Cinnamomi and poria composition, method to prepare same and uses thereof
AssigneeJiangsu Kanion Pharmaceutical Co., Ltd.
InventorWei Xiao
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Abstract
This invention provides a method for identifying a composition of Cinnamomi and Poria. This invention further provides a composition comprising: Ramulus Cinnamomi, Poria Cortex, Moutan Radicis, Radix Paeonize Alba, and Semen Persicae. This invention provides various uses of these compositions.
Claims61
A method for identifying a composition of Cinnamomi and Poria comprising the steps of:
- a) dissolving the composition of Cinnamomi and Poria with an appropriate aqueous solution mixed with an appropriate organic solvent;
- and
- b) performing gas chromatographic analysis using a HP-5 5% phenyl methyl siloxane capillary column.
A method f or identifying a composition of Cinnamomi and Poria comprising the steps of:
- a) dissolving the composition of Cinnamomi and Poria with an aqueous solution;
- and
- b) separating the dissolved mater with an C 18 column under high pressure liquid chromatography.
A method for identifying a composition of Cinnamomi and Poria comprising:
- a) extracting the composition of Cinnamomi and Poria by an appropriate organic solvent;
- b) using appropriate standard for liposoluble matter in the composition of Cinnamomi and Poria, as internal control;
- and
- c) performing high pressure liquid chromatography using a C18 column.
A composition comprising:
- a). 1.3-1.9% paeoniflorin;
- and
- b). 0.7-1.1% Paeonol.
A method for obtaining a composition of Cinnamomi and Poria comprising steps of:
- a) obtaining, pruning, washing and cutting the plant parts:
- stem of Cinnamomum cassia Presl (Fam. Lauraceae), fungus of Poria cocos (Schw.) Wolf (Fam. Polyporaceae), Root of Paeonia suffruticosa Andr. (Fam. Ranunculaceae). and fruit of Prunus persica (L.) Batsch or Prunus davidiana (Carr.) Franch. (Fam. Rosaceae);
- b) drying the said plants to form 5 medicinal materials:
- Ramulus Cinnamomi, Poria Cortex, Moutan Radicis, Radix Paeonize Alba and Semen Persicae;
- c) Smashing Ramulus Cinnamomi, Semen Persicae and Moutan Radicis into coarse powders and chopping Radix Paeonize Alba into slice;
- d) Sterilizing the Poria Cortex before granulating 50% of its formula weight into fine powder and filtering the powder;
- e) putting full amount of powder of Cortex Moutan through a process of hot reflux in water and collecting its distillate;
- (residue and fluid reserved)
- f) filtering and vacuum drying said distillate to obtain crude Paeonol;
- g) dissolving the curde paeonol into 95% alcohol;
- Slowly adding the solution into saturated water solution of β-cyclodextrin while agitating it at thermostatic 80° C. to form a mixture A;
- h) exhausted filtering mixture A;
- washing the residue with anhydrous alcohol and letting it dried, a clathrate A is obtained;
- i) distilling full amount of Ramulus Cinnamomi in water for four hours and collecting its volatile matter;
- (residue and fluid reserved)
- j) dissolving the volatile matter into 95% alcohol;
- slowly adding the solution into saturated water solution of β-cyclodextrin while agitating it at thermostatic 45° C. to form a mixture B;
- k) exhausted filtering mixture B;
- washing the residue with anhydrous alcohol and letting it dried, a clathrate B is obtained;
- l) mixing residues from step (f) and (j) with full amount of Radix Paeonize Alba, Semen Persicae, 50% of Poria Cortex and 90% alcohol;
- extracting the mixture, filtering the extract and recovering alcohol from the filtered extract;
- (residue reserved)
- m) adding water in residue from step (m), distilling it and filtering the water extract;
- n) mixing water extract from step (n), alcohol extract from step (m), fluid from step (f) and step (j);
- enriching the mixture to form a creamed extractive;
- o) mixing the creamed extractive with Poria Cortex powder from step (e);
- grinding the mixture into fine powder after vacuum drying it to form a granule;
- p) mixing the fine powder with some 60% alcohol and starch gum;
- Granulating the powder to 30 meshes;
- q) mixing certain amount of silicon dioxide with clathrate A from step (i) and clathrate B from step (l);
- and
- r) mixing the mixture from step (r) with the granule from step (p) to obtain a final granule—the composition of Cinnamomi and Poria.
