Summary of the invention
Object of the present invention is exactly for above-mentioned defect of the prior art, provide a kind of can the Chinese medicine formula of effectively the kidney invigorating and essence nourishing, brain-strengthening, resisting fatigue.
To achieve these goals, technical scheme provided by the invention is: the Chinese medicine formula of a kind of the kidney invigorating and essence nourishing, brain-strengthening, resisting fatigue, it is prepared by the following material according to parts by weight: Cistanche Tubulosa extract 112 ~ 130 parts, Radix Et Caulis Acanthopanacis Senticosi extract 105 ~ 120 parts, Radix Panacis Quinquefolii extract 50 ~ 72 parts, microcrystalline Cellulose 160 ~ 190 parts.
Further, above-mentioned a kind of the kidney invigorating and essence nourishing, brain-strengthening, the Chinese medicine formula of resisting fatigue, the leaching process of described Cistanche Tubulosa extract is: extracted twice by the Cistanche Tubulosa stem powder methanol eddy of 5.0kg drying, each 3 hours, be decompressed to vacuum 0.07 ~ 0.08MPa to concentrate, after solvent evaporated, obtain Cistanche Tubulosa-methanolic extract 1340 g, get wherein 160 g and carry out silica gel column chromatography, with chloroform-methanol-water gradient elution, through thin layer chromatography inspection, merge into 6 eluted fraction Fr.1 ~ Fr.6, after microwave vacuum drying, pulverize, in microwave-vacuum drying, vacuum is 0.07 ~ 0.08MPa, baking temperature is 60 DEG C, drying time is 6 ~ 8 hours.
Second object of the present invention there is provided the preparation method of Chinese medicine formula of above-mentioned a kind of the kidney invigorating and essence nourishing, brain-strengthening, resisting fatigue, comprises the following steps:
1) proportional quantity is taken after Cistanche Tubulosa extract being crossed 80 mesh sieves;
2) proportional quantity is taken after Radix Et Caulis Acanthopanacis Senticosi extract being crossed 80 mesh sieves;
3) proportional quantity is taken after Radix Panacis Quinquefolii extract being crossed 80 mesh sieves;
4) proportional quantity is taken after microcrystalline Cellulose being crossed 80 mesh sieves;
5) step 1)-step 4) is obtained sieve after the Cistanche Tubulosa extract of proportional quantity, Radix Et Caulis Acanthopanacis Senticosi extract, Radix Panacis Quinquefolii extract and microcrystalline Cellulose mix homogeneously, obtain mixed powder and be finished product.
Further, above-mentioned a kind of the kidney invigorating and essence nourishing, brain-strengthening, the preparation method of the Chinese medicine formula of resisting fatigue, it is characterized in that, the leaching process of the Cistanche Tubulosa extract in described step 1) is: extracted twice by the Cistanche Tubulosa stem powder methanol eddy of 5.0kg drying, each 3 hours, be decompressed to vacuum 0.07 ~ 0.08MPa to concentrate, after solvent evaporated, obtain Cistanche Tubulosa-methanolic extract 1340 g, get wherein 160 g and carry out silica gel column chromatography, with chloroform-methanol-water gradient elution, through thin layer chromatography inspection, merge into 6 eluted fraction Fr.1 ~ Fr.6, after microwave vacuum drying, pulverize, in microwave-vacuum drying, vacuum is 0.07 ~ 0.08MPa, baking temperature is 60 DEG C, drying time is 6 ~ 8 hours.
The Chinese medicine formula of the kidney invigorating and essence nourishing provided by the invention, brain-strengthening, resisting fatigue, the needs for fatiguability crowd, use theory of Chinese medical science, in conjunction with modern Chinese medicine pharmacological research achievement, with Herba Cistanches extract, Radix Et Caulis Acanthopanacis Senticosi extract, Radix Panacis Quinquefolii extract for primary raw material, be equipped with the health food with alleviating physical fatigue function that suitable adjuvant is processed into, improved the quality of life of fatiguability crowd by alleviating physical fatigue.
