CN103877039B - Ganoderma sinense polysaccharide dispersible tablet and preparation method thereof - Google Patents
Ganoderma sinense polysaccharide dispersible tablet and preparation method thereof Download PDFInfo
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Abstract
The invention provides a ganoderma sinense polysaccharide dispersible tablet and a preparation method thereof. The ganoderma sinense polysaccharide dispersible tablet is prepared from the following components in percentage by weight: 20-45% of ganoderma sinense polysaccharide powder, 40-65% of filler, 3-8% of a disintegrating agent, 5-20% of an adhesive, 1.5-3.5% of a corrigent and 0.5-3.0% of a lubricant. The ganoderma sinense polysaccharide dispersible tablet provided by the invention is good in dispersion uniformity and stability, and the technical problems of moisture absorption and sticking in the preparation process are solved. The prepared ganoderma sinense polysaccharide dispersible tablet can be used for treating neurasthenia, leucopenia and thrombopenia as well as symptoms of leucopenia caused by ionizing radiation, occupational hemopoiesis injury and radiotherapy and chemotherapy of tumor patients and the like, and is non-irritant to human body and few in adverse effects.
Description
Technical field
The present invention relates to field of medicaments, particularly relate to dispersible tablet of a kind of Ganoderma polysaccharide and preparation method thereof.
Background technology
Leukopenia refers to that peripheral blood leucocyte absolute counting continues lower than 4.0 * 10
9/ L.Neutrophilic granulocyte is leukocytic main component, so neutrophilic granulocyte reduces, often causes leukopenia.The degree that primary disease reduces according to neutrophilic granulocyte can be divided into slightly, moderate, severe leukopenia.On the patient clinical of general slight minimizing, there is not characteristic symptom, show as protopathy symptom more.Moderate and severe minimizing person easily occur to infect and occur the nonspecific symptoms such as tired, unable, dizzy, loss of appetite.Blood platelet disorder is because platelet counts reduces (thrombocytopenia) or hypofunction (Thromboasthenia) causes tampon to form bad and hemorrhage causing.Platelet count is lower than normal range 140,000～400,000/μ l.Thrombocytopenia may come from platelet and produce deficiency, and spleen is to hematoblastic detention, and platelet destruction or utilization increase and be diluted.No matter the serious thrombocytopenia due to which kind of reason, all can cause typically hemorrhage: multiple ecchymosis, is most commonly in shank; Or be subject to the position of microtrauma to occur little being dispersed in property ecchymosis; Mucosal bleeding (epistaxis, gastrointestinal tract and urogenital tract and vaginal hemorrhage); With operation after bleed profusely.Gastrointestinal tract is bled profusely and central nervous system's internal hemorrhage can threat to life.
In the work of contact ionization radiation, as improper in safeguard procedures, abuse, the irradiated dosage of human body surpasses certain limit, illeffects can occur.Under electric radiation effect, the extent of reaction of body depends on the sensitivity of the kind of ionizing radiation, dosage, illuminate condition and body.Ionizing radiation can cause radiation sickness, and it is the systemic reaction of body, and pathological change all occurs for nearly all organ, system, but wherein obvious with the change of nervous system, hemopoietic organ and digestive system.Ionizing radiation can be divided into acute radiation injury and chronic radioactive damage to the damage of body.In short time, accept the irradiation of doses, can cause the acute injury of body, see at ordinary times nuclear accident and radiation therapy patient.And in the long period, disperse to accept the irradiation of doses, and can cause chronic radioactive damage, as skin injury, hematopoietic disorders, leukocyte and thrombocytopenia, fertility are impaired etc.In addition, tumour patient there will be leukopenia, thrombocytopenia, Immune Dysfunction after Radiotherapy chemotherapy, thereby causes the diseases such as body void is weak, inappetence, vomiting, insomnia, badly influences patient's orthobiosis and recovery.
The at present control to leukopenia due to radiotherapy and chemotherapy medicine, Western medicine generally adopts the medicines such as leucogen, batilol and granulocyte colony stimulating factor, has the not good enough or good effect of curative effect but expensive, the deficiency such as action time is short.