A method for determination of total paeoniflorin and total paeonol in a Cinnamomi and Poria composition comprising steps of:
- a) preparing the assay comprising the steps of:
- I. accurately weighing a suitable amount of standard paeoniflorin;
- dissolving it in chromatographically pure methanol to form a standard solution containing 0.9 mg. of standard paeoniflorin per 1 ml;
- II. dilute said standard solution of paeoniflorin to 18.0 μg./ml standard solution before using;
- III. accurately weighing a suitable amount of standard paeonol;
- dissolving it in chromatographically pure methanol to form a standard solution containing 0.3 mg. of standard paeonol per 1 ml;
- IV. dilute said standard solution of paeonol to 6.0 μg./ml standard solution before using;
- V. accurately weighing approximately 0.5 g. of granular of Cinnamomi and Poria composition;
- and dissolving it with 20 ml. water to form a water solution;
- VI. putting said solution in ultrasound for 10 minutes for dispersing;
- VII. extracting the solution in a separating funnel with 30 ml. analytical pure chloroform each time for 5 times;
- obtaining a solution A by combining the extracts;
- VIII. distilling solution A on a water bath of 70° C. to a suitable volume;
- mixing it with analytically pure chloroform to a constant volume of 50 ml in a measuring flask;
- VII. accurately sucking 5 ml. of the 50 ml. solution from step (VI);
- mixing it with analytically pure chloroform to a constant volume of 50 ml;
- and filtrating the diluted solution with 0.45 μm. filtration membrane to obtain a sample solution I;
- VIII. extracting the water solution left from step (V) with analytical pure water saturated n-butanol 30 ml. each time for 5 times;
- combining the extracts;
- IX. mixing the combination from step (VIII) with analytical pure water saturated n-butanol to a constant volume of 200 ml in a measuring flask to obtain solution B;
- IX. distilling to dry 50 ml solution B on a water bath;
- dissolving the residue with chromatographically pure methanol to a constant volume of 25 ml in a measuring flask;
- and
- X. accurately sucking 5 ml. of the 25 ml. solution from step (IX);
- mixing it with chromatographically pure methanol to a constant volume of 25 ml;
- filtrating the diluted solution with 0.45 μm. filtration membrane to obtain sample solution II.
- b) using methanol solution of paeoniflorin (18.0 μg/ml) and methanol solution of paeonol (6.0 μg/ml) obtained from steps (II) and (IV) as the standard solutions;
- and
- c) performing HPLC assay under following conditions:
- I. spectrum column:
- ALLtech-426 C18 5 μm., 4.6×250 mm;
- II. detector:
- ALLtech UVIS-201;
- pump:
- ALLtech-426 HPLC pump;
- injection valve:
- 7725i with 10 μl volume;
- III. column temperature:
- room temperature;
- flow rate 1 ml/min;
- IV. injection volume:
- 10 μl;
- V. detective wavelength:
- 230 nm (paeoniflorin) and 274 (paeonol);
- VI. mobile phase:
- methanol-water 35:65 (paeoniflorin) 60:40 (paeonol);
- and
- VII. number of theoretical plates:
- base on peak of paeoniflorin, the number of theoretical plates should be no less than 5000;
- base on peak of paeonol, the number of theoretical plates should be no less than 1500.
- d). performing HPLC assay with following steps:
- I. injecting 10 μl. sample solution I (for paeonol) or sample solution II (for paeoniflorin) into HPLC to perform chromatography under given circumstance;
- and
- II. measuring area of the peaks to calculate the relative components of paeoniflorin and paeonol in the Cinnamomi and Poria composition.
A pharmaceutical composition for treating gynecological blood stasis, cardio-cerebral vascular diseases, respiratory system and urinary system diseases comprising the following materials in weight proportion:
- 59 Ramulus Cinnamomi 1-2 portion Poria Cortex 1-2 portion Moutan Radicis 1-2 portion Radix Paeonize Alba 1-2 portion Semen Persicae 1-2 portion
A method for obtaining a composition comprising:
- distilling a required amount of Cortex Moutan with water through a process of hot reflux and collecting its distillate, filtering and drying said distillate after its cooling down to obtain crude Paeonol;
- mixing the residues with required amount of Ramulus Cinnamomi, Radix Paeonize Alba, Semen Persicae and 50% of Poria Cortex, adding alcohol to the mixture and extract, extracting the mixture, filtering the extract to obtain an alcohol extract;
- adding water to residue from the alcohol extraction, extracting and filtering it to obtain a water extract;
- Mixing the alcohol extract, water extract and solution from distilling of Cortex Moutan, enriching the mixture to a creamed extract;
- and granulating the rest 50% of Poria Cortex into fine powder, mixing the fine powder with the creamed extract, granulating the mixture after vacuum drying, mixing the granule with crude Paeonol;
- and filling the mixture in to capsules to form the product.
Dependencies are inferred from the claim text.