The Modern preparations technology such as this formula is sieved by employing, weigh, mix, soft material processed, granulation, drying, granulate, total mixed, tabletting, inner packing, outer package, inspection warehouse-in, in the Workshop Production by health food GMP certification, formulate rational method of quality control, and strict management of product measure, ensure that the steady quality of product, safe and reliable.This product confirms safe, nontoxic through the test of health food Toxicological evaluation, can long-term taking; The health care with alleviating physical fatigue is confirmed through animal function test; Confirm not add prohibited items through drug-testing test; Verify steady quality, controlled through hygiology, stability, functional component, dosage form is reasonable.
Beneficial effect of the present invention is:
1) with the biological product clear efficacy that the raw rare medicinal herbs of Novel sand is major ingredient, the world, domestic health industry is met to the market orientation of biological health goods and demand:
The health food regulated internal organs etc. based on Chinese medicine is subject to concern and the favor of people always, this product take natural plant extracts as primary raw material, through scientific compatibility, the health food with alleviating physical fatigue function made, has no side effect, be applicable to sub-health population, improve the health of sub-health population, play prevention of disease effect, improve the quality of life of people, after putting on market, vast potential for future development will be had.
2) high-quality herbaceous material traceability system is set up:
In the product of this Project-developing, major ingredient Cistanche Tubulosa is all from own standardization plantation farm, specifically set up the basic condition of traceability system, traceability system can realize all batch products from raw material to finished product, from finished product to raw material 100% two-way tracing function, the maximum featured function of this system is exactly the safety of data, and the link of each artificial input is all backed up in realtime by software.
3) use membrance separation purification by liquid extraction technology to carry out solidifying extraction to batching, realize Cistanche Tubulosa efficiency utilization:
This technology effectively can remove thalline, improves product content and purity; Separation condition is gentle, without phase-state change, be thus conducive to biological activity and the physical and chemical stability of preservation effective ingredient; Avoid allogenic material and affect the quality of effective ingredient; Without the need to adding solvent, simplifying production technology, shortening the production cycle, improve production security;
4) employing herbal essences multidimensional synthesis pressed-disc technique is produced:
Realize the additive-free tabletting of 100% pure powder, increase buccal, mucosal absorption new tunnel in mouth, ensure that herbaceous plant essential ingredient utilizes to maximize, directly enter blood circulation of human body, without the first pass effect of gastrointestinal tract and liver, efficient convenience, carry, transport, take all more convenient, be easy to consumer accept and take.
5) scientific composition, ensures science, reasonability that novel compatibility has:
The traditional Chinese medical science is thought, the appearance of fatigue phenomenon, has close relationship with the imbalance of the five internal organs, simultaneously, the traditional Chinese medical science is thought again, the whole vital movement of people, entirely relies in " vigour ", vigour natural endowment is in congenital and nourished the day after tomorrow, be the source of body energy, combine from different internal organs and just produce different functions, so vigour is weak, each function inhibitory state at a low ebb of human body will be made, also just constitute and produce tired basic reason.This product with Herba Cistanches extract, Radix Et Caulis Acanthopanacis Senticosi extract, Radix Panacis Quinquefolii extract for primary raw material.Through each raw material of inquiry this product not at the row of " eighteen incompatible medicaments ", " nineteen medicaments of mutual restraint ", without incompatibility; In formula, Herba Cistanches enters kidney channel, kidney-replenishing, benefiting essence-blood, the main marrow improving inspiration by invigorating kidney-QI of kidney storing essence, is people's the congenital foundation; Radix Et Caulis Acanthopanacis Senticosi enters spleen, kidney, heart channel, replenishing QI to invigorate the spleen, tonifying the kidney for tranquilization, spleen transporting and transforming nutrients from foodstuff, is source of generating QI and blood, is people's the foundation of acquired constitution; Radix Panacis Quinquefolii boosting qi and nourishing yin, clearing away heat and promoting production of body fluid.Take a broad view of we, Herba Cistanches enters kidney channel, and the congenital foundation is grown, and Radix Et Caulis Acanthopanacis Senticosi i.e. the kidney invigorating but also spleen invigorating are also calmed the nerves, and the foundation of acquired constitution are mended, Radix Panacis Quinquefolii YIN nourishing and the production of body fluid promoting, three's compatibility, play effect of alleviating physical fatigue altogether.
