CN112472766A - Preparation process and detection method of radix salviae miltiorrhizae and blood slices - Google Patents

Preparation process and detection method of radix salviae miltiorrhizae and blood slices Download PDF

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CN112472766A
CN112472766A CN202011462693.8A CN202011462693A CN112472766A CN 112472766 A CN112472766 A CN 112472766A CN 202011462693 A CN202011462693 A CN 202011462693A CN 112472766 A CN112472766 A CN 112472766A
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parts
mobile phase
setting
blood
tablets
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贺东兵
马雨涵
吴义兵
周华平
陈莹
张箭
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Hefei China Resources Shenlu Pharmaceutical Co ltd
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Hefei China Resources Shenlu Pharmaceutical Co ltd
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/48—Fabaceae or Leguminosae (Pea or Legume family); Caesalpiniaceae; Mimosaceae; Papilionaceae
    • A61K36/487—Psoralea
    • A—HUMAN NECESSITIES
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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/06—Fungi, e.g. yeasts
    • A61K36/07—Basidiomycota, e.g. Cryptococcus
    • A61K36/076—Poria
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    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
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    • A61K36/23—Apiaceae or Umbelliferae (Carrot family), e.g. dill, chervil, coriander or cumin
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    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
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Abstract

The invention discloses a preparation process and a detection method of danqi and blood tablets, wherein the danqi and blood tablets comprise the following raw materials in parts by weight: 12-18 parts of fructus psoraleae, 12-16 parts of prepared fleece-flower root, 3-7 parts of radix ophiopogonis, 4-8 parts of codonopsis pilosula, 3-7 parts of astragalus membranaceus, 3-7 parts of fried bighead atractylodes rhizome, 3-7 parts of poria cocos, 2-6 parts of fried rhizoma atractylodis, 5-10 parts of rhizoma paridis, 5-10 parts of rhizoma cyperi, 6-8 parts of salvia miltiorrhiza, 2-5 parts of divaricate saposhnikovia root, 4-10 parts of eclipta, 2-8 parts of lithospermum, 5-14 parts of fried tribulus terrestris and 2-6 parts of. The preparation process of the Chinese patent medicine film-coated tablet can ensure the quality stability of the medicine, and is more beneficial to the control of the preparation forming and tablet weight difference through the improvement of a new drying process and a new tabletting process; meanwhile, the detection method for integrally controlling the product quality is provided, so that the product quality and the uniform stability of the sample are better guaranteed.

Description

Preparation process and detection method of radix salviae miltiorrhizae and blood slices
Technical Field
The invention belongs to the technical field of medicine production, and relates to a preparation process and a detection method of danqi and blood tablets.
Background
Vitiligo is a common dermatosis, is a limited skin pigment decoloration, has no special diseased part, during disease occurrence, single or a plurality of pure white plaques with different sizes and shapes are often generated on the skin, the area of the plaques is gradually enlarged, the number of the plaques is gradually increased, the boundary of the white plaques is clear, hairs in the plaques are also whitened, the surface of the white plaques is smooth, scales or scabs are not generated, patients have no subjective symptoms, the secretion function is normal, the vitiligo is only sensitive to sunlight, the vitiligo is generated when the vitiligo is slightly sunned, part of the patients have itching feeling after the sunburn, the disease course is slow, the vitiligo is not resolved for a long time, and the main harm to the patients is unsightly. Thus, the disease is not difficult to diagnose, but difficult to treat. The disease is caused by different etiologies and theories, but most of the traditional Chinese medicine thinks that the disease is caused by melanocyte damage caused by mental internal injury, stagnation of liver qi, unsmooth qi activity, wind and blood pulsation, qi stagnation and blood stasis, blood deficiency and skin nutrition, immune function and secretory metabolic disorder and other mental factors, so that pigment decoloration is caused to cause the disease. At present, a plurality of medicines for treating leucoderma are prepared, such as patent medicines: the spot-removing pill, the leukoderma removing pill, the Baishi pill, the leukoplakia tincture and the like, but the medicines have low cure rate, high recurrence rate and long treatment time, some medicines have allergy and slight toxic reaction, and some medicines are easy to cause side effects of liver, spleen, kidney swelling and the like; ultraviolet irradiation is rarely used because it tends to cause adverse factors such as cataract, skin atrophy, and even skin cancer.