Ganoderma (Ganoderma Sinense zhao Xu et zhang) is a kind of important medicinal fungi of Basidiomycetes, Polyporaceae, Ganoderma.According to < < herbal classic > > and < < Compendium of Materia Medica > >, record, the favourable joint of Ganoderma, protect god, beneficial vital essence, hard muscles and bones, good color, treat asthenia, clothes effects such as strengthening by means of tonics such as make light of one's life by commiting suicide, always do not prolong life for a long time, can be used for treatment deafness.
The eighties in last century, both at home and abroad the Radix Paeoniae Rubra of sibling species (being Ganoderma) is studied more, but less to the research of Ganoderma.In recent years, multiple pharmacologically active and the clinical practice of Ganoderma are continually developed, thereby have caused the attention of the domestic field of Chinese medicines.For example, (the research of Ganoderma polysaccharide radioprotective and effect in increasing leukocyte such as Liu Zhifang, In Jiangxi Science, 1985,3 (1), 1-8) studied the effect of Ganoderma polysaccharide radioprotective and leukocyte increasing, result of study shows, Ganoderma polysaccharide has certain prevention and good therapeutic effect to hemopoietic type acute radiation sickness, clinical treatment a variety of causes leukopenia 175 examples, total effective rate is 72.57%, long-term effect reaches 80%, have no side effect, can be used as the control medicine that radiation and other bring out hemopoietic damage.(Ganoderma exhausts the effect in rat resisting kinetic fatigue He Kang tissue injury in power to Zhu Zixin, sports science, 2012,32 (9), 75-80) studied supplementary Ganoderma polysaccharide powder and male SD rat power has been exhausted to the impact of athletic performance, energy metabolism and tissue injury that motion causes, result shows, supplements the effect that Ganoderma polysaccharide powder can significantly strengthen rat motor performance and resisting kinetic fatigue, can to a certain degree alleviate cardiac muscle, skeletal muscle, hepar damnification.In China, leukocyte and thrombocytopenic patient's quantity increase increasingly, but effectively preventing means are few at present, and therefore, the exploitation of Ganoderma polyose is great for clinical meaning with application.
Ganoderma polysaccharide is in Ganoderma culture, to extract the total polysaccharides body obtaining, and due to its unique function and hypotoxicity, it will have very wide prospect on clinical practice and health food development.At present, the Ganoderma polyose on market is mainly the coated tablet that Ganoderma polysaccharide powder is made, and it is strengthening by means of tonics that its function cures mainly, nourishing blood to tranquillize the mind, for neurasthenia, leukocyte and thrombocytopenia, degradation disease under hemocyte after ionizing radiation and occupational hemopoietic damage and tumor patient Radiotherapy chemotherapy.This product has been recorded in health drug standard promulgated by the ministries or commissions of the Central Government (the 11 of Traditional Chinese medicine historical preparation).But oral conventional tablet often slowly affects the abundant absorption of medicine because of disintegrate and drug-eluting, child, old man and the patient who swallows have any problem while taking, and when drug dose, larger or once take sheet number when many, problem is particularly outstanding.Though oral liquid taking convenience, less stable, packing, transportation, storage are all inconvenient, and are difficult for grasping taking dose.
Dispersible tablet has the advantage of oral tablet and oral liquid concurrently, and good stability is easy to carry, and taking convenience etc. have dispersion high, and dissolution rate is fast, absorption is fast, and bioavailability is high, and untoward reaction is few; Can swallow, chew, contain and suck, also can be placed in after water disperses and take separately or be equal to clothes with fruit juice, milk, especially be applicable to old man, child and the patient of solid difficulty that swallows; Because its preparation technology is identical with conventional tablet, production equipment, without advantages such as specific (special) requirements, is therefore received to the concern of researcher day by day.
But, because Ganoderma polysaccharide is soluble in water, in the process of preparing Ganoderma polysaccharide sheet, easily there is the phenomenons such as moisture absorption, sticking, affected quality and the production efficiency of dispersible tablet; In addition, applicant finds, when major auxiliary burden for example filler and disintegrating agent and their consumption selected not at that time, the hardness of Ganoderma polysaccharide dispersible tablet, disintegration rate etc. do not reach requirement, and the poor stability of dispersible tablet, can not meet clinical Treatment need.At present, in prior art, not yet find to disclose Ganoderma polysaccharide dispersible tablet.
