A concentrated Huoxin Pills and its preparation method

Abstract

The present invention relates to the technical field of traditional Chinese medicines, and particularly relates to a concentrated Huoxin Pills and a preparation method thereof. The preparation method includes: weighing raw materials Ganoderma lucidum, artificial musk, bear bile, bezoar, pearls, ginseng, bufotalin, aconite root, borneol, safflower and starch; pulverizing Ganoderma lucidum, ginseng, bufotalin, aconite root and safflower to obtain a powder, boiling with water and then keeping warm and stirring to obtain Intermediate Product 1; adding ficin and zingibain to Intermediate Product 1, inactivating the enzymes to obtain Intermediate Product 2; sterilizing Intermediate Product 2, adding a carbon source, a nitrogen source and a fermenting bacterium, fermenting, sterilizing, filtering to obtain the filtrate of Intermediate Product 3; adding artificial musk, bear bile, bezoar, pearls, borneol and starch to Intermediate Product 3, stirring, concentrating under reduced pressure, pelletizing, and drying to obtain the concentrated Huoxin Pills. The concentrated Huoxin Pills prepared by the present invention have excellent blood lipid-lowering effects, can significantly reduce the contents of TC, TG and LDL-C in serum and effectively increase the content of HDL-C.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicines, and particularly relates to a concentrated Huoxin Pills and a preparation method thereof. Background Art

[0002] The formula of Huoxin Pills is Ganoderma lucidum, artificial musk, bear bile, in vitro cultivated calculus bovis, pearl, ginseng, bufotalin, aconite root, borneol and safflower. In the formula, Ganoderma lucidum, safflower and ginseng benefit qi and activate blood circulation, and are used as the monarch drugs together. Calculus bovis and borneol have the effects of aromatic resuscitation, promoting qi movement and dissipating stasis; musk and bufotalin are pungent, dispersing, warm and dredging, aromatic and spreading, resuscitating and relieving arthralgia, and are used as the minister drugs together. Bear bile and pearl calm the mind and tranquilize the spirit; aconite root is pungent, warm and dry, tonifying fire and assisting yang, dispelling cold and relieving arthralgia, which can not only assist in benefiting qi and promoting yang, but also prevent the cold nature of calculus bovis, pearl and bear bile, and are used as the assistant drugs together. The combination of various drugs has the functions of benefiting qi and activating blood circulation, aromatic resuscitation, relieving arthralgia and relieving pain. Clinically, Huoxin Pills are used to treat chest tightness, stabbing pain in front of the heart, palpitation, shortness of breath, fatigue, thready pulse and purple tongue caused by insufficient heart qi, blood stasis in the heart vessels, blockage of the heart vessels and failure of the chest yang to spread.

[0003] On the basis of having the effect of treating cardiovascular diseases, Huoxin Pills also need to further expand its process to obtain concentrated pills and endow them with excellent effects in preventing or treating hyperlipidemia, so as to expand its application. Summary of the Invention

[0004] In view of the above technical problems, the present invention proposes the technical solution of the present invention, and the technical solution of the present invention includes a concentrated Huoxin Pills and a preparation method thereof.

[0005] The present invention provides a preparation method of a concentrated Huoxin Pills, comprising the following steps:

[0006] Step 1: Weigh raw materials: Ganoderma lucidum, artificial musk, bear bile, calculus bovis, pearl, ginseng, bufotalin, aconite root, borneol, safflower and starch;

[0007] Step 2: Crush Ganoderma lucidum, ginseng, bufotalin, aconite root and safflower to obtain a powder, boil with water and keep stirring while warming to obtain Intermediate Product 1;

[0008] Step 3: Add ficin and zingibain to Intermediate Product 1, carry out enzymatic hydrolysis and inactivate the enzyme to obtain Intermediate Product 2;

[0009] Step 4: Sterilize Intermediate Product 2, add a carbon source, a nitrogen source and a fermentation bacterium, carry out fermentation, sterilize, and filter to obtain the filtrate of Intermediate Product 3;

[0010] Step 5: Add artificial musk, bear bile, calculus bovis, pearl, borneol and starch to Intermediate Product 3, stir, concentrate under reduced pressure, make pills, and dry to obtain the concentrated Huoxin Pills.

[0011] Preferably, in step 1, the raw materials are weighed by parts by mass: 20-40 parts of Ganoderma lucidum, 0.2-0.5 part of artificial musk, 0.5-2 parts of bear bile, 0.2-0.5 part of bezoar, 0.2-0.4 part of pearl, 20-30 parts of ginseng, 2-5 parts of bufotalin, 8-15 parts of aconite, 0.2-0.5 part of borneol, 2-6 parts of safflower, and 3-6 parts of starch.