Danqi and xue pian are Chinese patent medicines for treating leucoderma, and have the effects of tonifying qi and regulating blood, promoting blood circulation by removing blood stasis, relaxing tendons and activating collaterals, strengthening spleen and liver and enhancing immunity. Patent CN1219540C discloses the formulation range and the simplified preparation method of the tablet, but the drying time is long according to the method, and the prepared tablet is easy to absorb moisture and is not beneficial to storage, and has certain influence on the stability of the medicine. In addition, the existing quality standard WS-5904(b-0904) -2014Z only controls the content of psoralen and isopsoralen, and cannot control the medicine quality on the whole, so that the improvement of the preparation process of the danqi and the blood tablet and the development of the detection method of the danqi and the blood tablet are the problems to be solved urgently at present.
Disclosure of Invention
The invention aims to provide a preparation process and a detection method of danqi and blood tablets, the preparation process of the Chinese patent medicine film-coated tablet can ensure the quality stability of the medicine, and in addition, the control of preparation forming and tablet weight difference is facilitated through the improvement of a new drying process and a new tabletting process; meanwhile, the detection method for integrally controlling the product quality is provided, and the product quality is better guaranteed.
The purpose of the invention can be realized by the following technical scheme:
a preparation process of radix salviae miltiorrhizae and blood tablets comprises the following raw materials in parts by weight:
12-18 parts of fructus psoraleae, 12-16 parts of prepared fleece-flower root, 3-7 parts of radix ophiopogonis, 4-8 parts of codonopsis pilosula, 3-7 parts of astragalus membranaceus, 3-7 parts of fried bighead atractylodes rhizome, 3-7 parts of poria cocos, 2-6 parts of fried rhizoma atractylodis, 5-10 parts of rhizoma paridis, 5-10 parts of rhizoma cyperi, 6-8 parts of salvia miltiorrhiza, 2-5 parts of divaricate saposhnikovia root, 4-10 parts of eclipta, 2-8 parts of lithospermum, 5-14 parts of fried caltrop and 2-6 parts of liquorice;
the Danqi and blood tablet is prepared by the following steps:
step A1, adding 16 pure medicinal materials such as fructus Psoraleae, etc. into an extraction tank, adding water, soaking for 30 minutes, taking out, adding water, heating and decocting for 2 times, decocting for 2 hours for the first time and 1 hour for the second time, and mixing decoctions;
step A2, concentrating the decoction prepared in the step A1 into clear paste with the relative density of 6-12 Baume degrees, centrifugally separating the clear paste, taking the supernatant, concentrating again, controlling the temperature at 95 ℃, and concentrating into thick paste with the relative density of 1.25-1.28;
step A3, performing pulse drying on the thick paste prepared in the step A2, and then grinding and crushing to prepare dry extract particles;
step A4, putting the dry extract granules, magnesium stearate, talcum powder and corn starch into an HD-600 type multidirectional motion mixer, mixing for 6 minutes to prepare granules, putting the granules on a tablet machine to prepare tablets;
and step A5, pouring the tablets into a coating pan, starting the coating pan, setting the air inlet temperature to be 50-80 ℃, starting to spray coating liquid, adjusting the air inlet temperature to be 30-45 ℃, the rotating speed of the coating pan to be 180rpm and the supply speed of the coating liquid to be 2mL/s after the tablets are basically coated tightly, reducing the rotating speed of the coating pan to be 60-70rpm when the tablets are dry and not sticky, stopping heating, and taking out products when the temperature is reduced to be below 30 ℃ to prepare the danqi and the blood tablets.
Further, the amount of the decocted water added in the step A1 is 10-12 times of the weight of the medicinal materials.
