Dry granulation process for brain pulse benefiting

Abstract

The dry granulation process comprises the following steps: directly using raw powder of pseudo-ginseng as a medicine, extracting volatile oil from turmeric and angelica sinensis by adopting a distillation method, and carrying out inclusion on the volatile oil by adopting beta-cyclodextrin so as to enhance the stability; motherwort, astragalus membranaceus, ligusticum chuanxiong hort, safflower carthamus, radix paeoniae rubra, radix paeoniae alba and radix cyathulae are decocted with water, so that the maximum use and quality stability of the medicinal materials are ensured. The dry granulation process is more matched with the characteristics of the product, and after the dry granulation process is changed into the dry granulation process, the steps of drying and total discharge in the original wet granulation can be removed, so that the production efficiency of the product is improved, the production process is easier to control, and the post operation is simpler.

Description

Technical Field

[0001] The invention belongs to the technical field of biomedicine, and particularly relates to a dry granulation process of Naomaili. Background Art

[0002] Naomaili Granules are composed of motherwort, Chinese angelica, Panax notoginseng, and salvia miltiorrhiza. They have the effects of promoting blood circulation and removing blood stasis, invigorating qi and unblocking meridians, and are used to treat acute phase of meridians in stroke of qi deficiency and blood stasis type (cerebral infarction). Naomaili Granules can reduce the scope of cerebral infarction and alleviate behavioral disorders after cerebral ischemia in animals; the results of animal length tests show that long-term use of the drug has no toxic side effects on animals; the results of clinical studies show that Naomaili Granules have significant efficacy in treating stroke of blood stasis and qi deficiency type, with no obvious adverse reactions.

[0003] Naomaili Granule is an oral Chinese medicine preparation produced based on the classic prescription "Buyang Huanwu Decoction" in combination with modern clinical needs and using modern pharmaceutical technology. It ensures that the quality of Naomaili Granule is controllable and the efficacy is stable. It can be used for the clinical treatment of the acute stage of meridians in stroke (cerebral infarction) of qi deficiency and blood stasis type.

[0004] Ingredients of Naomaili Granules: Motherwort, Panax notoginseng, Astragalus, Turmeric, Ligusticum chuanxiong, Safflower, Salvia miltiorrhiza, Red Peony Root, Angelica sinensis, White Peony Root, and Cyathula.

[0005] Indications: Activate blood circulation and dissipate blood stasis, invigorate qi and dredge meridians. Used in acute stage of meridians in stroke (cerebral infarction) of qi deficiency and blood stasis type, with symptoms such as hemiplegia, hemiplegia, crooked mouth and tongue, and slurred speech.

[0006] Pharmacological action: The rat cerebral / middle artery ligation cerebral ischemia test showed that this product can reduce the scope of cerebral infarction and alleviate the behavioral disorders after cerebral ischemia in animals. In addition, this product can increase cerebral blood flow in anesthetized dogs, reduce vascular resistance, and reduce platelet aggregation induced by arachidonic acid and ADP.

[0007] Traditional Chinese patent medicines use wet granulation technology. Since there are many process parameters and competing mechanisms in the wet granulator, it is generally recognized that it is difficult to design and scale up the process, whether from laboratory equipment or scale-up batch equipment to production batch equipment, or from existing production equipment to equipment with greater production capacity. If the pilot production is linearly scaled up according to the small-scale prescription process, it often fails to achieve the expected results, resulting in a large waste of materials and energy. Summary of the invention

[0008] The object of the present invention is to provide a dry granulation process for Naomaili, which better matches the characteristics of the product. After changing to dry granulation, the steps of drying and total drainage in the original wet granulation can be removed, thereby improving the production efficiency of the product, making it easier to control the production process, and simplifying job operations.

[0009] To achieve the above object, the present invention provides the following technical solutions:

[0010] A dry granulation process of Naomaili comprises the following steps:

[0011] The raw powder of Panax notoginseng was used directly as medicine, and the volatile oils of turmeric and angelica were extracted by distillation, and the volatile oils were encapsulated with β-cyclodextrin to enhance stability.

