CN103816114B - Ganoderma sinense polysaccharide oral liquid composition and preparation method thereof - Google Patents
Ganoderma sinense polysaccharide oral liquid composition and preparation method thereof Download PDFInfo
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Abstract
The invention discloses a ganoderma sinense polysaccharide oral liquid composition and a preparation method thereof. The ganoderma sinense polysaccharide oral liquid composition comprises the following components in parts by weight; 5 to 12 parts of ganoderma sinense polysaccharide, 0.5 to 3.5 parts of a solubilizer, 0.3 to 2.0 parts of a suspending agent, 1.0 to 3.0 parts of a flavoring agent, and 0.1 to 0.5 part of a preservative. The oral liquid composition provided by the invention has the advantages of high stability and excellent mouthfeel, and can effectively prevent and treat leukopenia and thrombocytopenia after being taken.
Description
Technical field
The present invention relates to field of medicaments, particularly relate to liquid oral compositions of a kind of Ganoderma polysaccharide and preparation method thereof.
Background technology
Ganoderma (weight portion anoderma Sinense zhao Xu et zhan weight portion) belongs to Ganodermataceae, comprises sporophore and mycelium.Ganoderma polysaccharide is in Ganoderma culture, to extract the total polysaccharides body obtaining, and has strengthening by means of tonics, the effects such as tranquilizing by nourishing the heart.Ganoderma polysaccharide sheet is the applicant in 1978 for the clinical a kind for the treatment of neurasthenia who has no side effect who provides is provided, leukocyte and thrombocytopenia, the active drug of the symptom such as leukopenia after ionizing radiation and occupational hemopoietic damage and tumor patient Radiotherapy chemotherapy, for first research and development new drug of the whole nation, within 1985, obtain and produce certification.At present, Ganoderma polysaccharide sheet is described in the ten WS of the Sanitation Ministry medicine standard < < Traditional Chinese medicine historical preparation > >
3in-B-2241-96.But conventional tablet often stripping is slower, and be difficult for taking for the patient of child and stupor, vomiting.Therefore, still need to develop new dosage form, to meet the demand of different crowd.
Dispersion that liquid preparation has medicine is large, it is fast to absorb, and with solid dosage forms comparison, can bring into play rapidly drug effect; Be easy to divided dose, taking convenience, is specially adapted to the advantages such as child and gerontal patient, is therefore widely used clinically.At present, on market, do not find the liquid oral compositions of Ganoderma polysaccharide.
But, because the dispersion of liquid preparation Chinese medicine is large, there is larger boundary and interface energy, therefore, have unstability to a certain degree, and aqueous liquid preparation easily goes mouldy.For different medicines, should select suitable adjuvant and amount ranges thereof according to himself feature, to obtain good stability, guarantee safety and the effectiveness of clinical application.
Summary of the invention
The object of the invention is for problems of the prior art, a kind of Ganoderma polyoses oral liquid compositions is provided, this liquid oral compositions is good stability not only, and mouthfeel is good, after taking, can effectively prevent and treat leukocyte and thrombocytopenia.
The present invention is achieved by the following technical solutions.
On the one hand, the invention provides a kind of Ganoderma polyoses oral liquid compositions, the supplementary material that this liquid oral compositions comprises following weight proportion:
。
Preferably, the supplementary material that described Ganoderma polyoses oral liquid compositions comprises following weight proportion:
。
The Ganoderma polysaccharide powder using in Ganoderma polyoses oral liquid compositions 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, being evaporated to relative density 1.10～1.20(50 ℃ of heat surveys) clear paste, 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%.
In Ganoderma polyoses oral liquid compositions of the present invention, described solubilizing agent is selected from one or more in ethanol, propylene glycol, Polyethylene Glycol; Described suspending agent is selected from one or more in polyvinylpyrrolidone, sodium alginate, sodium carboxymethyl cellulose; Described correctives is selected from one or more in stevioside, aspartame, xylitol, sodium chloride; Antiseptic is selected from one or more in ethyl hydroxybenzoate, propylparaben, Potassium Benzoate.
As the embodiment being more preferably, described solubilizing agent is that weight ratio is 1:(0.3 ~ 0.6) propylene glycol and Polyethylene Glycol; Described suspending agent is polyvinylpyrrolidone; Described correctives is that weight ratio is 1:(0.1 ~ 0.4) aspartame and sodium chloride; Antiseptic is that weight ratio is ethyl hydroxybenzoate and the propylparaben of 1:1.