Further, the dosage of the thick paste in the step A3 is 2.5-3.5kg, and the procedure of pulse drying is set as follows: setting the water bath temperature at 75-85 ℃ in the first stage, setting the pulse waiting time at 3-10 seconds, setting the pulse running time at 0.5 second, drying for 60 minutes, setting the water bath temperature at 75 ℃ in the second stage, setting the pulse waiting time at 10-30 seconds, setting the pulse running time at 0.5 second, drying for 60 minutes, setting the water bath temperature at 65-75 ℃ in the third stage, setting the pulse waiting time at 60 seconds, setting the pulse running time at 1 second, and drying for 120-fold 180 minutes.
Further, in the step a4, the amount of magnesium stearate is 1% of the weight of the dry extract particles, the amount of talc powder is 3% of the weight of the dry extract particles, and the amount of corn starch is 4% of the weight of the dry extract particles.
Further, the dosage of the coating solution in the step A5 is 6% of the mass of the pressed tablet, and the mass concentration of the coating solution is 14-20%.
Further, the detection method of the danqi and blood slices comprises the following steps:
step S1, setting the detection condition of the liquid chromatogram;
step S2, weighing appropriate amount of psoralen glycoside, isopsoralen glycoside, stilbene glycoside, psoralen, and isopsoralen reference substance, adding methanol, and ultrasonically dissolving and dispersing to obtain reference substance solution;
step S3, grinding the danqi and the blood slices into fine powder, weighing a proper amount of fine powder, adding methanol 1, weighing, ultrasonically treating for 20 minutes, cooling to room temperature, adding methanol 2 to supplement the lost weight, filtering with a 0.45-micron filter membrane, and obtaining the filtrate as a test solution;
step S4, respectively absorbing 10 μ L of reference solution and sample solution, injecting into a liquid chromatograph, measuring, recording chromatogram, and finding out from sample characteristic map, the detection method can effectively separate characteristic peaks, and the peak-appearing time is controlled within 50 minutes, so that the detection method is more efficient, 13 characteristic peaks are presented in the chromatogram, and besides psoralen characteristic peak and isopsoralen characteristic peak, stilbene glucoside peak, psoralen glucoside peak and isopsoralen glucoside peak are separated and determined, thereby providing qualitative basis for quantitative determination of medicine components.
Further, the detection conditions of the liquid chromatography in step S1 are: the filler is octadecylsilane chemically bonded silica, the column temperature is 30 ℃, the detection wavelength is 220nm, the mobile phase A is acetonitrile, the mobile phase B is a phosphoric acid solution with the mass fraction of 1%, and the gradient elution is 0-5min, 15% of the mobile phase A + 85% of the mobile phase B, 5-25min, 25% of the mobile phase A + 75% of the mobile phase B, 25-32min, 28% of the mobile phase A + 72% of the mobile phase B, 32-40min, 40% of the mobile phase A + 60% of the mobile phase B, 40-47min, 80% of the mobile phase A + 20% of the mobile phase B, 47-55min, and 80% of the mobile phase A + 20% of the mobile phase B.
Further, the dose of the psoralen, isopsoralen, stilbene glycoside, psoralen, isopsoralen and methanol in step S2 is 40 μ g of psoralen, 40 μ g of isopsoralen glycoside, 50 μ g of stilbene glycoside, 20 μ g of psoralen and 20 μ g of isopsoralen, and the ultrasonic treatment time is 20-30 minutes.
Further, the amount of the fine powder and methanol 1 in step S3 is 1 g: 50mL, 75% of methanol 1 and 75% of methanol 2.
The invention has the beneficial effects that: the invention provides a preparation process of radix salviae miltiorrhizae and blood tablets, which can ensure the quality stability of the medicine, and is more beneficial to the control of preparation forming and tablet weight difference through the improvement of a drying process and a tabletting process. Meanwhile, the detection method for integrally controlling the product quality is provided, so that the product quality and the uniform stability of the sample are better guaranteed.
Detailed Description
The technical solutions of the present invention will be described clearly and completely with reference to the following embodiments, and it should be understood that the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.