[0012] Motherwort, Astragalus, Chuanxiong, Safflower, Red Peony Root, White Peony Root, and Cyathula are decocted in water to ensure maximum utilization of the medicinal materials and quality stability.

[0013] The following steps are also included: GC chromatography, LC-MS chromatography and fingerprint techniques are used to quantitatively and qualitatively identify the active ingredients of stachydrine hydrochloride and the composition of volatile oils to ensure that the active ingredients are clear.

[0014] The method also includes the following steps: using GC chromatography, LC-MS chromatography and fingerprint spectrum and other technologies to quantitatively and qualitatively identify the effective components of Panax notoginseng saponins and the composition of volatile oil to ensure that the effective components are clear.

[0015] Compared with the prior art, the present invention has the following beneficial effects:

[0016] Naomaili Granules are based on the "Buyang Huanwu Decoction" and innovatively add nine blood-activating drugs such as Leonurus japonicus, such as Astragalus membranaceus for replenishing qi, White Peony Root and Angelica sinensis for nourishing blood. It effectively avoids the disadvantages of qi and blood loss caused by overuse of blood-activating and stasis-removing drugs. For the four main medicinal materials, Leonurus japonicus, Panax notoginseng, Salvia miltiorrhiza and Angelica sinensis, the company's internal control standards far higher than the national standards have been formulated to ensure the high quality of the products. The granulation process has been improved, the production cycle has been shortened, and the cost has been significantly reduced. The traditional wet granulation process has been improved, and the production process has been changed from wet granulation to dry granulation. The new production process reduces production costs.

[0017] (1) The dry granulation process is more suitable for the characteristics of the product. After changing to dry granulation, the drying and total drainage steps in the original wet granulation can be removed, thereby improving the production efficiency of the product, making it easier to control the production process, and simplifying job operations;

[0018] (2) The dry granulation process can reduce production energy consumption, save energy and reduce emissions. The production time from granulation to obtaining the total mixed intermediate is greatly reduced from 24 hours / batch of the wet process to 8 hours / batch. The labor hours, utility system and fuel energy consumption are greatly reduced, which can reduce production costs to a certain extent.

[0019] (3) Compared with wet granulation, the yield of dry granulation can be higher. Therefore, in the dry granulation process, the yield requirement of the granulation process is increased from 85% of the wet method to 90%.

[0020] (4) The product has a high content of crude drugs, and the daily dosage is equivalent to taking 106.8g of crude drugs, and the single dosage is about 20 times that of similar products. The high quality of the preparation is ensured by adopting different extraction processes and qualitative and quantitative analysis of the 8 main active ingredients.

[0021] (5) During the production process of Naomaili Granules, the extracts of 11 medicinal materials are fully mixed with the dry extract and then made into Naomaili Granules using an advanced dry granulation process, thereby retaining the active ingredients to the greatest extent.

[0022] (6) In terms of quality control, we established internal control standards that are higher than those in the Chinese Pharmacopoeia, and conducted quantitative and qualitative tests on the active ingredients of the eight medicinal materials in the formula to ensure that the quality of Naomaili Granules is controllable and the therapeutic effect is stable. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] Figure 1 This is the reference characteristic spectrum of Panax notoginseng saponins. DETAILED DESCRIPTION

[0024] The following will be combined with the accompanying drawings of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0025] Embodiment 1.

[0026] A dry granulation process of Naomaili comprises the following steps:

[0027] The raw powder of Panax notoginseng was used directly as medicine, and the volatile oils of turmeric and angelica were extracted by distillation, and the volatile oils were encapsulated with β-cyclodextrin to enhance stability.

[0028] Motherwort, Astragalus, Chuanxiong, Safflower, Red Peony Root, White Peony Root, and Cyathula are decocted in water to ensure maximum utilization of the medicinal materials and quality stability.