[0012] Preferably, in step 2, the mass ratio of the powder to water is 1:15-40; the heat preservation and stirring conditions are: heat preservation and stirring at 70-82 °C for 2-6 hours.

[0013] Preferably, in step 3, the addition amounts of ficin and zingibain added to intermediate product I are 220-400 u / g and 250-500 u / g respectively; the enzymatic hydrolysis conditions are: enzymatic hydrolysis at 40-60 °C with stirring for 2-5 hours.

[0014] Preferably, in step 4, the carbon source includes glucose, and its addition amount to product II is 1-4 wt%; the nitrogen source includes potassium dihydrogen phosphate, and its addition amount to product II is 0.02-0.065 wt%.

[0015] Preferably, in step 4, the fermenting bacteria are viable bacteria of Lactobacillus casei - like CICC 6235 and Bacillus subtilis CICC 10262, and the composition ratio of the viable bacteria is 1:1.2-2.5. The total inoculation amount of the viable bacteria of the fermenting bacteria in intermediate product II is 1.1×10 10 -3.7×10 10 cfu / g.

[0016] Preferably, in step 4, the fermentation conditions are stirring at 30-38 °C for 100-200 hours.

[0017] Preferably, in step 5, the vacuum concentration temperature is 50-55 °C, and the vacuum concentration is carried out until the water content is 10-15 wt%.

[0018] Preferably, in step 5, vacuum drying is adopted, and the drying temperature is 60-70 °C.

[0019] Preferably, in step 5, the drying is carried out until the water content is lower than 5 wt%.

[0020] The present invention also provides the concentrated Huoxin Pills prepared according to the said preparation method.

[0021] The beneficial effects of the present invention:

[0022] The preparation method includes: weighing raw materials Ganoderma lucidum, artificial musk, bear bile, bezoar, pearls, ginseng, bufotoxin, aconite, borneol, safflower and starch; pulverizing Ganoderma lucidum, ginseng, bufotoxin, aconite and safflower to obtain a powder, boiling with water and then keeping warm and stirring to obtain Intermediate Product 1; adding ficin and zingibain to Intermediate Product 1, inactivating the enzymes to obtain Intermediate Product 2; sterilizing Intermediate Product 2, adding a carbon source, a nitrogen source and fermenting bacteria, fermenting, sterilizing, filtering to obtain the filtrate of Intermediate Product 3; adding artificial musk, bear bile, bezoar, pearls, borneol and starch to Intermediate Product 3, stirring, concentrating under reduced pressure, pelletizing, and drying to obtain the concentrated Huoxin Pills. The concentrated active pills prepared by the present invention have excellent lipid-lowering effects, can significantly reduce the contents of TC, TG and LDL-C in serum and effectively increase the content of HDL-C.

[0023] The present invention adopts enzymolysis and fermentation processes, both of which can effectively improve the efficacy of the pills and increase their lipid-lowering effects.

[0024] When the present invention performs enzymolysis, ficin and zingibain are used in combination, which can produce a compound effect, effectively reduce the contents of TC, TG and LDL-C in serum and increase the content of HDL-C, endowing the active pills with excellent lipid-lowering effects.

[0025] In the fermentation process of the present invention, Lactobacillus casei CICC 6235 and Bacillus subtilis CICC 10262 are used for combined fermentation, and the two have a synergistic effect in promoting the lipid-lowering effect. The combined fermentation of the two can significantly reduce the contents of TC, TG and LDL-C and increase the content of HDL-C. And in the fermentation process, when the viable bacteria of Lactobacillus casei CICC 6235 and Bacillus subtilis CICC 10262 are in the range of 1:1.2 - 2.5 in terms of quantity ratio, the prepared active pills have better effects.

[0026] The preparation method of the present invention is simple, and the prepared active pills have excellent effects and have good application prospects. Specific Embodiments

[0027] The following will elaborate on the present invention in combination with specific embodiments, and various effects of the present invention will be presented more clearly therefrom. Those skilled in the art should understand that these specific embodiments are used to illustrate the present invention rather than limit the present invention.

[0028] Starch: Corn starch with a mesh number lower than 100. Lactobacillus casei CICC 6235 and Bacillus subtilis CICC 10262 are purchased from the China Center for Industrial Culture Collection. Bezoar: In vitro cultivated bezoar, purchased from Wuhan Jianmin Dapeng Pharmaceutical Co., Ltd.

