screen is fixed in the decoction vessel, the uniformly mixed raw materials are poured into the vessel, drinking water is poured into the vessel, the vessel is operated to decoct the raw materials, and after the decoction is completed, the filter screen filters out the residue to obtain the concentrated liquid medicine.
7. The method of claim 3, wherein the thin-layer chromatography identification in step S6 is performed to study the thin-layer chromatography identification of the prescription drugs, and the identification method with strong specificity and good reproducibility is selected to control the product quality, for the drugs with no identification item and content determination in the legal standards of the drugs, the reference substance is the first choice of the reference drug, and the second choice of the reference substance with high reproducibility and content identification is the second choice, the work has been carried out to study the preparation method of the test sample, to select the development conditions, to select the inspection conditions, to investigate the specificity and to examine the reproducibility, to compose the drugs according to the prescription, and to refer to the pharmacopeia method, to the astragaloside in Astragalus membranaceus, the wolfberry polysaccharides and betaine in Lycium barbarum, the dipsacus asperoides VI in Dipsacus asperoides, and the hydrochloric acid water in Leonurus sibirica, when the ingredients of ferulic acid in Chinese angelica, schizandrol in schisandra and lobetyolin in codonopsis pilosula can be qualitatively identified are preferred, several qualitative identification items are determined, the original medicinal materials which are powdered and granulated in a prescription are microscopically identified, the identification is observed and identified under a microscope, the microbial limit inspection is carried out, the microbial limit inspection method of the product is researched by utilizing the requirement of the microbial limit inspection method, and the conventional inspection is carried out on the ginseng-wolfberry fruit extract granules, wherein the conventional inspection comprises the conventional inspection of properties, moisture, weight difference, dissolution time limit and the like; the content determination research is carried out according to the medicine formed by a prescription, referring to a pharmacopeia method, in the aspects of determining dipsacus asperoides VI in dipsacus asperoides by adopting a high performance liquid chromatography, determining wolfberry polysaccharides in wolfberry by adopting a visible-ultraviolet spectrophotometry method, determining betaine in wolfberry by adopting a thin layer chromatography, determining hydrochloric acid threonine in leonurus by adopting a TCL method, determining ferulic acid in a angelica by adopting an HPLC method, determining schizandrol A in schisandra by adopting an HPLC method, determining astragaloside in astragalus by adopting an HPLC method or a TCL method and the like, and the experimental research is carried out to find indexes suitable for the quantitative control of the preparation.
8. The method for preparing the granule for strengthening the immunity according to claim 3, wherein the clinical study observation in S7 includes the case-by-case criteria: the female is not pregnant after taking any contraceptive measures for more than 1 year of regular life; the sperm examination meets the diagnosis standard of oligospermia; anti-sperm antibody negative; the detection method comprises the following steps: performing a complete set of correlation analysis by using a computer-aided semen analysis technology; case grouping and administration methods; case grouping: according to the principles of random, contrast and balance, 120 patients with oligospermia meeting the inclusion standard are numbered according to the sequence of treatment, and are randomly divided into a contrast group taking spermatogenic capsules and a treatment group taking ginseng-wolfberry spermatogenic granules according to a random number table, wherein each group comprises 60 patients; the administration method comprises the following steps: the treatment group takes ginseng, medlar and sperm strengthening granules orally; the control group orally takes the positive control medicine spermatogenic capsule 4 times/time, 3 times/day; observation indexes are as follows: after 1 treatment course, observing the clinical curative effect and the change of sperm parameters; clinical cure: the pregnancy of the female or the sperm density, the motility and the like are recovered to be normal; the method has the following advantages: although the sperm detection is abnormal, the sperm motility rate and the activity of a grade or a + b grade sperms are improved by more than or equal to 30 percent, and the sperm density is improved by more than or equal to 2 multiplied by 109/L after the oligospermia is treated; and (4) invalidation: those which do not meet the above standards.