Summary of the invention
The object of the invention is to overcome the defect of the easy moisture absorption of Ganoderma polysaccharide, thereby provide, a kind of disintegration rate is fast, good stability, is suitable for the Ganoderma polysaccharide dispersible tablet of industrialized great production.Dispersible tablet of the present invention has strengthening by means of tonics, and the effects such as tranquilizing by nourishing the heart can be used for treating neurasthenia, leukocyte and thrombocytopenia, the disease such as leukopenia after ionizing radiation and occupational hemopoietic damage and tumor patient Radiotherapy chemotherapy, and non-stimulated to human body, and untoward reaction is few.
The present invention is achieved by the following technical solutions.
In a specific embodiment, a kind of Ganoderma polysaccharide dispersible tablet is provided, described dispersible tablet comprises Ganoderma polysaccharide powder, filler, disintegrating agent, binding agent, binding agent and lubricant.
Applicant studies discovery, because Ganoderma polysaccharide has hygroscopicity, not only can affect the stability of dispersible tablet in storage process, and in preparation process, easily occur the phenomenons such as moisture absorption, sticking, has affected quality and the production efficiency of dispersible tablet.For this reason, applicant conducts in-depth research for the above-mentioned shortcoming of Ganoderma polysaccharide, and finds, by selecting suitable filler and disintegrating agent, not only can effectively control the hygroscopicity of dispersible tablet, can also realize disintegration rate faster simultaneously.
Therefore,, for Ganoderma polysaccharide dispersible tablet of the present invention, preferably the one-tenth by following percentage by weight is grouped into:
| Ganoderma polysaccharide powder | 20％～45％ |
| Filler | 40％～65％ |
| Disintegrating agent | 3％～8％ |
| Binding agent | 5％～20％ |
| Correctives | 1.5％～3.5％ |
| Lubricant | 0.5％～3.0％ |
Wherein, filler is selected from one or more in starch, microcrystalline Cellulose and calcium sulfate; Disintegrating agent is selected from one or more in polyvinylpolypyrrolidone, low-substituted hydroxypropyl cellulose and carboxymethyl starch sodium; Binding agent is selected from alcoholic solution or starch slurry; Correctives is selected from one or more in aspartame, saccharin sodium and sodium chloride; Lubricant is selected from one or more in micropowder silica gel, Pulvis Talci and magnesium stearate.
As the further preferred specific embodiment, described dispersible tablet can be grouped into by the one-tenth of following percentage by weight:
| Ganoderma polysaccharide powder | 30％～40％ |
| Filler | 40％～55％ |
| Disintegrating agent | 5％～8％ |
| Binding agent | 5％～10％ |
| Correctives | 1.5％～2.0％ |
| Lubricant | 0.5％～1.5％ |
In the more preferred specific embodiment, filler is that weight ratio is microcrystalline Cellulose and the calcium sulfate of 1:10～10:1; Binding agent is 20%～40% alcoholic solution or 3%～6% starch slurry; Correctives is aspartame and the sodium chloride of 1:4～4:1.
The Ganoderma polysaccharide powder using in Ganoderma polysaccharide dispersible tablet of the present invention can be commercially available.Also can prepare by the following method: Ganoderma sporophore and/or mycelium are cleaned, drain, decoct with water secondary, decoct for the first time 1.5～3 hours, medicinal liquid filters with 100～120 order filter clothes, medicinal residues add 3～5 times of water gagings to decoct for the second time again 1.5～3 hours, medicinal liquid filters with 100～120 order filter clothes, merge secondary and decoct gained medicinal liquid, be evaporated to the clear paste of relative density 1.10～1.20 (50 ℃ of heat are surveyed), in clear paste, stir and add 95% ethanol to reaching 60～65% containing alcohol amount, standing 20～30 hours, get supernatant and reclaim ethanol extremely without alcohol taste, precipitate after recovery ethanol is at 50～80 ℃ of vacuum dryings, dry extract moisture control is in 3%, dry extract is put Highefficientpulverizer and is ground into fine powder, cross 100～120 mesh sieves, obtain Ganoderma polysaccharide powder.The yield of this preparation method can reach 10% left and right.