Example 1
A method for detecting danqi and blood slices comprises the following steps:
step S1, setting detection conditions of liquid chromatography, wherein a filler is octadecylsilane chemically bonded silica, the column temperature is 30 ℃, the detection wavelength is 220nm, the mobile phase A is acetonitrile, the mobile phase B is a phosphoric acid solution with the mass fraction of 1%, and the gradient elution is 0-5min, 15% of the mobile phase A + 85% of the mobile phase B, 5-25min, 25% of the mobile phase A + 75% of the mobile phase B, 25-32min, 28% of the mobile phase A + 72% of the mobile phase B, 32-40min, 40% of the mobile phase A + 60% of the mobile phase B, 40-47min, 80% of the mobile phase A + 20% of the mobile phase B, 47-55min and 80% of the mobile phase A + 20% of the mobile phase B.
Step S2, weighing a proper amount of psoralen, isopsoralen, stilbene glucoside, psoralen and isopsoralen reference substances, adding methanol, and performing ultrasonic dissolution and dispersion to obtain a reference substance solution, wherein the dosage of the psoralen, isopsoralen, stilbene glucoside, psoralen, isopsoralen and methanol is 40 mu g of psoralen, 40 mu g of isopsoralen, 50 mu g of stilbene glucoside, 20 mu g of psoralen and 20 mu g of isopsoralen, and the ultrasonic time is 20-30 minutes;
step S3, grinding radix salviae miltiorrhizae and hematochezia into fine powder, weighing 1g of fine powder, adding 50mL of methanol 1, weighing, ultrasonically treating for 20 minutes, cooling to room temperature, adding methanol 2 to supplement the lost weight, filtering with a 0.45-micrometer filter membrane, and obtaining a filtrate, namely a test solution, wherein the mass fraction of the methanol 1 is 75%, and the mass fraction of the methanol 2 is 75%;
in step S4, 10. mu.L of each of the reference solution and the sample solution is aspirated and injected into a liquid chromatograph, and the measurement is performed and the chromatogram is recorded.
Example 2
The preparation process of the radix salviae miltiorrhizae and blood tablets is characterized in that the radix salviae miltiorrhizae and blood tablets comprise the following raw materials in parts by weight:
12 parts of fructus psoraleae, 12 parts of prepared fleece-flower root, 3 parts of dwarf lilyturf tuber, 4 parts of codonopsis pilosula, 3 parts of astragalus root, 3 parts of fried bighead atractylodes rhizome, 3 parts of poria cocos, 2 parts of fried rhizoma atractylodis, 5 parts of rhizoma paridis, 5 parts of rhizoma cyperi, 6 parts of salvia miltiorrhiza, 2 parts of divaricate saposhnikovia root, 4 parts of eclipta, 2 parts of lithospermum, 5 parts of fried tribulus terrestris and 2 parts;
the Danqi and blood tablet is prepared by the following steps:
step A1, adding 16 clean medicinal materials such as fructus psoraleae and the like into an extraction tank, adding water, soaking for 30 minutes, taking out, adding water, heating and decocting for 2 times, decocting for 2 hours for the first time and decocting for 1 hour for the second time, and combining the decoctions, wherein the water adding amount of the decoction is 10 times of the weight of the medicinal materials.