9. The method of claim 3, wherein the animal experiment in S7 utilizes the effect of the ginseng wolfberry sperm-strengthening particles on sperm quality and the anti-oxidation effect of weak sperm rats to randomly divide 50 male rats into 5 groups, each group comprises 10 rats, each rat is administered with ornidazole 400 mg/kg/d to establish a rat weak sperm disease model except for a normal group, the rats are administered with low, medium and high doses of the ginseng wolfberry sperm-strengthening particles through gastric gavage respectively, the normal group is administered with 0.5% sodium carboxymethylcellulose, each group of rats is administered with 21 days continuously to detect the sperm motility, sperm motility rate, sperm count, epididymal malondialdehyde content and superoxide dismutase, glutathione peroxidase and nitric oxide synthase activities, each group of rat testis and epididymal tail are fixed with 3% glutaraldehyde, conventional pathological section, observing the change of the number of spermatogenic epithelium, epididymal epithelium and sperm in the lumen of the rat, and observing the cell and subcellular structures of the spermatogenic epithelium, epididymal epithelium and sperm by adopting a transmission electron microscope; influence of the ginseng-wolfberry sperm-strengthening particles on sperm related enzyme activity of the weak sperm rat 50 male SD rats are randomly divided into 5 groups, 10 rats in each group are subjected to gastric lavage with ornidazole to establish a rat weak sperm disease model, the expression of sperm adenylate cyclase and phosphodiesterase gene of the weak sperm rat is detected by adopting real-time fluorescence quantitative PCR, and the influence of sperm acrosome enzyme activity is detected; the influence of the ginseng and medlar sperm-strengthening particles on the energy metabolism and the expression of related proteins of the rat with weak sperm is that 60 SD healthy male rats are randomly divided into a normal group, a model group, a group with high, medium and low doses of the ginseng and medlar sperm-strengthening particles and a positive control group, the rat model with weak sperm is established by adopting the induction of ornidazole gavage, the concentrations of alpha-glucosidase, fructose, lactate dehydrogenase and malondialdehyde of epididymis tissues of the rat are detected, and the expression of Fas, Fas L, Bcl-2 and Bax proteins in testicular parenchyma tissues of the rat of each group is detected by adopting an immunohistochemical method; the real-time fluorescent quantitative PCR method is adopted to detect the mRNA level of the nuclear factor NF-E2 related factor and succinate dehydrogenase of the epididymis tissue of the rat.
10. The method for preparing Shenqi Qiangjing particles for enhancing immunity as claimed in claim 3, wherein the toxicological study in S7 comprises selecting 60 healthy Kunming mice by acute toxicity test, randomly dividing into 6 groups, each group comprising 10 mice, respectively administering 6 different doses of Shenqi Qiangjing particles by intragastric administration, administering once by intragastric administration, observing for 14 days after administration, observing for the observation index including animal weight change, diet, appearance, behavior, secretion, excretion, death and toxic reaction, performing gross autopsy when observing animal toxic reaction, performing microscopic examination on tissues when recording all pathological tissues, and determining half lethal dose or maximum tolerance of Shenqi Qiangjing particles;
long-term toxicity test, selecting 80 adult healthy SD rats with male and female halves, randomly dividing into 4 groups, each group being 20, dividing into a blank control group, a ginseng and medlar sperm strengthening particle high dose group, a ginseng and medlar sperm strengthening particle medium dose group and a ginseng and medlar sperm strengthening particle low dose group, the blank group being perfused with equal volume drinking water every day, the administration group converting the human equivalent dose according to the body surface area, respectively administering 1/2, 1 and 2 times of ginseng and medlar sperm strengthening particles with the human equivalent dose, perfusing the stomach every day for 1 time, continuously administering for 6 months, weighing 1 time every week, adjusting the administration dose according to the body weight, observing the general conditions of the rats during the experiment, including appearance signs, behavior activity, gland secretion, respiration, defecation, food intake, body weight, death and other conditions, simultaneously determining hematology organ index, hydropathy chemical index, index body weight index and pathological histological detection, and statistical analysis all adopting sps 22.0 statistical software to carry out analysis, the measurement data is expressed in x +/-s, the mean t test of two samples is adopted for comparison among groups, and the variance analysis is adopted for the comparison of the mean of the samples among the groups; the difference is considered to be significant when P is less than 0.05, and in the reproductive toxicity research, 80 adult healthy SD rats are selected, the male-female ratio is 1: 2, cage feeding is started, cage feeding is carried out after administration, the cage feeding is carried out, 20 animals are randomly divided into 4 groups, each group is divided into a blank control group, a ginseng and medlar sperm strengthening particle high dose group, a ginseng and medlar sperm