Meanwhile, and entrust professional disease prevention and control center to carry out the zoopery of alleviating physical fatigue function in strict accordance with health food inspection and assessment technical specification to product, result of the test shows that this product has alleviating physical fatigue function.
Technical scheme provided by the invention also has the following advantages:
one, declare function according to the efficacy effect of Herba Cistanches and health food, develop the functional biological health food having and alleviate physical resisting fatigue, memory reinforcing, loosening bowel to relieve constipation, carried out scientific composition and compatibility:
1) screening of formula:
Screening technique: use alleviating physical fatigue, memory reinforcing, improve the method for inspection of intestinal health functional check method (zoopery: body weight, Loaned swimming test, blood lactase acid, serum urea, hepatic glycogen or muscle glycogen).
The selection result: product has alleviating physical fatigue, memory reinforcing, improves intestinal health function.
Screening foundation: " health food inspection and assessment technical specification " (version in 2010).
2) clear efficacy:
Product provided by the invention is the needs for fatiguability crowd, use theory of Chinese medical science, in conjunction with modern Chinese medicine pharmacological research achievement, with Herba Cistanches extract, Radix Et Caulis Acanthopanacis Senticosi extract, Radix Panacis Quinquefolii extract for primary raw material, be equipped with the health food with alleviating physical fatigue function that suitable adjuvant is processed into, improved the quality of life of fatiguability crowd by alleviating physical fatigue.
two, Cistanche Tubulosa chemical composition and bioactivity research:
Project is by cooperating with Xinjing Vygur Autonomous Region Chinese Medicine and Ethnic Medicine Research Inc., technical staff is appointed to carry out learning and communication to Xinjing Vygur Autonomous Region Chinese Medicine and Ethnic Medicine Research Inc., the Cistanche Tubulosa of South Sinkiang product is carried out to separation and the bioactivity research of chemical composition, be divided into from identifying 39 compounds from Cistanche Tubulosa, wherein noval chemical compound 9, known compound 10.In 9 noval chemical compounds, 2 is phenethyl alcohol glycosides, and 6 is monoterpene (glycosides) class.
Carry out extraction and isolation flow process: drying tube flower herba cistanches stem powder (5.0 kg) methanol eddy extracts twice, and each 3 hours, concentrating under reduced pressure solvent evaporated obtained methanolic extract 1340 g.Get wherein 160 g and carry out silica gel column chromatography, with chloroform-methanol-water gradient elution, through thin layer chromatography inspection, merge into 6 eluting stream parts (Fr.1 ~ Fr.6).
In biological activity research: project has carried out the research that Cistanche Tubulosa extract affects high salt raising rat blood pressure, erythrocyte membrane fluidity and whole blood viscosity.The contraction of Late Cambrian Cistanche Tubulosa methanolic extract to the isolated rat thoracic aorta that norepinephrine is induced has vasodilator effect; and determine that vasodilator effect effective ingredient is phenethyl alcohol glycoside compounds verbascoside (1), the echinacoside (2) of 4 bit strip coffee acyls of glucose, and acylated sugars pipe spends sugar (3), Cistanche Tubulosa glycosides F(4).
In the Hydrolysis kinetics of Cistanche Tubulosa effective ingredient: the screening of raw material, high energy-collecting ultrasonic ripple extraction, membrance separation, concentrated, drying, sterilizing, pulverize, sieve, check, pack, put all employing state-of-the-art technologies in storage and complete.
three, the research of the aspect such as the technique of product, quality standard and security related, stability, functional, hygiology:
1) screening of formula:
Screening technique: use alleviating physical fatigue, memory reinforcing, improve the method for inspection of intestinal health functional check method (zoopery: body weight, Loaned swimming test, blood lactase acid, serum urea, hepatic glycogen or muscle glycogen).
The selection result: product has alleviating physical fatigue, memory reinforcing, improves intestinal health function.
Screening foundation: " health food inspection and assessment technical specification " (version in 2003).