On the other hand, the invention still further relates to the preparation method of Ganoderma polysaccharide dispersible tablet.By controlling kind and the consumption of adjuvant, use the method that comprises following steps can prepare Ganoderma polysaccharide dispersible tablet of the present invention:
A, mixing: by recipe quantity, take each raw material, by Ganoderma polysaccharide powder, filler, disintegrating agent, correctives mix homogeneously;
B, granulation: with 20%～40% alcoholic solution or 3%～6% starch slurry, to the soft material processed of the mixture in steps A, cross 16～18 mesh sieves and granulate;
C, dry: wet granular is dried at 50～70 ℃, and the moisture that makes granule is 3.0%～5.0%;
D, granulate: dried granule is crossed to 14～16 mesh sieve granulate;
E, tabletting: lubricant is joined in the granule of whole good grain, mix homogeneously, is pressed into dispersible tablet.
Further, the invention still further relates to the purposes of above-mentioned Ganoderma polysaccharide dispersible tablet, described purposes is preparation treatment neurasthenia, leukocyte and thrombocytopenia, the medicine of the leukopenia causing after ionizing radiation, occupational hemopoietic damage or tumor patient Radiotherapy chemotherapy.
Compared with prior art, tool has the following advantages dispersible tablet of the present invention:
1, by using starch, microcrystalline Cellulose and calcium sulfate as filler, overcome and caused the poor defect of the excessive disintegrate bringing of viscosity because of the moisture absorption of Ganoderma polysaccharide, and adding and binding agent that viscosity is less in conjunction with appropriate disintegrating agent, not only compact property is better to make dispersible tablet of the present invention, also has good disintegrating property simultaneously; In addition, the present invention, by using aspartame, saccharin sodium and sodium chloride as correctives, has greatly improved dispersible tablet solution mouthfeel after disintegrate in water, is conducive to increase patient's compliance.
2, by using specific adjuvant and controlling its amount ranges, solved the technical problem that easily occurs moisture absorption and sticking technique in the film-making process of prior art, be applicable to industrialized great production.
3, the therapeutic effect of dispersible tablet is determined, can effectively treat neurasthenia, leukocyte and thrombocytopenia, the leukopenia causing after ionizing radiation, occupational hemopoietic damage or tumor patient Radiotherapy chemotherapy, and little to the zest of human body and toxic and side effects, drug safety is high.
The specific embodiment
Below by specific embodiment, the composition of dispersible tablet of the present invention and clinical effectiveness are elaborated, but these embodiment can not limit scope of the present invention.
Embodiment 1
The preparation of Ganoderma polysaccharide powder:
Ganoderma sporophore and/or mycelium are cleaned, drain, decoct with water secondary, decoct for the first time 2 hours, medicinal liquid filters with 100 order filter clothes, medicinal residues add 5 times of water gagings to decoct for the second time again 2 hours, medicinal liquid filters with 100 order filter clothes, merge secondary and decoct gained medicinal liquid, be evaporated to the clear paste of relative density 1.15 (50 ℃ of heat are surveyed), in clear paste, stir and add 95% ethanol to reaching 62% containing alcohol amount, standing 24 hours, get supernatant and reclaim ethanol extremely without alcohol taste, precipitate after recovery ethanol is at 60 ℃ of vacuum dryings, dry extract moisture control is in 3%, dry extract is put Highefficientpulverizer and is ground into fine powder, cross 100 mesh sieves, obtain Ganoderma polysaccharide powder.
Embodiment 2
Prescription:
| Ganoderma polysaccharide powder | 35 % by weight |
| Starch | 30 % by weight |
| Microcrystalline Cellulose | 12 % by weight |
| Polyvinylpolypyrrolidone | 5 % by weight |
| 4% starch slurry | 15 % by weight |
| Aspartame | 1.2 % by weight |
| Sodium chloride | 0.6 % by weight |
| Micropowder silica gel | 1.2 % by weight |
Preparation method:
Take each raw material, by Ganoderma polysaccharide powder, starch, microcrystalline Cellulose, polyvinylpolypyrrolidone, aspartame and sodium chloride mix homogeneously; With 4% starch slurry, to mixture soft material processed, cross 18 mesh sieves and granulate; Wet granular is dried at 50 ℃, and the moisture that makes granule is 3.0%; Dried granule is crossed to 16 mesh sieve granulate; Micropowder silica gel is joined in the granule of whole good grain, mix homogeneously, is pressed into dispersible tablet.This dispersible tablet is all disintegrates in 3 minutes, and by No. two sieves.