strengthening particle medium dose group and a ginseng and medlar sperm strengthening particle low dose group, the blank group is filled with drinking water with equal volume by stomach every day, the administration group calculates the equivalent dose according to the body surface area, 1/2, 1 and 2 times of equivalent dose of ginseng and medlar sperm strengthening particles are respectively administered to a human body, the stomach filling administration is carried out for 1 time every day, female rats are continuously administered with 21d, administration is continued in the cage mating period after 21d, administration is carried out until the 15 th day of pregnancy of the rats after pregnancy, clinical manifestations and pathological changes are observed, and the male rat fertility rate, the female rat sexual cycle, the pregnancy rate, the pregnant rat mortality rate and the dead fetus rate of each dose group are counted;
embryo-fetus development toxicity test: randomly grouping, performing intragastric administration on the rats after pregnancy, giving a solvent control and ginseng and wolfberry sperm-strengthening particles, killing the female rats at 20d of pregnancy (GD 20), taking out the fetus, checking the corpus luteum number, the nidation number, the live fetus number, the dead fetus number and the like, performing genotoxicity research, and performing an Ames test: setting five dose groups, a solvent control group, a spontaneous control group and a positive control group of the ginseng medlar sperm-strengthening particles, using a liver S9 of a male rat induced by the combination of beta-naphthoflavone and phenobarbital, preparing an S9 mixed solution according to a standard method to be used as an activation system, testing four strains of TA97, TA98, TA100 and TA102, measuring S9 activity by using an indirect mutagen, performing a flat plate doping method test under the condition of adding and not adding an S9 test after steam sterilization at 0.103 MPa for 20 min, simultaneously using three parallel dishes in each group, and repeating the test, wherein the S9 positive control: TA97 and TA98 were treated with 0.5 μ g/dish of 4-nitroquinoline-N-oxide; TA100 NaN3 at 1.5 mug/dish; TA102 MMC with 1.0 mug/vessel; the positive control TA102 of + S9 uses 1-8-dihydroxy anthraquinone of 50 mug/vessel, the other three fungus forests use 2-AF of 20 mug/vessel, the volume of the positive control added into each vessel is 0.1 mL, the number of the retromorphous colonies of the test object group is increased by more than one time, namely the number of the retromorphous colonies is equal to or more than 2 times the number of the untreated control, the positive reaction which has the dose reaction relation or has the repeatability and the statistical significance is carried out on at least one test point, namely the positive mutation test of the test object is determined;
bone marrow cell micronucleus assay: half of each mouse, 60 mice, 25-30 g of initial weight are randomly divided into 5 groups, namely a blank control group, a high-dose group of ginseng and medlar sperm-strengthening granules, a medium-dose group of ginseng and medlar sperm-strengthening granules, a low-dose group of ginseng and medlar sperm-strengthening granules and a cyclophosphamide positive control group, oral gavage is carried out, the interval is 24 h every time, the observation is carried out for 30 h after the first contamination, a 30 h twice-dosing method is adopted, the gavage interval is 24 h, taking sternum marrow, making a sheet, fixing and Giemsa staining the sternum marrow, counting the number of micronucleus PCB contained in 1000 pleochromophilic erythrocytes of each mouse under an oil lens, calculating the micronucleus cell rate (%), observing the ratio (PCE/NCE) of the pleochromophilic erythrocytes to mature erythrocytes in 200 erythrocytes, and comparing the test group with a control group, wherein the test result is positive when the micronucleus rate has an obvious dose response relation and has statistical significance; positive if the result is reproducible when the difference is statistically significant but dose-response is absent, teratospermia test: the method comprises the following steps of randomly dividing Kunming mice into 5 groups, namely a blank control group, a high-dose group of ginseng and wolfberry fruit sperm-strengthening particles, a medium-dose group of ginseng and wolfberry fruit sperm-strengthening particles, a low-dose group of ginseng and wolfberry fruit sperm-strengthening particles and a cyclophosphamide positive control group (CP, 40 mg/kg. BW), carrying out oral gavage for 5 days according to 20 mL/kg. BW every day, observing for 35 days after first contamination, taking bilateral epididymis of the mice killed after cervical vertebra removal, counting 1000 complete sperms of each male mouse under a high power microscope after fixing 1% of methanol and carrying out eosin staining, distinguishing the number of malformed sperms and the type of the malformed sperms to determine the teratospermia rate, wherein the teratospermia rate of each dose group is at least the same as that of the negative control group or has a statistically significant meaning and a dose response relationship, and then determining the mice to be positive.
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| CN109260315A (en) * | 2018-10-30 | 2019-01-25 | 广西中医药大学第附属医院 | It is a kind of for improving the pharmaceutical composition and preparation method of sperm quality |
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