[0029] Preparation of Huoxin Pills:

[0030] Pill 1:

[0031] Step 1: Weigh the raw materials by parts by mass: 30 parts of Ganoderma lucidum, 0.4 part of artificial musk, 1 part of bear bile, 0.35 part of bezoar, 0.3 part of pearl, 25 parts of ginseng, 4 parts of bufotalin, 12 parts of aconite root, 0.4 part of borneol, 5 parts of safflower and 5 parts of starch;

[0032] Step 2: Crush Ganoderma lucidum, ginseng, bufotalin, aconite root and safflower to obtain powder, add water 32 times the mass of the powder, boil, keep warm at 78 °C, stir at 60 rpm for 4.5 hours to obtain Intermediate Product 1;

[0033] Step 3: Add ficin at 300 u / g of Intermediate Product 1 and ginger protease at 400 u / g of Intermediate Product 1, enzymatically hydrolyze at 55 °C and stir at 60 rpm for 3.8 hours, then inactivate the enzyme to obtain Intermediate Product 2;

[0034] Step 4: Sterilize Intermediate Product 2, add carbon source glucose at 3.2% of the mass of Intermediate Product 2, potassium dihydrogen phosphate as nitrogen source at 0.05% and fermentation bacteria, control the fermentation temperature at 37 °C and stir at 60 rpm for 170 hours, then sterilize and filter to obtain the filtrate of Intermediate Product 3;

[0035] Among them, the fermentation bacteria are live bacteria of Lactobacillus casei - like CICC 6235 and Bacillus subtilis CICC 10262, which are composed according to a quantity ratio of 1:2, and the total inoculation quantity of live bacteria of the fermentation bacteria in Intermediate Product 2 is 2.70×10 10 cfu / g;

[0036] Step 5: Add artificial musk, bear bile, bezoar, pearl, borneol and starch to Intermediate Product 3, stir at 80 rpm for 0.5 hour, then concentrate under reduced pressure at 55 °C until the water content is 14 wt%, make pills, and dry in vacuum at 68 °C until the water content is 4.27 wt% to obtain the concentrated Huoxin Pills.

[0037] Pill 2:

[0038] Step 1: Weigh the raw materials by parts by mass: 20 parts of Ganoderma lucidum, 0.2 part of artificial musk, 1.5 parts of bear bile, 0.2 part of bezoar, 0.4 part of pearl, 30 parts of ginseng, 5 parts of bufotalin, 15 parts of aconite root, 0.2 part of borneol, 2 parts of safflower and 5 parts of starch;

[0039] Step 2: Crush Ganoderma lucidum, ginseng, bufotalin, aconite root and safflower to obtain powder, add water 35 times the mass of the powder, boil, keep warm at 80 °C, stir at 60 rpm for 4 hours to obtain Intermediate Product 1;

[0040] Step 3: Add ficin at 400 u / g of Intermediate Product I and zingibain at 320 u / g of Intermediate Product I to Intermediate Product I, enzymatically hydrolyze at 52 °C with stirring at 60 rpm for 3.2 hours, and then inactivate the enzyme to obtain Intermediate Product II;

[0041] Step 4: Sterilize Intermediate Product II, add carbon source glucose at 3.15% of the mass of Intermediate Product II, potassium dihydrogen phosphate as nitrogen source at 0.06%, and fermentation bacteria, control the fermentation temperature at 35 °C with stirring at 60 rpm for 120 hours, and then sterilize and filter to obtain the filtrate of Intermediate Product III;

[0042] Among them, the fermentation bacteria are live bacteria of Lactobacillus casei - like CICC 6235 and Bacillus subtilis CICC 10262, which are composed according to a quantity ratio of 1:1.5, and the total inoculation quantity of live fermentation bacteria in Intermediate Product II is 2.85×10 10 cfu / g;

[0043] Step 5: Add artificial musk, bear bile, bezoar, pearls, borneol and starch to Intermediate Product III, stir at 80 rpm for 0.5 hours, then concentrate under reduced pressure at 55 °C until the water content is 13.8 wt%, make pills, and dry in vacuum at 68 °C until the water content is 4.15 wt% to obtain the concentrated Huoxin Pills.

[0044] Pill 3:

[0045] Step 1: Weigh raw materials by mass: 30 parts of Ganoderma lucidum, 0.4 part of artificial musk, 1 part of bear bile, 0.35 part of bezoar, 0.3 part of pearls, 25 parts of ginseng, 4 parts of bufotalin, 12 parts of aconite, 0.4 part of borneol, 5 parts of safflower and 5 parts of starch;

[0046] Step 2: Crush Ganoderma lucidum, ginseng, bufotalin, aconite and safflower to obtain powder, add water 32 times the mass of the powder, boil and keep warm at 78 °C with stirring at 60 rpm for 4.5 hours to obtain Intermediate Product I;

[0047] Step 3: Sterilize Intermediate Product I, add carbon source glucose at 3.2% of the mass of Intermediate Product I, potassium dihydrogen phosphate as nitrogen source at 0.05%, and fermentation bacteria, control the fermentation temperature at 37 °C with stirring at 60 rpm for 170 hours, and then sterilize and filter to obtain the filtrate of Intermediate Product II;

[0048] Among them, the fermentation bacteria are live bacteria of Lactobacillus casei - like CICC 6235 and Bacillus subtilis CICC 10262, which are composed according to a quantity ratio of 1:2, and the total inoculation quantity of live fermentation bacteria in Intermediate Product I is 2.70×10 10 cfu / g;

[0049] Step 5: Add artificial musk, bear bile, bezoar, pearls, borneol and starch to Intermediate Product II, stir at 80 rpm for 0.5 hour, then concentrate under reduced pressure at 55°C until the water content is 14 wt%, make pills, and dry in vacuum at 68°C until the water content is 4.27 wt% to obtain the concentrated Huoxin Pills.