[0029] The following steps are also included: GC chromatography, LC-MS chromatography and fingerprint techniques are used to quantitatively and qualitatively identify the active ingredients of stachydrine hydrochloride and the composition of volatile oils to ensure that the active ingredients are clear.

[0030] The method also includes the following steps: using GC chromatography, LC-MS chromatography and fingerprint techniques to quantitatively and qualitatively identify the effective components of notoginseng saponins and the composition of volatile oils, to ensure that the effective components are clear; the specific steps are as follows:

[0031] Preparation method: Take 1500g of Panax notoginseng slices, add water to boil, filter, concentrate the filtrate into a clear paste (the paste yield is 37-67%), add appropriate amount of auxiliary materials, dry (or dry and crush), then add appropriate amount of auxiliary materials, mix well, granulate, and make 1000g.

[0032] Properties: This product is light brown to yellow-brown granules; slight odor, bitter taste with sweet aftertaste.

[0033] Identification: Take 1g of this product, grind it, add 10 drops of water, stir well, then add 10ml of water-saturated n-butanol, seal it, ultrasonicate it for 10 minutes, let it stand for 2 hours, centrifuge it, take the supernatant, add 3 times the amount of water saturated with n-butanol, shake it well, let it stand to separate, take the n-butanol layer, evaporate it to dryness, add 1ml of methanol to the residue to dissolve it, and use it as the test solution. Take 0.5g of Panax notoginseng control medicinal material and prepare the control medicinal material solution in the same way. Or take 30mg of Panax notoginseng formula granule control extract and prepare the control extract solution in the same way. According to the thin layer chromatography method (Chinese Pharmacopoeia General Chapter 0502), 1μl of the test solution, 2μl of the control medicinal material solution or 8μl of the control extract solution are respectively spotted on the same silica gel G thin layer plate, and the lower layer solution placed below 10°C in chloroform-ethyl acetate-methanol-water (15:40:22:10) is used as the developing agent. Develop, take out, dry, spray with 10% sulfuric acid ethanol solution, heat at 105°C until the spots are clearly colored, and examine under ultraviolet light (365nm). In the chromatogram of the test sample, at the corresponding position of the chromatogram of the control medicinal material or the control extract, a fluorescent spot of the same color appears.

[0034] Characteristic spectrum: Determined by high performance liquid chromatography (Chinese Pharmacopoeia General Chapter 0512).

[0035] Chromatographic conditions and system suitability test: octadecylsilane bonded silica gel as filler; acetonitrile as mobile phase A, 0.1% phosphoric acid solution as mobile phase B, gradient elution according to the following table: flow rate 0.3ml / min; column temperature 30℃; detection wavelength 203nm. The theoretical plate number should be no less than 5000 based on the ginsenoside Rg peak.

[0036] Table 1. Chromatographic conditions and system suitability test data.

[0037]

[0038] Preparation of reference solution Take 0.6g of Panax notoginseng reference medicinal material, add 50ml of 70% methanol, heat and reflux for 30 minutes, cool, filter, and take the filtrate as the reference medicinal material reference solution; or take an appropriate amount of Panax notoginseng formula granule reference extract, add 70% methanol and ultrasonically treat (power 300W, frequency 40kHz) for 30 minutes to make a solution containing 8mg per 1ml, filter, and take the filtrate as the reference solution of the formula granule control extract. Take an appropriate amount of Panax notoginseng saponin R, ginsenoside Rg1, and ginsenoside Rbi reference substances, accurately weigh, add methanol to make a mixed solution containing 70ug of Panax notoginseng saponin R, 35ug of ginsenoside Rg, and 40ug of ginsenoside Rb1 per 1ml, as the reference solution.

[0039] Preparation of test solution: Take an appropriate amount of the product, grind it into powder, take about 0.2g, weigh it accurately, put it in a stoppered conical flask, accurately add 25ml of 70% methanol, weigh it, ultrasonically treat it (power 300W, frequency 40kHz) for 30 minutes, cool it, weigh it again, make up the lost weight with 70% methanol, shake it well, filter it, and take the filtrate to obtain it.