Embodiment 3:
Prescription:
| Ganoderma polysaccharide powder | 23 % by weight |
| Calcium sulfate | 60 % by weight |
| Carboxymethyl starch sodium | 5.5 % by weight |
| Polyvinylpolypyrrolidone | 1.5 % by weight |
| 30% ethanol | 5 % by weight |
| Saccharin sodium | 2.5 % by weight |
| Pulvis Talci | 2.5 % by weight |
Preparation method:
Take each raw material, by Ganoderma polysaccharide powder, calcium sulfate, carboxymethyl starch sodium, polyvinylpolypyrrolidone, saccharin sodium mix homogeneously; With 30% ethanol, to mixture soft material processed, cross 16 mesh sieves and granulate; Wet granular is dried at 70 ℃, and the moisture that makes granule is 3.5%; Dried granule is crossed to 16 mesh sieve granulate; Pulvis Talci is joined in the granule of whole good grain, mix homogeneously, is pressed into dispersible tablet.This dispersible tablet is all disintegrates in 3 minutes, and by No. two sieves.
Embodiment 4:
Prescription:
| Ganoderma polysaccharide powder | 43 % by weight |
| Starch | 32.7 % by weight |
| Calcium sulfate | 11 % by weight |
| Low-substituted hydroxypropyl cellulose | 4 % by weight |
| 3% starch slurry | 6 % by weight |
| Saccharin sodium | 1.3 % by weight |
| Sodium chloride | 0.5 % by weight |
| Magnesium stearate | 1.5 % by weight |
Preparation method:
Take each raw material, by Ganoderma polysaccharide powder, starch, calcium sulfate, low-substituted hydroxypropyl cellulose, saccharin sodium and sodium chloride mix homogeneously; With 3% starch slurry, to mixture soft material processed, cross 18 mesh sieves and granulate; Wet granular is dried at 70 ℃, and the moisture that makes granule is 4.0%; Dried granule is crossed to 16 mesh sieve granulate; Magnesium stearate is joined in the granule of whole good grain, mix homogeneously, is pressed into dispersible tablet.The dispersing uniformity of this dispersible tablet is that in 3 minutes, whole disintegrates are also sieved by No. two.
Embodiment 5:
Prescription:
| Ganoderma polysaccharide powder | 38 % by weight |
| Microcrystalline Cellulose | 40.2 % by weight |
| Carboxymethyl starch sodium | 8 % by weight |
| 40% ethanol | 10 % by weight |
| Aspartame | 2.0 % by weight |
| Micropowder silica gel | 1.0 % by weight |
| Pulvis Talci | 0.8 % by weight |
Preparation method:
Take each raw material, by Ganoderma polysaccharide powder, microcrystalline Cellulose, carboxymethyl starch sodium, aspartame mix homogeneously; With 40% ethanol, to mixture soft material processed, cross 16 mesh sieves and granulate; Wet granular is dried at 60 ℃, and the moisture that makes granule is 3.0%; Dried granule is crossed to 16 mesh sieve granulate; Micropowder silica gel, Pulvis Talci are joined in the granule of whole good grain, mix homogeneously, is pressed into dispersible tablet.This dispersible tablet is all disintegrates in 3 minutes, and by No. two sieves.
Embodiment 6:
Prescription:
| Ganoderma polysaccharide powder | 35 % by weight |
| Microcrystalline Cellulose | 28 % by weight |
| Calcium sulfate | 12 % by weight |
| Carboxymethyl starch sodium | 4.2 % by weight |
| Low-substituted hydroxypropyl cellulose | 1.8 % by weight |
| 6% starch slurry | 13 % by weight |
| Aspartame | 3.0 % by weight |
| Micropowder silica gel | 3.0 % by weight |
Preparation method:
Take each raw material, by Ganoderma polysaccharide powder, microcrystalline Cellulose, calcium sulfate, carboxymethyl starch sodium, low-substituted hydroxypropyl cellulose, aspartame mix homogeneously; With 6% starch slurry, to mixture soft material processed, cross 18 mesh sieves and granulate; Wet granular is dried at 55 ℃, and the moisture that makes granule is 3.0%; Dried granule is crossed to 16 mesh sieve granulate; Micropowder silica gel is joined in the granule of whole good grain, mix homogeneously, is pressed into dispersible tablet.This dispersible tablet is all disintegrates in 3 minutes, and by No. two sieves.