[0050] Pill 4:

[0051] Step 1: Weigh the raw materials according to parts by mass: 30 parts of Ganoderma lucidum, 0.4 part of artificial musk, 1 part of bear bile, 0.35 part of bezoar, 0.3 part of pearls, 25 parts of ginseng, 4 parts of bufotalin, 12 parts of aconite, 0.4 part of borneol, 5 parts of safflower and 5 parts of starch;

[0052] Step 2: Crush Ganoderma lucidum, ginseng, bufotalin, aconite and safflower to obtain a powder, add water 32 times the mass of the powder, boil, keep warm at 78°C, and stir at 60 rpm for 4.5 hours to obtain Intermediate Product I;

[0053] Step 3: Add ficin at 700 u / g of Intermediate Product I to Intermediate Product I, enzymatically hydrolyze at 55°C and stir at 60 rpm for 3.8 hours, then inactivate the enzyme to obtain Intermediate Product II;

[0054] Step 4: Sterilize Intermediate Product II, add carbon source glucose at 3.2% of the mass of Intermediate Product II, nitrogen source potassium dihydrogen phosphate at 0.05% and fermentation bacteria, control the fermentation temperature at 37°C and stir at 60 rpm for 170 hours, then sterilize and filter to obtain the filtrate of Intermediate Product III;

[0055] Among them, the fermentation bacteria are live bacteria of Lactobacillus casei - like CICC 6235 and Bacillus subtilis CICC 10262 composed according to a quantity ratio of 1:2, and the total inoculation quantity of live fermentation bacteria in Intermediate Product II is 2.70×10 10 cfu / g;

[0056] Step 5: Add artificial musk, bear bile, bezoar, pearls, borneol and starch to Intermediate Product III, stir at 80 rpm for 0.5 hour, then concentrate under reduced pressure at 55°C until the water content is 14 wt%, make pills, and dry in vacuum at 68°C until the water content is 4.27 wt% to obtain the concentrated Huoxin Pills.

[0057] Pill 5:

[0058] Step 1: Weigh the raw materials according to parts by mass: 30 parts of Ganoderma lucidum, 0.4 part of artificial musk, 1 part of bear bile, 0.35 part of bezoar, 0.3 part of pearls, 25 parts of ginseng, 4 parts of bufotalin, 12 parts of aconite, 0.4 part of borneol, 5 parts of safflower and 5 parts of starch;

[0059] Step 2: Grind Ganoderma lucidum, ginseng, bufotalin, aconite root, and safflower into powder, add water 32 times the mass of the powder, boil, keep warm at 78 °C, stir at 60 rpm for 4.5 hours to obtain Intermediate Product 1;

[0060] Step 3: Add 700 u / g of ginger protease in Intermediate Product 1, enzymatically hydrolyze at 55 °C and stir at 60 rpm for 3.8 hours, then inactivate the enzyme to obtain Intermediate Product 2;

[0061] Step 4: Sterilize Intermediate Product 2, add carbon source glucose at 3.2% of the mass of Intermediate Product 2, nitrogen source potassium dihydrogen phosphate at 0.05%, and fermentation bacteria, control the fermentation temperature at 37 °C and stir at 60 rpm for 170 hours, then sterilize and filter to obtain the filtrate of Intermediate Product 3;

[0062] Among them, the fermentation bacteria are live bacteria of Lactobacillus casei - like CICC 6235 and Bacillus subtilis CICC 10262, and the composition ratio of the number is 1:2. The total inoculation number of live fermentation bacteria in Intermediate Product 2 is 2.70×10 10 cfu / g;

[0063] Step 5: Add artificial musk, bear bile, bezoar, pearls, borneol, and starch to Intermediate Product 3, stir at 80 rpm for 0.5 hours, then concentrate under reduced pressure at 55 °C until the water content is 14 wt%, make pills, and dry in vacuum at 68 °C until the water content is 4.27 wt% to obtain the concentrated Huoxin Pills.