More preferably, described solubilizing agent is that weight ratio is 1:(0.32 ~ 0.40) propylene glycol and Polyethylene Glycol; Described correctives is that weight ratio is 1:(0.15 ~ 0.25) aspartame and sodium chloride.
Liquid oral compositions of the present invention can be mixture, oral liquid or syrup.
On the other hand, the invention provides the preparation method of described Ganoderma polyoses oral liquid compositions.
The preparation method of oral liquid comprises following steps: solubilizing agent is added in 1/3 ~ 2/3 purified water, stir, then add Ganoderma polysaccharide powder, 35 ~ 40 ℃ are stirred to dissolving completely; In solution, add suspending agent and correctives, mix homogeneously, is cooled to room temperature, standby; Add antiseptic, after mix homogeneously, add purified water to 1000ml, fill, 115 ℃ of sterilizings 15 ~ 20 minutes, obtain.
The preparation method of syrup comprises following steps: solubilizing agent is added in 1/3 ~ 2/3 purified water, stir, then add Ganoderma polysaccharide powder, 35 ~ 40 ℃ are stirred to dissolving completely; In solution, add suspending agent and correctives, mix homogeneously, is cooled to room temperature, standby; Get white sugar, clear water and mix, heating is dissolved, and mixs homogeneously with above-mentioned solution, adds antiseptic, fill after stirring, and 115 ℃ of sterilizings 15 ~ 20 minutes, obtain.
In addition, the present invention also provides the application of described Ganoderma polyoses oral liquid compositions in preparation prevention and treatment leukocyte and thrombocytopenia disease drug.
Compared with prior art, tool has the following advantages Ganoderma polyoses oral liquid compositions of the present invention:
1, the present invention, by using specific adjuvant and consumption thereof, makes the good stability of liquid oral compositions, has guaranteed safety and the effectiveness of clinical application;
2, the mouthfeel of liquid oral compositions of the present invention is good, is particularly suitable for waiting in child and old age taking of special population;
3, liquid oral compositions technique of the present invention is simple, cost is low, is applicable to suitability for industrialized production, after taking, can effectively prevent and treat leukocyte and thrombocytopenia.
The specific embodiment
Below by specific embodiment, the composition of liquid oral compositions of the present invention and clinical effectiveness are elaborated.
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, being evaporated to relative density 1.15(50 ℃ of heat surveys) clear paste, 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:
。
Preparation method:
Propylene glycol and Polyethylene Glycol are added in 1/3 purified water, stir, then add Ganoderma polysaccharide powder, 35 ℃ are stirred to dissolving completely; In solution, add sodium carboxymethyl cellulose, aspartame and sodium chloride, mix homogeneously, is cooled to room temperature, standby; Add ethyl hydroxybenzoate and propylparaben, after mix homogeneously, add purified water to 1000ml, fill, 115 ℃ of sterilizings 15 minutes, obtain.
embodiment 3
Prescription:
。
Preparation method:
Ethanol is added in 1/3 purified water, stir, then add Ganoderma polysaccharide powder, 40 ℃ are stirred to dissolving completely; In solution, add polyvinylpyrrolidone and aspartame, mix homogeneously, is cooled to room temperature, standby; Get white sugar, clear water and mix, heating is dissolved, and mixs homogeneously with above-mentioned solution, adds Potassium Benzoate, fill after stirring, and 115 ℃ of sterilizings 15 minutes, obtain.
embodiment 4
Prescription:
。
Preparation method:
Propylene glycol is added in 2/3 purified water, stir, then add Ganoderma polysaccharide powder, 38 ℃ are stirred to dissolving completely; In solution, add polyvinylpyrrolidone and stevioside, mix homogeneously, is cooled to room temperature, standby; Add ethyl hydroxybenzoate and propylparaben, after mix homogeneously, add purified water to 1000ml, fill, 115 ℃ of sterilizings 20 minutes, obtain.
embodiment 5
Prescription:
。
Preparation method:
Polyethylene Glycol is added in 2/3 purified water, stir, then add Ganoderma polysaccharide powder, 40 ℃ are stirred to dissolving completely; In solution, add sodium alginate, aspartame and sodium chloride, mix homogeneously, is cooled to room temperature, standby; Add ethyl hydroxybenzoate and propylparaben, after mix homogeneously, add purified water to 1000ml, fill, 115 ℃ of sterilizings 20 minutes, obtain.
test example 1
The stability of Ganoderma polyoses oral liquid compositions of the present invention has been investigated in this test.