[0040] Determination method: Accurately pipette 1 μl of reference solution and test solution respectively, inject into liquid chromatograph, and determine.

[0041] The test sample chromatogram should show characteristic peaks corresponding to the five retention times in the reference drug chromatogram. Peak 1, peak 2, and peak 4 should correspond to the retention times of the corresponding reference drug peaks. The relative retention time of peak 3 and S1 peak (peak 2) is about 1.06; the relative retention time of peak 5 and S2 peak (peak 4) is about 1.20.

[0042] Inspection: Heavy metals and harmful elements shall be determined according to the lead, cadmium, arsenic, mercury and copper determination method (Chinese Pharmacopoeia General Chapter 2321) atomic absorption spectrophotometry or inductively coupled plasma mass spectrometry. Lead shall not exceed 5 mg / kg; cadmium shall not exceed 1 mg / kg; arsenic shall not exceed 2 mg / kg; mercury shall not exceed 0.2 mg / kg; copper shall not exceed 20 mg / kg.

[0043] Solubility is checked according to the solubility test method for granules (Chinese Pharmacopoeia General Chapter 0104), and heated with water

[0044] Add 200ml, stir for 5 minutes (heat and boil for 5 minutes if necessary), and observe immediately. It should be completely dissolved or slightly turbid, without burnt debris or foreign matter.

[0045] Extract: Take an appropriate amount of this product, grind it into powder, take about 2g, weigh it accurately, add 100ml of ethanol accurately, and determine it according to the hot soaking method under the determination method for alcohol-soluble extract (General Chapter 2201 of the Chinese Pharmacopoeia). It shall not be less than 10.0%.

[0046] Content determination: Determine according to high performance liquid chromatography (Chinese Pharmacopoeia General Chapter 0512). Chromatographic conditions and system suitability test are the same as the characteristic spectrum item.

[0047] Preparation of reference solution: same as reference solution under characteristic spectrum. Preparation of test solution is same as characteristic spectrum.

[0048] Determination method: Accurately pipette 1 μl of reference solution and test solution respectively, inject into liquid chromatograph, and determine.

[0049] Each 1g of this product contains notoginsenoside R1(C 47 H 80 O 18 )、ginsenoside Rg1(C 42 H 72 O 14 ) and ginsenoside Rb1(C 54 H 92 O 23 ) should be 38 to 90 mg.

[0050] The main ingredients of the finished product of Naomaili are: Motherwort, Panax notoginseng, Astragalus, Turmeric, Chuanxiong, Safflower, Salvia miltiorrhiza, Red Peony Root, Angelica sinensis, White Peony Root, and Cyathula.

[0051] Properties: This product is brown granules; slightly fragrant and slightly bitter.

[0052] Functions and indications: Activating blood circulation and removing blood stasis, invigorating qi and unblocking meridians. Used in the acute stage of meridians in stroke (cerebral infarction) of qi deficiency and blood stasis type, with symptoms such as hemiplegia, hemiplegia, crooked mouth and tongue, and slurred speech.

[0053] The main ingredients of the finished product are as follows:

[0054] 1. Motherwort:

[0055] This product is the fresh or dried aerial part of Leonurus japonicus Houtt., a plant of the Lamiaceae family. Fresh products are harvested from the seedling stage in spring to the pre-flowering stage in early summer; dried products are harvested in summer when the stems and leaves are lush and the flowers have not yet bloomed or have just bloomed, and then dried in the sun, or cut into sections and dried in the sun.