[0064] Pill 6:

[0065] Step 1: Weigh raw materials by mass parts: 30 parts of Ganoderma lucidum, 0.4 part of artificial musk, 1 part of bear bile, 0.35 part of bezoar, 0.3 part of pearls, 25 parts of ginseng, 4 parts of bufotalin, 12 parts of aconite root, 0.4 part of borneol, 5 parts of safflower, and 5 parts of starch;

[0066] Step 2: Grind Ganoderma lucidum, ginseng, bufotalin, aconite root, and safflower into powder, add water 32 times the mass of the powder, boil, keep warm at 78 °C, stir at 60 rpm for 4.5 hours to obtain Intermediate Product 1;

[0067] Step 3: Add 300 u / g of ficin and 400 u / g of ginger protease in Intermediate Product 1, enzymatically hydrolyze at 55 °C and stir at 60 rpm for 3.8 hours, then inactivate the enzyme and filter to obtain the filtrate of Intermediate Product 2;

[0068] Step 4: Add artificial musk, bear bile, bezoar, pearls, borneol, and starch to Intermediate Product 2, stir at 80 rpm for 0.5 hours, then concentrate under reduced pressure at 55 °C until the water content is 14 wt%, make pills, and dry in vacuum at 68 °C until the water content is 4.27 wt% to obtain the concentrated Huoxin Pills.

[0069] Pill 7:

[0070] Step 1: Weigh the raw materials by parts by mass: 30 parts of Ganoderma lucidum, 0.4 part of artificial musk, 1 part of bear bile, 0.35 part of bezoar, 0.3 part of pearl, 25 parts of ginseng, 4 parts of bufotalin, 12 parts of aconite root, 0.4 part of borneol, 5 parts of safflower and 5 parts of starch;

[0071] Step 2: Crush Ganoderma lucidum, ginseng, bufotalin, aconite root and safflower to obtain powder, add water 32 times the mass of the powder, boil, keep warm at 78 °C, stir at 60 rpm for 4.5 hours to obtain Intermediate Product 1;

[0072] Step 3: Add ficin at 300 u / g of Intermediate Product 1 and zingibain at 400 u / g of Intermediate Product 1, enzymatically hydrolyze at 55 °C and stir at 60 rpm for 3.8 hours, then inactivate the enzyme to obtain Intermediate Product 2;

[0073] Step 4: Sterilize Intermediate Product 2, add carbon source glucose at 3.2% of the mass of Intermediate Product 2, potassium dihydrogen phosphate as nitrogen source at 0.05% and fermentation bacteria, control the fermentation temperature at 37 °C and stir at 60 rpm for 170 hours, then sterilize and filter to obtain the filtrate of Intermediate Product 3;

[0074] Among them, the fermentation bacteria are Lactobacillus casei - like CICC 6235, and the total viable inoculation quantity of the fermentation bacteria in Intermediate Product 2 is 2.70×10 10 cfu / g;

[0075] Step 5: Add artificial musk, bear bile, bezoar, pearl, borneol and starch to Intermediate Product 3, stir at 80 rpm for 0.5 hours, then concentrate under reduced pressure at 55 °C until the water content is 14 wt%, make pills, and dry in vacuum at 68 °C until the water content is 4.27 wt% to obtain the concentrated Huoxin Pills.

[0076] Pill 8:

[0077] Step 1: Weigh the raw materials by parts by mass: 30 parts of Ganoderma lucidum, 0.4 part of artificial musk, 1 part of bear bile, 0.35 part of bezoar, 0.3 part of pearl, 25 parts of ginseng, 4 parts of bufotalin, 12 parts of aconite root, 0.4 part of borneol, 5 parts of safflower and 5 parts of starch;

[0078] Step 2: Crush Ganoderma lucidum, ginseng, bufotalin, aconite root and safflower to obtain powder, add water 32 times the mass of the powder, boil, keep warm at 78 °C, stir at 60 rpm for 4.5 hours to obtain Intermediate Product 1;

[0079] Step 3: Add ficin at 300 u / g of Intermediate Product I and zingibain at 400 u / g of Intermediate Product I to Intermediate Product I, enzymatically hydrolyze at 55°C with stirring at 60 rpm for 3.8 hours, and then inactivate the enzyme to obtain Intermediate Product II;

[0080] Step 4: Sterilize Intermediate Product II, add carbon source glucose at 3.2% of the mass of Intermediate Product II, nitrogen source potassium dihydrogen phosphate at 0.05%, and fermentation bacteria, control the fermentation temperature at 37°C with stirring at 60 rpm for 170 hours, then sterilize and filter to obtain the filtrate of Intermediate Product III;

[0081] Among them, the fermentation bacteria are Bacillus subtilis CICC 10262, and the total viable inoculation quantity of the fermentation bacteria in Intermediate Product II is 2.70×10 10 cfu / g;

[0082] Step 5: Add artificial musk, bear bile, bezoar, pearl, borneol and starch to Intermediate Product III, stir at 80 rpm for 0.5 hour, then concentrate under reduced pressure at 55°C to a water content of 14 wt%, make pills, and dry in vacuum at 68°C to a water content of 4.27 wt% to obtain the concentrated Huoxin Pills.