Step A2, concentrating the decoction prepared in the step A1 into clear paste with the relative density of 8 Baume degrees, centrifugally separating the clear paste, taking the supernatant, concentrating again, controlling the temperature to be 95 ℃, and concentrating into thick paste with the relative density of 1.25;
step A3, performing pulse drying on the 3.0kg thick paste prepared in the step A2, and then grinding and crushing to obtain dry extract particles, wherein the pulse drying program is set as follows: setting the water bath temperature to be 75 ℃ in the first stage, setting the pulse waiting time to be 6 seconds, setting the pulse running time to be 0.5 second, and drying for 60 minutes, setting the water bath temperature to be 75 ℃ in the second stage, setting the pulse waiting time to be 15 seconds, setting the pulse running time to be 0.5 second, and drying for 60 minutes, setting the water bath temperature to be 75 ℃ in the third stage, setting the pulse waiting time to be 60 seconds, setting the pulse running time to be 1 second, and drying for 180 minutes;
step A4, putting the dry extract granules, magnesium stearate, talcum powder and corn starch into an HD-600 type multidirectional motion mixer, mixing for 6 minutes to obtain granules, putting the granules on a tablet press to obtain tablets, wherein the dosage of the magnesium stearate is 1% of the weight of the dry extract granules, the dosage of the talcum powder is 3% of the weight of the dry extract granules, and the dosage of the corn starch is 4% of the weight of the dry extract granules;
step A5, pouring the tablets into a coating pan, starting the coating pan, setting the air inlet temperature to be 50 ℃, starting to spray coating liquid, adjusting the air inlet temperature to be 30 ℃, the rotating speed of the coating pan to be 180rpm and the supply speed of the coating liquid to be 2mL/s after the tablets are basically tightly coated, reducing the rotating speed of the coating pan to be 60rpm after the tablets are dried and not sticky, stopping heating, and taking out the product after the temperature is reduced to be below 30 ℃, thereby preparing the danqi and the blood tablets, wherein the using amount of the coating liquid is 6% of the mass of the tablets, and the mass concentration of the coating liquid is 16%.
Example 3
The preparation process of the radix salviae miltiorrhizae and blood tablets is characterized in that the radix salviae miltiorrhizae and blood tablets comprise the following raw materials in parts by weight:
16 parts of fructus psoraleae, 14 parts of prepared fleece-flower root, 5 parts of dwarf lilyturf tuber, 6 parts of codonopsis pilosula, 5 parts of astragalus root, 5 parts of fried bighead atractylodes rhizome, 5 parts of poria cocos, 4 parts of fried rhizoma atractylodis, 7 parts of rhizoma paridis, 7 parts of rhizoma cyperi, 7 parts of salvia miltiorrhiza, 3 parts of divaricate saposhnikovia root, 7 parts of eclipta, 5 parts of lithospermum, 9 parts of fried tribulus terrestris and 4 parts;
the Danqi and blood tablet is prepared by the following steps:
step A1, adding 16 clean medicinal materials such as fructus psoraleae and the like into an extraction tank, adding water, soaking for 30 minutes, taking out, adding water, heating and decocting for 2 times, decocting for 2 hours for the first time and decocting for 1 hour for the second time, and combining the decoctions, wherein the water adding amount of the decoction is 10 times of the weight of the medicinal materials.
Step A2, concentrating the decoction prepared in the step A1 into clear paste with the relative density of 10 Baume degrees, centrifugally separating the clear paste, taking the supernatant, concentrating again, controlling the temperature to be 95 ℃, and concentrating into thick paste with the relative density of 1.26;
step A3, performing pulse drying on the 3.0kg thick paste prepared in the step A2, and then grinding and crushing to obtain dry extract particles, wherein the pulse drying program is set as follows: setting the water bath temperature to be 80 ℃ in the first stage, setting the pulse waiting time to be 8 seconds, setting the pulse running time to be 0.5 second, and drying for 60 minutes, setting the water bath temperature to be 75 ℃ in the second stage, setting the pulse waiting time to be 15 seconds, setting the pulse running time to be 0.5 second, and drying for 60 minutes, setting the water bath temperature to be 68 ℃ in the third stage, setting the pulse waiting time to be 60 seconds, setting the pulse running time to be 1 second, and drying for 160 minutes;
step A4, putting the dry extract granules, magnesium stearate, talcum powder and corn starch into an HD-600 type multidirectional motion mixer, mixing for 6 minutes to obtain granules, putting the granules on a tablet press to obtain tablets, wherein the dosage of the magnesium stearate is 1% of the weight of the dry extract granules, the dosage of the talcum powder is 3% of the weight of the dry extract granules, and the dosage of the corn starch is 4% of the weight of the dry extract granules;
step A5, pouring the tablets into a coating pan, starting the coating pan, setting the air inlet temperature to be 60 ℃, starting to spray coating liquid, adjusting the air inlet temperature to be 35 ℃, the coating pan rotating speed to be 190rpm and the coating liquid supply speed to be 2mL/s after the tablets are basically tightly coated, reducing the coating pan rotating speed to be 65rpm after the tablets are dried and are not sticky, stopping heating, and taking out the product after the temperature is reduced to be below 30 ℃ to prepare the danqi and blood tablets, wherein the using amount of the coating liquid is 6% of the tablet mass, and the mass concentration of the coating liquid is 14%.