[0056] Properties: Fresh motherwort has no stems in the seedling stage, and the basal leaves are rounded, 5 to 9 shallowly lobed, and each lobe has 2 to 3 blunt teeth. The stem is square columnar before flowering, with many branches on the upper part, and concave on all four sides to form longitudinal grooves, 30 to 60 cm long, 0.2-0.5 cm in diameter; the surface is green; the texture is fresh and tender, and there is pith in the middle of the cross section. The leaves are alternate and opposite, with petioles; the leaves are green, fresh and tender, and juicy when rubbed; the lower stem leaves are palmately 3-lobed, and the upper leaves are deeply or shallowly pinnately lobed into 3 pieces, and the lobes are entire or have a few serrations. The smell is slight and the taste is slightly bitter.

[0057] The surface of the stem of Leonurus japonicus is gray-green or yellow-green; the body is light, tough, and has pith in the middle of the cross section. The leaves are gray-green, often wrinkled, broken, and easy to fall off. The cymes are axillary, the small flowers are lavender, the calyx is tubular, and the corolla is two-lipped.

[0058] Nature and flavor: bitter, pungent, slightly cold. Enters the liver, pericardium, and bladder meridians.

[0059] Functions and indications: promoting blood circulation and regulating menstruation, promoting diuresis and reducing swelling, clearing away heat and detoxifying. Used for irregular menstruation, dysmenorrhea, amenorrhea, lochia retention, edema, oliguria, sores and swelling. 2. Panax notoginseng:

[0061] This product is the dried root and rhizome of Panax notoginseng (Burk.) FHChen of the Araliaceae family. It is dug up in autumn before the flowers bloom, washed, and the main root, lateral root and rhizome are separated and dried. The lateral root is commonly known as "tendon strip" and the rhizome is commonly known as "cut mouth".

[0062] Properties: The taproot is conical or cylindrical, 1 to 6 cm long and 1 to 4 cm in diameter. The surface is gray-brown or gray-yellow, with intermittent longitudinal wrinkles and root scars. There is a stem scar at the top and tumor-like protrusions around it. It is heavy and solid, with gray-green, yellow-green or gray-white cross-section, and the wood is slightly radially arranged. It has a slight smell and tastes bitter and sweet.

[0063] The ribs are cylindrical or conical, 2 to 6 cm long, with a diameter of about 0.8 cm at the upper end and about 0.3 cm at the lower end.

[0064] The cut is in irregular wrinkled blocks or strips, with several obvious stem marks and ring marks on the surface. The center of the cross section is gray-green or white, and the edges are dark green or gray.

[0065] Nature and flavor: sweet, slightly bitter, warm. Enters the liver and stomach meridians.

[0066] Functions and indications: dissipate blood stasis and stop bleeding, reduce swelling and relieve pain. Used for hemoptysis, hematemesis, epistaxis, bloody stool, metrorrhagia, bleeding from trauma, stabbing pain in the chest and abdomen, and swelling and pain from falls.

[0067] 3. Astragalus:

[0068] This product is the dried root of Astragalus membranaceus (Fisch.) Bge. var. mongholicus (Bge.) Hsiao or Astragalus membranaceus (Fisch.) Bge. of the Leguminosae family. It is dug up in spring and autumn, the fibrous roots and root heads are removed, and then dried in the sun.

[0069] Properties: This product is cylindrical, some with branches, thicker at the top, 30-90cm long, 1-3.5cm in diameter. The surface is light brown or light brown, with irregular longitudinal wrinkles or grooves. It is hard and tough, not easy to break, with strong fiber and powdery cross section, yellowish-white cortex, light yellow wood, with radial texture and cracks, the center of the old root is occasionally withered, dark brown or hollow. It has a slight odor, a slightly sweet taste, and a slight bean smell when chewed.

[0070] Nature and flavor: sweet, slightly warm. Enters the lung and spleen meridians.

[0071] Functions and indications: tonify qi and raise yang, consolidate the exterior and stop sweating, promote diuresis and reduce swelling, promote the production of body fluids and nourish blood, relieve stagnation and relieve numbness, expel toxins and discharge pus, and heal sores and promote tissue regeneration. It is used for qi deficiency and fatigue, poor appetite and loose stools, sinking of qi in the middle, chronic diarrhea and prolapse of the anus, bloody stool and metrorrhagia, spontaneous sweating due to exterior deficiency, edema due to qi deficiency, internal heat and thirst, sallow complexion due to blood deficiency, hemiplegia, pain and numbness, carbuncle that is difficult to heal, and carbuncle that does not heal for a long time.