[0083] Pill 9:

[0084] Step 1: Weigh raw materials by mass parts: 30 parts of Ganoderma lucidum, 0.4 part of artificial musk, 1 part of bear bile, 0.35 part of bezoar, 0.3 part of pearl, 25 parts of ginseng, 4 parts of bufotalin, 12 parts of aconite root, 0.4 part of borneol, 5 parts of safflower and 5 parts of starch;

[0085] Step 2: Crush Ganoderma lucidum, ginseng, bufotalin, aconite root and safflower to obtain powder, add water 32 times the mass of the powder, boil, keep warm at 78°C and stir at 60 rpm for 4.5 hours to obtain Intermediate Product I;

[0086] Step 3: Add ficin at 300 u / g of Intermediate Product I and zingibain at 400 u / g of Intermediate Product I to Intermediate Product I, enzymatically hydrolyze at 55°C with stirring at 60 rpm for 3.8 hours, and then inactivate the enzyme to obtain Intermediate Product II;

[0087] Step 4: Sterilize Intermediate Product II, add carbon source glucose at 3.2% of the mass of Intermediate Product II, nitrogen source potassium dihydrogen phosphate at 0.05%, and fermentation bacteria, control the fermentation temperature at 37°C with stirring at 60 rpm for 170 hours, then sterilize and filter to obtain the filtrate of Intermediate Product III;

[0088] Among them, the fermentation bacteria are composed of viable bacteria of Lactobacillus paracasei CICC 6235 and Bacillus subtilis CICC 10262 in a quantity ratio of 1:0.2, and the total viable inoculation quantity of the fermentation bacteria in Intermediate Product II is 2.70×10 10cfu / g;

[0089] Step 5: Add artificial musk, bear bile, bezoar, pearl, borneol and starch to Intermediate Product III, stir at 80 rpm for 0.5 hours, then concentrate under reduced pressure at 55°C until the water content is 14 wt%, make pills, and dry in vacuum at 68°C until the water content is 4.27 wt% to obtain the concentrated Huoxin Pills.

[0090] Pill 10:

[0091] Step 1: Weigh the raw materials by mass parts: 30 parts of Ganoderma lucidum, 0.4 part of artificial musk, 1 part of bear bile, 0.35 part of bezoar, 0.3 part of pearl, 25 parts of ginseng, 4 parts of bufotalin, 12 parts of aconite, 0.4 part of borneol, 5 parts of safflower and 5 parts of starch;

[0092] Step 2: Crush Ganoderma lucidum, ginseng, bufotalin, aconite and safflower to obtain powder, add water 32 times the mass of the powder, boil, keep warm at 78°C, and stir at 60 rpm for 4.5 hours to obtain Intermediate Product I;

[0093] Step 3: Add ficin at 300 u / g of Intermediate Product I and zingibain at 400 u / g of Intermediate Product I to Intermediate Product I, enzymatically hydrolyze at 55°C and stir at 60 rpm for 3.8 hours, then inactivate the enzyme to obtain Intermediate Product II;

[0094] Step 4: Sterilize Intermediate Product II, add carbon source glucose at 3.2% of the mass of Intermediate Product II, nitrogen source potassium dihydrogen phosphate at 0.05% and fermentation bacteria, control the fermentation temperature at 37°C and stir at 60 rpm for 170 hours, then sterilize and filter to obtain the filtrate of Intermediate Product III;

[0095] Among them, the fermentation bacteria are live bacteria of Lactobacillus casei - paracasei CICC 6235 and Bacillus subtilis CICC 10262, and the composition ratio of the number is 1:5. The total inoculation number of live bacteria of the fermentation bacteria in Intermediate Product II is 2.70×10 10 cfu / g;

[0096] Step 5: Add artificial musk, bear bile, bezoar, pearl, borneol and starch to Intermediate Product III, stir at 80 rpm for 0.5 hours, then concentrate under reduced pressure at 55°C until the water content is 14 wt%, make pills, and dry in vacuum at 68°C until the water content is 4.27 wt% to obtain the concentrated Huoxin Pills.

[0097] Effect test of Huoxin Pills:

[0098] Modeling experiment: A number of SPF-grade male SD rats weighing 200 ± 20 g (Chengdu Ensville Biotechnology Co., Ltd.) were selected. All rats were fed with ordinary feed for 5 days for adaptation; then some rats were continuously fed with high-fat feed (high-fat feed with 45% of energy from fat, Jiangsu Xietong Pharmaceutical Biotechnology Co., Ltd.) for 6 weeks for modeling, and some rats were fed with ordinary feed for 6 weeks; the successfully modeled rats were randomly divided into a model control group, a positive drug group, and groups 1-10 of the pill, a total of 13 groups, with 10 rats in each group, and 10 rats were randomly selected from the rats fed with ordinary feed as the blank group rats.