Test example 1:
The stability of Ganoderma polysaccharide dispersible tablet of the present invention has been investigated in this test.
1, investigate sample
The Ganoderma polysaccharide dispersible tablet preparing with reference to embodiment 2.
2, test method
Respectively Ganoderma polysaccharide dispersible tablet of the present invention is carried out to photo-stability testing, hot test, accelerated test and long term test.Experimental condition is:
(1). light stability test: test sample opening is placed in the lighting box that daylight lamp is housed, under the condition that is 4500lx ± 500lx in illumination, place 10 days, in sampling in the 5th and the 10th day, detect.
(2). hot test: test sample opening is placed in sealing clean container, at 60 ℃ of temperature, place 10 days, in the 5th day and sampling in the 10th day, detect.
(3). accelerated test: place six months under the condition of 40 ℃ ± 2 ℃ of temperature, relative humidity 75% ± 5%.At duration of test, sample respectively once 1st month, 2 months, 3 months, 6 the end of month, detect.
(4). long term test: place 36 months under the condition of 25 ℃ ± 2 ℃ of temperature, relative humidity 60% ± 10%.Respectively at 0 month, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months, 36 samplings at the end of month, detected.
3, result of the test
Photo-stability testing, hot test, accelerated test and the long-term test results of Ganoderma polysaccharide dispersible tablet of the present invention are in Table 1.
Result of the test shows, Ganoderma polysaccharide dispersible tablet of the present invention, to light, thermally-stabilised, can be preserved and reach 3 years under room temperature state.
Table 1 Ganoderma polysaccharide dispersible tablet stability test result:
Test example 2:
This test has been investigated adjuvant of the present invention and has been formed the impact on sticking in tabletting process and dispersible tablet dispersing uniformity.
1, investigate sample
The Ganoderma polysaccharide dispersible tablet preparing with reference to embodiment 2～6.
2, test method
Hygroscopicity assay method: the supplementary material of of the present invention group and matched group is prepared to Ganoderma polysaccharide dispersible tablet with reference to the method for embodiment 2, be then placed in (25 ℃, preserve under condition RH75%) 30 days, according to formula: weightening finish %=(sheet weight
30d-sheet weight
0d) * 100%/sheet weight
0dcalculate the weightening finish percentage ratio of dispersible tablet.Weightening finish percent value is larger, shows the easier moisture absorption of dispersible tablet.
Sticking investigation method: the supplementary material of of the present invention group and matched group is prepared to Ganoderma polysaccharide dispersible tablet with reference to the method for embodiment 2, observe and whether occur sticking phenomenon in tabletting process.
Hardness measurement method: the supplementary material of of the present invention group and matched group is prepared to Ganoderma polysaccharide dispersible tablet with reference to the method for embodiment 2, be placed in (25 ℃, under condition RH75%), preserve 30 days, then measure the hardness of dispersible tablet.
Dispersing uniformity assay method: the supplementary material of of the present invention group and matched group is prepared to Ganoderma polysaccharide dispersible tablet with reference to the method for embodiment 2, get 6 by official method and be placed in 250mL beaker, add the water 100mL of 15-25 ℃, jolting 3 minutes.
3, result of the test
Supplementary product consumption the results are shown in Table 2 to the impact of sticking and dispersible tablet disintegration.