Example 4
The preparation process of the radix salviae miltiorrhizae and blood tablets is characterized in that the radix salviae miltiorrhizae and blood tablets comprise the following raw materials in parts by weight:
18 parts of fructus psoraleae, 18 parts of prepared fleece-flower root, 7 parts of dwarf lilyturf tuber, 8 parts of codonopsis pilosula, 7 parts of astragalus root, 7 parts of fried bighead atractylodes rhizome, 7 parts of poria cocos, 6 parts of fried rhizoma atractylodis, 10 parts of rhizoma paridis, 10 parts of rhizoma cyperi, 8 parts of salvia miltiorrhiza, 5 parts of divaricate saposhnikovia root, 10 parts of eclipta, 8 parts of lithospermum, 14 parts of fried tribulus terrestris and 6 parts;
the Danqi and blood tablet is prepared by the following steps:
step A1, adding 16 clean medicinal materials such as fructus psoraleae and the like into an extraction tank, adding water, soaking for 30 minutes, taking out, adding water, heating and decocting for 2 times, decocting for 2 hours for the first time and decocting for 1 hour for the second time, and combining the decoctions, wherein the water adding amount of the decoction is 10 times of the weight of the medicinal materials.
Step A2, concentrating the decoction prepared in the step A1 into clear paste with the relative density of 12 Baume degrees, centrifugally separating the clear paste, taking the supernatant, concentrating again, controlling the temperature to be 95 ℃, and concentrating into thick paste with the relative density of 1.28;
step A3, performing pulse drying on the 3.0kg thick paste prepared in the step A2, and then grinding and crushing to obtain dry extract particles, wherein the pulse drying program is set as follows: setting the water bath temperature to be 80 ℃ in the first stage, setting the pulse waiting time to be 10 seconds, setting the pulse running time to be 0.5 second, and drying for 60 minutes, setting the water bath temperature to be 75 ℃ in the second stage, setting the pulse waiting time to be 30 seconds, setting the pulse running time to be 0.5 second, and drying for 60 minutes, setting the water bath temperature to be 75 ℃ in the third stage, setting the pulse waiting time to be 60 seconds, setting the pulse running time to be 1 second, and drying for 180 minutes;
step A4, putting the dry extract granules, magnesium stearate, talcum powder and corn starch into an HD-600 type multidirectional motion mixer, mixing for 6 minutes to obtain granules, putting the granules on a tablet press to obtain tablets, wherein the dosage of the magnesium stearate is 1% of the weight of the dry extract granules, the dosage of the talcum powder is 3% of the weight of the dry extract granules, and the dosage of the corn starch is 4% of the weight of the dry extract granules;
and step A5, pouring the tablets into a coating pan, starting the coating pan, setting the air inlet temperature to be 60 ℃, starting to spray coating liquid, adjusting the air inlet temperature to be 35 ℃, the rotating speed of the coating pan to be 200rpm and the supply speed of the coating liquid to be 2mL/s after the tablets are basically tightly coated, reducing the rotating speed of the coating pan to be 70rpm when the tablets are dry and not sticky, stopping heating, and taking out the product when the temperature is reduced to be below 30 ℃ to prepare the danqi and blood tablets, wherein the using amount of the coating liquid is 6% of the mass of the tablets, and the mass concentration of the coating liquid is 20%.
Comparative example
Danqi and blood tablets are commonly found on the market.