[0099] Before the administration experiment, the medicinal solutions were prepared: Medicinal solution for the positive drug group: Simvastatin tablets (Hangzhou Merck Sharp & Dohme Pharmaceutical Co., Ltd.) were diluted with normal saline to obtain a simvastatin active concentration of 0.4 mg / mL as the medicinal solution for the positive drug group; Medicinal solutions for groups 1-10 of the pill: The above-mentioned pills 1-10 were respectively diluted with normal saline to a concentration of 1.3 mg of pill / mL as the medicinal solutions.

[0100] Administration experiment: Rats in the positive drug group and groups 1-10 of the pill were given intragastric administration at a dose of 1 mL of medicinal solution / 100 g of rat once a day, while rats in the model group and the blank group were given intragastric administration in the same way with an equal amount of normal saline; during the administration period, the positive drug group, groups 1-10 of the pill, and the model group continued to be fed with high-fat feed, and the blank group continued to be fed with ordinary feed; the administration experiment lasted continuously for 2 months.

[0101] 12 hours after the last administration, the rats were anesthetized, blood was taken from the abdominal artery, serum was separated, and the contents of TC, TG, LDL-C, and HDL-C were measured according to the instructions of the kit. The data were statistically analyzed using SPSS 26.0 software. One-way ANOVA was used for comparison among multiple groups. Compared with the model control group, the P values of each group of data were all less than 0.05, showing statistical significance. The test results of each group are shown in Table 1.

[0102] Table 1: Contents of TC, TG, LDL-C, and HDL-C

[0103] Test TC / mmol / L TG / mmol / L LDL-C / mmol / L HDL-C / mmol / L Blank group 2.536±0.217 1.125±0.103 0.863±0.095 1.651±0.184 Model group 4.395±0.453 2.702±0.298 2.094±0.253 0.896±0.079 Positive drug group 2.948±0.241 1.364±0.142 1.152±0.127 1.467±0.153 Pill 1 group 2.993±0.305 1.429±0.163 1.176±0.114 1.375±0.141 Pill 2 group 3.012±0.229 1.442±0.171 1.185±0.205 1.369±0.158 Pill 3 group 3.281±0.374 1.635±0.209 1.324±0.197 1.297±0.105 Pill 4 group 3.097±0.427 1.501±0.114 1.229±0.106 1.346±0.167 Pill 5 group 3.125±0.198 1.523±0.195 1.245±0.122 1.338±0.144 Pill 6 group 3.672±0.336 1.916±0.247 1.526±0.169 1.192±0.109 Pill 7 group 3.256±0.295 1.617±0.190 1.312±0.110 1.304±0.136 Pill 8 group 3.289±0.392 1.640±0.227 1.328±0.154 1.295±0.118 Pill 9 group 3.084±0.203 1.494±0.134 1.223±0.135 1.350±0.152 Pill 10 group 3.153±0.260 1.543±0.125 1.257±0.101 1.332±0.128

[0104] The data in Table 1 were converted to calculate the decrease degree △ values of TC, TG, and LDL-C and the increase degree △ values of HDL-C content in each group compared with the model group. The results are shown in Table 2.

[0105] Table 2: Change values of TC, TG, LDL-C, and HDL-C contents compared with the model group

[0106] Test △TC / mmol / L △TG / mmol / L △LDL-C / mmol / L △HDL-C / mmol / L Blank group 1.859 1.577 1.231 0.755 Positive drug group 1.447 1.338 0.942 0.571 Pill 1 group 1.402 1.273 0.918 0.479 Pill 2 group 1.383 1.260 0.909 0.473 Pill 3 group 1.114 1.067 0.770 0.401 Pill 4 group 1.298 1.201 0.865 0.450 Pill 5 group 1.270 1.179 0.849 0.442 Pill 6 group 0.723 0.786 0.568 0.296 Pill 7 group 1.139 1.085 0.782 0.408 Pill 8 group 1.106 1.062 0.766 0.399 Pill 9 group 1.311 1.208 0.871 0.454 Pill 10 group 1.242 1.159 0.837 0.436

[0107] In the above table, TC is total serum cholesterol, which refers to the sum of cholesterol contained in all lipoproteins in the blood and serves as an indicator of lipid metabolism. TG is triglyceride, and an increase in triglyceride may cause hyperlipidemia. HDL-C is high-density lipoprotein, which is a lipoprotein that can transport cholesterol to the liver for metabolism and mainly acts on anti-atherosclerosis. LDL-C is low-density lipoprotein cholesterol. Low-density lipoprotein is prone to invading blood vessels and depositing in the intima, thus forming plaques.