1, investigate sample
The Ganoderma polyoses oral liquid compositions obtaining with reference to prescription and the preparation method of embodiment 2.
2, test method
Accelerated test: get totally 20 parts of Ganoderma polyoses oral liquid compositionss of the present invention, under the condition of 40 ℃ ± 2 ℃ of temperature, relative humidity 75% ± 5%, place 6 months, in duration of test each sampling in the 0th, 1,3,6 month once, investigate character, pH value and the content of liquid oral compositions.
Long term test: get totally 30 parts of Ganoderma polyoses oral liquid compositionss of the present invention, under the condition of 25 ℃ ± 2 ℃ of temperature, relative humidity 60% ± 10%, place 24 months, respectively at each sampling in 0,3,6,12,24 month once, investigate character, pH value and the content of liquid oral compositions.
Result of the test is in Table 1.
3, result of the test
Result shows, Ganoderma polyoses oral liquid compositions of the present invention is through accelerating to investigate 6 months and long term test 24 months, and its character, pH value and medicament contg were compared and had no significant change with 0 month, illustrated that Ganoderma polyoses oral liquid composition stable of the present invention is good.
。
test example 2
The mouthfeel of Ganoderma polyoses oral liquid compositions of the present invention has been investigated in this test.
1, investigate sample
Of the present invention group: the Ganoderma polyoses oral liquid compositions obtaining with reference to prescription and the preparation method of embodiment 2.
Contrast groups 1: with reference to the Ganoderma polyoses oral liquid compositions of embodiment 2 preparations, difference is that correctives is sucrose 1.8g.
Contrast groups 2: with reference to the Ganoderma polyoses oral liquid compositions of embodiment 2 preparations, difference is that correctives is that aspartame and sodium chloride are total to 1.5g.
Contrast groups 3: with reference to the Ganoderma polyoses oral liquid compositions of embodiment 2 preparations, difference is that correctives is that aspartame and sodium chloride are total to 2.5g.
2, subjects
Select 20 healthy, 20 ~ 40 years old volunteer without any bad habit, men and women half and half, gets the liquid oral compositions of of the present invention group and matched group 1 ~ 3 for volunteer oral, each oral 10ml, stop and spue after 10 seconds, and gargle for several times by purified water, according to the immediate mouthfeel of following marking Standard Selection marking, calculate the meansigma methods of mouthfeel mark, score value is higher, and mouthfeel is better.
3, mouthfeel marking standard
Taste is sweet, aftertaste is better: 10 ~ 15 minutes;
Micro-sweet, aftertaste is poor: 5 ~ 10 minutes;
Can not stand: 0 ~ 5 minute.
4, result of the test
The liquid oral compositions mouthfeel marking of of the present invention group and matched group the results are shown in Table 2.
。
Result shows, the mouthfeel of oral liquid of the present invention is good, and uses the liquid oral compositions sweet taste of cane sugar substitution correctives of the present invention less obvious, and aftertaste is poor, in addition, correctives consumption in liquid oral compositions is too much or when very few, all can cause the mouthfeel variation of oral liquid.
test example 3
The therapeutic effect of Ganoderma polyoses oral liquid compositions of the present invention has been investigated in this test.
1, investigate sample
The Ganoderma polyoses oral liquid compositions obtaining with reference to prescription and the preparation method of embodiment 2.
The therapeutic effect of Ganoderma polyoses oral liquid compositions of the present invention has been investigated in this test.
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 200 routine leukopenias (wherein 98 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: 1 of oral Ganoderma polyoses oral liquid (10ml/ props up), 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 81.32%, to the total effective rate of levels in patients with thrombocytopenia platelet-increasing role, be 73.6%, contrast with the powerful SHENGBAI PIAN of positive control drug simultaneously, P>0.05, shows that leukopenia, thrombocytopenia that Ganoderma polyoses oral liquid 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 polyoses oral liquid is used safety, without obvious toxic-side effects.