The impact of table 2 supplementary product consumption on sticking and dispersible tablet disintegration:
| ? | Hygroscopicity (weightening finish %) | Sticking | Hardness (N) | Dispersing uniformity (dividing) |
| Embodiment 2 | 1.2 | NoSticking | 86 | In 3 minutes, all disintegrate is also sieved by No. two |
| Embodiment 3 | 1.2 | NoSticking | 85 | In 3 minutes, all disintegrate is also sieved by No. two |
| Embodiment 4 | 1.22 | NoSticking | 87 | In 3 minutes, all disintegrate is also sieved by No. two |
| Embodiment 5 | 1.25 | NoSticking | 86 | In 3 minutes, all disintegrate is also sieved by No. two |
| Embodiment 6 | 1.3 | NoSticking | 88 | In 3 minutes, all disintegrate is also sieved by No. two |
Result shows, Ganoderma polysaccharide dispersible tablet hygroscopicity of the present invention is less, and hardness is moderate, there will not be sticking in pressing process, and dispersing uniformity is good, meets the needs of clinical practice.
Test example 3:
The therapeutic effect of Ganoderma polysaccharide dispersible tablet of the present invention has been investigated in this test.
1, investigate sample
The Ganoderma polysaccharide dispersible tablet preparing with reference to embodiment 2.
2, treatment target
Leukopenia and levels in patients with thrombocytopenia.
3, test method
The Affiliated Hospital to Jiangxi College of Traditional Chinese Medicine and the second the People's Hospital, Linchuan city of Jiangxi province carry out leukocyte increasing, Platelet Clinical observation to 150 routine leukopenias (wherein 97 examples are with thrombocytopenia) patient.And contrast with the 100 effective powerful SHENGBAI PIAN of positive drug of example (wherein 52 examples are with thrombocytopenia).
Case selection standard is:
(1), Western medicine diagnose standard: peripheral white blood cells is lower than 4.0 * 10
9/ L, neutrophilic granulocyte percent normally or slightly reduces; Or companion's platelet count is lower than 100 * 10
9/ L.Can accompany dizzy weak, extremity are aching and limp, low grade fever, the disease such as nervous; Can there is Radiotherapy chemotherapy history, have contact noxious substance or harmful pharmacohistory.
(2), differential diagnosis in tcm standard: select qi-blood deficiency syndrome: pale complexion, dizziness and blurred vision, deficiency of QI with disinclination to talk, spiritlessness and weakness, forgetful, pale tongue, thready pulse.
Observation index:
(1), safety observation index: observe treatment front and back breathing, blood pressure, body temperature, heart rate, electrocardiogram, liver function, renal function and routine blood test, urine, stool etc.
(2), health giving quality observation: observe clinical symptoms and the variation of tongue arteries and veins for the treatment of front and back and observe weekly routine blood test, platelet variation.
Verification method:
(1), checking group: 3 of oral Ganoderma polysaccharide dispersible tablets, every day three times.
(2), matched group: 3 of powerful SHENGBAI PIAN, every day three times.
(3), the course for the treatment of: 4 weeks.
(4), during clinical verification, stop using other to verifying influential medicine.
4, curative effect judging standard
Clinical recovery: the symptom of blood deficiency disease, sign disappear, and total mark is 0, and leukocyte continuous quadratic result is 4.5 * 10
9the above person of/L; Platelet count is 100 * 10
9more than/L.
Effective: symptom, sign obviously alleviate, by +++ one+or ++ one-, total mark reduces more than 2/3, and leukocyte, platelet continuous quadratic result increase more than 50%, or numeration of leukocyte is 4.0 * 10
9/ L is above, platelet count is 80 * 10
9more than/L.
Effective: symptom, sign alleviate or improve, by +++ one ++ or ++ one+,+mono--, total mark reduces more than 1/3, and leukocyte, platelet continuous quadratic result increase more than 30%, or numeration of leukocyte is 3.0 * 10
9/ L is above, platelet count is 60 * 10
9more than/L.
Invalid: symptom, sign be without improvement, total mark reduces below 1/3 or is unchanged, and leukocyte increases lower than 30%, and platelet count is 60 * 10
9below/L, or also original low-level person.
5, result of the test
To the total effective rate of leukopenia, be 81.29%, to the total effective rate of levels in patients with thrombocytopenia platelet-increasing role, be 73.04%, contrast with the powerful SHENGBAI PIAN of positive control drug simultaneously, P>0.05, shows that leukopenia, thrombocytopenia that Ganoderma polysaccharide dispersible tablet causes Radiotherapy chemotherapy and unknown cause have significant curative effect.Three large conventional, platelet counts all clinical cases have all been detected before and after treatment simultaneously, liver, renal function and electrocardiogram have rising after leukocyte count, platelet count treatment, and other are all in normal range, show that Ganoderma polysaccharide dispersible tablet is used safety, without obvious toxic-side effects.