[0108] According to the test results in Table 1-2, the concentrated active pills prepared by the present invention have excellent lipid-lowering effects, can significantly reduce the contents of TC, TG and LDL-C in serum and effectively improve the content of HDL-C.

[0109] According to the test results of groups 1, 3, and 6 of the pills in the table, the present invention adopts the enzymolysis and fermentation processes, both of which can effectively improve the efficacy of the pills and increase their lipid-lowering effects.

[0110] According to the test results of groups 1, 4-5 of the pills in the table, when the present invention performs enzymolysis, using ficin and zingibain in combination can produce a compound effect, effectively reducing the contents of TC, TG and LDL-C in serum and improving the content of HDL-C, and endowing the active pills with excellent lipid-lowering effects.

[0111] According to the test results of groups 1, 7-10 in the table, during the fermentation process of the present invention, Lactobacillus casei CICC6235 and Bacillus subtilis CICC 10262 are used for combined fermentation, and the two have a synergistic effect in promoting the lipid-lowering effect. The combined fermentation of the two can significantly reduce the contents of TC, TG and LDL-C and increase the content of HDL-C. And during the fermentation process, when the viable bacteria of Lactobacillus casei CICC 6235 and Bacillus subtilis CICC 10262 are selected in the range of the quantity ratio of 1:1.2-2.5, the prepared active pills have better effects.

[0112] Obviously, those skilled in the art can make various changes and modifications to the present invention without departing from the spirit and scope of the present invention. Thus, if these modifications and variations of the present invention fall within the scope of the claims of the present invention and their equivalent technologies, the present invention is also intended to include these changes and modifications.

Claims

1. A method for preparing concentrated heart-activating pills, characterized in that: The following steps are involved: Step 1: weigh the raw materials: ganoderma lucidum, artificial musk, bear gall, bezoar, pearl, ginseng, toad venom, aconite root, borneol, safflower and starch; Step 2: Ganoderma lucidum, ginseng, toad venom, aconite root and safflower are crushed to obtain powder, and water is added to boil and then stirred to obtain intermediate product 1; Step 3: Adding ficin and ginger protease to the intermediate product 1, performing enzymolysis at 40-60° C. and stirring for 2-5 hours to inactivate the enzymes, thereby obtaining the intermediate product 2; Step 4: sterilize the intermediate product II, add a carbon source, a nitrogen source and fermentation bacteria, ferment, sterilize, and filter to obtain an intermediate product III filtrate; Step 5: adding artificial musk, bear gall, bezoar, pearl, borneol and starch to the intermediate product three filtrate, stirring, concentrating under reduced pressure, making pills, and drying to obtain the concentrated heart-activating pills; The fermentation bacteria were Lactobacillus paracasei CICC 6235 and Bacillus subtilis CICC 10262; The weight parts of the raw materials in step 1 are: 20-40 parts of ganoderma lucidum, 0.2-0.5 parts of artificial musk, 0.5-2 parts of bear gall, 0.2-0.5 parts of bezoar, 0.2-0.4 parts of pearl, 20-30 parts of ginseng, 2-5 parts of toad venom, 8-15 parts of aconite, 0.2-0.5 parts of borneol, 2-6 parts of safflower and 3-6 parts of starch; In step 4, the fermentation condition is 30-38° C. with stirring for 100-200 hours.

2. The preparation method according to claim 1, characterized in that: In step 2, the mass ratio of powder to water is 1:15-40; the heat preservation and stirring conditions are: heat preservation and stirring at 70-82° C. for 2-6 hours.

3. The preparation method according to claim 1, characterized in that: In step 3, the amounts of ficin and gingerin added to the intermediate product 1 are 220-400 U / g and 250-500 U / g respectively.

4. The preparation method according to claim 1, characterized in that: In step 4, the carbon source includes glucose, which is added to the intermediate product 2 in an amount of 1-4wt%; the nitrogen source includes potassium dihydrogen phosphate, which is added to the intermediate product 2 in an amount of 0.02-0.065wt%.

5. The preparation method according to claim 1, characterized in that: In step 4, the fermentation bacteria are composed of live bacteria of Lactobacillus paracasei CICC 6235 and Bacillus subtilis CICC 10262 in a ratio of 1:1.2-2.5, and the total inoculation number of live bacteria of the fermentation bacteria in the intermediate product 2 is 1.1×10 10 -3.7×10 10 cfu / g.

6. The preparation method according to claim 1, characterized in that: In step 5, the mixture is concentrated under reduced pressure to a water content of 10-15 wt%.

7. The preparation method according to claim 1, characterized in that: In step 5, the drying temperature is 50-70°C.

8. Concentrated heart-activating pills prepared by the preparation method according to any one of claims 1 to 7.