Claims (7)
1. a Ganoderma polyoses oral liquid compositions, is characterized in that, the supplementary material that described liquid oral compositions comprises following weight proportion:
Ganoderma polysaccharide powder 5 ~ 12 weight portions
Solubilizing agent 0.5 ~ 3.5 weight portion
Suspending agent 0.3 ~ 2.0 weight portion
Correctives 1.0 ~ 3.0 weight portions
Antiseptic 0.1 ~ 0.5 weight portion;
Described solubilizing agent is selected from one or more in ethanol, propylene glycol, Polyethylene Glycol; Described suspending agent is selected from one or more in polyvinylpyrrolidone, sodium alginate, sodium carboxymethyl cellulose; Described correctives is selected from one or more in stevioside, aspartame, xylitol, sodium chloride; Antiseptic is selected from one or more in ethyl hydroxybenzoate, propylparaben, Potassium Benzoate;
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 polyoses oral liquid compositions as claimed in claim 1, is characterized in that the supplementary material that described liquid oral compositions comprises following weight proportion:
Ganoderma polysaccharide powder 6 ~ 8 weight portions
Solubilizing agent 1.5 ~ 2.0 weight portions
Suspending agent 0.8 ~ 1.2 weight portion
Correctives 1.8 ~ 2.3 weight portions
Antiseptic 0.15 ~ 0.3 weight portion.
3. Ganoderma polyoses oral liquid compositions as claimed in claim 1 or 2, is characterized in that, described solubilizing agent is that weight ratio is 1:(0.3 ~ 0.6) propylene glycol and Polyethylene Glycol; Described suspending agent is polyvinylpyrrolidone; Described correctives is that weight ratio is 1:(0.1 ~ 0.4) aspartame and sodium chloride; Antiseptic is that weight ratio is ethyl hydroxybenzoate and the propylparaben of 1:1.
4. Ganoderma polyoses oral liquid compositions as claimed in claim 3, is characterized in that: described solubilizing agent is that weight ratio is 1:(0.32 ~ 0.40) propylene glycol and Polyethylene Glycol; Described correctives is that weight ratio is 1:(0.15 ~ 0.25) aspartame and sodium chloride.
5. Ganoderma polyoses oral liquid compositions as claimed in claim 1, is characterized in that described liquid oral compositions is mixture, oral liquid or syrup.
6. the preparation method of Ganoderma polyoses oral liquid compositions as claimed in claim 5, is characterized in that:
The preparation method of oral liquid comprises following steps: solubilizing agent is added in 1/3 ~ 2/3 purified water, stir, then add Ganoderma polysaccharide powder, 35 ~ 40 ℃ are stirred to dissolving completely; In solution, add suspending agent and correctives, mix homogeneously, is cooled to room temperature, standby; Add antiseptic, after mix homogeneously, add purified water to 1000ml, fill, 115 ℃ of sterilizings 15 ~ 20 minutes, obtain;
The preparation method of syrup comprises following steps: solubilizing agent is added in 1/3 ~ 2/3 purified water, stir, then add Ganoderma polysaccharide powder, 35 ~ 40 ℃ are stirred to dissolving completely; In solution, add suspending agent and correctives, mix homogeneously, is cooled to room temperature, standby; Get white sugar, clear water and mix, heating is dissolved, and mixs homogeneously with above-mentioned solution, adds antiseptic, fill after stirring, and 115 ℃ of sterilizings 15 ~ 20 minutes, obtain.
7. the application of the Ganoderma polyoses oral liquid compositions as described in one of claim 1 ~ 5 in preparation prevention and treatment leukocyte and thrombocytopenia disease drug.
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| CN104664204A (en) * | 2014-12-19 | 2015-06-03 | 渤海大学 | Ginger polysaccharide oral liquid composition and preparation method thereof |
| CN105475990B (en) * | 2015-11-30 | 2019-10-08 | 杭州鑫伟低碳技术研发有限公司 | A kind of manufacturing method of lucidum spore powder or ganoderma lucidum polysaccharide suspended gel |
| CN107115295A (en) * | 2017-04-28 | 2017-09-01 | 杭州华东医药集团新药研究院有限公司 | A kind of fluid composition containing cordyceps sinensis and preparation method thereof |
| CN109350597A (en) * | 2018-09-28 | 2019-02-19 | 四川农业大学 | Codonopsis pilosula var. modesta polysaccharide/synanthrin oral liquid formulations and preparation method |
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