2) production technology of product:
The screening of raw material, high energy-collecting ultrasonic ripple extraction, membrance separation, concentrated, drying, sterilizing, pulverize, sieve, check, pack, put all most advanced production Technology of employing in storage and complete.Workshop is between 100,000 grades of medicine special-purpose vehicles.
3) formulation of target level of product quality: determine by health (functional) food universal standard GB16740 and relevant criterion.
4) detection method (mensuration of echinacoside, acteoside, total saponin content) of product efficacy composition:
Use LC-2010CHT type high performance liquid chromatograph, AE-140 type electronic balance; Chromatographic column: octadecylsilane chemically bonded silica is that the equipment such as the chromatographic column of filler measure.
5) Product Safety evaluation experimental method is pharmaceutical grade Demonstration Method:
Acute toxicity: select body weight to be the Kunming mouse of 18g ~ 22g, male and female half and half are tested.
Mutagenicity test: carry out Salmonella reversion test, mice bone marrow micronucleus, mouse inbred strain; Little Polychromatic erythrocyte micronucleus test; Mouse inbred strain.
10 days feeding trials: get SD rat 80, male and female half and half, if 3 Dose Groups Study.
Function animality is tested: SPF level Male Kunming strain mice 160.
6) dosage choice and sample treatment adopt mice burden swimming test, comprise serum urea mensuration, anthrone method liver glycogen measures, blood lactase acid measures.
7) drug-testing experiment:
Product provided by the invention detects through institute of sports medicine drug-testing center of General Administration of Sport, does not find the stimulant of World Anti-Doping Agency's regulation forbidding in 2007, narcotic analgesics, steroidal, diuretic, beta blocker, β 2-agonist, functional drug and glucocorticoid.
Detailed description of the invention
component Source:
Radix Et Caulis Acanthopanacis Senticosi extract: purchased from Jilin Hongjiu Biotech Co., Ltd..
Radix Panacis Quinquefolii extract: purchased from Jilin Hongjiu Biotech Co., Ltd..
Column layer chromatography silicone rubber: purchased from Qingdao Marine Chemical Co., Ltd..
embodiment 1:
A preparation method for the Chinese medicine formula of the kidney invigorating and essence nourishing, brain-strengthening, resisting fatigue, comprises the following steps:
1) 112kg is taken after Cistanche Tubulosa extract being crossed 80 mesh sieves; The leaching process of Cistanche Tubulosa extract is: the Cistanche Tubulosa stem powder methanol eddy of every 5kg drying extracts twice, each 3 hours, be decompressed to vacuum 0.07MPa to concentrate, after solvent evaporated, obtain Cistanche Tubulosa-methanolic extract 1340 g, get wherein 160 g and carry out silica gel column chromatography, with chloroform-methanol-water gradient elution, through thin layer chromatography inspection, merge into 6 eluted fraction Fr.1 ~ Fr.6, after microwave vacuum drying, pulverize, in microwave-vacuum drying, vacuum is 0.07MPa, and baking temperature is 60 DEG C, and drying time is 6 hours;
2) 105kg is taken after Radix Et Caulis Acanthopanacis Senticosi extract being crossed 80 mesh sieves;
3) 50kg is taken after Radix Panacis Quinquefolii extract being crossed 80 mesh sieves;
4) 160kg is taken after microcrystalline Cellulose being crossed 80 mesh sieves;
5) step 1)-step 4) is obtained sieve after the Cistanche Tubulosa extract of proportional quantity, Radix Et Caulis Acanthopanacis Senticosi extract, Radix Panacis Quinquefolii extract and microcrystalline Cellulose mix homogeneously, obtain mixed powder and be finished product.