[0072] 4. Turmeric

[0073] This product is the dried rhizome of Curcuma Longa L., a plant of the ginger family. It is dug up in winter when the stems and leaves wither, washed, boiled or steamed until thoroughly cooked, dried in the sun, and the fibrous roots are removed.

[0074] Properties: This product is irregularly oval, cylindrical or spindle-shaped, often curved, some with short forked branches, 2 to 5 cm long, 1 to 3 cm in diameter. The surface is dark yellow, rough, with wrinkled texture and obvious links, and there are round branch marks and root marks. The texture is solid and not easy to break. The cross section is brown to golden yellow, horny, with a waxy luster, the inner cortex ring pattern is obvious, and the vascular bundles are scattered in dots. The aroma is unique, and the taste is bitter and spicy.

[0075] Nature and flavor: pungent, bitter, warm. Enters the spleen and liver meridians.

[0076] Functions and indications: It can promote blood circulation and qi circulation, relieve pains from menstruation. It is used for chest and flank pain, chest pain, heart pain, dysmenorrhea, amenorrhea, masses, rheumatic pain in the shoulder and arm, and swelling and pain caused by falls.

[0077] 5. Chuanxiong:

[0078] This product is the dried rhizome of the plant Chuanxiong Ligusticum chuanxiong Hort. of the Umbelliferae family. It is dug up in summer when the nodes on the stem are prominent and slightly purple, the sand is removed, the stem is dried in the sun, and the fibrous roots are removed.

[0079] Properties: This product is an irregular nodular fist-shaped mass with a diameter of 2 to 7 cm. The surface is gray-brown or brown, rough and wrinkled, with many parallel raised whorls, a sunken circular stem scar on the top, and many small tubercle-like root scars on the lower side and the whorls. The texture is solid and not easy to break. The cross section is yellow-white or gray-yellow, with scattered yellow-brown oil chambers, and the cambium ring is wavy. The smell is strong and fragrant, the taste is bitter and spicy, with a slight numbing feeling on the tongue, and a slight sweet aftertaste.

[0080] Nature and flavor: pungent, warm. Enters the liver, gallbladder and pericardium meridians.

[0081] Functions and indications: Promote blood circulation and qi, dispel wind and relieve pain. Used for chest pain, chest and flank pain, swelling and pain due to falls, irregular menstruation, amenorrhea, dysmenorrhea, abdominal pain due to lumps, headache, and rheumatic pain.

[0082] 6. Safflower

[0083] This product is the dried flower of Carthamus tinctorius L., a plant of the Asteraceae family. The flowers are picked when they turn from yellow to red in summer and dried in the shade or in the sun.

[0084] Properties: This product is a tubular flower without ovary, 1-2cm long. The surface is reddish yellow or red. The corolla tube is slender, with 5 lobes at the tip, and the lobes are narrow strips, 5-8mm long; there are 5 stamens, and the anthers are aggregated into a tube, yellow-white; the stigma is long cylindrical, slightly forked at the top. It is soft. It has a slight fragrance and a slightly bitter taste.

[0085] Nature and flavor: pungent, warm. Enters the heart and liver meridians.

[0086] Functions and indications: Promote blood circulation and menstruation, dissipate blood stasis and relieve pain. Used for amenorrhea, dysmenorrhea, lochia retention, lumps and masses, chest pain, abdominal pain due to stasis, stabbing pain in the chest and ribs, injuries from falls, and sores and swelling.

[0087] 7. Salvia miltiorrhiza:

[0088] This product is the dried root and rhizome of Salvia miltiorrhiza Bge., a plant of the Lamiaceae family. It is dug in spring and autumn, desilted, and dried.