Claims (6)
1. a Ganoderma polysaccharide dispersible tablet, the raw material that it is characterized in that described dispersible tablet is grouped into by the one-tenth of following percentage by weight:
Ganoderma polysaccharide powder 20%～45%
Filler 40%～65%
Disintegrating agent 3%～8%
Binding agent 5%～20%
Correctives 1.5%～3.5%
Lubricant 0.5%～3.0%;
Wherein, filler is selected from one or more in starch, microcrystalline Cellulose and calcium sulfate; Disintegrating agent is selected from one or more in polyvinylpolypyrrolidone, low-substituted hydroxypropyl cellulose and carboxymethyl starch sodium; Binding agent is selected from alcoholic solution or starch slurry; Correctives is selected from one or more in aspartame, saccharin sodium and sodium chloride; Lubricant is selected from one or more in micropowder silica gel, Pulvis Talci and magnesium stearate;
The preparation method of described Ganoderma polysaccharide powder is: Ganoderma sporophore and/or mycelium are cleaned, drain, decoct with water secondary, decoct for the first time 1.5 ~ 3 hours, medicinal liquid filters with 100 ~ 120 order filter clothes, medicinal residues add 3 ~ 5 times of water gagings to decoct for the second time again 1.5 ~ 3 hours, medicinal liquid filters with 100 ~ 120 order filter clothes, merge secondary and decoct gained medicinal liquid, be evaporated to 50 ℃ of heat and survey the clear paste of relative density 1.10～1.20, in clear paste, stir and add 95% ethanol to reaching 60 ~ 65% containing alcohol amount, standing 20 ~ 30 hours, get supernatant and reclaim ethanol extremely without alcohol taste, precipitate after recovery ethanol is at 50 ~ 80 ℃ of vacuum dryings, dry extract moisture control is in 3%, dry extract is put Highefficientpulverizer and is ground into fine powder, cross 100 ~ 120 mesh sieves, obtain Ganoderma polysaccharide powder.
2. Ganoderma polysaccharide dispersible tablet as claimed in claim 1, the raw material that it is characterized in that described dispersible tablet is grouped into by the one-tenth of following percentage by weight:
Ganoderma polysaccharide powder 30%～40%
Filler 40%～55%
Disintegrating agent 5%～8%
Binding agent 5%～10%
Correctives 1.5%～2.0%
Lubricant 0.5%～1.5%.
3. Ganoderma polysaccharide dispersible tablet as claimed in claim 1 or 2, is characterized in that filler is that weight ratio is microcrystalline Cellulose and the calcium sulfate of 1:10～10:1.
4. Ganoderma polysaccharide dispersible tablet as claimed in claim 1 or 2, is characterized in that binding agent is 20%～40% alcoholic solution or 3%～6% starch slurry.
5. the preparation method of the Ganoderma polysaccharide dispersible tablet as described in one of claim 1 ~ 4, is characterized in that comprising the following steps:
A, mixing: by recipe quantity, take each raw material, by Ganoderma polysaccharide powder, filler, disintegrating agent, correctives mix homogeneously;
B, granulation: with 20%～40% alcoholic solution or 3%～6% starch slurry, to the soft material processed of the mixture in steps A, cross 16 ~ 18 mesh sieves and granulate;
C, dry: wet granular is dried at 50 ~ 70 ℃, and the moisture that makes granule is 3.0% ~ 5.0%;
D, granulate: dried granule is crossed to 14 ~ 16 mesh sieve granulate;
E, tabletting: lubricant is joined in the granule of whole good grain, mix homogeneously, is pressed into dispersible tablet.
6. the Ganoderma polysaccharide dispersible tablet as described in one of claim 1 ~ 4 is in preparation treatment neurasthenia, leukocyte and thrombocytopenia, the purposes in the leukopenia medicine causing after ionizing radiation, occupational hemopoietic damage or tumor patient Radiotherapy chemotherapy.
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