embodiment 2:
A preparation method for the Chinese medicine formula of the kidney invigorating and essence nourishing, brain-strengthening, resisting fatigue, comprises the following steps:
1) 130kg is taken after Cistanche Tubulosa extract being crossed 80 mesh sieves; The leaching process of Cistanche Tubulosa extract is: the Cistanche Tubulosa stem powder methanol eddy of every 5kg drying extracts twice, each 3 hours, be decompressed to vacuum 0.08MPa to concentrate, after solvent evaporated, obtain Cistanche Tubulosa-methanolic extract 1340 g, get wherein 160 g and carry out silica gel column chromatography, with chloroform-methanol-water gradient elution, through thin layer chromatography inspection, merge into 6 eluted fraction Fr.1 ~ Fr.6, after microwave vacuum drying, pulverize, in microwave-vacuum drying, vacuum is 0.08MPa, and baking temperature is 60 DEG C, and drying time is 8 hours;
2) 120 kg are taken after Radix Et Caulis Acanthopanacis Senticosi extract being crossed 80 mesh sieves;
3) 72 kg are taken after Radix Panacis Quinquefolii extract being crossed 80 mesh sieves;
4) 190 kg are taken after microcrystalline Cellulose being crossed 80 mesh sieves;
5) step 1)-step 4) is obtained sieve after the Cistanche Tubulosa extract of proportional quantity, Radix Et Caulis Acanthopanacis Senticosi extract, Radix Panacis Quinquefolii extract and microcrystalline Cellulose mix homogeneously, obtain mixed powder and be finished product.
embodiment 3:
A preparation method for the Chinese medicine formula of the kidney invigorating and essence nourishing, brain-strengthening, resisting fatigue, comprises the following steps:
1) 121kg is taken after Cistanche Tubulosa extract being crossed 80 mesh sieves, the leaching process of Cistanche Tubulosa extract is: the Cistanche Tubulosa stem powder methanol eddy of every 5kg drying extracts twice, each 3 hours, be decompressed to vacuum 0.075MPa to concentrate, after solvent evaporated, obtain Cistanche Tubulosa-methanolic extract 1340 g, get wherein 160 g and carry out silica gel column chromatography, with chloroform-methanol-water gradient elution, through thin layer chromatography inspection, merge into 6 eluted fraction Fr.1 ~ Fr.6, after microwave vacuum drying, pulverize, in microwave-vacuum drying, vacuum is 0.075MPa, baking temperature is 60 DEG C, drying time is 7 hours,
2) 112 kg are taken after Radix Et Caulis Acanthopanacis Senticosi extract being crossed 80 mesh sieves;
3) 61kg is taken after Radix Panacis Quinquefolii extract being crossed 80 mesh sieves;
4) 175 kg are taken after microcrystalline Cellulose being crossed 80 mesh sieves;
5) step 1)-step 4) is obtained sieve after the Cistanche Tubulosa extract of proportional quantity, Radix Et Caulis Acanthopanacis Senticosi extract, Radix Panacis Quinquefolii extract and microcrystalline Cellulose mix homogeneously, obtain mixed powder and be finished product.
Be below key technology of the present invention point:
1, with pure Chinese medicinal plant extracts such as Cistanche Tubulosas for main formula raw material;
2, Chinese medicinal plant extractive technique innovation:
According to production technology system and the industry standard of Herba Cistanches main active substances phenethyl alcohol glycosides extract, the extractive technique to Herba Cistanches advanced person of Introduced from Japan advanced person and material, the extracting method of design Herba Cistanches active component, the extraction of super cumulative, membrance separation and high-speed countercurrent chromatography, reverse phase silica gel (ODS) separation equipment is adopted to carry out enrichment, echinacoside content in extracted Herba Cistanches extract is made to bring up to 27% by 12.5%, Determination of Acteoside brings up to 8% by 1%, total glycosides >=80%;
3, setting up high-quality herbaceous material can traceability system, realizes production system innovation:
In product provided by the invention, major ingredient Cistanche Tubulosa is all from own standardization plantation farm, specifically set up the basic condition of traceability system, traceability system can realize all batch products from raw material to finished product, from finished product to raw material 100% two-way tracing function.The maximum featured function of this system is exactly the safety of data, and the link of each artificial input is all backed up in realtime by software.
Last it is noted that the foregoing is only the preferred embodiments of the present invention, be not limited to the present invention, although with reference to previous embodiment to invention has been detailed description, for a person skilled in the art, it still can be modified to the technical scheme described in foregoing embodiments, or carries out equivalent replacement to wherein portion of techniques feature.Within the spirit and principles in the present invention all, any amendment done, equivalent replacement, improvement etc., all should be included within protection scope of the present invention.