The following performance tests were performed on the danqi and blood tablets of examples 2, 3, 4 and comparative example 1:
the danqi and blood tablets of examples 2, 3 and 4 and comparative example 1 were placed in an environment with relative humidity of 40% and 80% for 6 hours, respectively, and the surface of the tablet was observed to see if it was dry or sticky;
the therapeutic effect of the danqi and blood tablets of examples 2, 3 and 4 and comparative example 1 was tested, and 100 patients with vitiligo, 50 patients for male and female, were evenly divided into 4 groups, and were taken twice a day in the morning and evening, and the therapeutic effect was observed, and the test data are shown in the following table:
Figure BDA0002832226070000091
Figure BDA0002832226070000101
it can be seen from the table that the surfaces of the danqi and the blood tablets prepared in examples 2, 3 and 4 are still dry and non-sticky after being placed in the environment with the relative humidity of 40% and 80% for 6 hours, and maintain good properties, while the surfaces of the danqi and the blood tablets prepared in comparative examples are very sticky after being placed in the environment with the humidity of 80% for 6 hours, which indicates that the preparation method of the invention can ensure the quality stability of the medicine, is more beneficial to the control of the preparation forming and the tablet weight difference through the improvement of a new drying process and a new tabletting process, and the curative effect tests of examples 2, 3 and 4 and comparative examples show that the danqi and the blood tablets of the examples have equivalent medicinal effects with the common danqi and the blood tablets in the market, and even the danqi and the blood tablets of the examples show more excellent medicinal effects.
The preferred embodiments of the invention disclosed above are intended to be illustrative only. The preferred embodiments are not intended to be exhaustive or to limit the invention to the precise embodiments disclosed. Obviously, many modifications and variations are possible in light of the above teaching. The embodiments were chosen and described in order to best explain the principles of the invention and the practical application, to thereby enable others skilled in the art to best utilize the invention. The invention is limited only by the claims and their full scope and equivalents.

Claims (9)

1. The preparation process of the radix salviae miltiorrhizae and blood tablets is characterized in that the radix salviae miltiorrhizae and blood tablets comprise the following raw materials in parts by weight: 12-18 parts of fructus psoraleae, 12-16 parts of prepared fleece-flower root, 3-7 parts of radix ophiopogonis, 4-8 parts of codonopsis pilosula, 3-7 parts of astragalus membranaceus, 3-7 parts of fried bighead atractylodes rhizome, 3-7 parts of poria cocos, 2-6 parts of fried rhizoma atractylodis, 5-10 parts of rhizoma paridis, 5-10 parts of rhizoma cyperi, 6-8 parts of salvia miltiorrhiza, 2-5 parts of divaricate saposhnikovia root, 4-10 parts of eclipta, 2-8 parts of lithospermum, 5-14 parts of fried caltrop and 2-6 parts of liquorice;
the Danqi and blood tablet is prepared by the following steps:
step A1, adding 16 pure medicinal materials such as fructus Psoraleae, etc. into an extraction tank, adding water, soaking for 30 minutes, taking out, adding water, heating and decocting for 2 times, decocting for 2 hours for the first time and 1 hour for the second time, and mixing decoctions;
step A2, concentrating the decoction prepared in the step A1 into clear paste with the relative density of 6-12 Baume degrees, centrifugally separating the clear paste, taking the supernatant, concentrating again, controlling the temperature at 95 ℃, and concentrating into thick paste with the relative density of 1.25-1.28;
step A3, performing pulse drying on the thick paste prepared in the step A2, and then grinding and crushing to prepare dry extract particles;
step A4, putting the dry extract granules, magnesium stearate, talcum powder and corn starch into a mixer, mixing for 6 minutes to prepare granules, putting the granules on a tablet machine to prepare tablets;
and step A5, pouring the tablets into a coating pan, starting the coating pan, setting the air inlet temperature to be 50-80 ℃, starting to spray coating liquid, adjusting the air inlet temperature to be 30-45 ℃, the rotating speed of the coating pan to be 180rpm and the supply speed of the coating liquid to be 2mL/s after the tablets are basically coated tightly, reducing the rotating speed of the coating pan to be 60-70rpm when the tablets are dry and not sticky, stopping heating, and taking out products when the temperature is reduced to be below 30 ℃ to prepare the danqi and the blood tablets.