[0089] Properties: The rhizome of this product is short and thick, and sometimes the stem base remains at the top. There are several roots, which are long cylindrical and slightly curved. Some are branched and have whisker-like fine roots, 10-20 cm long and 0.3-1 cm in diameter. The surface is brownish red or dark brownish red, rough, and has longitudinal wrinkles. The outer bark of old roots is loose, mostly purple-brown, and often peels off in scales. It is hard and brittle, with loose cross-sections, cracks or slightly flat and dense. The cortex is brownish red, the wood is grayish yellow or purple-brown, and the duct bundles are yellowish white and arranged radially. The smell is slight and the taste is slightly bitter.

[0090] The cultivated variety is relatively sturdy, with a diameter of 0.5 to 1.5 cm. The surface is reddish brown with longitudinal wrinkles, and the outer skin is tightly attached and not easy to peel off. The texture is solid, the cross section is relatively flat, and it is slightly horny.

[0091] Nature and flavor: bitter, slightly cold. Entries to the heart and liver meridians.

[0092] Functions and indications: Promote blood circulation and remove blood stasis, relieve pain, clear the heart and relieve vexation, cool blood and eliminate carbuncle. Used for chest pain, abdominal pain, lumps and accumulation, heat pain, restlessness and insomnia, irregular menstruation, dysmenorrhea and amenorrhea, sores and swelling.

[0093] 8. Red Peony Root:

[0094] This product is the dried root of Paeonia lactiflora Pall. or Paeonia veitchiiLynch, a plant of the Ranunculaceae family. It is dug up in spring and autumn, the rhizome, fibrous roots and mud and sand are removed, and then it is dried in the sun.

[0095] Properties: This product is cylindrical, slightly curved, 5 to 40 cm long, 0.5 to 3 cm in diameter. The surface is brown, rough, with longitudinal grooves and wrinkles, root marks and horizontal lenticel-like protrusions, and some of the outer skin is easy to fall off. It is hard and brittle, easy to break, white or pink in cross section, narrow cortex, obvious radial texture of wood, and some have cracks. It has a slight fragrance and tastes slightly bitter and sour.

[0096] Nature and flavor: bitter, slightly cold. Enters the liver meridian.

[0097] Function and main effect: Clearing away heat and cooling blood, dispersing blood stasis and relieving pain. Used for heat entering the blood, fever-induced rashes, hematemesis and epistaxis, red and swollen eyes, liver depression and hypochondriac pain, amenorrhea and dysmenorrhea, abdominal pain due to lumps and masses, injuries from falls, carbuncles, swellings and ulcers.

[0098] 9. Angelica

[0099] This product is the dried root of Angelica sinensis (Oliv.) Diels, a plant of the Umbelliferae family. It is dug up in late autumn, the fibrous roots and mud are removed, and after the water evaporates slightly, it is bundled into small bundles, put on a shed, and slowly dried with fireworks.

[0100] Properties: This product is slightly cylindrical, with 3 to 5 or more branch roots at the bottom, 15 to 25 cm long. The surface is light brown to brown, with longitudinal wrinkles and long horizontal lenticel-like protrusions. The root head (guitou) has a diameter of 1.5 to 4 cm, with annular patterns, blunt at the top, or with several obvious protruding rhizome marks, with purple or yellow-green stem and leaf sheath residues; the main root (guishen) has an uneven surface; the branch root (guiwei) has a diameter of 0.3 to 1 cm, thick at the top and thin at the bottom, mostly twisted, with a few fibrous root marks. It is flexible, with a yellow-white or light yellow-brown cross section, thick cortex, cracks and many brown dot-shaped secretion cavities, lighter wood color, and yellow-brown cambium ring. It has a strong aroma and tastes sweet, spicy, and slightly bitter.

[0101] Nature and flavor: sweet, pungent, warm. Enters the liver, heart and spleen meridians.

[0102] Functions and indications: nourishing blood and activating blood circulation, regulating menstruation and relieving pain, moistening intestines and relieving constipation. Used for blood deficiency and sallow complexion, dizziness and palpitations, irregular menstruation, amenorrhea and dysmenorrhea, abdominal pain due to deficiency and cold, rheumatic arthralgia, injuries from falls, carbuncle, ulcers, dry intestines and constipation. Wine Angelica activates blood circulation and regulates menstruation. Used for amenorrhea and dysmenorrhea, rheumatic arthralgia, injuries from falls.

[0103] 10. White Peony Root:

[0104] This product is the dried root of Paeonia lactiflora Pall., a plant of the Ranunculaceae family. It is dug up in summer and autumn, cleaned, the head, tail and thin roots are removed, boiled in boiling water and then the skin is removed or the skin is peeled and then boiled, and then dried.

[0105] Properties: This product is cylindrical, straight or slightly curved, flat at both ends, 5 to 18 cm long, 1 to 2.5 cm in diameter. The surface is off-white or light brownish red, smooth or with longitudinal wrinkles and fine root marks, occasionally with residual brownish brown outer skin. The texture is solid, not easy to break, the cross section is relatively flat, off-white or slightly brownish red, the cambium ring is obvious, and the rays are radial. The smell is slight, and the taste is slightly bitter and sour.

[0106] Nature and flavor: bitter, sour, slightly cold. Enters the liver and spleen meridians.

[0107] Functions and indications: nourishing blood and regulating menstruation, consolidating yin and stopping sweating, softening the liver and relieving pain, and calming liver yang. Used for blood deficiency and sallow complexion, irregular menstruation, spontaneous sweating, night sweats, flank pain, abdominal pain, cramps in the limbs, headache and dizziness.

[0108] 11. Sichuan Achyranthes:

[0109] This product is the dried root of Cyathμla officinalis Kuan, a plant of the Amaranthaceae family. It is dug in autumn and winter, the root head, fibrous roots and mud and sand are removed, and it is baked or sun-dried until half dry, piled up to recover moisture, and then dried or sun-dried.

[0110] Properties: This product is nearly cylindrical, slightly twisted, slightly thinner or with a few branches, 30-60cm long, 0.5-3cm in diameter. The surface is yellow-brown or gray-brown, with longitudinal wrinkles, root marks and many horizontal lenticel-like protrusions. It is tough and not easy to break. The cross section is light yellow or brownish yellow, and the vascular bundles are dot-shaped and arranged in several concentric rings. It has a slight odor and tastes sweet.

[0111] Nature and flavor: sweet, slightly bitter, neutral. Enters the liver and kidney meridians.

[0112] Functions and indications: Removes blood stasis and promotes menstruation, dredges joints, promotes diuresis and relieves stranguria. Used for amenorrhea, retained placenta, injuries from falls, rheumatic arthralgia, foot paralysis and muscle spasm, hematuria and stranguria.

Claims

1. A dry granulation process for Naomaili, characterized in that The steps include: The raw powder of Panax notoginseng was used directly as medicine, and the volatile oils of turmeric and angelica were extracted by distillation, and the volatile oils were encapsulated with β-cyclodextrin to enhance stability. Motherwort, Astragalus, Chuanxiong, Safflower, Red Peony Root, White Peony Root, and Cyathula are decocted in water to ensure maximum utilization of the medicinal materials and quality stability.

2. The dry granulation process of Naomaili according to claim 1, characterized in that: The method also includes the following steps: using GC chromatography, LC-MS chromatography, fingerprint spectrum and other technologies to quantitatively and qualitatively identify the active ingredients and volatile oil composition of stachydrine hydrochloride to ensure that the active ingredients are clear.

3. The dry granulation process of Naomaili according to claim 1, characterized in that: The method also includes the following steps: using GC chromatography, LC-MS chromatography and fingerprint spectrum and other technologies to quantitatively and qualitatively identify the effective components of Panax notoginseng saponins and the composition of volatile oil to ensure that the effective components are clear.

Images