2. The process of claim 1, wherein the preparation process comprises the following steps: the amount of the decocted water added in the step A1 is 10-12 times of the weight of the medicinal materials.
3. The process of claim 1, wherein the preparation process comprises the following steps: the dosage of the thick paste in the step A3 is 2.5-3.5kg, and the pulse drying program is set as follows: setting the water bath temperature at 75-85 ℃ in the first stage, setting the pulse waiting time at 3-10 seconds, setting the pulse running time at 0.5 second, drying for 60 minutes, setting the water bath temperature at 75 ℃ in the second stage, setting the pulse waiting time at 10-30 seconds, setting the pulse running time at 0.5 second, drying for 60 minutes, setting the water bath temperature at 65-75 ℃ in the third stage, setting the pulse waiting time at 60 seconds, setting the pulse running time at 1 second, and drying for 120-fold 180 minutes.
4. The process of claim 1, wherein the preparation process comprises the following steps: the amount of the magnesium stearate, the talcum powder and the corn starch in the step A4 are respectively 1 wt% of the dry extract particles, 3 wt% of the dry extract particles and 4 wt% of the dry extract particles.
5. The process of claim 1, wherein the preparation process comprises the following steps: the dosage of the coating solution in the step A5 is 6% of the mass of the tablet, and the mass concentration of the coating solution is 14-20%.
6. A method for detecting danqi and blood slices is characterized in that: the detection method of the danqi and blood slices comprises the following steps:
step S1, setting the detection condition of the liquid chromatogram;
step S2, weighing appropriate amount of psoralen glycoside, isopsoralen glycoside, stilbene glycoside, psoralen, and isopsoralen reference substance, adding methanol, and ultrasonically dissolving and dispersing to obtain reference substance solution;
step S3, grinding the danqi and the blood slices into fine powder, weighing a proper amount of fine powder, adding methanol 1, weighing, ultrasonically treating for 20 minutes, cooling to room temperature, adding methanol 2 to supplement the lost weight, filtering with a 0.45-micron filter membrane, and obtaining the filtrate as a test solution;
in step S4, 10. mu.L of each of the reference solution and the sample solution is aspirated and injected into a liquid chromatograph, and the measurement is performed and the chromatogram is recorded.
7. The method of claim 6, wherein the method comprises the steps of: the detection conditions of the liquid chromatography in step S1 are: the filler is octadecylsilane chemically bonded silica, the column temperature is 30 ℃, the detection wavelength is 220nm, the mobile phase A is acetonitrile, the mobile phase B is a phosphoric acid solution with the mass fraction of 1%, and the gradient elution is 0-5min, 15% of the mobile phase A + 85% of the mobile phase B, 5-25min, 25% of the mobile phase A + 75% of the mobile phase B, 25-32min, 28% of the mobile phase A + 72% of the mobile phase B, 32-40min, 40% of the mobile phase A + 60% of the mobile phase B, 40-47min, 80% of the mobile phase A + 20% of the mobile phase B, 47-55min, and 80% of the mobile phase A + 20% of the mobile phase B.
8. The method of claim 6, wherein the method comprises the steps of: the dose of the psoralen, isopsoralen, stilbene glucoside, psoralen, isopsoralen and methanol in the step S2 is that 40 mug of psoralen, 40 mug of isopsoralen, 50 mug of stilbene glucoside, 20 mug of psoralen and 20 mug of isopsoralen are added into each 1000mL of methanol, and the ultrasonic time is 20-30 minutes.
9. The method of claim 6, wherein the method comprises the steps of: the dosage of the fine powder and the methanol 1 in the step S3 is 1 g: 50mL, 75% of methanol 1 and 75% of methanol 2.
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